AA

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