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| An IRB is responsible for, among other things, considering the beneficence of a research proposal. This essentially means reviewing the risks and considering if the potential benefits make those risks reasonable. | The [[UnitedStates/EthicsLaw/CommonRule|Common Rule]] also specifies when an application must be made for IRB review. An application for IRB review must cover: * a risk/benefit analysis * the informed consent process and informed consent documentation process * the assent process and assent documentation process, if necessary * the identification and selection processes for subjects * safeguards for vulnerable populations, if necessary * the privacy and confidentiality process * the data governance process * the qualifications of involved researchers, especially with regard to data governance and analysis * the research design * compliance with laws, regulations, and policies, if necessary === Reviewing Risk === While an application must include a risk/benefit analysis, the IRB is responsible for assessing the reasonability of risks given the benefits. |
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| === Expedited Review === Some research proposals and continuing reviews are eligible for [[UnitedStates/EthicsLaw/ExpeditedReview|expedited review]]. The alternative is called '''convened review'''. |
Institutional Review Boards
Institutional Review Boards (IRBs) are supervisory bodies that ensure compliance with ethics law.
Contents
Definition
The Common Rule sets out requirements for IRBs.
An IRB must have the expertise and professional competence required to review a research proposal.
An IRB must include 5 people at minimum, and must satisfy these characteristics with at least 1 person:
- A person not otherwise affiliated with the institution
- A scientist
- A non-scientist
The board must be diverse (race, gender, culture, etc.).
The board must have the power to disapprove of a research proposal, conduct continuing review of research, and discontinue research based on results of continuing review.
Subpart C
For IRBs implementing subpart C (for prisoners), they are additionally required to have...
- A majority of members that are not otherwise affiliated with the prison
- A prisoner or prisoner representative
The prisoner or prisoner representative member must have a vote on any components of the research proposal relevant to subpart C, but can be deprived of that vote and excluded from quorum on all other components.
Applications
The Common Rule also specifies when an application must be made for IRB review.
An application for IRB review must cover:
- a risk/benefit analysis
- the informed consent process and informed consent documentation process
- the assent process and assent documentation process, if necessary
- the identification and selection processes for subjects
- safeguards for vulnerable populations, if necessary
- the privacy and confidentiality process
- the data governance process
- the qualifications of involved researchers, especially with regard to data governance and analysis
- the research design
- compliance with laws, regulations, and policies, if necessary
Reviewing Risk
While an application must include a risk/benefit analysis, the IRB is responsible for assessing the reasonability of risks given the benefits.
Risks for behavioral research generally fall into one of these categories:
- invasion of privacy
- breach of confidentiality
- study procedures themselves
Risks need to considered in a variety of dimensions. Degree of risk is generally understood as a function of the severity of risked outcomes and the likelihood of risked outcomes. Risks are also often dependent on situations, such as legality and cultural norms.
Expedited Review
Some research proposals and continuing reviews are eligible for expedited review. The alternative is called convened review.