CMCC COURSE DESCRIPTION
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RM2202
STUDENT INVESTIGATIVE PROJECT
2002 MANUAL
TABLE OF CONTENTS
Course Description............................................................................................... 3
Procedural Steps ...................................................................................………… 6
Ground Rules............................................................................................………10
Primer for Writing Case Reports..............................................................……….11
The Quick’n’Dirty Critical Appraisal Checklists
For Intervention Original Research Papers (ORPs)………………………...15
For Correlational ORPs .............................................................……..……17
For Systematic Reviews...............................................................…………19
Proposal Topic Registration Form...........................................................………..20
The Formatted Proposal Form
Instructions...................................................................................…………21
The Form...................................................................................…………...36
Sample Proposal...........................................................................………...45
Appendices
SIP Proposal Eligibility Checklist ...................................….............…..52
Student-Supervisor Contract……....................................….............….54
Example of a Literature Search History ...........................................n/a
Application for Access to CMCC Clinics Form ............…………...56
Informed Written Consent Form ......……………….....…………...57
Final Paper Layout
Non-case Report........ ………………….....……………….....…………...68
Case Report................ ………………….....……………….....…………..72
Summary of Expenses for Reimbursement .................................................70
CMCC COURSE DESCRIPTION
Faculty: Carol Hagino, BSc, MBA
email: carol.hagino@utoronto.ca & cc: chagino@cmcc.ca
office tel.#: 416.482.2340 ext. 264
office locn: 2nd fl. AV Weir Bldg. 1931 Bayview Ave. (CNIB side)
Department: Research
Course Number: RM2202
Academic Credit Weight:
Course Title:
RM2202 STUDENT INVESTIGATIVE PROJECT (SIP) LECTURE-PORTION
Course Description:
RM2202 LEARNING OBJECTIVES
At the end of this course the student should be able to:
1. Demonstrate an understanding of the concepts underpinning the methods of conducting research by choosing an appropriate question and selecting the best study design for a Student Investigative Project (SIP).
2. Apply previously learned critical appraisal skills through the development and completion of a critical literature review in a publishable format for his/her SIP.
3. Write a SIP research proposal which must obtain IRB approval.
4. Successfully carry out his/her IRB-approved study in accordance with their IRB-approved proposals.
5. Write a final report in a format acceptable for publication in a peer-reviewed journal.
RM2202 DESCRIPTION
The RM2202 lecture portion consists of 8, 1-hr. lectures Mondays 1-2pm, between August 26-October 21/02 inclusive, in the 2nd yr room. While RM1301 is a lecture-only course designed to develop the student’s theory, knowledge, and skills for critically reading the scientific healthcare research literature, RM2202 is intended to give students some exposure to the experience of designing, conducting, and writing the type of research papers they will be critically reading during their years of study at CMCC, and in practice. By analogy, RM1301 in effect endeavors to teach students to drive a car, while RM2202 endeavors to teach students how to build one. The lecture portion of RM2202 prepares students with the theory behind building that “car,“ that is, preparing a viable research question, preparing a blueprint-plan [proposal] for answering the question, collecting and analyzing the data which will answer the question, and preparing a journal-quality research report with which to present the findings.
RM2202 DETAILED SYLLABUS
Introduction & Procedural Overview
[1 hr.]
1. RM2202 intro:
-explanation of what the course is, its purpose, how graded (the RM2202 proposal and final paper)
2. Procedural overview:
-the major steps and due dates involved
Writing the Proposal
[steps 3-5: 2hrs.]
3. Framing the research question:
3.1 Feasible types of research questions
-illustration with some examples
4. Using a student-initiated vs faculty-initiated study:
4.1 Permissible student-initiated study designs: observational [basic science, cross-sectional surveys, administrative databases]; experimental: non-clinical/treatment RCTs, systematic reviews (including meta-analyses), pre-post (B/A) studies and case reports which do NOT involve modifying the normal plan of management; correlational: reliability and validity of outcome measures and diagnostic tests.
4.2 Permissible faculty-initiated study designs: all of the above including IRB-approved intervention type RCTs which involve modifying the normal plan of management.
5. Getting a suitable supervisor:
5.1 For case-reports, other student-initiated studies, faculty-initiated studies
5.2 Eligible faculty supervisors and their areas of interest
[4 hrs.]
6.The new structured proposal format:
6.1 The formatted Abstract
6.2 The Introduction:
-the Literature Review, Rationale, Objective
-1 hr. refresher lecture on conducting a literature search, presented by CMCC reference librarian Ms. Anne Taylor-Vaisey
-critically summarizing the relevant literature in the context of the SIP research question/objective
6.3 The Methods and Materials section:
-study design [cross-sectional survey, case report, systematic overview, etc.]
-subject recruitment issues
-questionnaire development issues
-review of sample size estimates: realistic levels of statistical significance, power, effect sizes; illustration using a few examples
-1 hr. lecture on the ethical issues to be aware of when designing the study, and the informed written consent form, presented by Dr. Cam McDermaid.
-other methodological issues to be aware of and incorporate/avoid
-data analysis: review of descriptive statistics; review of most frequently-used hypothesis-testing inferential statistics, confidence intervals
6.4 The Reference section:
-Vancouver vs Harvard/Oxford thesis formats
6.5 The Budget section:
-permissable expenses
-expense justification
-Illustration of these concepts with an example
6.6 The Appendices section:
-facilities access permission forms
-questionnaire specimens
-informed consent forms
-letters/information to subjects
Writing the Final Paper
[1hr.]
7. The Results section:
-summarizing/presenting the data analyses
-illustration of tabular, graph and text format examples
8. The Discussion & Conclusion sections:
-correctly interpreting the data
-discussing the data in terms the study's methodological limitations
-how the results compare to the literature
-recommendations for future study
-illustration with a journal paper example
END OF LECTURE PORTION OF RM2202
CONTINUATION OF SELF-DIRECTED PORTION OF RM2202
[variable hrs.]
Instruction:
Frequency of course offering: RM2202 is offered once in the 2nd year of the new curriculum. 2002 will be the last year of the 3rd: yr equivalent; from 2003 on, it will be introduced in 2nd yr.
Number of lecture contact hours: 7 hrs. [i.e. 7classes Aug.-Oct./02 @ 1hr.]
Course Notes: This year’s set of course notes are available as a download (DL) from the 2nd yr website [url: ], and at the CMCC Bookstore (CNIB side of Bayview); any additional notes and overheads presented during lectures will be made available to ‘Note-service’ as a website UL or hardcopy.
Evaluation:
RM2202 is graded as a 'pass-with-distinction/pass/fail' course, whereby both the proposal and final paper must achieve "pass" status. The proposal receives "pass" status once it has achieved Institutional Review Board (IRB) approval. The final paper receives "pass" status once the project supervisor and course-coordinator are satisfied that the manuscript is of publishable quality, and have signed off on it. Exemptions are not granted for this course.
Course Rationale:
RM2202 gives students the opportunity to further develop the critical reading skills that were initiated with RM1301, by requiring that they use these skills to appraise the papers they will use in the proposal and final paper’s Introduction, Methods, and Discussion sections. Students are also expected to acquire the habit of routinely checking for the validity, reliability and responsiveness of the outcome measures they will use in clinical practice and any other research endeavors they may later engage in. The course will also give students a humbling appreciation for what is involved in properly conducting even the simplest of good-quality research projects. They will also gain some experience in how to properly conduct and write-up good quality, simple practice-base studies such as case reports, which will prove useful for writing publishable case-reports once they are in practice.
Brief Course Description:
RM2202 is an abbreviated lecture-based course which endeavors to prepare students for properly planning, conducting, and writing up their Student Investigative [research] Project.
Expected Enrolment: ~ 160 students in each of 2nd year, and 3rd year.
RM2202 STUDENT INVESTIGATIVE PROJECT (SIP) PROCEDURAL STEPS
1. Decide if you are doing case-report or not.
If you decide you ARE going to do a case report (probably on one of your own patients when you finally get into clinic OR on a senior’s patient if you want to finish earlier), then consult with a clinician or 2 on a feasible case-report topic and go to step 4.
If you decide NOT to do a case report, then decide who you want to work with ---although you have the option to work solo’. Your SIP group can under no circumstances exceed 4 students, including yourself. You CAN work with students from another year.
2. The Faculty Supervisor:
If you’re not doing a case report, then you need to get a CMCC faculty member to agree to be your supervisor. There’s a little contract (see pg.54) that the supervisor and student investigator(s) have to submit to the Office of Research Administration (ORA), with the idea being that neither party take their mutual responsibilities lightly.
3. The Topic:
Discuss your study topic and Ground Rules (next section, pg.10) with your supervisor. You should do a quick electronic literature search to see whether there’s a lot or just a little literature already ‘out there’ on the topic(s) you are brainstorming on. Some CMCC faculty may have their own projects on the go, and may be prepared to mold all or part of their project into a form suitable as a RM2202project for 1-4 students.
So, if you’re NOT doing a case report, you have 4 topic options:
3.1 You can assist with an existing faculty project, if the faculty investigator is agreeable to this.
3.2 The student investigators develop a topic idea proposed by the supervisor.
3.3 The student investigators develop their own topic idea.
3.4 The student investigators and their supervisor develop a topic idea together.
4. Topic Registration/Approval [due: Mon. Oct. 7, 2002]:
Register your topic via email per the instructions on pg.20.
You will be emailed back by Carol Hagino regarding whether your topic has been approved (i.e. deemed feasible), or requires some tweaking to make it do-able and reasonably worthwhile.
5. The Proposal:
The electronic proposal forms are included in the course manual which will be made available for DL’g at the following url: . Only one Formatted Proposal Form is submitted per topic/project.
6. The Literature Search:
Once you have received your topic-approval email from Carol Hagino, you should conduct your literature search in earnest now. CMCC’s reference librarian, Anne Taylor-Vaisey has set up an outstanding page on the CMCC website, which will let you do all your literature searching from the comfort of your [or somebody else’s] computer. Go check out:
It’s go everything you need except pizza and beer is right there! If you’re still a bit shaky on how to do a world-class literature search, then you can do one or both of the following 2 things:
6.1 Contact Anne at atvaisey@cmcc.ca for assistance.
6.2 For RM2202: Be there for her little refresher session on how to do “safe searching,” which is scheduled for:TBA
7. Completing the Formatted Proposal Form:
With the help of the guidelines on pg.22 and the instructions embedded right in the proposal form, start filling in the Formatted Proposal Form, on pg.36, and an electronic copy of which will be emailed to you. Please use the electronic version. Your supervisor should be checking your draft on a regular basis. This can be done going back and forth electronically, or during your in-person meetings.
