Application for Initial IRB Review of Research Protocol



Initial Application for University of University Institutional Review Board ReviewBottom of FormPART A – To Be Completed for ALL CATEGORIES of ResearchApplication for Initial IRB Review of Research ProtocolPART A – To Be Completed For ALL CATEGORIES of ResearchGeneral InstructionsThe Institutional Review Board (IRB) Application becomes the permanent record of the compliance of the investigator(s) with laws and regulations protecting the rights and welfare of human participants in research. Sufficient detail of the proposed protocol must be included to permit the University of University (ULV) IRB to render a decision about whether the safeguards in the research protocol protect the rights and welfare of human participants and benefits justify any risks. Applications with insufficient detail will be returned to the applicant, without review.As of September 1, 2016, the ULV IRB has transitioned to electronic submissions through the IRBManager software. This form is intended to be used as a teaching tool, for senior thesis, and/or to organize your study. Please visit the IRB website for further instructions about submitting your ULV IRB application through IRBManager, which is similar enough that many of these answers can be copied and pasted into IRBManager. Visit the ULV IRB website for IRB forms, examples, and templates, and application guidance documents. Student researchers must obtain faculty advisor/mentor approval prior to ULV IRB submission. Researchers must complete human subjects training prior to conducting research. Please check the ULV IRB website for further information. Consult the website or your research supervisor/advisor/mentor for more information on research protocols that may be considered exempt, qualify for expedited review, or require full standard ULV IRB review.Additional information is available on the website on how to compile and submit your application. InformationTitle of proposed research study: (All titles should be in standard mixed case, where the first letter of each word is capitalized and followed by lower case letters.)The Freshmen 15 InterventionResearcher’s Assurance: I certify that the information provided in this application is complete and correct. I understand that as principal investigator (researcher), I have ultimate responsibility for the conduct of the study, adherence to ethical standards, and protection of the rights and welfare of human participants. I agree to: (1) conduct the study according to the approved protocol; (2) make no changes to the approved study without prior ULV IRB approval; (3) use the approved procedure and form(s) for obtaining informed consent; and, (4) promptly report any significant adverse events to the ULV IRB within five working days of occurrence.Arthur DoyleAugust 9, 2015Researcher’s Name DateFaculty Advisor/Sponsor’s Assurance: By my approval by either electronic signature below or email with the application, the advisor/mentor certifies that the student or guest researcher has sufficient knowledge to conduct the study in keeping with the protection of human participants. Further, the advisor/mentor agrees to: (1) monitor study progress; (2) supervise the researcher in solving problems in the research as they arise; (3) ensure that the researcher promptly reports significant adverse events; (4) identifies an alternate advisor/mentor or sponsor in the event that the current is unavailable (on leave or sabbatical) and advises the ULV IRB in writing of such arrangements.Advisor/Mentor/Supervisor/Sponsor Name DateType of Application:xNew ProposalModified Protocol/Application Resubmission (Research Project No.____________)Principal Researcher Position:xProfessor/Faculty Doctoral Student ………………………………………Anticipated GraduationMaster’s Student ……………………………………….Anticipated GraduationUndergraduate ………………………………………...Anticipated GraduationOther (write in ULV or external position): Principal Researcher’s Affiliation:xCollege of Arts and Sciences……………………………Program/MajorKinesiologyCollege of Business and Public Management…………..ProgramCollege of Education and Organizational Leadership…..ProgramCollege of LawOther (write in ULV or external affiliation): 6.Principal Researcher’s Contact Information:Name:Arthur DoyleDaytime Phone:(123)456-7891E-mail Address:professordoyle@University.eduResearch Assistants:Name:Sherlock HolmesDegree: B.S.Daytime Phone:987-654-3214E-mail Address: Sherlock.holmes@University.eduName:John WatsonDegree: B.S.Daytime Phone:876-564-6542E-mail Address: John.watson@univeristy.eduIf Student, ULV Advisor/Mentor/Supervisor Contact Information; ORIf External Researcher, Contact Information:Name:Daytime Phone:External Researcher Institution:External Researcher ULV Contact:Check the category that applies to your research:ULV Doctoral DissertationULV Masters Thesis/ProjectULV Undergraduate Research/Senior ProjectULV Graduate Student Research Project (non-degree)xULV Faculty or Staff Professional/Academic ResearchULV Institution or Program ResearchOutside Research by External ULV ResearcherBriefly describe the purpose(s) of the study (Give as many details as possible for study purpose. Include research questions and key variables):Young adults exhibit an increasing prevalence of obesity, linked to metabolic disturbances that may contribute to increased risk of type II diabetes, cardiovascular heart disease, and other conditions