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 Essentials http://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 Website 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

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 Charts http://www. hhs
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
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
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 Research 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 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
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.