8. Proposal Submission [due: Mon. Jan. 13, 2003]:
The due date for submitting the completed proposal form to Carol Hagino , in on or before Mon. Jan. 13, 2003. Everything indicated on the Checklist on pg.36 must be included in the proposal package, or it gets sent right back to the investigators or the supervisor, with the net effect that there may be a considerable delay in getting the proposal reviewed now. This sort of thing seriously messes up our reviewing efficiency/timeliness.
Here’s how you submit your proposal:
8.1 For case reports: ONE hardcopy, and one emailed or diskette copy to Carol Hagino. There will be a drop-off box outside Carol Hagino’s office door for the hardcopies.
8.2 For non-case reports: FOUR hardcopies, and one emailed or diskette copy to Carol Hagino. There will be a drop-off box outside Carol Hagino’s office door for the hardcopies.
9. Proposal Review:
If everything is in order according to the Checklist on pg.36., then the study contact person will receive an email from Carol Hagino stating that the proposal has been received and is “in the Institutional Review Board (IRB) mill” now.
The case reports are forwarded to only ONE IRB reviewer for expedited review, as are any studies which do not involve live human subjects. Studies which involve live human subjects are forwarded to THREE IRB reviewers. Expedited reviews usually require only 2 weeks, while the regular [3 IRB reviewer] reviews require about 3 weeks.
10. IRB Request for Resubmission vs IRB Approval:
When the IRB review is completed, the study contact person will be notified by email [probably by Carol Hagino] that the proposal has completed its review. Most first submissions require some tweaking and a resubmission, so the email will probably state that the proposal requires revisions to be made per the reviewers’ attached notes, and that the proposal package ---including the reviews--- should be picked up ASAP from the container outside Carol Hagino’s office door. The email and the returned-proposal package will also state a date by which the revised proposal package should be resubmitted [in order to keep the IRB machine running smoothly]. You will be asked to submit all the old marked up proposal manuscripts and reviewers’ comments along with the new, revised proposal. That’s because the reviewers will not be re-reading the proposal again word-for-word. They will just be checking their comments/requests against the new version; therefore, this 2nd review should be completed fairly quickly ---within 1-2 weeks.
If you have done everything the reviewers requested, you should be looking forward to an email notification informing the study contact-person that the proposal has now received IRB approval. You will be asked to pick up the proposal package from that container outside Carol’s office door, and to incorporate into the final report, any fine-tuning comments the reviewers made [but didn’t think were serious enough to request ANOTHER resubmission!].
11. Data Collection and Analysis:
Well, now, of course, you go and follow the plan outlined in your Methods section, and collect the data. If your data require some descriptive and inferential statistical analyses, email Carol Hagino to make an appointment for an analysis session. Please take note that YOU DO THE WORK.!!! She just shows you how to input the data, analyze and interpret it, and write it up with the right lingo.
Case report people should just contact Carol Hagino by email whenever they need some interpretive, or other assistance.
12. Final Report Write-up [due: Mon. Jan. 19, 2004]:
OK. Last lap. Now you go back to your old proposal form, copy out the Abstract, Introduction, and Methods parts that you need for your final report, and paste them into the appropriate [non-case or case-report] final report formats shown on pgs. 68 and 72. CHANGE ALL THE FUTURE TENSES TO PAST TENSES!!! Then add on your Results, Discussion and Conclusion sections in the format shown. And PLEASE DON’T FORGET to add a few lines of Results and Conclusions on to the end of your Abstract!!! [For some reason, just about everybody forgets to do this!]
Once you’ve incorporated all the feedback from your supervisor, and your supervisor deems it’s ready for submission to Carol Hagino, then submit ONE hardcopy to Carol (her mailbox is in the copier room across the hall from her office) with the supervisor’s signature on it [indicating that s/he approves of the manuscript] Carol won’t accept the report without the supervisor’s signature.
13. Finally Completing/Passing RM2202:
You’re almost “there” at this point, but don’t rest easy quite yet! If Carol wants some more revisions, then you’ve got to make them, in order to pass the course. Not to worry though. As we all know, she’s eminently reasonable, and always looking out for your best interests (
Case report people should send Carol Hagino their final draft via an email attachment. Carol will send back comments and corrections. Make those, and then hand in a hardcopy of the final report to Carol (her mailbox is in the copier room across the hall from her office).
You will receive an email from Carol Hagino once Student Services has been notified that you have satisfactorily completed all your RM2202 requirements.
14. Then What?
All those report hardcopies wind up being scrutinized by an IRB subcommittee for the 4 top papers which receive the $1,000, $500, $400, and $250 bursaries awarded at Convocation.
THEN, all those report hardcopies go down to the library for binding and shelving there.
If your paper was particularly good, we might bug you a bit about seriously considering submitting it to an appropriate journal for publication. Consider that a compliment, rather than an annoyance!
GROUND RULES
1. Number of students per study:
1.1. Max. 4 student investigators per study I.e. group size cannot exceed 4 members
1.2. Can do solo.
1.3. Case reports are strictly solo or 2 students max. endeavors.
2. SIP faculty supervisor:
2.1. All SIPs require a CMCC faculty supervisor. With the exception of case reports, student investigators are responsible for acquiring their own faculty supervisor.
2.2. Case report studies, by default, have Carol Hagino as their supervisor. The student investigator has the option of acquiring another faculty supervisor if s/he wishes. Later, at the time the student investigator actually treating the case in clinic, the supervising clinician may also become a study co-supervisor if both student and clinician agree to this arrangement.
3. The supervisor and student investigator(s) should meet in person about once a month. At each meeting, a ‘To-Do List’ should be drawn up for each student investigator as well as the supervisor, and the date set for the next meeting should be set.
4. The supervisor is responsible for advising his/her student investigators; and for proofing and providing feedback on proposal and final report drafts; s/he is also responsible for approving [via a signature on the manuscript cover] the proposal and final report manuscripts which are submitted to Carol Hagino. Carol Hagino cannot process the proposal and final report manuscripts without this requisite supervisor approval.
3. Non-eligible studies:
3.1. Student-initiated treatment RCTs
3.2. Student initiated animal studies
4. Eligible studies:
4.1. Case reports
4.2. Systematic reviews
4.3 Administrative/clinic database studies
4.4 Pre-post studies in which the core treatment does not deviate from what would normally have been prescribed/approved by the supervising clinician; additional outcome measures can be included provided that the burden on the patient does not become excessive.
4.5 Cross-sectional surveys
5.Reimbursable/non-reimbursable expenses
5.1. In your proposal, you can submit for a maximum of $200 to cover specific expenses which must be clearly described on the proposal’s budget page.. Your study doesn’t automatically receive $200 for you to spend as you please.
5.2. You cannot submit for funds to cover a study subject’s clinic fees, since it is not considered an ethical practice.
Primer for Writing Case Reports
Types of Case Reports:
1. retrospective
2. prospective
1. Retrospective Case Reports
Often times one of the faults of retrospective case reports is that authors do the best job possible while managing a case, but may not use the best outcome measures available because they do not know what they are. This fault detracts from the credibility of the report and is something that can be avoided with some early planning (7).
2. Prospective Case Reports
The author actually plans out patient care ahead of time.In preparation for a case report, the doctor reviews the literature to determine the best outcome measures to assess patient progress and also learns how his or her planned case will contribute to the literature.
Purposes Served by Case Reports:
▪ To present an unusual or unknown disorder (1,5).
▪ To present unusual etiology for a case (1).
▪ To present a challenging differential diagnosis (1).
▪ To describe mistakes in diagnosis, their causes and consequences (1).
▪ To describe an unusual setting for care (1).
▪ To present information that can not be reproduced due to ethical reasons (1,5).
▪ To stimulate further research.
▪ To describe unusual or puzzling clinical features (3,4)
▪ To describe improved or unique technical procedures (2,4)
Limitations of Case Reports:
One can never conclude based upon the observations of a single patient, that any particular management strategy will be effective for other patients with the same condition, because without a case series, there is no way to know if this case is the only one on the planet which would react this way; therefore, generalizability is very limited with only one case. It is essential that authors remember that the intention of a case report is to describe and discuss a clinical event, not to prove anything.
With a case report, is almost impossible to control for placebo, natural history, and outside confounder biases. There is little the clinician can do to prevent patients from introducing a variety of confounding factors into their lives that may also impact on the patient’s response to care; therefore with no parallel/concurrent control, no conclusions can be drawn with regard to treatment effectiveness. At best, the investigator can say that, “the results SUGGEST that the treatment was effective,” and recommend that a larger, more confirmatory study be performed.
Case Report Components (in order of appearance in the case report manuscript):
1. Title
2. Structured abstract
3. Introduction
4. Case report (methods & results)
5. Discussion
6. Conclusion
7. Acknowledgements (if applicable)
8. References
9. Tables
10. Figure captions
1.Title
The title should clearly indicate that this is a case report, and should inform the reader what the purpose of the report is.
2.Structured Abstract
Most journals adopted the structured abstract format over ten years ago (19). Case report abstracts generally consist of the following subsections:
▪ Objective
▪ Clinical Features:
-Focus on the primary aspects of the patient’s condition
▪ Intervention and Outcome:
-Briefly describe methods used to care for the patient and/or assess the patient’s status.
-Briefly summarize outcomes of care, including changes in the primary outcome measures
▪ Conclusion:
-Summarize what the case contributes to the literature.
-State the overall conclusion learned from the study.
▪ Key Words:
-Medical subheadings (MeSH)
-List additional words that may be unique to the case or to the profession. (20).
3.Introduction
The purpose of the paper should be clearly described up front in the introduction (3,10). In addition, background information needs to be provided in order to demonstrate how the case contributes to the literature. Information from a review of the literature allows the author to demonstrate that he or she understands the context of this case in relation to previously published data (2,3,10); for example, the incidence of the disorder, and the number of previously reported cases.
It is important to limit the amount of information in the introduction only to what is adequate to familiarize readers with the topic. The author should also define unusual terms or words that are essential to understanding information in the paper.
4.Case Report
This section describes the patient, outcome measures, assessment protocols, and treatment, if applicable. Sufficient detail must be presented in order to understand the author’s patient assessment. It is important to describe procedures in a clear manner so that other doctors will be able to use the same protocol (20). When chiropractic adjustments are given to a patient, the frequency and type of adjustments should be described in enough detail that the reader could reproduce them. A rationale for the management of the patient should be provided (2).
When reporting the patient data for a prospective case report, valid and reliable outcome measures such as the visual analog pain scale (21), neck disability index (22), vital signs and other outcome measurews provide more objective information than reporting that the patient had “severe pain”, was “disabled from a neck injury” or “had hypertension”.
In the case report section, just report the facts. The explanation and discussion of the case belongs in the discussion section. If it has not already been presented in the introduction, an overview of how the condition is typically managed provides readers with information to compare the case report methods with.
