California State University, San Bernardino



*Please note, this is template to help you prepare your IRB application but you will still need to submit everything through the online Cayuse system.PROJECT REVIEW:The Faculty Adviser(s), Student Researcher(s), and External Researcher(s) MUST complete the CITI Course in Human Subjects Online Training before submitting IRB application. All researchers (investigators, key personnel, and other involved in the study) must include a completed copy of your CITI Training Completion report with the IRB application. The IRB training should be completed before completing the IRB application. Please attach your CITI human participants (subjects) training completion report in section 15 under CITI Human Subjects Training.Note: Regarding the new online IRB application system (Cayuse IRB). CSUSB faculty will have direct access to the online application. Use the People Finder tool which allows you to search for faculty by inputting their names which automatically populates the investigator/researcher into the IRB application. You can enter multiple faculty members if more than one investigator is involved in the research study. User Access Issues: The most common user access issue is when a student has both a student email () and CSUSB staff email (studentid@coyote.csusb.edu). When you attempt to log-in the system will give you an errorstudentname@csusb.edu message. Please send the error message using the print screen (PrtScn) function and send it to Mr. Adam Beam at or Mr. Michael Gillespie atAdam.Beam@csusb.edumgillesp@csusb.edu. If the problem persists you would need to contact Cayuse User Support at or by sending Cayuse an email at . You may also contact Cayuse User Support directly atsupport@1-503-297-2108 ext. 1 or 1-877-689-3661 to assist you with Cayuse IRB access issues.On Being A Scientist: A Guide To The Responsible Conduct of Research: "The responsible conduct of research guide highlights 3 important obligations that motivate their(scientists/researchers) adherence to professional standards. "First, researchers have an obligation to honor the trust that their colleagues place in theme." "Second, researchers have an obligation to themselves." "Third, because scientific results greatly influence society, researchers have an obligation to act in ways that serve the public."(On Being A Scientist: A Guide to Responsible Conduct of Research (2009, p. 2). The publication is free for download at the following website: IRB Committee are you asking to review this IRB application/protocol? (i.e., Main IRB Committee, Department of Psychology IRB Sub-Committee, or Social Work IRB Sub-Committee). Please ensure you select the appropriate IRB reviewers for your protocol as this will delay the processing and review of your IRB application. The Main (primary) IRB reviews administrative (exempt) , expedited and full board human subject protocols. The Main IRB Committee has designated primary reviewers for the Department of Psychology and the School of Social Work. The primary reviewers in Psychology and Social Work may only review administrative(exempt) and expedited review human subjects protocols.Main IRB CommitteeDepartment of Psychology Designated IRB ReviewersSchool of Social Work Designated IRB Reviewers2. DATA COLLECTION DATES:Please enter the data collection start and end date on the day you submit your IRB application. The data collection dates must give time for the IRB to review your protocol. Please allow two weeks from the date you submit your IRB application in for Administrative(Exempt) or Expedited Review and one month for Full Board Review. For (Example: if today's date was June 1, 2XXX please use June 16, 2XXX (15 days) as the start date for Administrative (Exempt) and Expedited Review and if your submitting under Full Board review use July 1, 2XXX as the start date). From:To:3. INVESTIGATOR(S):If you're a student investigator/researcher, did your faculty advisor review your IRB application and provide approval for you to submit the IRB application?YesNoPrincipal Investigator(Contact info needed- college, address, phone number, email)What is your status at CSUSB?StudentFacultyStaffOtherWhat college are you in? (i.e. College of Social and Behavioral Sciences, College of Education, College of Natural Sciences, College of Arts and Letters, College of Extended Learning)What is the name of your department? (i.e., Psychology, Teachers Education and Foundations, Biology, English, etc....)For students (or faculty who are teaching courses) this research is for: Graduate Thesis (master?s)Independent StudyDissertation (doctoral)Course: Project (master?s)Other: (describe other project here)Co-Principal Investigator(s)(Contact info here)Other InvestigatorsAdd additional Investigators here: Phone # (if not listed above)Primary Contact for this study (may be the same as the PI):Phone # (if not listed above)Add additional investigator's in the text box below (faculty, student's, other) if needed. Include their first and last name and contact information (email addresses).4. PARTICIPANTS:(approximate number in all applicable categories):Number of Participants ProposedNumber of participants proposed:Demographic Information: FemaleMaleOtherChildren (17 or younger)Adults (18 years of age or older)Patients in institutionsCSUSB