1. Primary Care and Community Outreach Research VCOM Institutional Review Board Jim Mahaney, PhD Associate Dean for Biomedical Affairs, Virginia Campus Past Chair, VCOM IRB

2. The VCOM IRB The role of the VCOM IRB is to oversee and foster the ethical treatment of human research participants in VCOM research studies – including Primary Care and Community Medicine research. Governed by the Department of Health and Human Services: OHRP –45.CFR.46 – the “Common Rule” Specific guidance given for education applications Also governed by the Food and Drug Administration –21.CFR.50 and 21.CFR.56 – FDA Regulations The VCOM IRB is also service oriented, seeking to help new and experienced investigators develop human subjects research projects and navigate the application process. At all times, the IRB’s goal is to foster research.

3. VCOM IRB Essentials http://www.vcom.edu/research/irb/index.html http://www.vcom.edu/research/irb/index.html Key Personnel: –Dr. Dixie Tooke-Rawlins: Institutional Official –Dr. Gunnar Brolinson: IRB Chair pbrolins@vcom.vt.edu –Ms. Eryn Perry: IRB Director Help and guidance on IRB applications, reviews, general questions eperry@vcom.vt.edu –Ms. Stephanie Hurt: IRB Coordinator All correspondence with the IRB, submission of applications, inquiries about pending reviews shurt@vcom.vt.edu

4. The VCOM IRB Website http://www.vcom.edu/research/irb/index.html http://www.vcom.edu/research/irb/index.html Information about the Application Submission Process (PLEASE start here!) Forms and instructions Required training Policies and Procedures Contact information for help and guidance –Ms. Eryn Perry: project design, application guidance and help –Ms. Stephanie Hurt: application submission and compliance with requirements

5. Research at VCOM and VCOM-Affiliated Sites Oversight of human subjects research is dependent on several factors: –Research onsite at VCOM by Faculty / Students Direct oversight by the VCOM IRB –Research at a VCOM Clinical Partner Training Site Depends on agreement and whether site has its own IRB Usually written into agreement or a relationship exists between IRBs –Research by VCOM Faculty / Students at other sites Requires interaction with other site IRB, or creation of IRB relationship

6. Important Rule! Absolutely NO HUMAN SUBJECT RESEARCH may be done at VCOM or by VCOM personnel at other sites prior to approval by the VCOM IRB. Any human subject data collected prior to approval…or during a “lapsed” protocol…is void and cannot be used or published in any way. NO RETROACTIVE APPROVAL OF RESEARCH PROTOCOLS

7. Getting Started with Human Subject Research First, a researcher develops his/her idea for a study –Develop a research proposal first! Work out your ideas Plan your study Enlist your co-investigators and students. Next, one must determine if this is human subject research…and what level of review is needed for this project –Exempt: not human subject research –Expedited: only minimal risk –Full Board: more than minimal risk, special populations

8. Decision Charts http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html The Office for Human Research Protections (OHRP) under the Department of Health & Human Services (HHS) provides decision charts as a guide for institutional review boards (IRBs), investigators, and others who need to decide if an activity is research involving human subjects that must be reviewed by an IRB under at 45 Code of Federal Regulations part 46. The decision charts address decisions on the following:  whether an activity is research that must be reviewed by an IRB  whether the review may be performed by expedited procedures, and  whether informed consent or its documentation may be altered or waived.  Specific help with these decisions can be obtained from Eryn Perry:  Ask for help and guidance early in the process for maximum benefit and time savings.

9. Is it Human Subjects Research?

10. Is the study Exempt?

12. Expedited Review

13. Who Decides? The IRB (usually the IRB Chair) is the decision maker as to whether any proposed study is human subject research and what level of IRB review is needed. Many institutions require even exempt human subject research to be reviewed on an annual basis as it is easy for a study to morph into one that needs IRB review without a research team realizing it. General Rule: it is far better to seek IRB approval…even for an exemption…than risk being wrong.

14. IRBs, institutions, and sponsors generally require key research personnel to complete formal training in the protection of human research subjects. –VCOM uses the CITI Training System –http://www.vcom.edu/research/irb/required_education.htmlhttp://www.vcom.edu/research/irb/required_education.html –https://www.citiprogram.org/https://www.citiprogram.org/ –https://phrp.nihtraining.com/users/login.phphttps://phrp.nihtraining.com/users/login.php –Other equivalent training will be accepted This training must be completed prior to submission of a protocol to an IRB. Proof of certification required! It is the investigator’s responsibility to complete his / her training and receive proof of certification, and to keep a record of this certification for use with IRB applications. Absolutely NO human subjects research may be conducted without certification of IRB training. Investigators, students, primary project persons. Next: Get the Required Training

15. Forms, forms and more forms! http://www.vcom.edu/research/irb/forms.html http://www.vcom.edu/research/irb/forms.html IRB Application Form (required) –This is a SUMMARY of the overall research proposal. It is NOT the proposal. IRB Form A, B or C (one of these is required) –Each one corresponds to a level of IRB Review (Exempt, Expedited, Full Board) IRB Form F (Optional based on design of study) –Waiver of Informed Consent or Documentation of Informed Consent Informed Consent Documents (Required unless waived)

16. Informed Consent http://www.vcom.edu/research/irb/forms.html Most adult subjects: Consent Document –18 years old and up Minors: Assent Document –They can agree (assent) to be part of study –Parents CANNOT consent for the child –Parents CANNOT force child to participate Parent(s) / Guardian(s) Permission Form: –Provide permission for their child to participate –Is not the same thing as consent or assent –Child may refuse even if parent says yes The informed consent document may be modified depending on the type of study and risk involved with the study Documenting informed consent can be waived by the IRB under special circumstances –Most commonly for anonymous surveys where the informed consent would be the only link between the participant and the survey.

17. HIPAA and Research http://privacyruleandresearch.nih.gov/ http://privacyruleandresearch.nih.gov/ The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule is the comprehensive Federal protection for the privacy of protected health information (PHI). PHI relates to any data or information about a patient or subject that is personally identifiable and/or link the information directly and uniquely to the patient/subject. HIPAA focuses mostly on health care delivery rather than research, but if research activities access PHI or generate new PHI, HIPAA is a consideration for that research. –Example of HIPAA requirement: direct examination of patient medical records without the consent of the patient. –Contrast: Physician with regular access to medical records may provide de-identified data from records Note: even in this case, many hospitals / clinics still require HIPAA waiver or consent from patient. So human subjects research may or may not be subject to the HIPAA Privacy Rule. The IRB will help make this determination and to facilitate getting the proper permissions / waiver as needed.

18. Submit your Application Stephanie Hurt, IRB Coordinator –shurt@vcom.vt.edushurt@vcom.vt.edu –Will check submission to ensure all is in order Copy of Research Proposal required! –Details of study not always clear from the application Documentation of IRB Training Certificate: Investigator’s responsibility IRB Application and all related forms –Informed Consent, Assent, Permissions –Surveys, tests, teaching instruments, plans –Mission research with non-English speaking subjects? Documents in subject’s language must be submitted, and they must be certified translations of the English version.

19. The VCOM IRB is Here to Help How can we help you today?