5.Discussion
Writers should provide some suggestions or hypotheses regarding the outcome of the case and why the care provided may or may not have been beneficial (10).Authors must include in the discussion other possible reasons for the outcome of the case, such as the natural history of the disorder or other factors. Since the case is subject to many unknown variables, the author should present some of these to the reader (3,10):
• Faults in the case or quality of reporting should be identified.
• Some suggestion(s) for future inquiry into the topics should be presented.
• Focus on what is to be learned from the case report, and how this relates to the purpose of the paper..
6.Acknowledgements
It may be appropriate to acknowledge the work of a colleague who has assisted the author in the preparation of the manuscript, such as a proofreader or a person who has provided ideas for the manuscript. These people can be acknowledged briefly in this section. People mentioned in this section must give consent for their name to appear in print, which can be obtained by asking them to sign a brief statement that they know that their name will be listed in the acknowledgements section.
7.References
References should be used to support information which is not common knowledge, pertains to the disorder under study, the clinical actions taken, and the decisions to be considered after reading the case report (1). The Vancouver format should be used.
Primer References:
1. Janicek M. Clinical case reporting in evidence-based medicine. Oxford: Butterworth-Heinemann: 1999.
2. CrollTP. Preparation of a dental case history report for publication. J Am Dent Assoc 1981:102: 59-61.
3. DeBakey L, DeBakey S. The case report. I. Guidelines for preparation. Int J Cardiol 1983:4(3):357-64.
4. Iles RL, Piepho RW. Presenting and publishing case reports. J Clin Pharmacol 1995:36:573-579.
5. Doherty M. What value case reports? Ann Rheum Dis 1994:53(1):1-2.
6. Gehlbach SH. Interpreting the medical literature. New York: McGraw-Hill, Inc: 1993:17.
7. Keating JC. Towards a philosophy of the science of chiropractic: a primer for clinicians. Stockton, CA: Stockton Foundation for Chiropractic Research: 1992:199-222.
8. American Medical Association. 51 landmark articles in medicine, Chicago: American Medical Association: 1985.
9. Keating JC, Giljum K, Menke M, Lonczak RS, Meeker WC. Toward an experimental chiropractic: time series designs. J Manipulative Physiol Ther 1985:8(4):229-238.
10. Squires BP. Case reports: what editors want from authors and peer reviewers. CMAJ 1989;141(5):379-380.
11. Green BN, Johnson CD, Andrew T, Martin P. Improving historical research reports: a case report format and example in Arden Zimmerman. DC. J Chiropr Humanities 1998:8:43-54.
12. Riddoch J. Evaluation of practice. Physiotherapy 1991:77(9):439-444.
13. Kratochwill TR, Levin JR. Single-case research design and analysis: new directions for psychology and education. Hillsdale, NJ: Lawrence Erlbaum Associates, Publishers: 1992:1-14.
14. Young KJ. Pituitary adenoma: pre and postsurgical findings with magnetic resonance imaging. Topics in diagnostic Radiology and advanced Imaging 1999;7(1):23-25.
15. Polgar S, Thomas SA. Introduction to research in the health sciences. Melbourne: Churchill Livingstone: 1995:99-105.
16. Waalen JK. Single subject research designs. J Canadian Chiropr Assoc 1991:35(2):95-97.
17. Helawa A, Walker JM. Critical evaluation of research in physical rehabilitation: towards evidence-based practice. Philadelphia: W.B. Saunders Co; 2000:28.
18. Green BN, Johnson CD. Writing better case reports. J Sports Chiropr Rehabil 2000;14(2):46-47.
19. Lawrence DJ. Structured abstracts and the JMPT. J Manipulative Physiol Ther 1992;15(2):77-82.
20. Lawrence DJ, Mootz RD. Research Agenda Conference 3: editor’s presentation: streamlining manuscript submission to scientific journals. J Neuromusculosketal System 1998:6(4):161-167.
21. Price DD, Bush FM, Long S, Harkins SW. A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain 1994:56(2):217-26.
22. Vernon H, Mior S. The neck disability index: a study of reliability and validity. J Manipulative Physiol Ther 1991;14(7):409-415.
23. Kaufman RL, Bird J. Manipulative management of post-Colle’s fracture weakness and diminished active range of motion. J Manipulative Physiol Ther 1999;22(2): 105-107.
24. Willis JC. Notes for authors. Chiropr Hist 2000;20(1):5.
The Quick’n’Dirty Checklist
to Critically Appraise
Intervention Original Research Papers (ORPs)
|Checklist Dimension|Dimension Description |Specific Assessment Items |
|SP |Sample Profile |• sample representative of target population? |
| |(demographics, complaint severity etc.)|• similar treatment groups at baseline? |
| | |• non-compliance/drop-out bias 4%).
Rationale [in the Introduction and sometimes the Abstract too]:
The “Rationale” subsection in the Introduction should explain why this study has any scientific/social merit.
Example:
Continuing on with the Internet-usage study example used in the Objective example above:
This study is important because it will help CMCC course coordinators to determine if Internet usage in 2002-2003 is high enough to warrant making more course material available via this medium. In the interests of efficiently budgeting MIS resources, those classes demonstrating the highest usage levels will be served first.
Literature Review of Previous and Related Work in the Area [in the Introduction ]:
Your literature search-strategy must be included in the Appendices section. After having retrieved all the relevant literature as revealed by an electronic, this section should succinctly summarize: the strengths and weaknesses of the published work to-date; how your study will utilize the strengths, and address one of more of the weaknesses.
Some of this literature will build on your core Rationale [for the study], and some of it will help shape your Methods section. That portion which impacts on your methodology, can be referenced again in the Methods section.
If there is NO [or VERY little] literature currently available on your topic, then that of course provides you with even a STRONGER rationale for defending the merit of your study! Should a search of the literature reveal virtually nothing, then it is suggested that you “widen out” your search; for example, going back to the Internet-usage study example used in the Objective example above, you might find NO literature if you only search for CMCC-based studies. If you widen out to include all chiropractic colleges worldwide, you might find a little more ---but only a little. If you widen out even more to include medical schools, you might find substantially more literature. So your argument in your Literature Review might be that while medical schools have investigated this situation, chiropractic schools have not, and this discrepancy should be addressed; hence, you are going to address it.
Any statements which are not common knowledge should be referenced, and referencing should follow the Vancouver format.
Methods and Materials:
The proposal form provides detailed guidance regarding what to include in this section, but essentially this whole section must describe how you plan to carry out the study, and this description must be in sufficient detail that another qualified investigator could repeat your study reasonably faithfully.
Unless you are conducting a case report, you must include a sample size estimate with your Methods section. You can email Carol Hagino about setting up a brief appointment to help you perform this estimate.
Typically, the Methods section will include a reproducibly detailed description of:
1. The study design (e.g. RCT, Pre-Post Study, Cohort Trial, Inter-examiner Reliability Study, Case Report etc.)
2. The sample profile/characteristics i.e. inclusion and exclusion criteria.
3. The sample size estimate.
4. How the sample will be recruited (e.g. class announcements, advertisements, email spams, via intake packages handed out by clinic reception, etc.)
5. How informed consent will be obtained.
6. How any other ethical issues will be dealt with.
7. The baseline and outcome measures to be collected; the necessary equipment, ‘manpower’ and expertise required to collect them; why THESE particular ones, and their reliability and validity specifications.
8. How the sample will be processed and the data will be obtained. A description of all the necessary equipment, ‘manpower’ and expertise required to process the subjects should be described.
9. How subject compliance will be maximized.
10.Both the descriptive and inferential statistical analyses [of the data] strategies.
Permission documentation must be provided in the Appendices section if you are accessing off-campus facilities not available to the public, and/or will be accessing CMCC patients, records, equipment, or other facilities.
References:
The Vancouver format should be followed, as shown in the proposal form and/or .
| |
Budget:
Each project has a $200 ceiling with regard to reimbursable expenses. These expenses must be described in detail. You only get reimbursed for those expenses you applied for, and which were approved in your proposal ---and that you have receipts for. “Miscellaneous” expenses are not accepted; neither are expenses which are normally part of fulfilling the requirements of a course; for e.g., toner, proposal and report copies.
| |
|PROJECT BUDGET |
|($200 maximum) |
|Title: |Project Year | |
| | | |
|EQUIPMENT |JUSTIFICATION |AMOUNT |
| |(Describe why this equipment is necessary for your project) | |
| | | |
| | | |
| | | |
| | | |
|SUPPLIES Itemize by category (e.g. stationary, copying costs etc.) | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
|TRAVEL | | |
| | | |
|OTHER EXPENSES (Itemize by category) | |
| | | |
| | | |
| | | |
| | | |
|TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD | |
| |$0.00[pic]$0 |
Appendices:
Please follow the instructions in the formatted proposal form regarding what to include in this section.
The Formatted Proposal Form
Office of Research Administration (ORA): ext 267 e-mail: cmcdermaid@cmcc.ca
(Please complete, print and submit this form as three hard copies and an electronic version on diskette to the ORA.)
This form uses tables for formatting and check boxes. To complete a checkbox, just type an “x” into the box. To complete text sections, type in the space available below the table. Don’t write in the table itself. Text should appear in Arial 10 point font. The formatting may change, depending on how much you type in each section. You can carriage return some sections to the next page if it improves the appearance of the form. Hand written applications will be returned unreviewed.
|Date | |Application Status | |New | |Resubmission | |Addendum | |Renewal | |
| |IRB # |
|Project Title: | |
|PERSONNEL |NAME |PHONE/EXT |E - MAIL |
|Contact | | | |
|Investigator | | | |
|Co-Investigators | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
|Faculty Supervisor | | | |
| |
|Faculty Supervisor Assurance |
I certify that the student(s) or guest investigator(s) conducting the research is/are knowledgeable about the regulations and policies governing research with human participants and has/have sufficient training and experience to conduct this study in accordance with the approved protocol. I agree:
▪ To meet with the student investigator(s) on a regular basis to monitor the research progress;
▪ To be available, should problems arise during the course of the research, to supervise the investigator(s) in solving such problems;
▪ To ensure that the investigator will promptly report significant adverse effects to the IRB within five (5) working days of occurrence;
▪ If I am unavailable, as when on sabbatical leave, vacation or absent longer than one month, I will arrange for an alternate faculty supervisor to assume my responsibility during my absence, and I will advise the IRB in writing of such arrangements and;
▪ Submitting, at minimum, a progress report annually or in accordance with the terms of IRB approval.
