1. Susan Sonne, PharmD, BCPP Chair, MUSC IRB II
Institutional Review Board for Human Research (IRB) Human Subject Protections
Susan Sonne, PharmD, BCPP
Chair, MUSC IRB II

2. Typical Class Concerns
Ensure informed consent is done correctly
Protect participants’ privacy and confidentiality
Protect participants from harm
How to recruit people for research
Follow federal regulations and IRB guidelines

3. The Belmont Report
3 Basic Principles for Protection of Human Subjects:
Respect
voluntary informed consent
privacy
protections for vulnerable populations
Beneficence
Justice

4. Informed Consent
Essential to ethical conduct of clinical investigation
Potential subject chooses whether or not they will participate
Obtained after full information is given and understood
Explanation of study objective, potential benefits, risks, inconveniences, subject’s rights and responsibilities

5. Therapeutic Misconception
Most studies are not designed to directly benefit study participants
Important to help participant understand that research is not the same as clinical treatment
If participant does not understand the difference, consent is not valid

6. Beneficence Protecting them from harm
Persons treated in an ethical manner
Protecting them from harm
Helping to secure their well being

7. Protecting Participants from Harm
Does not mean study must be minimal risk
Have appropriate selection criteria to exclude individuals at greater risk of harm
Have study procedures to evaluate participants’ safety
Have DSMB to monitor study progress
Potentially stop study early / revise protocol if there are significant risks or benefits identified

8. Justice Equals ought to be treated equally Fairness in distribution
Who ought to receive the benefits of research and bear the burden of research?
Equals ought to be treated equally
Fairness in distribution
What is deserved

9. Inclusion Criteria
Criteria, if fulfilled, will make a person eligible to participate in a research study
Typically used to define the study sample
Age range
Disease state
Other characteristics needed for inclusion

10. Exclusion Criteria
List of criteria that get applied to those who meet inclusion criteria
Presence of any ONE criterion would exclude person from participating
NOT the polar opposite of inclusion criteria!
Typically used to define safety issues and confounding variables
Concomitant medications
Comorbid conditions

11. All Human Subjects Research
Must be reviewed and approved by the IRB
Must comply with applicable federal and state regulations
Must be conducted the way it is currently approved
Principal Investigator is ultimately responsible

12. IRB Purpose
To protect the rights and welfare of human research subjects
Authority to approve, require modification and disapprove any research involving human subjects

13. Institutional Review Board
responsible to verify
Safety
Integrity
Human rights
Public reassurance
Scientific content

14. What information is reviewed?
Protocol
Informed Consent Document(s)
Informed Consent process
HIPAA Authorizations/Waivers
Personnel-including who will obtain consent
Recruitment process/plan
Advertisements
Investigator’s brochure
Compensation
IND/IDE information (if applicable)
Adverse events/DSMB

15. Submitting an IRB Application
Pay attention to deadlines!
Clearly articulate what you are doing for research purposes
Do a mental walk through of your study
Where will it be done? By whom?
How will you enroll participants? How will you determine inclusion/exclusion criteria?
What will participants do? In what order?
What data do you need? How/where will data be stored?

16. The Mountain of Responsibility
FDA
Sponsor
Investigator
Protecting Participants
Implementing Study
Reporting Accurately
Research Team
Coord, RA, etc

17. Investigator Obligations
Conducts a clinical investigation
Responsible for
All procedures conducted
All data collected
May delegate work in conducting study but they retain responsibility

18. OHRP Suspensions
During the last 6-7 years, OHRP has suspended all human research at the following institutions:
University of Illinois, Chicago Campus
University of Colorado
Duke University
Johns Hopkins
University of Pennsylvania
And others

19. Call the SUCCESS CENTER
Regulatory Support
Call the SUCCESS CENTER At
Free Service
Can help craft consent
Can help determine level of review
Can help with eIRB application

20. What do you think?
A basic scientist colleague conducts research on different biomarkers associated with the immune response. He has been doing this type of research for many years and is proud that he has had a consistent lab staff for the last 15 years. When he needs whole blood for his tests, he typically just asks his lab staff to provide a sample without IRB approval.
What are the regulatory concerns?
Are there ethical concerns?
Are there scientific concerns with this practice?

21. Useful Regulatory/Policy Material
MUSC IRB
Office for Human Research Protections
Food & Drug Administration