later in life. Obesity rates have been shown to increase within the first year on a college campus in both males and females at both a state and private University in the US. Recently lower BMI levels were seen following 6 weeks of feedback incorporating an internet intervention in college age first year students. Therefore, the focus of this study is to observe the impact of the academic semester in addition to an intervention group obtaining four 1-hour health (once a month) and wellness seminars on the following variables: dietary intake and behaviors, physical activity habits, body composition measurements, and medical history and lifestyle (caloric education, socioeconomic status, physical activity, etc.) behaviors in young male and female first year college students within the first academic semester (Fall 2015 – December 2015) on the University main campus. It is hypothesized that first year resident students who attend the monthly seminars (Group 1) will result in a positive impact on their health in regards to their body composition values (Group 2). It is also hypothesized that for group 2 an intervention of lecture health based seminars (see attached summaries of activities for young first year college students (18-20 years) who are residents on the main campus will result in possible weight loss or maintenance ultimately reducing their potential risk for disease later in life in order to lead a possible healthy life. Protocol Methods/ProceduresDescribe the maximum expected sample size and characteristics of the sample of human participants: (Please make sure to include all characteristics associated with population (e.g. age range, total number of participants, gender, inclusion or exclusion criteria, how you plan to gain access to the potential participants, etc.)Group1: 650 first year college students (male and female) are expected to complete the electronic survey portion of this study. Participants will be asked for their University Student ID number. Group 2: 300 young (18-20 years) first year college student residents in Baker and Conan dormitories (male and female) will be recruited for this 1 semester intervention study following initial screening procedures including exclusion criteria, see below.Total number of expected participants: 650 first year University studentsExclusion Criteria: Participants will be unable to participate if they are found to have any of the following at the time of study participation: under the age of 18 years or over the age of 20 years, sophomore, junior, or senior status, previously enrolled in classes on the University campus, pregnant or planning on becoming pregnant, non-resident at University Baker and Conan dormitories (Group 2). Research staff will review this list of exclusion criteria with each participant at the time of consent in order to identify eligibilityPlease check any of the following “vulnerable populations” included in your sample (Proposing to study any of these populations may require full ULV IRB review completion of Part B questions):Children/Minors (if children are involved state age, legal parent/guardianship status)Persons with Intellectual or Developmental Disabilities Frail Older AdultsAdults or Legal Guardians of individuals with Physical Disability or Mental IllnessAdults with legal guardiansPeople who are economically or educationally disadvantaged Other special populations (prisoners, pregnant women, patients, undocumented individuals, etc.) 11. Describe how participants will be recruited or selected: (From what source(s), i.e., hospital, institution, school, class, shopping mall, etc.? Attach letters of permission from all participating organizations/off site locations on their official letterhead and/or IRB approval from the organization related to recruitment. Will you be naming the organization in the presentation/publication/dissemination of the findings? If so, seek out permission to use the organizational name. Attach any recruitment materials in final form, e.g., letters, postcards, flyers, for ULV IRB review and approval.)University, Main Campus, first year studentsUniversity, Main Campus, first year student residents at Baker and Conan DormitoriesThe PI (Dr. Arthur Doyle) and research assistants (Sherlock Holmes and John Watson) will be responsible for recruitment, retention and coordination of subjects. Recruitment strategies include:Group 1: Mass email survey to all incoming first year University students. The email will include an active Qualtrics survey link (Active survey link here) sent by the University Housing and Residential Life office of Baker and Conan dormitories. (See Attached Proposed Email)Group 2: Baker and Conan dormitory group information session (5-10 minutes), on site freshmen orientation recruiting. Group presentations will include a brief overview of the study (similar to the description provided in the Informed Consent), and will provide interested individuals with information to contact the researchers if they wish to participate or receive more information regarding the study.Permission has been obtained from the Housing and Residential Life and is provided as an attachment.All data collection will occur on the University main campus either in the Baker and Conan dormitories and/or in main campus lecture halls. The Housing and Residential Life will be responsible for setting the location for the monthly health and wellness seminars. 