HUMAN SUBJECT RESEARCH APPLICATION

Transcription

1 FERRIS STATE UNIVERSITY Institutional Review Board for Human Subjects in Research Office of Research and Sponsored Programs 1010 Campus Drive, FLITE 410D, Big Rapids, MI HUMAN SUBJECT RESEARCH APPLICATION FSU IRB Human Subjects Research Application 1 of 10 IRB USE ONLY Rec d: IRB Study #: Category: Rev iewer: Approved: Applications must be submitted via to IRB@ferris.edu. Investigator signatures must be included; typed signatures are NOT acceptable. All Investigators (Faculty and Students) must have completed the appropriate CITI training modules; attach certificate with application. Investigators may not begin data collection without IRB approval. PROJECT TITLE: I. INVESTIGATOR INFORMATION Any full time faculty, part-time faculty, emeriti faculty or other qualified adjunct/affiliate faculty or administrative staff of FSU may serve as the PI. Students may not serve as the PI, but must have a Faculty Advisor who holds responsibility for the project. Students may only serve as s. See Investigator Policies for more details. Principal Investigator/Faculty Advisor Check if this is: Undergrad Project Master s Thesis Ed.D/Ph.D. Dissertation Check if this is: Undergrad Project Master s Thesis Ed.D/Ph.D. Dissertation List any additional investigators at the end of this application and attach CITI certifications.

2 II. SPONSOR AND FUNDING FSU IRB Human Subjects Research Application 2 of 10 A: No Funding sought/obtained: B. University Department/College: C. External Agency/Fund: Applicable Funding Agency/Sponsor (Specify): If applicable, FSU Contracts and Grants App. #: For funded research, a copy of the Grant Award (minus the budgetary information) must be included. If the Grant has not been awarded at the time of IRB submission, a statement must be added to the Abstract Section stating that an Addendum will be submitted once the Grant has been awarded and what the project plans are should funds not be awarded. III. CONFLICT OF INTEREST DISCLOSURE 1. Do any of the investigators have a financial*, personal, or professional interest related to this research? *See Ferris State University Conflict of Interest Policy for Investigators for details and definitions No Yes (If yes, complete CITI COI Training & submit disclosure form to ORSP) IV. LEVEL OF REVIEW CATEGORY Investigators are encouraged to select a review category; determination of review is made by the IRB. Exempt Reviews involve no more than minimal risk & data cannot be identified, either directly or through identifiers linked to subjects. Expedited Reviews involve no more than minimal risk, but data can be identified. Although not reviewed by the Full IRB, Exempt & Expedited applications must be reviewed by at least one IRB member, per University policy and federal regulations. 1. Exempt Category: Select the appropriate category(s): My investigation is research in a Commonly Accepted Educational Setting, involving normal educational practices OR uses an anonymous educational test (1 or 2) My research uses an Anonymous Survey or Interview. (2 or 3) My research collects data by Observation of Public Behavior without electronic recording. (2 or 3) My research uses publicly available data and individuals will not be identified (4) or My research uses existing non-public data, records, or documents, individuals will not be identified, and I have obtained permission from the following individual(s) or agency to access the data: _. (4) My research is conducted by the approval of the Department of Health & Human Services OR is a taste & good quality food evaluation. (5 or 6) My research consists entirely of the components checked above; involves no more than minimal risk and human subject data cannot be identified, either directly or indirectly through identifiers. 2. Expedited Review: Specify category or categories: (1-7) Refer to the Federal Review Categories for additional information about Expedited Categories. Expedited projects involve no more than minimal risk, but data can be identified; projects will be reviewed by at least one IRB committee member and/or an expert subject matter. 3. Full Committee Review Category: This proposal is submitted for FULL committee review and will be reviewed at the next IRB monthly meeting. 4. A. Proposed/Estimated start date for project: B. Proposed/Estimated end date for project: _ Note: You may not begin data collection without IRB approval. The IRB meets once each month during the regular academic year and as needed during the summer semester. Limited reviews should be expected between semesters, during final examination periods and university closures. Researchers should submit a completed application to the IRB at least one month prior to when they wish to collect data.

