Institutional Review Board (IRB) for Human Subject Protections:

Working with the IRB

Erin McClure, PhDErin McClure, PhDDepartment of Psychiatry and Behavioral SciencesDepartment of Psychiatry and Behavioral Sciences

Previous TrainingPrevious Training

Previous TrainingPrevious Training

The Belmont Report

3 Basic Principles for Protection of Human Subjects:

– Respectvoluntary informed consentprivacyprotections 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 MisconceptionTherapeutic Misconception

Most studies are not designed to directly Most studies are not designed to directly benefit study participantsbenefit study participants

Important to help participant understand that Important to help participant understand that research is not the same as clinical research is not the same as clinical treatmenttreatment

If participant does not understand the If participant does not understand the difference, consent is not validdifference, 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!

– http://academicdepartments.musc.edu/research/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 learnedLessons learned– They are doing their job! i.e., protecting They are doing their job! i.e., protecting

human subjectshuman subjects

– Support as much as you can with evidenceSupport as much as you can with evidence

– Pick your battlesPick your battles

– Communicate frequently with IRB staffCommunicate frequently with IRB staff

– ““Better to ask for forgiveness than Better to ask for forgiveness than permission.” Well, sometimes….permission.” Well, sometimes….

Working with the IRB

Informed consent while Informed consent while

under the influenceunder the influence

Examples and Experiences

Deception or withholding Deception or withholding informationinformation

Examples and Experiences

Pregnancy and urine drug screensPregnancy 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 Conducting research with adolescentsadolescents

Examples and Experiences

Conducting multi-site studiesConducting multi-site studies

Examples and Experiences

Use of “experimental” devicesUse of “experimental” devices

Examples and Experiences

Regulatory Support

Call the SUCCESS CENTERCall the SUCCESS CENTER

At 792-8300At 792-8300

Useful Regulatory/Policy Material

MUSC IRBMUSC IRB http://academicdepartments.musc.edu/research/http://academicdepartments.musc.edu/research/

ori/irb/ori/irb/ http://academicdepartments.musc.edu/research/http://academicdepartments.musc.edu/research/

ori/irb/deadlines.htmlori/irb/deadlines.html

Office for Human Research ProtectionsOffice for Human Research Protections http://www.hhs.gov/ohrp/http://www.hhs.gov/ohrp/

Food & Drug AdministrationFood & Drug Administration http://www.fda.gov/oc/ohrt/irbs/default.htmhttp://www.fda.gov/oc/ohrt/irbs/default.htm