Signature of Faculty Supervisor: Date:
Required Attachments (check ‘x’ those appended)
| |Literature search strategy (do not included retrieved abstracts) | |Consent form and patient information |
| |Letters of permission for access to facilities/resources | |Advertising used in the study |
A. SUMMARY OF PROPOSED RESEARCH
|1. Research Category |
| | | Involves live human participants |
|Categorize your proposed research | |Uses identifiable personal information |
|Categorize your proposed research | |Uses identifiable personal information |
|(‘x’ as many as apply) | |Uses info previously collected for purposes other than the |
| | |proposed research |
| | | |
|2. Full Text Abstract |
|The following section is intended to give the investigator a brief orientation to your study and may be published by the College. |
|This full text abstract of your research should be a brief summary with the following subheadings: |
|Study objective |
|Brief rationale for the study |
|Research design |
|Study location and facilities |
|Description of the sample and target population |
|Research protocol (in order of occurrence) |
|Outcome measures/data being collected |
|Data analysis strategy |
|Each topic in this section should consist of only a few clearly written concise sentences. The entire section should not be longer|
|than 500 words. |
|Study Location and facilities: |
| |
| Where will the study be conducted? List the institutions/sites/specific rooms, equipment and facilities. Include (as an |
|Appendix) written permission for access to resources such as rooms, equipment, databases or records. |
B. INTRODUCTION
|1. Purpose and Background |
| |
| Describe the purpose and background rationale for the proposed project. Provide a review of the relevant literature with |
|regard to how it addresses your research question(s). |
|2. Statement of Research Hypothesis(es) |
| |
| Provide a detailed statement of the research hypothesis(es)/ question(s ) to be examined. |
C. METHODS AND PROCEDURES
|Study Participants |
|1. Sample Characteristics and Sample Size |
|Describe in detail the sample to be recruited including gender distribution, age range, socioeconomic profile, complaint profile |
|and any special characteristics of sample. Justify any exclusion criteria. If you are using identifiable personal information, |
|identify the information to be used and its source. State the proposed sample size along with a justification or the sample size |
|(including power, alpha [statistical significance level], and effect size specifications). |
|2. Recruitment Process |
| Describe how and where the participants will be recruited (e.g. direct recruitment, advertising, notice via email, class |
|announcements etc.). Indicate where the study will take place. Describe any possible relationship between I investigator(s) and |
|participant(s) (e.g. instructor - student; manager - employee). Attach a copy of any poster(s), advertisement(s) or letter(s) to |
|be used for recruitment as appendices. If you are using identifiable personal information, describe how it will be obtained, who |
|will have access to it. |
|3. Compensation of Participants |
| | | | | |
| Will participants receive compensation for participation? | |Yes | |No |
| If yes, please provide details. If participant(s) choose to withdraw, how will you deal with compensation? Note that |
|RM4402 funds can not be used to reimburse clinic patients for the costs of chiropractic care. |
|4. Feedback to Participants |
| |
| Whenever possible, upon completion of the study, participants should be informed of the results. Describe below the |
|arrangements for provision of this feedback. |
|Informed Consent Process |
|1. Consent Form |
| |
| Attach the Informed Written Consent Form as an Appendix, including any information about the study that will be provided to the |
|participants. If written consent will not/cannot be obtained or is considered inadvisable, justify this and outline the process |
|that will be used to fully inform participants. |
|2. Capacity to Consent |
| | | | | |
| Are participants competent to consent? | |Yes | |No |
| If no, describe the procedures to be used to obtain the consent of the parent or guardian. Attach a copy of the |
|information/consent form to be used as an Appendix. |
|3. Deception |
| |
| Will deception be used in this study? | |Yes | |No |
| If yes, please justify the need for deception. Explain the debriefing procedures to be used, and attach a copy of the written|
|debriefing as an Appendix |
|Research Procedures |
|1. Description of Research Procedures |
| |
| Describe, sequentially and in detail, all procedures in which the research participants will be involved (e.g. paper and pencil tasks, interviews, |
|surveys, questionnaires, physical assessments, physiological tests, time requirements, etc). |
|Where possible, provide reliability, validity, and relevance/sensibility information on outcome measures to be used. |
|Attach as appendices a copy of any questionnaires and/or test instruments to be used. |
|Data Analysis |
|1. Description of Analysis |
| |
| Provide a brief description of the planned data analysis. The description should include a description of the statistics to be used (including the |
|level of statistical significance, if applicable). State what will be considered clinically important changes/differences/associations in the outcomes. If|
|your project includes several outcomes or research questions, identify the analysis (e.g. statistical test) which will be used for each outcome or |
|question. |
|RISKS AND BENEFITS OF THE RESEARCH |
|The purpose of this section is to describe the benefits and risks to participants in your research. This section should demonstrate that the benefits |
|exceed the risks and the risks have been minimized as much as possible. It is important that you take the participants perspective and consider the risks |
|and benefits that may be important to them. |
|1. Direct Benefits to Participants |
| |
| Describe any direct benefits to participants from their involvement in the project. |
|2. Indirect Benefits |
| |
| Describe any benefits to the scientific community/society that would justify involvement of participants in this study. |
|3. Risks to Participants |
| |
| Describe the known and anticipated risks of the proposed research, specifying the particular risk(s) associated with each procedure or task. |
|Consider, physical, psychological, emotional and social risks. Describe any benefits to the scientific community/society that would justify involvement of |
|participants in this study. |
|4. Minimization of Risks |
| |
| Every effort should be taken to minimize risks as much as possible, even if the risks are minimal. Describe how you will minimize the risks or |
|potential risks to the participants. |
|5. Mitigation of Risks |
| |
| If your study has the potential to injure, upset or identify ill, distressed, or disturbed individuals, describe the arrangements you have made to |
|mitigate these effects (e.g. Student services counselling, referral for care). |
|Confidentiality |
|1. Data Management |
| |
| Will the data be treated as confidential? | |Yes | |No |
| Describe the procedures to be used to ensure confidentiality or anonymity of participants and the confidentiality of data both during the conduct of |
|the research and in the release of its findings. Explain how written records, video/audio tapes and questionnaires will be secured, and provide details of |
|their final disposal/data locking |
|FOR EACH OF THE FOLLOWING SECTIONS, PLACE EACH SECTION AT THE START OF A SEPARATE PAGE |
|REFERENCES |
|Use the Vancouver style (for details see: ) Do NOT include the references themselves. |
|PROJECT TIMELINE |
|Provide a timeline that shows the approximate time to completion for major milestones in the study. |
|INVESTIGATOR ROLES/RESPONSIBILITIES |
| |
|Project Personnel: List the research team, including the faculty supervisor, and their proposed roles (in point form) in the research project. Students who |
|are participating for research credit must be identified. Support staff such as secretaries, assistants, etc. need not be named; the team’s contact |
|personnel must be identified. All members of the research team must sign the personnel list below. |
| | | |
|Team member name |Proposed role in project |Signature of team member |
|Contact Person |communications between the supervisor, and course coordinator | |
| | | |
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| | | |
| |
|PROJECT BUDGET |
|(Student projects have maximum budget of $200) |
|Title: |Project Year | |
| | | |
|EQUIPMENT |JUSTIFICATION |AMOUNT |
| |(Describe why this equipment is necessary for your project) | |
| | | |
| | | |
| | | |
| | | |
|SUPPLIES Itemize by category (e.g. stationary, copying costs etc.) | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
|TRAVEL | | |
| | | |
|OTHER EXPENSES (Itemize by category) | |
| | | |
| | | |
| | | |
| | | |
|TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD | |
| |$0.00[pic]$0 |
ATTACHMENTS/APPENDICES:
Append attachments as identified on the cover page.
Sample Formatted Proposal
Office of Research Administration (ORA): ext 267 e-mail: cmcdermaid@cmcc.ca
(Please complete, print and submit this form as three hard copies and an electronic version on diskette to the ORA.)
This form uses tables for formatting and check boxes. To complete a checkbox, just type an “x” into the box. To complete text sections, type in the space available below the table. Don’t write in the table itself. Text should appear in Arial 10 point font. The formatting may change, depending on how much you type in each section. You can carriage return some sections to the next page if it improves the appearance of the form. Hand written applications will be returned unreviewed.
|Date |2002-08-11 |Application Status |x |New | |Resubmission | |Addendum | |Renewal | |
| |IRB # |
|Project Title: |Inter-examiner reliability in the assessment of manipulative skills of students |
|PERSONNEL |NAME |PHONE/EXT |E - MAIL |
|Contact |Jane Doe |416.633.2345 |jdoe@ |
|Investigator | | | |
|Co-Investigators | | | |
| |Joe Shmoe |416.482.4567 |Jshmoe@yahoo.ca |
| | | | |
| | | | |
| | | | |
| | | | |
|Faculty Supervisor(s) |G Till, K Ross, Dept of Applied Chiropractic, CMCC |198, 166 |gtill@cmcc.ca, kross@cmcc.ca |
| |
|Faculty Supervisor Assurance |
I certify that the student(s) or guest investigator(s) conducting the research is/are knowledgeable about the regulations and policies governing research with human participants and has/have sufficient training and experience to conduct this study in accordance with the approved protocol. I agree:
▪ To meet with the student investigator(s) on a regular basis to monitor the research progress;
▪ To be available, should problems arise during the course of the research, to supervise the investigator(s) in solving such problems;
▪ To ensure that the investigator will promptly report significant adverse effects to the IRB within five (5) working days of occurrence;
▪ If I am unavailable, as when on sabbatical leave, vacation or absent longer than one month, I will arrange for an alternate faculty supervisor to assume my responsibility during my absence, and I will advise the IRB in writing of such arrangements and;
▪ Submitting, at minimum, a progress report annually or in accordance with the terms of IRB approval.
