Institutional Review Board (IRB) for Human Subject Protections: Working with the IRB Erin McClure, PhD Department of Psychiatry and Behavioral Sciences

Previous Training

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

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

Justice 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

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

Valid Informed Consent 3 Key Components 1. Informed 2. Understood 3. Voluntary

Ensuring Adequate Informed Consent   Given the imperative to protect the rights of participants, how can we be sure that our informed consent process is sufficient?   Ideas: – –Reading aloud – –Ask the participant questions – –Quiz – –Signatures and dates

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

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

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

Institutional Review Board Responsible for verifying 1.Safety 2.Integrity 3.Human rights 4.Public reassurance 5.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   FDA information (if applicable)   Medical device information   Adverse events/DSMB

Recruitment Process   How you recruit for your study must be approved by the IRB: – –Advertisements – –Word of mouth – –Medical Record Review – –Asking medical providers to provide letter to possible participants – –Directly approaching potential participant – –“Cold calling” is not allowed

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

Protecting Participants Implementing Study Reporting Accurately The Mountain of Responsibility

OHRP Suspensions   During the last 8-9 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

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

 Lessons learned –They are doing their job! i.e., protecting human subjects –Support as much as you can with evidence –Pick your battles –Communicate frequently with IRB staff –“Better to ask for forgiveness than permission.” Well, sometimes…. Working with the IRB

Informed consent while under the influence Examples and Experiences

Deception or withholding information Examples and Experiences

Pregnancy and urine drug screens “If you are or become pregnant and test positive for illegal drugs, it is a law that the South Carolina Department of Social Services (DSS) must be notified. You and your family will be evaluated by the agency. You could be ordered to mandatory drug treatment, lose custody of your children, or possibly be jailed.” Examples and Experiences

Conducting research with adolescents Examples and Experiences

Conducting multi-site studies Examples and Experiences

Use of “experimental” devices Examples and Experiences

Regulatory Support Call the SUCCESS CENTER At

Useful Regulatory/Policy Material  MUSC IRB  /ori/irb/ /ori/irb/ /ori/irb/  /ori/irb/deadlines.html /ori/irb/deadlines.html /ori/irb/deadlines.html  Office for Human Research Protections   Food & Drug Administration 