1. Introduction to Research Involving Human Subjects & the IRB at Florida Hospital
Presented by
Janice Turchin, IRB Manager Florida Hospital Institutional Review Board

2. Regulations and Oversight
Why Does Research Need to be Regulated?
What is IRB Oversight

3. Tuskegee Syphilis Study (1932-1972) Milgram’s Studies (1960’s)
Trigger Events
The Nazi Experiments
Concentration Camps WWII
Tuskegee Syphilis Study ( )
Infamous research to study the natural progression of untreated syphilis
Milgram’s Studies (1960’s)
Obedience Experiments – Participants believed they were delivering “electrical shocks”

4. Johns Hopkins: A Cautionary Tale 2001
Healthy volunteer dies following participation in trial.
Multiple failures on part of Medical School and Investigator.
Johns Hopkins entire research program temporarily shut down.
Criminal and Civil prosecutions.

5. Havasupai Indians and the Challenge of Informed Consent for Genomic Research
Dispute between Arizona State University and the Havasupai Indians over the allegedly improper research use of DNA from members of the tribe
Research a gene variant that might be contributing to the increasing rate of diabetes in the tribe.
Research proved to be unfruitful.
Blood was used for other research purposes including searching tribe members DNA for variants linked to schizophrenia.
Rights of research subjects can be violated when they are not fully informed about how their DNA might be used.
$700,000 Settlement

6. Ethical Milestones Nuremberg Code 1947 (Human consent is essential.)
National Commission for the Protection of Human Subjects Biomedical & Behavioral 1974 (First bioethical commission to shape Human Subjects Research.)
Belmont Report 1978
Common Rule 1991

7. Respect for Persons (“Be courteous”)
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, April 18, 1979
Respect for Persons (“Be courteous”)
People should be autonomous and not used as a means to an end.
Allow informed choice where participants can choose for themselves.
Provide additional protections for those who need it.
Derived concepts: Informed consent, Respect for privacy.
Beneficence (“Do good”)
We are obligated to protect persons from harm by clearly identifying and maximizing anticipated benefits while minimizing possible risks of harm.
Derived concepts: Good research design, Competent investigators, Favorable risk/benefit analysis.
Justice (“Be fair.”)
Requires that the benefits and burdens of research be distributed fairly.
Derived concepts: Equitable selection of subjects.

8. Title 45 Code of Federal Regulations, Part 46
“The Common Rule”
A federal policy regarding Human Subjects Protections that applies to 17 Federal agencies and offices.
Subpart A: Outlines the requirements for: assuring compliance by research institutions (Federalwide Assurance [FWA]); obtaining and documenting informed consent; IRB membership, function, operations, review of research, and record keeping.
Subparts B, C, D - Outline protections for vulnerable populations – Pregnant Women/Fetuses/Neonates, Prisoners, Children, respectively.

9. Food & Drug Administration (FDA) Human Research Regulations
21 CFR 11 Electronic Records/Signatures
21 CFR 50 Protection of Human Subjects
21 CFR 56 Institutional Review Boards
21 CFR 312 Investigational New Drug Application
21 CFR 312 Investigational Device Exemptions
ETC, ETC, ETC i.e. Licensing, Biological Products, Premarket Approval of Devices

10. HIPAA – Privacy Rule for Research
FH IRB acts as the “Privacy Board” for research
Patient Authorization – IRB Consent form template includes HIPAA authorization
Waiver of HIPAA Authorization – Retrospective chart reviews

11. What are Enforcement Options?
Suspension or termination of Institution
Oversight
Suspension or termination of PI
Criminal penalties
Fines and civil penalties
Loss of funding X

12. Research Regulation is Needed
How do we regulate Human Subjects research at Florida Hospital?

13. Institutional Review Board - IRB
Federal wide Assurance (FWA)
FH has negotiated with the Office for Human Research Protections (OHRP) that all of the institution’s human subject research activities, regardless of funding, will be guided by the Belmont Report, will comply with the Common Rule, and other regulations as applicable.
The purpose of an IRB is to review research involving human subjects to ensure their rights and welfare are adequately protected.
Board consists of physicians, nurses, community members (i.e. clergy and study participants), non-scientists.

14. Authority & Responsibilities - IRB
Federal Wide Assurance (FWA)
Assist and guide researchers to help protect the rights of human subjects
Charged with safeguarding the rights and welfare of human subjects
Review all research studies involving human subjects under the Florida Hospital auspices.
Audit research studies.
Report, as required, unanticipated problems involving risks to subjects or others; non-compliance; suspensions and termination to:
Sponsor
OHRP Office of Human Research Protection
FDA

15. What do I do if I want to do research at Florida Hospital?

16. What is Human Subjects Research?
Meets federal definition of “research”
Systematic investigation designed to develop or contribute to generalizable knowledge +
Meets definition of “human subject(s)”
The investigator will gather data about living individuals through intervention or interaction OR The investigator will gather data about living individuals that is private AND identifiable.

17. IRB Review of Research
All research projects are categorized into one of three categories for the IRB review process. Each category is different in the level of scrutiny and submission procedures. The IRB is responsible for making the final decision of which category a research project falls under.
Full Board Review
Expedited
Exempt
Not sure if your research fits the definition of Research?
Call IRB Office / Complete Determination Form

18. Criteria for IRB Approval
Risks are Minimized (Consistent with a sound research design and does not unnecessarily expose subjects to risk)
Risks are Reasonable in Relation to Benefits
Selection of Subjects is Equitable
Informed Consent will be Sought for Each Prospective Subject
Informed Consent will Be Documented
Research Plan Adequately Provides for Monitoring the Data Collected to Ensure Safety of the Subjects
Research Plan Adequately Protects the Privacy of Subjects and Maintains Confidentiality
When some or all of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards need to be included in the protocol to protect the rights and welfare of these subjects.

19. Levels of review- Exempt (reviewed by Chair or IRB designated member)
Minimal risk and fit into an “Exempt” category
Surveys or interviews UNLESS identifiers are recorded AND any disclosure of responses could reasonably place the subjects at risk
Collection of existing data or specimens IF the information is recorded in such a manner that subjects cannot be identified (directly or indirectly)

20. Levels of review- Expedited (reviewed by Chair or IRB designated member)
Minimal risk and fit into an “Expedited” category
Document review – Retrospective chart reviews
Surveys or interviews
Collection of specimens
Routine noninvasive procedures

21. Minimal Risk Definition
Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.

22. Full Board Protocol Review
Protocols which are more than minimal risk
PI is invited to meeting to present study and clarify IRB concerns
FH IRB meets twice a month
The Full Board has the authority to:
Approve
Require modifications prior to approval
Table until major issues are clarified
Disapprove all research activities including proposed changes in previously approved human subject research.

23. Advice for Common Errors with IRB Submissions
Forms - Go to IRBNet Library for each new submission
Templates to help
Credentials – Ensure study team has completed requirements
CITI training CV
Volunteer descriptions
Review protocol and consent form for clarity
Be clear about study processes/procedures
Content - Ensure all documents match in regards to study plans
Thorough Review – obtain review from others not affiliated with study

24. IRB Classes IRB 101 HIPAA For more information:
checkout our calendar on the IRB Website.
Stay tuned for new classes/lunch & learns.
Let us know what you are interested in knowing more about.

25. On Your Road to Research, don’t think of Compliance as . . . . .

26. On Your Road to Research . . . . .

27. Questions?

28. https://drupal02.floridahospital.org/irb/
Visit FH IRB Website