Educational Research and the VCOM Institutional Review Board

1. Educational Research and the VCOM Institutional Review Board Jim Mahaney, PhD VCOM IRB Chairman

2. The VCOM IRB The role of the VCOM IRB is to foster the ethical treatment of human research participants in VCOM research studies – including Educational Research. • Governed by the Department of Health and Human Services • 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

3. The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research issued by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research on April 18, 1979 • Respect for Persons • individuals should be treated as autonomous agents, and • persons with diminished autonomy are entitled to protection • Beneficence • do no harm, and • maximize possible benefits and minimize possible harms. • Justice • Who ought to receive the benefits of research and bear its burdens?

4. VCOM IRB Essentialshttp://www.vcom.edu/research/irb/index.html • Key Personnel: • Dr. Dixie Tooke-Rawlins: Institutional Official • Dr. Jim Mahaney: IRB Chair • Dr. Gunnar Brolinson: IRB Co-Chair • Ms. Eryn Perry: IRB Director • Help and guidance on IRB applications, reviews, general questions • Ms. Dawn Bennett: IRB Coordinator • All correspondence with the IRB, submission of applications, inquiries about pending reviews

5. The VCOM IRB Websitehttp://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

6. Important Rule! Absolutely NO HUMAN SUBJECT RESEARCH may be done at VCOM 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 Chartshttp://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 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?

11. Exemptions

13. Expedited Review

14. Who Decides? In most cases it is an IRB itself who needs to be the decision maker as to whether any proposed research is human subject and whether it needs IRB review. 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.

15. Next: Get the Required Training • 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.html • https://www.citiprogram.org/ • Other equivalent training will be accepted • NIH • Virginia Tech, etc • This training must be completed prior to submission of a protocol to an IRB. Proof of certification required! •  Refresher training required every 3 years • Absolutely NO human subjects research may be conducted without certification of IRB training. Investigators, students, primary project persons.

16. Forms, forms and more forms!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)

17. 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

18. Waiver of Informed Consent or Documentation of Informed Consent Waiver of Requirement for Signed Form • An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects, if it finds either: • That the only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or • That the research presents no more than minimal risk of harm to subjects, and involves no procedures, for which written consent is normally required outside of the research context.In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

19. HIPAA and Researchhttp://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 research activities may access PHI or generate new PHI. • So human subjects research may or may not be subject to the HIPAA Privacy Rule. • The IRB is here to help make this determination and to facilitate getting the proper permissions / waiver as needed.

20. Submit your Application • Dawn Bennett, IRB Coordinator • dbennett@vcom.vt.edu • Will check submission to ensure all is in order • Copy of Research Proposal • Documentation of IRB Training Certificate • 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.