Signature of Faculty Supervisor: Date:
Required Attachments (check ‘x’ those appended)
|x |Literature search strategy (do not included retrieved abstracts) |x |Consent form and patient information |
| |Letters of permission for access to facilities/resources | |Advertising used in the study |
B. SUMMARY OF PROPOSED RESEARCH
|1. Research Category |
| |x | Involves live human participants |
|Categorize your proposed research | |Uses identifiable personal information |
|(‘x’ as many as apply) |x |Uses info previously collected for purposes other than the |
| | |proposed research |
| | | |
|2. Full Text Abstract |
|The following section is intended to give the investigator a brief orientation to your study and may be published by the College. |
|This full text abstract of your research should be a brief summary with the following subheadings: |
|Study objective |
|The objective of this study was to determine the level of consistency amongst examiners in assessing students’ spinal manipulative |
|skills. |
| |
|Brief rationale for the study |
|In assessing students’ skills when performing spinal manipulative procedures, it appeared that students performed consistently |
|better with some examiners than with others. Furthermore, when 2 or more examiners assessed the same student concurrently, there |
|was sometimes a significant disparity in their scores, but the magnitude of this disparity was not known, and it was not known if |
|it was severe enough to warrant special remedial action in training the examiners. |
| |
|Research design |
|This is a retrospective correlational study ---specifically an inter-examiner and intra-examiner reliability study. |
| |
|Description of the sample and target population |
|Forty CMCC faculty examiners of varying experience were recruited for the examination assessment role, and 18 volunteer 2nd year |
|students were recruited to provide the 9 videos of the spinal manipulative maneuvers to be assessed by the 40 examiners. |
| |
|Study Location and facilities |
|The data were originally collected at the Canadian Memorial Chiropractic College (CMCC), in the Technique Lab. |
| |
|Research protocol (in order of occurrence) |
|Each examiner viewed each video clip twice, and after each viewing, assessed the performance of the student performing the |
|manipulation maneuver, based on the 6 criteria shown in Appendix 3. |
| |
|Outcome measures/data being collected |
| |
|Each topic in this section should consist of only a few clearly written concise sentences. The entire section should not be longer|
|than 500 words. |
|The 6 criteria summarized in Appendix 3 were assessed as individual scores on a 6-pt ordinal scale, as well as a composite score |
|out of 30. |
• Data analysis strategy
The within-examiner (intra-examiner) and between-examiner (inter-examiner) magnitude of agreement was quantified using the Intraclass Correlation Coefficient.
|3. Study Location and facilities |
|The data were originally collected at the Canadian Memorial Chiropractic College (CMCC), in the Technique Lab. |
| Where will the study be conducted? List the institutions/sites. List the facilities/resources required for the project. |
|Include (as an Appendix) written permission for access to resources such as rooms, equipment, databases or records. |
B. INTRODUCTION
|1. Purpose and Background |
|The objective of this study was to determine the level of consistency amongst examiners in assessing students’ spinal manipulative |
|skills. |
|In assessing students’ skills when performing spinal manipulative procedures, it appeared that students performed consistently |
|better with some examiners than with others. Furthermore, when 2 or more examiners assessed the same student concurrently, there |
|was sometimes a significant disparity in their scores, but the magnitude of this disparity was not known, and it was not known if |
|it was severe enough to warrant special remedial action in training the examiners. |
| |
|The evaluation of students’ clinical competency skills at the Canadian Memorial Chiropractic College has traditionally involved |
|history taking and physical examination skills; thus, the bulk of information regarding inter-examiner reliability relates to these|
|same areas of evaluation. The literature sites two major problems regarding inter-examiner reliability(1). The investigators usage |
|of a poorly designed test instrument; and (2) poor reliability amongst faculty members due to subjective bias and personality |
|styles(1,3-6). A number of difficulties exist with regard to the investigators’ test instruments. First the assessment is |
|restricted to time limitations leading to a generalization of the students’ abilities with only limited exposure to the |
|examiner(8). Second, there is generally poor correlation between subjective and objective testing (e.g. practical vs multiple |
|choice examination formats), suggesting perhaps that subjective clinical testing for evaluation should serve only a limited role in|
|giving a more generalized impression of the students’ abilities. Third, many researchers argue that a number on a rating scale |
|cannot possibly incorporate the many various qualities possessed by the student relating to maturity, responsibility, integrity and|
|compassion(12). |
|Studies of inter-examiner reliability reveal numerous other evaluation concerns. These include the examiners’ own skill in |
|understanding and performing the task being evaluated(6,11). In addition, there is the inherent problem of ensuring that examiner |
|uniformity of professionalism, involving conduct, characteristics, standards and methods of evaluation are consistent and |
|maintained throughout the examination procedures. This becomes increasingly more difficult as students proceed with their senior |
|year and attain levels of collegiality with their examiners. An increasing bias in favour of the student on the part of the |
|examiner (3,4,9) may include a reluctancy of an examiner to submit a failing grade when such action could produce a dismissal |
|decision by a standards committee (11,12). Finally, it has been documented that consistently lower assessments are made by |
|clinicians who use strictly objective assessment criteria as compared to those who utilize more subjective approaches (7,10). |
|It would appear then that inherent subjective bias such as personality factors among testers would undermine even the most |
|carefully designed evaluation procedure and hence decrease inter-examiner agreement. |
|The purpose then of this study is to determine one aspect of technique evaluation, specifically, what degree of inter-examiner |
|reliability exists, using established technique performance competency criteria, between the CMCC Technique Department Instructors |
|for the evaluation of student psychomotor skills. |
| Describe the purpose and background rationale for the proposed project. Provide a review of the relevant literature with |
|regard to how it addresses your research question(s). |
|Statement of Research Hypothesis(es) |
|The investigators’ research hypothesis is that the inter-examiner agreement will be less than the minimally desirable level of |
|ICC=.7 . |
| Provide a detailed statement of the research hypothesis(es)/ question(s ) to be examined. |
D. METHODS AND PROCEDURES
|Study Participants |
|1. Sample Characteristics and Sample Size |
|Describe in detail the sample to be recruited including gender distribution, age range, socioeconomic profile, complaint profile |
|and any special characteristics of sample. Justify any exclusion criteria. If you are using identifiable personal information, |
|identify the information to be used and its source. State the proposed sample size along with a justification or the sample size |
|(including power, alpha [statistical significance level], and effect size specifications). |
Two convenience samples were recruited for this study: 18 student volunteers and 40 faculty examiners. Nine volunteers from the 2nd Year class (2001/2) performed a spinal manipulative procedure of their choice on a fellow volunteer student, during which time they were videod by Dr Ross. At that time, this study was not envisaged, hence the specific wording of the consent form. Eleven technique tutors, twenty-five clinicians and four residents acted as "examiners". None of the data to be published will be of an identifiable nature.
|2. Recruitment Process |
| Describe how and where the participants will be recruited (e.g. direct recruitment, advertising, notice via email, class |
|announcements etc.). Indicate where the study will take place. Describe any possible relationship between I investigator(s) and |
|participant(s) (e.g. instructor - student; manager - employee). Attach a copy of any poster(s), advertisement(s) or letter(s) to |
|be used for recruitment as appendices. If you are using identifiable personal information, describe how it will be obtained, who |
|will have access to it. |
Dr Ross asked the 2nd Year class if any students wished to have themselves filmed whilst performing a manipulative technique of their choice. The filming took place in the Technique Lab at CMCC. Dr Ross lectured to the 2nd Year students in AC2203. Dr Till gave a 2-hour presentation to the 2nd Year students on homoepathy in AC 2410. The "examiners" were clinicians, technique tutors and residents. They were asked to assess each of the video clips as part of a "Biomechanics Seminar" which took place in Room 312 at CMCC. The only identifiable information are the video clips, which are recorded on the hard drive of Dr Ross' laptop, for which a password is required to access. The tabulated data is key-coded.
|3. Compensation of Participants |
| | | | | |
|Will participants receive compensation for participation? | |Yes |x |No |
|If yes, please provide details. If participant(s) choose to withdraw, how will you deal with compensation? Note that RM4402 funds|
|cannot be used to reimburse clinic patients for the costs of chiropractic care. |
|4. Feedback to Participants |
|Students and "examiners" will be provided with a copy of the results of the study once the follow-up study (intra-examiner |
|reliability) has been completed. |
| Whenever possible, upon completion of the study, participants should be informed of the results. Describe below the |
|arrangements for provision of this feedback. |
|Informed Consent Process |
|1. Consent Form |
| |
| Attach the Informed Written Consent Form as an Appendix, including any information about the study that will be provided to the |
|participants. If written consent will not/cannot be obtained or is considered inadvisable, justify this and outline the process |
|that will be used to fully inform participants. |
| |
|See page 60 and 61 for the informed written consent forms. |
|2. Capacity to Consent |
| | | | | |
| Are participants competent to consent? |x |Yes | |No |
| If no, describe the procedures to be used to obtain the consent of the parent or guardian. Attach a copy of the |
|information/consent form to be used as an Appendix. |
|3. Deception |
| |
| Will deception be used in this study? | |Yes |x |No |
| If yes, please justify the need for deception. Explain the debriefing procedures to be used, and attach a copy of the written|
|debriefing as an Appendix |
|Research Procedures |
|1. Description of Research Procedures |
| |
| Describe, sequentially and in detail, all procedures in which the research participants will be involved (e.g. paper and pencil tasks, interviews, |
|surveys, questionnaires, physical assessments, physiological tests, time requirements, etc). |
|Where possible, provide reliability, validity, and relevance/sensibility information on outcome measures to be used. |
|Attach as appendices a copy of any questionnaires and/or test instruments to be used. |
Second-year students who responded to a Technique Class announcement to volunteer being video-taped while performing a spinal manipulative (SM) maneuvre of their choice, were recruited and filmed by Dr. Ross. At a local chiropractic technique conference, the 40 examiners were recruited and permitted to watch the resulting videos as many times as they wished, before recording their personal scores of each of the students’ performances. While this method was different from real examination protocols, and was biased towards producing unrealistically high agreement coefficients (because of how often the examiners could review the tapes), it was reasoned that if poor agreement coefficients resulted from this study, that the inter-examiner agreement would very definitely, and undisputably be poor.
|Statistical Analysis |
|Description of Analysis |
|The data will be analysed using the Intraclass Correlation Coefficient with 95% Confidence Intervals.. |
| Provide a brief description of the planned data analysis. The description should include a description of the statistics to be used (including the |
|level of statistical significance, if applicable). State what will be considered clinically important changes/differences/associations in the outcomes. |
|If your project includes several outcomes or research questions, identify the analysis (e.g. statistical test) which will be used for each outcome or |
|question. |
|RISKS AND BENEFITS OF THE RESEARCH |
|The purpose of this section is to describe the benefits and risks to participants in your research. This section should demonstrate that the benefits |
|exceed the risks and the risks have been minimized as much as possible. It is important that you take the participants perspective and consider the risks |
|and benefits that may be important to them. |
|1. Direct Benefits to Participants |
|No one in the study will benefit directly, other than becoming aware of the problem of inconsistency in assessing students. Indirectly, all future students,|
|tutors and clnicians could benfit if future efforts to improve consistency are successful. |
|2. Indirect Benefits |
| |
| Describe any benefits to the scientific community/society that would justify involvement of participants in this study. |
Without the support of objective means to aid in the assessment of students' psychomotor skills, the exercise will probably always be plagued by subjectivity. Therefore, by identifying the magnitude of unreliability and possibly which aspect of the assessment that is/are mostly involved, could be a valuable base from which to try and improve the consistency by which examiners assess students' psychomotor skills performance.
|3. Risks to Participants |
| |
| Describe the known and anticipated risks of the proposed research, specifying the particular risk(s) associated with each procedure or task. |
|Consider, physical, psychological, emotional and social risks. Describe any benefits to the scientific community/society that would justify involvement of |
|participants in this study. |
The risks from the manipulative procedures are minimal. Given the confidential way in which the data will be treated, there should be no psychological, emotional or social risks to either the students or the "examiners".
|4. Minimization of Risks |
| |
| Every effort should be taken to minimize risks as much as possible, even if the risks are minimal. Describe how you will minimize the risks or |
|potential risks to the participants. |
Each student performed only one manipulation on his/her "patient". All data will be treated confidentially. Data and the videos will be destroyed at the end of this and any follow-up study.