12. Data will be collected by:Mail Survey/QuestionnaireTelephone Survey/InterviewIn-person InterviewxIn-person QuestionnaireObservationxExperimental Procedure – direct measure/self reportStandardized/Educational TestArchival or Secondary Data Source (abstracted/analyzed)xParticipant ObservationSound/Video Recording and Content AnalysisFocus Group InterviewxElectronic SurveyOther13. What will you do with the human participants? (Describe in detail all the methods and procedures that involve human participants. This section should help the ULV IRB Committee understand from initial contact to completion of the research protocol what will happen to participants and is the most important part of your application. State the following in chronological order: 1) what the participants will be asked to do, 2) where the research will occur, 3) what measures will be used (e.g. test), 4) what data and information will be collected and how, 5) whether participants will be identified (further elaborated on in the confidentiality section), 6) whether participants will receive an incentive to participate and if so describe, and 7) how long it will take to complete the instrument and/or task (if multiple items, break down by item). Please provide us with a link to the electronic survey and a PDF copy of the final version.There will be three parts/groups to the study: Group 1: Mass Email- Electronic survey through Qualtrics (University Student IDs will be collected) to all University first year students (650 students). Survey will ask about basic demographics, medical and lifestyle history and will include questions in regards to psychological, social, and environmental information.Group 2: A small group (approximately 300 students) of first year students who will consent to a series of body composition and dietary intake data collection pre and post-16 weeks. Group 2 participants will be asked to provide their University student ID number in order to link their Qualtrics survey responses (from Group 1).This research study will be working in conjunction with resident life and permissions have been obtained (see attached). Only first year residents of Baker and Conan Dormitories will be eligible to participate in Group 2 procedures. All study participants (Groups 1-2) will be blinded from their results (surveys, body composition, physical activity, etc. throughout the study). The following steps will occur:After IRB approval, a recruitment email that will contain study information and a link to an electronic survey will be emailed to all first year students from the Housing and Residential Life office. If this study does not receive ULV IRB approval in time to meet the Housing and Residential Life office’s freshmen orientation schedule, the recruitment email will be sent out as a mass email from the researchers, with permission from University IT, once IRB approval is granted. The research team will not have access to these email addresses. The survey will collect basic demographic information and will contain medical and lifestyle history questions (see attached). University Student ID numbers will be collected, however, the data will be analyzed in aggregate form except for Group 2 participants (who will also take the same survey). Group 2 participants will be selected from the data in order to be able to link and analyze Group 2 participant’s answers with body composition, physical activity, and dietary behavior. The survey will contain a consent form where they will choose to agree or disagree to take the study. Only students between the ages of 18-20 are eligible to participate. The survey will have 163 questions and should take about 45 minutes to complete. On August 24th, the first official floor meeting of both dormitories, the research group will be providing a 5-minute recruitment presentation at each dormitory. The residents will be informed about the Group 2 study where they will be asked to consent for pre and post 16-weeks body composition data collection and lecture seminar attendance. An “I am interested and would like more information” sheet will be available for the group to sign up (name and email address) once the researchers leave the dormitories. Researcher’s contact information will also be available to the residents. Once residents reach out to the researchers and vice versa, the researchers will set up a time for interested students to meet on a specific day of their orientation weekend (see step 3) to conduct the consenting and surveying process. Any students not wishing to participate in the research study will still be eligible for all housing activities.Between August 25 and September 25, the researchers will be set up at a table for recruitment for Group 2 purposes as dorm related events or within the dorm itself. Consenting (paper) and surveying (electronic through iPADs) can be completed at this time. All Group 2 participants will be asked to read and sign a consent form before collecting any data (see attached). For consenting or data collection purposes, privacy areas will be set up. Data collection for Group 2 will occur at set times and days that work for the consenting participants. Data collection will occur in either Baker or Conan. This will be the same process for pre and post 16-week data collection. Data collection specifics are below.Body composition scales will be locked in the dormitories (for the entire semester) and each Group 2 participant will