What does IRB stand for?

Institutional review boards (IRBs) or research ethics committees provide a core protection for human research participants through advance and periodic independent review of the ethical acceptability of proposals for human research.

What is the purpose of the IRB?

Purpose of IRBs

Institutional Review Boards, or IRBs, review research studies to ensure that they comply with applicable regulations, meet commonly accepted ethical standards, follow institutional policies, and adequately protect research participants.

What is the IRB also known as?

An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee at an institution that applies research ethics by reviewing the methods proposed for research involving human subjects, to ensure that the projects are ...

What is the IRB in psychology?

Institutional Review Boards (IRBs) are federally-mandated, locally-administered groups charged with evaluating risks and benefits of human participant research at their institution.

What is the IRB for dummies?

An IRB's purpose is to protect the participant rights and welfare of human research. In accordance with FDA regulations, an IRB has the authority to approve, require modifications to, or disapprove research when it believes the participant's rights or welfare are not properly protected.

How IRBs Protect Human Research Participants

What are 2 things that IRB requires?

Which 3 main areas does the IRB verify?

IRB must review all projects that meet the definition of research and that involve human participants prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major levels of human subjects' research review: Exempt, Expedited, and Full.

What are IRB requirements?

Risks to the subjects are minimal, and are reasonable in relation to anticipated benefits. The subject selection is equitable. Privacy and confidentiality are protected. Informed consent processes meet federal regulatory and U-M requirements.

What are the 4 important ethical issues IRB guidelines address?

Four requirements for ethical conduct of research follow directly from this principle of respect for persons: 1) Participants must voluntarily consent to participate in research; 2) The voluntary consent obtained from participants must be informed consent; 3) Protection of privacy and confidentiality must be ...

Why was the IRB created?

Promulgated by the Department of Health, Education and Welfare (DHEW), those regulations raised to regulatory status NIH's Policies for the Protection of Human Subjects, which were first issued in 1966. The regulations established the IRB as one mechanism through which human subjects would be protected.

Does the IRB still exist?

The IRB subsequently dissolved itself, although it is not known whether a formal decision was taken, or it simply ceased to function.

Who regulates the IRB?

IRBs are enacted under federal regulation, specifically 45 CFR 46, and are regulated by the Office for Human Research Protections (OHRP) within the U.S. Department of Health & Human Services (HHS).

Who Cannot be on an IRB committee?

The IRB is not comprised of either all male or all female members. The IRB is not comprised of members who represent only a single profession. At least one member has primary concerns in scientific areas.

What are the ethical principles of the IRB?

Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.

What are the ethical guidelines for IRB?

When reviewing research IRBs are guided by three ethical principles that are fundamental to human subject protection - respect for persons, beneficence, and justice.

How do I get an IRB?

What are IRB concerns?

The IRB is concerned with protecting the welfare, rights, and privacy of human subjects.

What information does the IRB not need?

If the project does not include any interaction or intervention with human subjects or include any access to identifiable private information, then the project does not require IRB review.

What should an IRB consist of at least?

What are the 3 types of IRB?

There are three types of IRB review: Expedited, Exempt and Full Board. Expedited review is only allowed for research projects that are no more than minimal risk and will be reviewed by an IRB Chair or Chair Designee (IRB Member).

What happens if you don't get IRB approval?

Under 45 CFR 46.103, the IRB must review and approve all non-exempt human subject research. Failure to obtain IRB approval before conducting research could result in the researcher being unable to use data and other information collected through the research process.

What documents need IRB approval?

Which type of IRB does not require approval?

“Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.

Who should be listed on an IRB?

Any individual engaged in the research project must be listed.

How long does the IRB process take?

How long does IRB review take? An expedited or exempt review may take about two weeks. Studies requiring convened review may take three or more weeks.