|5. Mitigation of Risks |
| |
| If your study has the potential to injure, upset or identify ill, distressed, or disturbed individuals, describe the arrangements you have made to |
|mitigate these effects (e.g. Student services counselling, referral for care). |
This study should not have any such effects.
|Confidentiality |
|1. Data Management |
| |
| Will the data be treated as confidential? |x |Yes | |No |
| Describe the procedures to be used to ensure confidentiality or anonymity of participants and the confidentiality of data both during the conduct of |
|the research and in the release of its findings. Explain how written records, video/audio tapes and questionnaires will be secured, and provide details of |
|their final disposal/data locking |
The video recordings are on the hard drive of Dr Ross, for which a password is required. They will be deleted once this study and the follow-up studies have benn completed. All data will be coded so that no individual will be identified in the published data. Only the researchers will have access to the code.
|FOR EACH OF THE FOLLOWING SECTIONS, PLACE EACH SECTION AT THE START OF A SEPARATE PAGE |
|REFERENCES |
|Use the Vancouver style (for details see: ) Do NOT include the references themselves. |
| |
| |
|Calhoun JG, Wooliscroft JO, Ten Haken JD. Internal medicine house officers’ performance as assessed by experts and standardized patients. Journal of Medical|
|Education 1987;62:754-60 |
|Carmichael JP. Inter- and Intra-Examiner Reliability of palpation for sacro-iliac Jt. Dysfunction. JMPT 1987;10(4):164-171. |
|Davis JK, Inandar S, Stone RK. Interrater agreement and predictive validity of faculty ratings of pediatric residents. J. of Med. Edu.1986;61:901-5. |
|Durand RP, Levine JH, Lichtenstein LS, Fleming GA & Ross GR. Teachers’ perceptions concerning the relative values of personal and clinical characteristics |
|and their influence on personal and clinical characteristics and their influence on the assignment of students clinical grades. Med. Ed 1988;22:335-41. |
|Elliot DL, Hickan DH. Evaluation of physical examinations skills. Reliability of faculty observers and patient instructors. JAMA 1987;258:3405-8. |
|Girshung AD. Comparison of intraining evaluation with tests of clinical ability in medical students. J. Med. Ed 1985;60:29-37. |
|Harper AC, Roy WB, Norman AR, et al. Difficulties in clinical skills evaluation. Medical Education 1983;17:24-7. |
|Henderham RC, Schroeder SA. An effective and efficient systems technique for establishing a competency performance-based program in the health sciences. |
|Laboratory Medicine 1980;11:93-5. |
|Irby DM. Clinical teaching and the clinical teacher. Clinical Education of Medical Students 1985;60:35-44. |
|Seibert ML. Establishing criteria for competency based education. American Journal of Medical Technology 1979;455:368-71. |
|Stemmler EJ. Promoting improved evaluation of students during clinical education: a complex management task. Clinical Education of Medical Students |
|1985;60:75-81. |
|Tonesk X. AANC program to promote improved evaluation of students during clinical education. Clinical Education of Medical Students 1985;60:83-88. |
|Szaraz ZT. Compendium of Chiropractic Technique. 1990. |
|PROJECT TIMELINE |
|Provide a timeline that shows the approximate time to completion for major milestones in the study. |
|INVESTIGATOR ROLES/RESPONSIBILITIES |
| |
|Project Personnel: List the research team, including the faculty supervisor, and their proposed roles (in point form) in the research project. Students who |
|are participating for research credit must be identified. Support staff such as secretaries, assistants, etc. need not be named; the team’s contact |
|personnel must be identified. All members of the research team must sign the personnel list below. |
| | | |
|Team member name |Proposed role in project |Signature of team member |
|Contact Person |communications between the supervisor, and course coordinator | |
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-+
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|PROJECT BUDGET |
|(Student projects have maximum budget of $200) |
|Title: |Project Year | |
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|EQUIPMENT |JUSTIFICATION |AMOUNT |
| |(Describe why this equipment is necessary for your project) | |
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|SUPPLIES Itemize by category (e.g. stationary, copying costs etc.) | |
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|TRAVEL | | |
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|OTHER EXPENSES (Itemize by category) | |
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|TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD | |
| |$0.00[pic]$0 |
ATTACHMENTS/APPENDICES:
Append attachments as identified on the cover page.
Assessor Consent:
Permission to Publish Data
Study title: Inter-examiner reliability in the assessment of manipulative skills of students.
Conducted by: Dr. Kim Ross and Dr. Glynn Till.
In December 2001 I observed nine video clips filmed by Dr K Ross of students performing spinal manipulative techniques. I was asked to grade each procedure in terms of the system used at CMCC, namely, doctor/patient position, contact and supporting hands, joint slack, line of drive, speed and depth of thrust, and overall technical performance. I was also asked to state what I liked most and least about each procedure.
The purpose of the above exercise was for the Department of Applied Chiropractic to determine the level of consistency amongst clinicians and tutors in the grading of students. I understand that the above investigators would now like to publish the data from this exercise and for that purpose they seek my consent to do so.
I understand that there are no direct benefits to me for participating. I understand that this study will provide insight into the consistency in the grading of manipulative skills of students. If I am interested in my personal performance, I can contact either of the investigators to review my results.
The potential risk to me of this study is that I may be concerned that my performance in this research may detrimentally influence my employment at CMCC. This risk is practically zero. My confidentiality is protected because no one person’s performance will be published or presented. All data will be presented or published in aggregate form. This means no one could identify my personal scores. The data collected in this study will be used only for the purposes of this study and will not be shared with anyone else. After the analysis is complete, my name will be replaced with a numbered code to prevent any identification of my scores when the study is over.
I understand the benefits and risks involved in this study and have had all my questions satisfactorily answered. I understand that I may withdraw my participation at any point throughout the study. I understand that a decision to withdraw from the study will not result in any repercussions towards myself as a tutor, clinician or resident, as the case may be, at the Canadian Memorial Chiropractic College. I hereby give my consent to make public the data resulting from my participation in the study.
Participant’s Name (please print):__________________________________
Participant’s Signature:____________________________________
Date:____/____/_________
D M Y
Student Demonstrator Consent:
Permission to Publish Data
Study title: Inter-examiner reliability in the assessment of manipulative skills of students.
Conducted by: Dr. Kim Ross and Dr. Glynn Till.
During 2001, I volunteered to be videotaped by Dr Ross whilst performing spinal manipulation/acting as a patient (delete whichever is inapplicable). I understand that the video clip was shown to a number of technique tutors and clinicians from CMCC for the purpose of determining examiner reliability in the grading of such performances. The manipulations were graded in terms of doctor/patient position, contact and supporting hands, joint slack, line of drive, depth and speed of thrust, and overall technical performance. I now understand that the abovementioned researchers wish to publish the data and they seek my permission to do so.
The specific details of the study have been explained to me. I understand the benefits and risks involved in this study and have had all my questions satisfactorily answered. I understand that my anonymity will be guaranteed and that I may withdraw my participation at any point throughout the study. I understand that a decision to withdraw from the study will not result in any repercussions towards myself as a student at the Canadian Memorial Chiropractic College. I hereby give my permission to make public the data resulting from my participation in the study.
Participant’s Name (please print):__________________________________
Participant’s Signature:____________________________________
Date:____/____/_________
D M Y
End of sample proposal.
RM2202 SIP Proposal Eligibility Checklist
Enclose a checked-off copy of this checklist with the proposal (place it in the Appendices section). The following items MUST be present in the SIP proposal submission in order for the proposal to be reviewed. If any item is missing, the proposal will be immediately returned to the student group or supervisor without being considered any further until the missing item(s) are included with the proposal package.. This may result in a substantial delay in the review process, and hence the study’s start-date.
• (this "Eligibility Checklist" (1st page after cover)
• (the faculty supervisor's name
• (4 copies of the proposal
• (the groups' contact student's name, phone # and email address on the cover
• (PAGINATION (pages must be numbered!!!)
• (double-spacing of the entire manuscript (including the Abstract)
• (the detailed Literature Search Strategy (in an appendix) i.e. the exact syntax entered into Medline or Mantis etc. (see e.g. next page)
• (a formatted (i.e. with subheadings) ABSTRACT
• (the student-supervisor CONTRACT (attached as an appendix)
• (the SUPERVISOR'S SIGNATURE ON THE COVER OF EACH COPY, indicating his/her approval of the version being submitted
• (Timeline of activities/investigators' tasks
• (a budget of ≤ $200
• (a sample of the informed consent form (in an appendix) IN THE FORM THE SUBJECT WILL SEE, including:
-a description of ALL risks of discomfort (no matter how minor) and other adverse effects;
-that the subject will incur NO PENALTY for withdrawal
-a statement of confidentiality to the subject
-evidence that the form's text does not exceed a gr.8 reading level.
• (Letter of Permission from any on- or off-campus authorities regarding access to facilites (rooms, equipment), and/or organizational membership (personnel, students).
All of the above apply for resubmissions, with the addition of the following for resubmissions:
• (-A COVER SUMMARY FORM OF ALL REVISIONS MADE
• (-all prior proposal manuscript submissions with the reviewer's comments on them and a copy of all 3 IRB reviewer comment forms must be included with the resusbmission package; this is in order to enable each reviewer to quickly check his/her requested revisions against what is resubmitted.
_________________________ _________
Supervisor Signature Date
INCLUDE THIS WITH EACH PROPOSAL SUBMISSION AS PART OF FACE PAGES
RM2202 SIP Student-Supervisor Contract
The student group agrees to :
1) Attend all mutually agreed-upon supervisor-student meetings (a minimum of 1/mo. is recommended).
2) Fulfill all the ‘chores’ on each student's "To-Do List" by the next scheduled supervisor-student meeting (or otherwise established date).
3) Submit all drafts/reports to the supervisor at the scheduled dates.
4) Notify the supervisor in a timely fashion (as established by mutual agreement) of any problems which may result in the delay of accomplishing a "To-Do List" item.
5) Be prepared to conduct the literature search, data collection and analysis to the satisfaction of the supervisor.
6) Be prepared to revise the manuscript (proposal/final paper) to the satisfaction of the supervisor.
VIOLATION OF THESE TERMS IS GROUNDS FOR THE
SUPERVISOR DISMISSING THE STUDENT GROUP,
in which case the group must find another supervisor.
The supervisor agrees to:
1) Attend all mutually agreed-upon supervisor-student meetings (a miimum of 1/mo. is recommended).
2) Fulfill all the ‘chores’ on his/her "To-Do List" by the next scheduled supervisor-student meeting (or otherwise established date).
3) Provide timely feedback (within 1 week) to the students on all drafts/reports/.
4) Notify the students in a timely fashion (as established by mutual agreement) of any problems which may result in the delay of accomplishing a "To-Do List" responsibility or providing feedback.