3 V. SUBJECT POPULATION & RECRUITMENT 1. Special Target Populations: Briefly describe the primary subject population. Who will be the primary participants? FSU IRB Human Subjects Research Application 3 of The study population will EXCLUDE (Check all that apply): Use of special populations requires specific procedures to ensure rights & privacy protections are upheld. Pregnant women Prisoners Individuals with mental disabilities Minors/children Non-English speakers Individuals with physical disabilities Human Fetuses/Neonates Others whose life circumstances may interfere with their ability to freely consent to participate Data will be collected ONLY from pre-existing records without direct contact (complete item 4 below) A. DESCRIBE how each population will be excluded: 3. Estimated number of subjects (including controls) 4. Will this research be conducted with subjects who reside in another country or could have difficulty understanding the research objectives due to cultural differences? No Yes a. If yes, will there be any corresponding complications in your ability to minimize risks to subjects, maintain their confidentiality and/or assure their right to voluntary informed consent? No Yes (If yes, describe these complications and how will you resolve them) 5. Subject Recruitment/Invitation to Participate in Research: I will be using recruitment materials for my study and have attached copies of these materials with this application (including script for verbal invitations, invitations, flyers, advertisements, letters or other recruitment documentation). CONSENT REQUIRED, See page 8. I, the researcher, will not be recruiting subjects to participate in this study. The research involves archival data from medical records. The research involves archival data from school or educational records. The research involves archival data from police or court records. The research involves observation of public behavior, without electronic recording. The research involves collection of other public records or data without identifying information of individual participants. Specify: 6. If recruiting subjects via electronic means (i.e., /social media, etc.) describe how you will be accessing addresses or social media sites including who will distribute e-recruitment. Appropriate approval letters/permission must be submitted with the application.

4 FSU IRB Human Subjects Research Application 4 of Prior association with one or more potential subjects. I, the researcher, have no prior association or relationship with any prospective subject. I, the researcher, have a prior relationship with one or more prospective subjects. (Describe the relationship in sufficient detail to be evaluated for potential limitations of subject s freedom to decline/withdraw participation.) 8. Will the subjects incur financial costs as a result of their participation in this study? (i.e., travel, cost of care) No Yes (If yes, include an explanation below and in the informed consent procedure.) 9. Will the research subjects be compensated or receive extra credit? No Yes (If yes, explain the compensation, including amount & payment schedule below and in consent form; if offering extra credit, describe extra credit opportunities that will be offered to those that decline participation in the research) 10. Is this research being conducted at an institution outside of Ferris State University? No Yes (If yes, include one copy of the approval letter from that agency or university) 11. Has this proposal been reviewed or approved by any IRB at another institution? No Yes (If yes, include one copy of IRB approval from that agency or university) 12. Is this project a Clinical Trial that will be registered at per the Food and Drug Administration Modernization Act of 1997 (FDAMA)? No Yes (If yes, identify who will register the clinical trial; i.e.: PI, study sponsor, etc.) VI. USE OF DRUGS/BIOLOGICS AND MEDICAL DEVICES A. Does the research involve the use of any drugs or biologics? No Yes If Yes, are the drugs/biologics approved for use by the Food and Drug Administration (FDA) (including prescription and non-prescription agents)? No Yes a. Give a complete list and description of the agents, manufacturer, and if FDA approved or not. B. Does this research involve any medical devices? No Yes If Yes, are the medical devices approved by the FDA? No Yes If No, provide the IND number for the unapproved device: a. Give a complete list and description of the devices, manufacturer and if FDA approved or not.

5 FSU IRB Human Subjects Research Application 5 of RESEARCH PROCEDURE OUTLINE 3. Abstract: Provide a brief (350 words or less) description of the project in general terms for the reviewer of any academic discipline. The description should include study purpose and an overview of the research design; such as sampling methods, instrumentation, procedures for collection and analysis, and predicted outcomes. 4. Procedure: Describe all activities to be used in collecting data from human subjects, including specific activities, instruments used, study location, duration of subject activities, etc. Copies of questionnaires, data collection forms, and other written materials to be provided to participants must be attached. For thesis/dissertations: The procedure must be the same as the methods chapter. An approved methods chapter signed by an advisor can be attached in place of this section.

6 FSU IRB Human Subjects Research Application 6 of Benefits: Describe any direct benefits to subjects or community, specifying direct and indirect benefits. Describe any benefits to the discipline/profession. 4.Risks: Describe a complete list of risks (minimal, medium & high risks) that may be posed to subjects. Minimal Risk is defined by the federal regulations as the probability and magnitude of physical or physiological harm that is normally encountered in the daily lives, or in routine medical, dental, or psychological examination of healthy persons (45 CFR subpart d). This research does NOT constitute risk to subjects beyond the minimal level. Describe minimal risks This research constitutes risk that is beyond the minimal level. Describe risks, why they exceed minimal level and why you believe the level of risk is warranted. 5. Protection of Subject Privacy/Confidentiality: a. Will data be collected in a manner that subjects are identified either directly or through identifiers? No Yes If yes, describe: b. Will data be reported in a manner that subjects are identified either directly or through identifiers? No Yes If yes, describe: c. Describe how you will ensure de-identification of research data and your plan for data protection:

7 FSU IRB Human Subjects Research Application 7 of Protection of study data & consent forms: a. Where will study data (paper and electronic versions) be stored? How will data be secured during transfers? b. Who will have access to study data? c. How long will the study data be stored? (IRB recommends study data be maintained for a minimum of 3 years from study end date) d. What measures will be taken to secure study data? (How will university computers be used and password protected? (locked file cabinet, encrypted, etc.) Note: Protected Health Information (PHI) data must be encrypted. e. If students are involved in this project, how they will be accessing, processing and storing data? f. Where will consents be stored and for how long? Who will have access to consents? Note: federal regulations require consents be maintained for a minimum of three (3) years from end date. g. If applicable, how will the study data be sent to the study sponsor (faxed, data entry into secure website, etc.)? h. For retrospective review studies (Exempt 1E and Expedited 2E) should further information on a subject be needed during the duration of the research, will a correlation tool linking subject data with a unique study identifier be kept to allow re-identification of subjects? No Yes If yes, where will it be stored, for how long, and who will have access to the information?

