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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

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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