5) Clearly delineate up-front to the students what his/her standards and criteria for ‘satisfactory work’ and ‘working style’ are before the signing of this contract; these standards can be as high as, but cannot exceed those required to produce a paper of publishable quality (in a peer-reviewed, scholarly journal).
6) Make sure the workload is distributed among the group members in a fair & mutually agreeable manner.
7) Ensure that all IRB submissions & resubmissions are properly signed and handed in on time.
8) Ensure that a qualified replacement supervisor is found for the SIP group in the event that s/he is unable to complete her/his supervisory duties.
By signing this contract, the supervisor and student investigators indicate that they understand and will abide by the terms and conditions described above.
Signatures:
Supervisor:
___________________________________________________________________-_________
Student Investigators:
___________________________________________________________________-_________
___________________________________________________________________-_________
___________________________________________________________________-_________
Date:
___________________________
SUBMIT THIS PAGE WITH YOUR PROPOSAL
|Student Application For Access to CMCC Clinics |
| |
|Permission must be obtained for access to clinic facilities (including staff or faculty), patient populations, or health record information for the purposes |
|of research. |
|Approval in Principle for Access to CMCC Clinics (to be completed by the researcher) |
|Contact Student: | |
|Type of access (check as many as apply) |9 clinic facilities 9 clinic patients 9 health records |
|Clinic |9 Herbert K. Lee clinic 9 The Rehabilitation Clinic 9 HK Lee radiology facilities |
| |(only these clinics allow student research) |
|Purpose of Research (Provide a brief description and attach a copy of the abstract.) As is relevant, you must include a) the type of facilities required, b)|
|the patient population you want to access (including numbers of patients etc.) and/or c) the health record information you require (including the specific |
|data requested, how you propose to retrieve it, who will act as the retrieval person, and why this information is essential to your research.) |
| |
| |
| |
|Preliminary Approval for Access to CMCC Clinics (to be completed by Associate Dean of Clinical Education) |
| | | |
|Health Information Custodian (Print Name) (Signature) |
|Conditions for Access: 1. Pending IRB approval |
| |
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|Cost of Retrieval | |Estimated duration of retrieval | |
|Final Approval |Attached IRB Certificate 9 |Date of Approval | |
| | |
| (Associate Dean of Clinical Education) |
|Conditions | |
| |
| |
|WRITTEN INFORMED CONSENT FORM |
|1. Title of Study: |
|2. Names of Investigators: |
|3. Name of Supervisor:: |
| |
| |
|4. Description of the Study: |
| |
| |
| |
|State that you are inviting the prospective subject’s participation in the study. Then state the study objective, and describe a subject’s role and what |
|s/he can expect to be exposed to (e.g. instruments, assessment tests, other outcome measures, interventions, how often, when, where, by whom, and the time |
|commitment involved). |
| |
| |
| |
|5. Direct Benefits to Participants |
| |
| Describe any direct benefits to participants from their involvement in the project. |
| |
|6. Indirect Benefits |
| |
| Describe any benefits to the scientific community/society that would justify involvement of participants in this |
|study. |
| |
|7. Risks to Participants |
| |
| Describe the known and anticipated risks of the proposed research (no matter how minimal or unlikely), specifying the particular risk(s) associated |
|with each procedure or task. Consider, physical, psychological, emotional and social risks. |
| |
|8. Minimization of Risks |
| |
| Every effort should be taken to minimize risks as much as possible, even if the risks are minimal. Describe how you will minimize the risks or |
|potential risks to the participants. |
| |
|5. Mitigation of Risks |
| |
| If your study has the potential to injure, upset or identify ill, distressed, or disturbed individuals, describe the arrangements you have made to |
|mitigate these effects (e.g. Student Services counselling, referral for care). |
| |
|6. Confidentiality |
|1. Data Management |
| |
| Describe the procedures to be used to ensure confidentiality or anonymity of participants and the confidentiality of |
|data both during the conduct of the research and in the release of its findings. Explain how written records, |
|video/audio tapes and questionnaires will be secured, and provide details of their final disposal/data locking. |
|7. Participant’s Written Consent |
| |
|This is to certify that I, ________________________________(name of the participant), agree to participate as a volunteer in a scientific study which is |
|authorized as part of the research program of the Canadian Memorial Chiropractic College. The study, and my role in it have been explained to me, and I |
|understand the explanation. I have been given the opportunity to ask whatever questions I had, and my questions have been answered to my satisfaction. |
| |
|The risks and possible discomforts have also been described to me in detail, and I understand the explanation. have been given the opportunity to ask |
|whatever questions I had, and my questions have been answered to my satisfaction. |
| |
|I understand that I am free to deny any interview or questionnaires, but that doing so may disqualify me from participating in the study. I understand that|
|any of my data or answers to questions will remain confidential with regard to my identity. I also understand that I am free to withdraw my consent and |
|terminate my participation at any time, without penalty. |
| |
| |
|Date:__________________________ |
| |
|Signature of Subject/Participant:____________________________________ |
| |
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|I, the undersigned, have fully explained the study to the above-named subject: |
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|Date:__________________________ |
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|Signature of Investigator:___________________________________________ |
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| |
Further Info on Designing an Informed Consent Form
Background
Informed consent is a requirement for all research. Participants have to make an informed and autonomous decision to take part in research.
An informed consent form is used to document that an informed consent process took place. Having someone read a form and sign it does not constitute informed consent. The consent process is a dialogue that allows the participant to ask questions, get clarification and generally be as informed as possible before making a decision to participate in the research. The form must contain all the information that might affect someone’s decision to participate. It also must be written so they can understand it.
Documentation of the consent is usually required in writing (e.g. a signed form). In some instances, for example a survey, the completion of the survey can be taken as documentation of the informed consent process. This doesn’t always apply. If the survey is dealing with sensitive issues, signed consent may be required. In all cases, the participants still have to be supplied with the information needed to make a decision to participate.
Required information
The following information is required in any consent form:
1. Information that the prospective subject is being invited to participate in a research project;
2. A statement that is comprehensible to all potential participants of the research purpose, the identity of the researchers, the expected duration and nature of the participation, and a description of the research procedures;
3. A description that is comprehensible to all potential participants of the foreseeable harms and benefits that may arise from participation in research, as well as the likely consequences of non-participation (particularly as relates to treatment) where there is a potential for psychological or physical harm;
4. An assurance that prospective subjects are free not to participate and have the right to withdraw at any time with no penalty or consequence to pre-existing entitlements (such as health care) and that they will be given continuing and meaningful opportunities for deciding whether or not to continue to participate;
5. The possibility of commercialization of research findings and any potential or existing conflict of interest on the part of the researchers, the College or sponsors.
6. Informed consent may not include any statement that waives any of the subject's legal rights.
Additional information may be required. The bottom line is that you should be able to read through the form and know exactly what you’re in for. The last page of this hand out includes a checklist that can help you make sure everything is there.
Readability
The form should be readable and understandable to the people who may participate. The target is generally Grade 6, which can be tough. Try to avoid jargon and lengthy sentences.
Try to use the active voice whenever possible. For example instead of:
The diary is to be completed every other day.
Use:
Complete the diary every other day
It’s okay to use bulleted lists if that makes it easier to understand. Try reading the form out loud. It’s easier to hear awkward structure than it to see it when you’re reading the form.
To test readability, most word processors have a readability index that guesstimates the Grade level of the writing. Shoot for six, which can be tough. In Word, click on Tools Spelling and Grammar (or hit the F7 key). Make sure the Check Grammar box is checked and under Options, select Show Readability Statistics. When you’re spell checking is complete, a box will pop up showing the readability of the document or any text you’ve selected.
FAQs (Frequently Asked Questions):
1. How long should a form be?
The form should be long enough to convey all the required information. Don’t worry if it goes more than one page. Make it readable and number the pages.
2. People won’t know how intelligent I am unless I use big words. That seems to make the readability higher. Why can’t I use sesquipedalian words?
Even smart people like writing to be clear and easy to read. It makes it faster to read. You’re not trying to impress anyone; you’re trying to inform them. For more information on readability, check out this website .
3. How much detail do I need to go into in the form?
The detail should be enough for someone to understand what is going to happen. Remember this should be in lay terms. For example, Sexual maturity will be assessed using the Tanner Scale doesn’t tell the layperson much. The Tanner scale uses drawings that show breast and pubic hair development (have a look in your Bates textbook) and can be self-assessed (the participant chooses the picture that suits them best) or is done by having an examiner inspect the participant. You can see how someone may be a little surprised in that study!
4. Should the form be written in first person (e.g. I understand) or third person (You will be asked…)?
Whatever is easier to read. Everyone has his or her preference. It may make more sense for someone to sign it if they say I understand…
Detailed Sample form
The next few pages contain a sample consent form for the application of a daily headache diary in chiropractic college students. It shows the elements of the consent as well as a few other tidbits. This should be used as a guide, not a cut-and-paste template. Using the list on the first page as a checklist
Canadian Memorial Chiropractic College
RM2202/4402 Student Research Project
Informed Consent Form
Research study: Relationship of headache frequency to academic stress in young adults.
Investigators: Igor Beevahr, Malexa Kriest Fourth year students
Faculty Supervisor Paige Turner DC
Purpose of this study:
This study is looking at the relationship between the numbers of headaches
a student gets and how much stress they are under at school. This study
may help us better understand the effects of stress on a student’s health.
I am being asked to take part because I am a student and I get headaches. I
understand that it is important that I understand the study before taking
part. I should not sign this form unless I understand everything on it.
I understand that I can ask questions at any time.
Description of the Study
• If I take part, I will be asked to complete a daily headache diary twice during the school year. Once during the month of September and once during the month of December. I will complete every day for each of these months. It takes about 15 seconds to complete each entry. The diary asks if I had a headache that day, how bad it was on a scale of 1 to ten and if I did anything to stop the headache (like taking a pill or getting a chiropractic treatment).
• In order to take part in this study, I should have at least two headaches a month. These headaches should not be related to my period.
• I will be asked some questions and fill out a questionnaire about my headaches before I start the study. I understand that I may not be able to take part, depending on what this questionnaires tell the investigators.
• Once I start the study, I will be given a diary for the month of September. When I’m done the diary I’ll put it in the investigator’s mailbox.
• In the last week of November, I will get a new diary in the mail. I will complete this diary every day and then put it in the mail when I’m done. I will be given and envelope and a stamp to do this.
Potential Risks
The only risk is the inconvenience of completing the diary.
Potential Benefits
The benefit in this student project is that it may give the researchers some information about how stressful periods, like exams, affect students’ health. The only direct benefit to me is that I may get a better idea of how often my headaches really happen.
If I’m interested in the results of this study, I will be told when it is published.
Reimbursement
I will be given two $5 gift certificates for the College bookstore. I will get each one when I hand in each diary.
Confidentiality and Privacy
My privacy will be protected in the following ways:
• My name will never be used in connection with this study if it is published or presented.