8 FSU IRB Human Subjects Research Application 8 of Consent Procedures. If recruiting subjects, select which type of consent procedure you will conducting: Informed Consent Procedure: Describe the consent process, including when and how (written/oral) consent will be obtained, by who, how subjects will be informed of potential risks and their right to withdraw, protection of privacy, contact information for research questions and contact information for the IRB in case of complaints/concerns. Copies of forms should be attached in the same format that they will be given to participants (Instructions are available on the IRB website). Parent/Guardian Permission and Assent: If enrolling children or persons of diminished mental capacity, state how parents/guardians will provide permission, whether the child/other participant s consent will also be obtained and if assent will be written or oral. Provide a copy of the script/form to be used in attaining consent and assent. Waiver of consent documentation: Request to waive collection of participant signature only; elements of consent must still be provided to subjects, either orally or written. Waiver of consent elements: The IRB may waive or alter elements of consent in some minimal risk studies/deception-research. If either type of waiver is requested, answer the following questions: 8. Why would explicit consent be impractical for this study? 9. Is the signed consent the only record linking subjects to research participation? No Yes 10. Does this research include any activity that would require consent in a non-research setting? No Yes SUPPORTING DOCUMENTS Each copy of the application must include: IRB application, information required in items above, and all relevant supporting documents including: consent forms, letters sent to recruit participants, questionnaires to be completed by participants, and any other material that will be presented, viewed or read to participants. Checklist: Reviews will not begin until the application is completed. Only check the items that apply. Signed application form; all investigators must provide signature Outside Approval letters/certification to conduct research/use data CITI Training Modules Certificate of Completion for all investigators Consent form (or script for verbal consent) Recruitment materials (advertisements, flyers and/or letters) Questionnaires/surveys/interview questions to be completed by participants or stimulus materials to be used Advisor approved copy of methods chapter of research proposal (thesis/dissertations only) Please one application including ALL investigator signatures to: IRB@ferris.edu Typed signatures are NOT acceptable. Applicants must either mail signatures to the primary address below or scan and upload signatures into a PDF file & them to the IRB. Legal Electronic signatures are accepted. CONTACT INFORMATION: Institutional Review Boad 1010 Campus Drive, FLITE 410D Big Rapids, MI Phone: (231) IRB@ferris.edu

9 FSU IRB Human Subjects Research Application 9 of 10 CERTIFICATION / SIGNATURE I certify that the information contained in the Ferris State University (FSU) Human Subjects IRB application and all attachments is true and correct. I certify that I have received approval to conduct this research from all persons named as collaborator(s), faculty advisor(s) and from official(s) of the projects sites. I certify that I have made my dean/department head aware of my plans to conduct this research. Should the IRB approve this proposal, I agree to conduct this research according to the approved protocol and in accordance with professional standards, federal regulations, and all FSU policies (confidentiality, data collection, informed consent, noncompliance, CITI training, etc.) governing the ethical conduct of research. I certify that I will comply with Ferris State University s IT Security policies & procedures when conducting my research study. I certify that use of educational records complies with the Family Educational Rights and Privacy Act (FERPA), if applicable. I certify that use of medical records complies with the Health Insurance Portability and Accountability Act (HIPAA), if applicable. I agree NOT to implement any changes in the protocol until such changes have been approved by the IRB. If during the course of this research, unanticipated risks of harm to subjects are discovered, I will report these to the IRB immediately. I agree to submit an annual review and a final report upon completion of the approved research. If this project is a clinical trial, I certify to register the clinical trial at clinicaltrials.gov, per the Food and Drug Administration Modernization Act of 1997 (FDAMA). Principal Investigator / Faculty Advisor Signature Signature Student Investigator Signature Student Investigator Signature

10 FSU IRB Human Subjects Research Application 10 of 10 Additional Investigators: List any additional investigators below and provide CITI Certifications: Check if this is: Undergrad Project Master s Thesis Ed.D/Ph.D. Dissertation Check if this is: Undergrad Project Master s Thesis Ed.D/Ph.D. Dissertation Check if this is: Undergrad Project Master s Thesis Ed.D/Ph.D. Dissertation Additional Investigator Signature Additional Investigator Signature Additional Investigator Signature Additional Investigator Signature