Institutional Review Boards

• Institutional review board (IRB)- administrative body ensuring human subjects protected in research
  • Often affiliated with university or hospitals
  • Review ethics protocols that include
  • How study will advance existing research
  • Who will be recruited- ages (especially If they’re minors), gender, race, sexuality
    • Ensure you engage appropriate populations
    • Making sure you protect vulnerable populations
  • All activities participants are asked to do and their methods
    • Interview, focus group, clinical trials, etc.
  • Consent process & compensation
    • Verbal vs written consent
    • What is in consent form?
    • Is compensation coercive?
  • Other aspects of a project
    • Timeline?
    • Done in phases?
    • Personnel?
    • Certification to work w/ human subjects
  • Usually there’s a template for this
• History of IRBs
  • Arose after violations of human rights in research (WWII Nazi & Japanese research)
  • 1950s-60s- early emergence
  • 1971- Stanford prison experiment
  • 1972- public revelation of Tuskegee syphilis experiment
  • 1979- Belmont report
  • Established principles of respect for autonomy, beneficence, justice in research
  • Common rule 1981- formal guidelines for IRBs
• Look different in different places
  • Ex- low risk social science research
  • May not be subject to IRB review in some European countries because you’re likely just talking to people
  • In US- still needs to be reviewed if you’re interviewing people to look for general trends
• Review all kinds of research and can specialize in some research
  • Hospital IRBs- clinical trials/studies
  • Social-behavioral IRBs- tends to review empirical social science & education research
  • Private IRBs- for-profit IRBs that companies can hire to review their research
• Characteristics
  • At least 5 members of diverse backgrounds
  • At  least 1 scientist/researcher
  • At least 1 community member that’s not staff, student, or researcher in the university
  • Can be paid/unpaid
  • Protect human subjects’ interests
  • Can be held liable for harm occurring to participants
  • Reason being that they did not thoroughly review protocol and account for potential risks to participants 
  • Participants need to be fully aware of risks and IRB needs to carefully review protocol
• Completes these tasks:
  • Ensures study personnel have necessary certifications
  • Initial review of ethics protocols for study
  • Work with researchers to make any adjustments
  • Review modifications to initial protocol as study expands/changes
  • In-depth audits, annual review of select protocols as needed
  • Can access confidential records of project for this
• Need IRB approval to start human research
  • Most cases- IRBs work with researchers to adjust study design to ensure participants be protected instead of outright denying researchers ability to begin their study
  • Can also outright approve/deny
• Follow Common Rule (rev. 2018)
  • Sets requirements for
  • IRB membership
  • Consent process
  • Types of ethics protocol reviews
  • Vulnerable populations
    • Prisoners (do not necessarily have autonomy)
    • children (mostly bc of extra documentation/paperwork)
    • students (possible coercion to participate, especially if they’re students @ the university where research is happening)
    • pregnant individuals
  • Populations that may be considered vulnerable but technically aren’t in some cases
    • Elderly (not vulnerable if they have clarity of mind)
    • Mental illness/personality disorders (not vulnerable if they’re stable on medication)
    • But IRB will ask how you ensure they have DMC and capacity to give consent
  • Other important parts
  • Must inform participants if data used for something else other than study
  • Must inform participants if their biospecimens will be used for purposes where there is commercial profit
  • Educational research is exempt from review if data is being gathered on educational practices already in use
    • You can’t determine whether it’s human subject research or not
  • Consent forms must be made publicly available online for some federal-funded clinical trials 
• IRBs interpret common rule guidelines
  • Different IRBs can make diff decisions
• 3 types of IRB review - IRB decides which one
  • Full review- all members of committee come together and read protocol and decide any modifications
  • Usually for studies with potential risk
  • Example- clinical trials for new medication
  • Expedited- only review by 1 member of the IRB
  • For studies with minimal risk but still considered human subjects research
  • Member chosen based on different characteristics
  • Example- study interviewing patients about experiences accessing mental healthcare
  • Exempt- ethics protocol is submitted but not reviewed by IRB bc they deem it not to be human subject research
  • Example- studying how much information students retain after class
  • Time length depends on IRB but generally takes a while
• Types of research not reviewed by IRB
  • Not direct work with human subjects
  • Animal research- reviewed by Institutional Animal Care and Use Committee
  • Research using existing de-identified data sets
  • Using deidentified human specimens
  • Educational research 
• Consider following in ethics protocols review
  • Confidentiality
  • Data management & security
  • Compensation of participants
  • Special accommodations for vulnerable populations
  • Risks and benefits
  • Placebos in clinical research
• Confidentiality is the main concern
  • Common suggestions
  • Never publicly name a research participant
    • But they can talk about
  • Data distinguished with participant ID # instead of their name
  • In presentation & published reports- participants given pseudonyms where appropriate
    • Certain details not provided if they’d result in identification of participants
• Data management is another important concern
  • Electronic storage needs to be encrypted
  • Physical forms needed to be stored in locked files in locked office
  • Only people designated as researchers and members of IRB can access
  • Store data in separate location than data identifying ID# and their name
• Compensation
  • Will they paid?
  • How much will they paid?
  • Is compensation coercive?
  • This depends on who’s compensated
  • Not compensating also unethical
  • Medical care provided for free viewed as “benefit” not as compensation
• Vulnerable populations special considerations
  • Pregnant people- Is the risk to the fetus mitigated? What happens if participant becomes pregnant?
  • Children- Can they give assent? Should parent/guardian consent be waived?
  • Prisoners- Do they have ability to freely decide? Autonomy is impacted
  • Students- Ensure grades and relationships to university will not be impacted
• Risk and benefits assessment
  • Risk should be minimized and/or made relative to benefits
  • Placebos
  • Should only be used when patients not put at undue risk by not receiving active treatment

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