studentsPrisonersFaculty or external reviewersPregnant womenChild Development CenterOther5. FUNDING:Grant Funding Questions Are you seeking funding for this research?NoYesOnly enter project period start and end date if you selected yes above. Please enter the name of the funding agency (federal, state, or local) in the text box below. Project period from Project period to Does the funding agency require IRB approval?NoYesN/A6. REVIEW CATEGORY: Please mark all items that apply.Note: Most research with children cannot be reviewed under Administrative (Exempt) review. The protocol would require either Expedited or Full Board review. See OHRP regulations. Administrative (Exempt) Review (based on the following categories):Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii)any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b) (2) of this section, if:(i) the human subjects are elected or appointed public officials or candidates for public office; or (ii)federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.Expedited Review ():See OHRP Expedited Review Criteria ListCollection of data from voice, digital, or image recordings made for research purposesModerate exercise, muscular strength testing, body composition and flexibility testing from healthy volunteers (excludes x-rays, or microwaves)Non-manipulative, non-stressful research on individual or group behavior Collection of biological specimens by noninvasive means (see full list at link below)Collection of blood samples by finger prick, heel stick, ear stick or venipunctureStudy of existing data, documents, records, or pathological or diagnostic specimensOtherFull Board Review: Involves vulnerable populations including children, prisoners, pregnant women, neonates, and fetuses.7. AFFIRMATION OF COMPLIANCE:Note: Faculty and Student investigators/researchers are required to notify the IRB of substantive changes to protocol, unanticipated adverse, or serious events are experienced by participants. . Projects lasting longer than one year require an annual request for Continuation (Protocol Renewal). If the project has ended within the IRB's one year approval period no further action is required by the investigator/researcher. Please note that non-compliance with the requirements of reporting to the IRB the items noted above may result in disciplinary action under the University Policy on Misconduct in Research and The consent forms and data must be kept at least three years after the study Authorship ends. I agree to follow the procedures outlined herein and to ensure that the rights and welfare of human participants will be protected. I will commence the study only after receiving approval from the IRB (or departmental Human Participants Review Board) and having complied with required modifications. I will promptly report additions, changes, or problems involving the rights or welfare of human participants to the IRB by contacting the Research Compliance Officer at . If the project continues for more than one year from themgillesp@csusb.edu approval date I will submit the required renewal form to the IRB for review and approval. Please note the Cayuse IRB system will notify you when your project if up for renewal at 90,60, and 30 days before the research study's protocol approval end date. I affirm that I have read and reviewed the accuracy of this application and accept responsibility for the ethical conduct of this research, supervision of human participants, and maintenance of data and informed consent documentation as required by the IRB.As the faculty advisor on this research study I agree by my certification (via CSUSB Cayuse take responsibility for oversight and research conduct of this study, including any toIRB)Co-Principal Investigator(s) and Other Investigators named in the investigators section of this IRB application.Signature of Principal Investigator:I, the investigator/researcher, agree to the Affirmation of Compliance requirements above.Please select YES below to proceed.YesNoSignature of Co-Investigator:APPROVAL OF FACULTY ADVISOR OR SPONSOR: The Faculty Advisor(s) named in Section 3: Investigators above in this submission record agrees by their certification (via CSUSB Cayuse IRB ) to the Affirmation Statement below:I affirm that I have proofread and reviewed the accuracy of this application and accept responsibility for the ethical conduct of research, student supervision, and documentation maintenance. (Copy and paste additional faculty advisor approval signatures and contact information lines as needed below.)I agree to follow the procedures outlined herein for my student(s) and to ensure that the rights and welfare of human participants are properly protected. I will ensure the study does not commence until the study has been approved by the CSUSB IRB or from the Psychologyor Social Work IRB committees (administrative and expedited review approval only) and having complied with required modifications. I will promptly report additions, changes, or problems involving the rights or welfare of human participants to the IRB by contacting the Research Compliance Officer at . If the project continues for more thanmgillesp@csusb.edu one year from the approval date, I will submit the required documentation. (Cut and paste additional faculty advisor signature lines as needed)APPROVAL OF LICENSED