be assigned a specific profile to a scale. Scales can hold 8 unique profiles for each individual. For pre and post 16-week data collection, Group 2 participants will be using their assigned scale each time they self-weigh in. Group 2 participants will have the ability to step on the scale any time they want in between pre and post data collection but participants will not be able to see any data collected including body composition until the study is complete. Data for all participants linked to a scale will be electronically sent to the researchers. The scales are linked to a health tracking app provided by Withings. An account will be made for each scale and Group 2 participants will not have the ability to view results, only the designated research team. All group 2 participants will be assigned a study ID number and the scale results will be linked to that study ID separate from any other demographic details. Group 2 participants will be asked to attend four 1.5-hour seminars throughout the semester (more details below) if they wish, however, since the seminars are a part of the dormitory program and they have the option to attend other seminars (not related to this study) it is not guaranteed that all of Group 2 participants will attend this study’s seminars. Therefore, attendance (University student ID number) will be taken (by the dormitory assigned Resident Advisor) at each seminar and the researchers will be able to track how many of the study’s seminars each Group 2 participant attends. Once a month, a 1.5-hour health and wellness seminar will be led by a faculty member on the research team. All Group 2 participants are encouraged to attend, however, all seminars will be open to all Conan and Baker residents regardless of age or academic standing. Due to this, Resident Advisors will be taking attendance at each of this study’s seminars (a usual practice regardless of this study). The Resident Advisors will give the attendance list to the research team in order to track the attendance of Group 2 participants. Summaries of the seminars are below.1.5-hour health and wellness seminars (total of 4):Seminar #1 (September) [Redacted: Brief Seminar Summary]Seminar #2 (October) [Redacted: Brief Seminar Summary]Seminar #3- (November)[Redacted: Brief Seminar Summary]Seminar #4-(December) -[Redacted: Brief Seminar Summary]Data Collection:Group 1) Online questionnaire through the use of Qualtrics. This will be distributed through a mass email to all first year University students either from the Housing and Residential Life office or through permissions from University it (mass email submission form).Group 2) An introductory session (in which Informed Consent is obtained) involving body composition measurements, self-report inventories which includes: current dietary intake (paper/pen format), medical and lifestyle history, and fitness/dietary behaviors, will be conducted in the Conan and Brandy dormitories on the University main campus will occur for Group 2. A post 16-week observational study design will be implemented with a final (follow-up) testing session at the same time of day encompassing body composition measurements and self-report current dietary intake and behaviors questionnaires for Group 2. Breakdown:Body composition (scale)Surveys (demographics, health and lifestyle)Caloric intake (through the use of paper diet diaries for 3-days only pre and post 16-weeks)More specifically, the body composition testing will include the following: body mass, percent body fat, fat free mass, fat mass, etc. using an electronic scale (Withings Body Scale) that will be locked down but available for use in the dormitories and then waist and hip girths will be measured using a standard tape measure. All participants will be instructed on how to operate the scale when self-weighing. Waist circumference will be measured between the lower margin of the last palpable rib and the top of the iliac crest; hip circumference will be taken around the widest portion of the gluteals. Female participants will be asked to provide the research team with menstrual cycle phase status and total number of days within a cycle for body composition purposes. Since the Withings Body Scale is connected to WiFi, data is automatically logged on the Withings body scale app. In this app, each person assigned to the scale (8 participants per scale) will be linked to a study ID number, no identifiable information will be provided in the scale itself. Only the researchers will have access to this data through the Withings Body Scale app (online account). Group 2 participants will be blinded of their data until the end of the study. Photographing Participants:Participants will be asked a yes or no question on the informed consent as to whether they agree or not to allow the research staff to take a photo during testing for presentation purposes ONLY.14. State when (approximate dates) and where the activities involving human participants will take place. (State when (approximate dates) and where the activities involving human participants will take place. The beginning date must be after approval by IRB. If location(s) require permission(s), please attach authorization letters. For on campus research use "ULV," otherwise state location. Will the research take place at a location off-campus (any ULV campus) that may require permissions? Examples could include, school districts, institutions of higher