• The diaries will be coded. I understand that I should not put my name on the diary. The researchers have a codebook that will link my name to the code. The faculty supervisor will have this book. It will be destroyed after results of the study are analysed.
No information that identifies me will be shared with anyone without my consent or unless required by law.
Participation and Withdrawal
I understand that taking part in this study is voluntary. I can refuse to take part or stop taking part at any time. There is no penalty to me if I stop the study. I understand that I will only get the gift certificates when I hand in the diaries.
Consent
The study has been explained to me and all my questions have been answered. I understand the risks and benefits of taking part. I know that I can ask questions at any time. I understand that I can stop taking part in the study at any time with no penalty.
I understand that my identity will be protected and that no information that identifies me will be used without my permission, unless required by law.
I’ve read and understood this form. By signing this form I give my consent to take part. Signing this form does not mean I’m waiving any rights I may have or released the investigators or the College from their professional and institutional responsibilities.
Date:
Name of participant (print):
Signature of participant:
Name of witness (print):
Signature of witness:
Comments
This is should be used as a guide. The format and content is somewhat flexible and will vary with the study. Try to keep it simple and straightforward for your research participants.
Consent Checklist (based on a list by D Maurer PhD, McMaster University)
The form clearly identifies:
| |The identity of the researcher(s), and if the researcher(s) is/are a student(s), the supervisor(s) (the person who is available|
| |to answer pertinent questions should be clearly identified); |
| | |
| |the sponsor(s) of the research |
| |
|The consent form clearly explains: |
| |that the proposed intervention/procedure is for research |
| |(why the research is being done); |
| |What the research involves; this should include details of what will happen to the participant, |
| |the nature of any randomization, the need to discontinue standard practice or therapy, and |
| |any possible use of a placebo); |
| |how long the research and each intervention will take); |
| |The nature of the harms and inconveniences and the likelihood of their occurrence |
| |the nature of the benefits to the participant or to others, and the likelihood of their occurrence |
| |the alternative(s) to research participation, if applicable |
| |whether confidentiality will be protected and the measures taken to ensure it. (Who will have |
| |access to the data? how will it be stored? will participants be identified in publications?); |
| |the details regarding reimbursement |
| |possible conflict of interest or commercialization of the findings |
| |that participation in research is voluntary (the right to refuse and the right to withdraw without |
| |prejudice) |
|The consent form does not include: |
| |any statement releasing the researcher(s), sponsor(s), institutions(s), or agents(s) from |
| |liability for negligence. |
| | |
|The consent form is written: |
| |in the prospective participant’s (or her or his substitute decision-maker’s) preferred language; |
| |in lay terms (ordinary language); |
| |at an appropriate level (taking into consideration the nature of the participant (e.g., child or |
| |adult); |
| |with simple explanations of all terms. |
Final Paper Layout:
Non-case Report
•NO POINT FORM
•DOUBLE SPACE
•PAGINATE
Cover Page
The cover-page should have the following information on it:
2003 CMCC RM4402
Student Investigative Project
Final Paper
TITLE OF THE STUDY:
student investigators:
CONTACT STUDENT NAME,
E-MAIL ADDRESS AND TELEPHONE #:
faculty supervisor NAME:
FACULTY SUPERVISOR
E-MAIL ADDRESS AND TELEPHONE #:
FACULTY SUPERVISOR
SIGNATURE & DATE OF SIGNATURE:
Abstract
•Same as proposal, except change future tense to past tense.
Introduction
•Same as proposal, except change future tense to past tense.
Methods & Materials
•Same as proposal, except change future tense to past tense.
Results
Please start this section on a fresh page, and address the following points:
•Summarize your observations/data and statistical analysis in graphs, tables and charts where ever possible.
•Less important detailed charts/tables should be placed in the Appendices section.
•Submit each chart/graph/table on a separate sheet of paper.
Discussion
Please start this section on a fresh page, and address the following points:
•Explain what your results mean, and how they relate to the study's objective.
•Offer an explanation about why the results turned out the way they did.
•Discuss how your results compare to previous studies.
•Discuss the clinical and/or research (further study) implications of the findings.
•Theorize over the limitations of the study (methods & materials); include a discussion about any methodological problems you encountered and how these might be addressed in future study.
•Make recommendations regarding further study. (One recommendation may be that further study is NOT recommended!)
•State the conclusion as it relates back to the objective.
Conclusion
•Reiterate the overall conclusion as it relates back to the objective.
•BRIEFLY summarize the main problems and recommendations.
Acknowledgements
•After getting their permission, you should use this section to thank all the people who made important contributions to the project but were not officially investigators.
•Any granting agencies, equipment/supplies donors should also be thanked for their support.
References
Please start this section on a fresh page, and list and number all your references in alphabetical order by principal author.
Make sure that the reference numbers in this section correspond to the reference numbers in the body of text.
Please follow the Vancouver format illustrated below:
Journal: 1. Sackett DL, How to read clinical journals: I. Why to read them and how to start reading them critically. Canadian Medical Association Journal 1981; 124: 555-558.
Textbook: 2. Eisen HN, Immunology: an introduction to molecular and cellular principles of the immune response. 5th ed. New York. Harper & Row, 1974: 406.
Appendices
Please ensure that each Appendix starts on a fresh page, and that an Appendix is incorporated under the following circumstances:
•Attach your ELECTRONIC LITERATURE SEARCH STRATEGY as "APPENDIX 1";
•If you administered a questionnaire, include a copy.
Summary of Expenses for Reimbursement
Your expense summary should be submitted to the course coordinator visibly clipped on to the cover sheet of your final paper . The summary should consist of:
•a cover sheet summarizing all the project expenses incurred;
only those expenses which were planned-for and approved-of in the proposal budget should be included;
•an attachment of all ORIGINAL (not copies) receipts matching these expenses;
•the name and address of ONE individual in the group to whom the the reimbursement cheque should be made out to. This individual will be responsible for dividing the cheque up amongst the rest of the group; and
•indicate whether you will pick your cheque up at the CMCC Accounting Office, or whether you prefer to have the cheque mailed to you; if the latter, then include the mailing address.
From the time your summary is submitted to the course coordinator to the time the CMCC Accounting Office has your cheque ready may require 2 weeks. If your cheque is not ready within 2 weeks, please notify the course coordinator via e-mail.
Final Paper Layout:
Case Report
•NO POINT FORM
•DOUBLE SPACE
•PAGINATE
Cover Page
The cover-page should have the following information on it:
2003 CMCC RM4402
Student Investigative Project
Final Paper
TITLE OF THE STUDY:
:
CASE REPORT
student investigators:
CONTACT STUDENT NAME,
E-MAIL ADDRESS AND TELEPHONE #:
faculty supervisor NAME:
FACULTY SUPERVISOR
E-MAIL ADDRESS AND TELEPHONE #:
FACULTY SUPERVISOR
SIGNATURE & DATE OF SIGNATURE:
Abstract
• Change future tense to past tense.
• Briefly describe the case and what was unusual about it or the intervention administered.
• Briefly describe the outcomes.
• KEYWORDS [i.e. key indexing terms: MeSH and text words used in the literature search]
Introduction
• Change future tense to past tense.
• Describe how this case differs from the norm.
• Move the bulk of the literature review to the Discussion section. [This is one area where a case report differs from non-case reports.]
Case Report
•This is section was NOT in the proposal, and is another departure from the non-case report format.
• A chronological description of the case is presented here. While the description should be fairly detailed, it should only include information and findings/outcomes relevant to the focal complaint and intervention/management.
Discussion
Please start this section on a fresh page, and address the following points:
•Explain what your findings/results mean, and how they affect the significance of this case.
•Offer a theoretical explanation about why the results turned out the way they did.
•Discuss how your results compare to previous studies; the Discussion section is also where the bulk of the literature review is presented.
•Discuss the clinical and/or research (further study) implications of the findings.
•Theorize over the limitations of the study (methods & materials); include a discussion about any methodological problems you encountered and how these might be addressed in future study.
•Make recommendations regarding further study. (One recommendation may be that further study is NOT recommended!)
•Describe what the clinician should learn from this case and be able to incorporate [or NOT incorporate or only incorporate with caution] into his/her own plan of management when encountering a similar case.
Conclusion
•Reiterate the importance and limitations of the case and the main teaching points.
•Summarize any recommendations for further study.
Acknowledgements
•Same as for non-case report.
References
Please start this section on a fresh page, and list and number all your references in alphabetical order by principal author.
Make sure that the reference numbers in this section correspond to the reference numbers in the body of text.
Please follow the Vancouver format illustrated below:
Journal: 1. Sackett DL, How to read clinical journals: I. Why to read them and how to start reading them critically. Canadian Medical Association Journal 1981; 124: 555-558.
Textbook: 2. Eisen HN, Immunology: an introduction to molecular and cellular principles of the immune response. 5th ed. New York. Harper & Row, 1974: 406.
Appendices
Please ensure that each Appendix starts on a fresh page, and that an Appendix is incorporated under the following circumstances:
•Attach your ELECTRONIC LITERATURE SEARCH STRATEGY as "APPENDIX 1";
•If you administered a questionnaire, include a copy.
Summary of Expenses for Reimbursement
Your expense summary should be submitted to the course coordinator visibly clipped on to the cover sheet of your final paper . The summary should consist of:
•a cover sheet summarizing all the project expenses incurred;
only those expenses which were planned-for and approved-of in the proposal budget should be included;
•an attachment of all ORIGINAL (not copies) receipts matching these expenses;
•the name and address of ONE individual in the group to whom the the reimbursement cheque should be made out to. This individual will be responsible for dividing the cheque up amongst the rest of the group; and
•indicate whether you will pick your cheque up at the CMCC Accounting Office, or whether you prefer to have the cheque mailed to you; if the latter, then include the mailing address.
From the time your summary is submitted to the course coordinator to the time the CMCC Accounting Office has your cheque ready may require 2 weeks. If your cheque is not ready within 2 weeks, please notify the course coordinator via e-mail.
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A date is required. Both the participant and the investigator need to sign. If parental consent is required add that too.
This wraps everything up. If it’s a long or complex consent form, this helps. If it’s short, some of these statements probably wouldn’t be necessary.
Describe the conditions of participation.
A bulleted list is used
to improve readability
Describe in detail how privacy and confidentiality will be protected.
Describe any compensation. If there’s none, say so.
A clear description of the benefit to the participant and the population at large. Be realistic. Don’t go beyond what your study is trying to do.
A clear description of the risks involved in the study. In this case they’re minimal. List all the risks that could be involved. If you’re not sure, say so.
A clear description of the study and what will happen to the participant. The whole consent form rates at Grade 6’ish (partly because of the headings).
This section provides an explanation of why the study is being done and why the person is being asked to take part.
The qualifications of the investigators
Investigators names
The title of the study
A sample heading identifying who is doing the study sponsor
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