PHYSICIANThis signature is required only if the project involves medical procedures and neither the investigator nor the faculty advisor is a licensed physician. Printed Name of Physician E-mail Address Phone Please upload a signed approval memo or form from the Physician listed above.8. RECRUITMENT OF PARTICIPANTS:Include your recruitment of participants information below.Describe sources of potential participants, how they will be selected and recruited, and how and where you will contact them. Include all relevant characteristics with regard to age, ethnicity, sex, institutional status (i.e., patients or prisoners), and general state of physical and mental health.Note: Recruitment issues can be especially critical when any federally defined vulnerable population's are involved in your research. These vulnerable populations include fetuses, pregnant women, prisoners, and children.Please note there are populations not defined by the federal regulations who may also be at risk by participating in a research study(this list is not all inclusive). These may includes those who are institutionalized such as in mental or behavioral health facilities. Person's that live in nursing homes or who may be in a chemical dependency center, half-way house, or assisted living facility. Other participants who may be at higher risk for participating in research studies may include the LGBTQ community, the poor, homeless, immigrants, and those who's cooperation in the research study may be dependent upon a guardian or advocate. Therefore, it is critical that you know and understand the population(s) you wish to study and provide adequate protections based on the degree of risk to those proposed participants.Insert text here:9. DESCRIPTION OF THE PROJECT:Include the description of the project section below.Briefly describe the objectives and methodology of your research (including hypothesis and/or research questions), data collection procedures, and features of the research design that involve specific procedures or special conditions for participants (including frequency, duration, and location of participation).Include your project description first before proceeding to the subheadings below (the project description should be from 3 paragraphs to 1 page in length).Once you have completed the project description it would be most helpful to organize this section with the following sub-headings with the highly recommended page lengths noted below: Background of Theory and/or Literature Review: 1 to 1 1/2 pages in length:Objectives of the study: 1/2 to 1 page in length:Hypothesis or Research Questions: 1/2 to 1 page in length:Methodology (the design of the study): 1/2 to 1 page in length:Data Collection (the who, what, when, where, and how you will collect the data): 1 to 3pages in length:Data Analysis (the statistical, qualitative (i.e., ethnographic, phenomenological, grounded theory, narrative, or case study) quantitative, and/or mixed methods you will use to analyze the data including statistical software such as SPSS): 1 to 2 pages in length:Dissemination (how will you present and publish your research: this includes presenting at a conference, publishing in a journal, thesis, or dissertation, etc...): 1/2 to 1 page in length:10. CONFIDENTIALITY OF DATA:Include the confidentiality of data section below.Clearly indicate specific procedures (e.g., coding of responses, aggregate reporting, etc.) to protect the confidentiality of participants and safeguard identifiable records and data. This includes safe and secure storage of the collected information and when the data will be destroyed after the data collection process has been completed. If not possible, state why. Again, this is the how, what, when, where, and how you will store and secure the data you have collected. If collecting your data through interviews or focus groups be specific as to the type of recordings (i.e., audio, video, photograph) and type of recording devices used (i.e., analog or digital). If transferring from analog (tape recordings) how will you transcribe the data and what will you do with the tape recordings after transcription. Also include how you will destroy the tape recording after transcription (i.e., demagnetize, shred, etc...). If digital recordings are used how will you be transferring the data from the digital recording device to a computer and what will be done with the data on the digital recording device after you have downloaded the data to the computer (i.e., data will be erased, deleted, etc...)Insert text here:11. RISKS AND BENEFITS:Include the risk and benefits section below. Describe in detail any immediate, short-term, or long-range risks that may arise for participants as a result of procedures associated with your study. Risks may be physical, psychological, social, legal, or economic; they would include side effects, risks of placebo, delay in customary treatment, etc. Indicate any precautions that will be taken to minimize risks. Also indicate any anticipated benefits to participants and/or society from the knowledge that may reasonably be expected to result from the study. Risks and benefits MUST BE included in the protocol and in the informed consent document. Insert text here:12. INFORMED CONSENT:Informed consent is usually written; however, in some circumstances it may be