education, businesses, etc. This is different than recruitment locations.) Start Date: Late August 2016End Date: June 2017Locations: University of University-Main Campus15. List the titles of any tests, questionnaires, or other instruments to be used that were developed by another person, along with the source where you obtained the material. Attach copies of all these materials and evidence of permission to use the material (i.e., purchase invoice, letter or e-mail from author or publisher, general permission on a website, PsycTests, Creative Commons license). If security or copyright prohibits attachment, explain. If none, state “No materials designed by another person are being used for this research.”Eating Behavior Patterns Questionnaire(adapted from Schulundt DG, PhD. Vanderbilt University School of Medicine SODA Questionnaire) (see permissions attached) Permissions Emotion Regulation Questionnaire (ERQ): -The ERQ items are copyright 1998 by Gross and John and are freely available for use at Gross’s website: Personality Inventory (TIPI): -The TIPI is freely available at Gosling’s website: Ethnic Discrimination (GED) Scale: -The GED is presented with permission to use in Landrine, Klonoff, Corral, Fernandez, & Roesch (2006). Depression, Anxiety, Stress Scales (DASS): -The DASS-21 (21-item short-form) is public domain and may be used without restriction from the following website: With Life Scale (SWLS): -The SWLS is in the public domain and does not need permission to use (Pavot & Diener, 1993). According to Pavot and Diener (1993), "The Satisfaction With Life Scale is in the public domain. Permission is not needed to use it" (p. 172). A screenshot of page 172 from their article, including the above quoted text highlighted in yellow, is attached to the survey on the separate Word document.16. List the titles and attach copies of any surveys, tests, assessments, questionnaires, or interviews that you developed. If none, state “No specially designed materials are being used for this research.”Medical History Questionnaire – Arthur DoyleLifestyle Behavior Questions – Arthur DoyleSociology and Environmental influence questions-Arthur Doyle Final electronic survey link: SURVEY LINK17. Are incentives being offered to participants (Will you offer money or other incentives for participants’ time)? NOxYES – What are the incentives?The students will be entered into an opportunistic drawing for the chance of winning 1 of 5 $10 gift cards to the University’s bookstore.18. What level of risk does this research present to the dignity, rights, health, welfare, or privacy of the participants? Consider and identify physical (more than the participant may encounter on a daily basis), psychological (involves a response to participation in a psychological way), social or group risk (when a participant belongs to a group, is employed, or is a student and their status is in jeopardy or impacted by participating or not in the research). No Risk to Participants (may require an Exempt IRB review) – Justify your rating belowxMinimal Risk to Participants (may require an Expedited IRB review) – Justify your rating belowMore than Minimal Risk to Participants (may require a Standard IRB review) – Explain and Specify Risks below (Complete Part B)Identity risk (loss of confidentiality or anonymity)- UNIVERSITY student ID numbers will not be used for any other purpose except linking Group 2 participants with their survey answers. All UNIVERSITY student ID numbers will be kept confidential and destroyed at the end of the study. Group 2 participants’ identity will be kept confidential at all times by the research team. Each participant will be given a study ID number that will be linked to all of the data collected. The key to the study ID and participant name will be kept in a lock file cabinet behind a locked door that only the research team will have access to. Signed consent forms will also be kept in this locked file cabinet, but separate from the data. Psychological or emotional risk (emotional distress, anxiety, etc.)- through the Qualtrics Survey: For the self-report questionnaires, participants may experience minimal discomfort in recalling and responding to survey questions, but not more than they experience in daily life. In those instances, participants will be advised to seek out their personal medical professional (or UNIVERSITY student health services, UNIVERSITY counseling center) to discuss not only the data collected but how to best deal with those values from a healthy living standpoint. The contact details for both services on campus are provided on the consent form. Body composition measurements: During the introductory or testing sessions, participants may experience minimal discomfort with the body composition testing and values but participants able to stop testing procedures at any time and can withdraw from the study at any time. Physical risk (physical exertion, ingestion of supplement, risky medical procedure)- NoneSocial or economic risk (loss of employment or student status, participation impactingacademic grade, etc.)