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

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

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

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

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

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

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

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

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

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

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

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

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

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

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?

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

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

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

Call the SUCCESS CENTER Regulatory Support Call the SUCCESS CENTER At 792-8300 Free Service Can help craft consent Can help determine level of review Can help with eIRB application

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?

Useful Regulatory/Policy Material MUSC IRB http://research.musc.edu/ori/irb/home Office for Human Research Protections http://www.hhs.gov/ohrp/ Food & Drug Administration http://www.fda.gov/oc/ohrt/irbs/default.htm