11/5 IRBs

institutional review board (IRB)

a group of people who reviews research studies to ensure they protect the rights and well-being of human subjects

• there are separate groups who review animal studies

• often found at universities and hospitals

• some specialize in clinical research while others focus on social/behavioral/educational research

why did IRBs emerge?

arose following historic violations of human rights in research, including experiments on prisoners/captvies during WWII

history of IRBs

1950s-60s: early emergence of IRBs

1971: Stanford prison experiment

1972: Public revelation of Tuskegee Syphilis Experiment

1979: Belmont Report (principles: respect for persons, beneficence, and justice)

1981: Common Rule (formal guidelines for IRBs)

The Common Rule / Federal Policy for the Protection of Human Subjects (updated 2018)

developed and updated by the US Dept. of Health + Human Services; sets out guidance relevant to IRBs including:

• who serves on an IRB

• types of IRB review

• policies around informed consent

• extra protections or considerations for vulnerable groups

why are IRBs important?

• they ensure that research is conducted in an ethical way

• they ensure research is carried out to meet current federal and organizational standards

• they educate researchers about current best practices

• they serve as another resource for participants to contact

• they can help researchers clarify their methods and study design

• they document any adverse outcomes to participants

who servers on an IRB?

• at least 5 MEMBERS (includes 1 from an outside community w/ no affiliation or family connection with the IRB’s home institution + at least 1 scientist/researcher)

• may also include paid IRB staff members including IRB coordinators and IRB director/chair

  • their job is to review protocols, answer questions, + assess protocol modifications

what gets submitted to the IRB?

• researchers submit a packet of documents to the IRB (must be reviewed + approved before the research can begin)

• contains a protocol (doc summarizing the goals of the study + what participants will be asked to do)

  • many IRBs hv templates that researchers can use

• includes consent docs, informational flyers or recruitment materials, + instruments (interview guides, survey questions, etc)

informed consent

means someone has been informed about the risks, benefits, and procedures of a study + freely agrees to participate

• often written but can be verbal

• must be provided by a legal adult / guardian or surrogate that’s able to make decisions freely

• documents must be written in plain, accessible language

Research is _____ and participants can end participation at any time

voluntary

T/F: If participants withdraw from a study, it needs to be clear what happens to the data

true

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