- first year UNIVERSITY students: first year students may feel that they need to participate in this study because they are not yet acclimated to the college life and may feel that participating is required but it is clearly stated in the consent form that participation is voluntary and becoming a study participant, or not, will not affect their standing with the University of University. This is stated in each consent form. 19. Describe the safeguards to protect against or to minimize ANY risk (For minimal or more than minimal):In order to further minimize risk in the study, two referrals are being placed on each consent form in case a participant becomes distressed from any study procedure. Additionally, the referrals are there if a participant, once they receive the data collected from the study, wishes to review the results with a physician for health reasons. Since all students should have access to student health services and the counseling center, the third referral would be their personal health care provider if needed. Pertinent permissions are included as an attachment.Student Health Services 2147 “Z” Street University, CA 91750XXX)XXX-XXXX Counseling Center 2215 Z. StreetUniversity, CA 91750(XXX)XXX-XXXX Psychological Emergency XXX)XXX-XXXX National Suicide Prevention Lifeline1?800?273?TALK (8255)If, as part of your management of risk, you are referring participants to an agency that is not a part of the University of University, please list the name of the agency here and if applicable attach a letter from that agency stating its qualifications and granting you permission to use its name. The ULV IRB requires a minimum of three referrals if you are referring participants to a non-ULV agency. 20. Describe any benefits to the participant(s) that may reasonably be expected from the research, including providing summary of research findings where appropriate, benefits to organizations, professionals, or others.Upon completion of the study, participants can be provided with their health information that was collected as part of the study (percent body fat, body weight, weight gain, dietary intake etc.) in order to review their personal information on their own time with a medical professional (or university student health services, university counseling center). Findings from this study could be used to develop future college health and wellness programs nationwide. Participants will be prompted to request the information from a research study investigator.21. Briefly describe the procedures for protecting the confidentiality of participants both during the project and after the research is completed (include where you will keep and how you will dispose of signed consent forms, if applicable. Signed consent forms must be archived for 3 years after the conclusion of the study). Include any procedures for keeping data secure and the location of secured data.Participants will be assigned a study ID number that will be created once Qualtrics entries have been linked with university Student IDs. after this, all university student id numbers will be destroyed. participants’ names, consent forms, study id numbers, university student id numbers, and data will be stored in a locked drawer in the primary investigator’s, dr. Arthur Doyle, office for three years. de-identified information (only using assigned study id numbers) will be entered into a password-protected excel file on the dr. Arthur Doyle’s computer. all survey data will be kept within the password protected qualtrics server that only the listed researchers have access to. the pi co-pis and research assistants (who have completed nih human subjects training) will have access to the data. dietary intake information will be collected and entered by research study staff into an online nutrition database with a generic research study log on and information entered will be organized by study id. Participants will be asked a yes or no question on the informed consent as to whether they agree or not to allow the research staff to take a photo during testing for presentation purposes ONLY. Care will be taken to block out identifiable characteristics in the photo such as the participants face if they are willing to allow a photo taken during testing. 22. Briefly describe the procedures you will use to obtain informed consent. Attach your proposed consent form(s) and include the text of oral explanations, if applicable, and any additional Informed Consent forms required by other participating organization(s). Explain if participants will be in a confidential location when provided with the consent, if you will go over the consent, and if they will have a chance to ask questions. Also, if collecting surveys in person, state if the consent and surveys will be collected separately so they cannot be re-associated. If Informed Consent is not required, please explain that in more detail here. Applications where consent may not be required can include:1) De-identified secondary data analysis, 2) Direct observation in public places, 3) Educational settings/standardized educational tests, 4) Public/elected officials. See ULV IRB Forms and Examples webpage for template and examples. (See ULV IRB web site for template and examples. Your program or College ULV IRB may also have samples.) xInformed Consent and/or Informed Assent requiredNo Informed Consent Required (provide justification why)xInformed Consent obtained/Information Sheet at the beginning of telephone interview or online survey or research (attach copy of either oral or electronic versions of informed consent.)Request for Waiver of Informed Consent (Complete Section in Part B; review ULV IRB website for explanation of circumstances for this type of informed consent) Group 1: Participants of the electronic