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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