oral or electronic in nature. Waivers of informed consent may be granted under certain limited conditions, and any request for such should include explicit justification. Remember that the informed consent should be unique to each study being proposed and should also be written at the 6th to 8th grade reading level or lower if needed. (An example of an informed consent format is provided on the IRB website. You do not have to follow the example format but it must include the federal required below in items a through i).The IRB requires a text of the proposed statement to be used for oral or electronic consent. Like written consent, they should include: a. Identification of the researcher(s)b. The nature and purpose of the study c. Expected duration of participant involvement d. How confidentiality or anonymity will be maintained e. The voluntary nature of participation f. Participants right to withdraw at any time without penalty g. Information about foreseeable risks and benefits (or none)h. Contact information for questions or additional information i. First paragraph should have a statement that the research has been approved by the Institutional Review Board of California State University, San Bernardino. The Informed Consent or text for oral consent must be provided to the IRB in the attachments section on the faculty member's/faculty adviser's office letterhead. If you are a student, your faculty adviser may be able to provide you with their office letterhead in a digital For(electronic) format so you can cut and paste your consent document onto the letterhead. non-English-speaking participants, be sure to include an accurate translation. See sample informed consent forms and checklist at or you may visit the IRB website OHRP websiteCopy and paste Informed Consent text here and will also need to attach document in online submission:13. CHILD ASSENT:Assent is defined by the regulations as follows: Assent means--a childs affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. (See federal regulation at 45 CFR 46.402 (b)) and OHRP questions and answers at )This means the child must actively show his or her willingness to participate in the research, rather than just complying with directions to participate and not resisting in any way. When judging whether children are capable of assent, the Institutional Review Board (IRB) is charged with taking into account the ages, maturity, and psychological state of the children involved. The IRB has the discretion to judge the child's capacity to assent for all the children involved in a proposed research activity, or on an individual basis. A child assent example is provided on the IRB website under the forms menu.Copy and paste Child Assent text here and will also need to attach document in online submission:14. DEBRIEFING STATEMENT:A debriefing statement is usually required only if any type of deception is used in the study. Participants may also be debriefed about their behavioral response(s) to the study. The two major goals of debriefing are de-hoaxing and de-sensitizing. Any undesirable influence the study may have on participants should be minimized or eliminated.The debriefing statement should describe the reason(s) for conducting the research, how participants can obtain results of the study, and contact information for additional details or answers to questions. Any potential predictions about study outcomes should be non-directional. It would also be advisable, for methodological purposes, to request that participants not reveal the nature of the study to other potential participants. Note that debriefing is normally only used when deception is utilized in the research otherwise it does not need to be included. If you are a student researcher please check with your faculty advisor on whether you should include a debriefing statement.Also, some researchers use an information form at the end to include relevant follow-up contact information of the faculty or student investigator(s). This may also include additional information for counseling services or emergency hotline numbers for those experiencing distress after a research/study procedure has ended and results in the participant recalling past instances of psychological or physical trauma. You may include an information or emergency contact form (so titled) if needed but please refer to your faculty advisor if you area student researcherCopy and paste Debriefing text here and will also need to attach document in online submission:15. ATTACHMENTS: All relevant project materials and documents, includingInclude attachments on the online submission.CITI Online Human Participants Training Completion Report for ALL researchers involvedInformed ConsentChild Assent Surveys, questionnaires, and measurement instrumentsLetters of approval/permission on letterhead from cooperating agencies, schools, board of education, school districts, and other agencies. If you're a student investigator/researcher you must attach your faculty advisor's approval letter, memo, or email as well as any additional approval/permission letters needed as described in this section.Debriefing statement or explanation sheet if applicableParticipant recruitment materials (e.g., fliers, advertisements)Other attachments ................
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