Qualtrics survey will be asked to read and agree/disagree to consent before beginning the survey. They will be prompted that by participating or not in the study, their student or housing status will not be in jeopardy.Group 2: Participants will be asked to read and sign their agreement to consent in the body composition/dietary intake/health and wellness seminars study before any data is collected. A PI, co-PI, or research assistant will go over the informed consent form with each participant.A research member will be explaining the informed consent form for each Group 2 potential participant. Each participant will be given keep a copy of the informed consent. All participants will be given the option to ask questions, they will be given ample time to consider participation and the benefits and risks associated with that participation. They can withdraw from the study at any time without any consequences and will be informed of that right prior to participation. The participants will be asked to review the bill of rights for all individuals participating in a research intervention and to sign the informed consent upon agreement of the terms and conditions associated with the study. All participants will be informed that there are three groups within the study based on how much data is collected to alleviate the potential confusion with multiple parameters to the study and each individual’s participation. 23. Will a form of debriefing be needed for this study protocol or for this population? If sensitive issues are raised in the research protocol, or if deception is used, describe the nature of any debriefing of subjects. (If not, state "No debriefing", and justify your decision.)NoChecklist of Attachments for Part A (some may be optional for some applicants)Letter (or email) from agency granting permission to use their name.xLetter (or email) of approval from participating organization on official letterhead or with official title.xCopyrighted tests, questionnaires, etc… and include evidence of permission to use.xAll other specially designed or public domain tests, questionnaires, interview protocols, debriefing etc.xProposed consent (or assent) forms, including text of oral explanations/scriptsxFinal format for online/electronic tests, questionnaires, etc. (link and PDF copy are required)xHuman Subjects Protections Certificate (NIH or CITI) for anyone engaged in the researchPART B To be completed for Standard Review Category Applications or Requests for Waiver of Informed Consent ONLYStandard Full ULV IRB Review Supplemental Questions24. To your knowledge, are there any laws or regulations relevant to the special nature of your population (An example for this would be for research involving minors (USA <18 years) and the fact that they are required to have parental or legal guardian consent prior to participation along with their assent.)? If so, explain how your research design deals with these laws or regulations.NA25. If the study includes participants from vulnerable populations describe how your protocol protects or accommodates their special vulnerabilities. Appropriate additional safeguards are necessary if potentially vulnerable subjects are to be involved in your research. Potentially vulnerable subjects include the elderly, prisoners, children, cognitively impaired people, people who are economically or educationally disadvantaged, pregnant women, neonates, or persons with impaired decisional capacity.For further information and clarification contact your College’s IRB representative or refer to the NIH website on the guidelines for the use of human subjects at . Briefly describe the training and experience that qualifies you to carry out the proposed research that involves more than a minimal risk to participants or includes vulnerable populations (Human subjects training (CITI or NIH Certification), certification in profession or field, experience from internship/practicum, etc.)NARequest for Waiver of Informed ConsentThe ULV IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirement to document informed consent, provided one of the following sets of conditions exists and is documented. The federal regulations do not allow a waiver of informed consent simply because the conditions of informed consent are difficult to carry out or because the conditions make it difficult to enroll subjects into the research. However, the ULV IRB may grant a waiver of informed consent under the following conditions:The research involves no more than minimal risk to the participants; The waiver or alteration will not adversely affect the rights and welfare of the participants; andThe research could not practicably be carried out without the waiver or alteration, and whenever appropriate, the participants will be provided with additional pertinent information after participation. 27. Explain why the proposed research could not be practicably carried out without the proposed waiver or alteration of the informed consent form or procedure.NA28. Describe any protocol for providing participants with additional pertinent information after their participation.NA29. State any risks to participants caused by their participation in this research, and justify that the requested waiver or alteration to usual informed consent procedures will not adversely affect the rights or welfare of the participants.NA ................
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