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