What does not require IRB approval?

What does not require IRB approval?

Actions taken for public health or clinical purposes, and not for research purposes, are not research procedures and do not require IRB approval before being implemented.

How long should an expedited IRB decision take?

one to three weeks

What is considered exempt research?

“Exempt” research are human subjects studies that present no greater than minimal risk to subjects and fit into one or more exempt categories (as described below).

What is non exempt research?

Non-Exempt Research (Needs IRB Approval): Any research, inclusive of surveys that involves minors, prisoners, clinical populations; inclusive of any clients in any therapeutic setting/relationship with a potential researcher; and any other vulnerable populations, such as older adults, should undergo IRB review.

Is informed consent required for exempt research?

The HHS regulations at 45 CFR part 46 for the protection of human subjects in research require that an investigator obtain the legally effective informed consent of the subject or the subject’s legally authorized representative, unless (1) the research is exempt under 45 CFR 46.101(b); (2) the IRB finds and documents …

Does exempt research require IRB review?

Exempt research must be initially reviewed by the IRB, but is then exempt from further review. Projects that do not meet the criteria for human subjects’ research are excluded from IRB review. Qualified IRB staff or members review applications to determine eligibility for exempt status.

What is limited IRB review?

Limited IRB review is a process that is required only for certain exemptions, and does not require an IRB to consider all of the IRB approval criteria in §46.111. In limited IRB review, the IRB must determine that certain conditions, which are specified in the regulations, are met.

What is the final rule?

A final rule, in the context of administrative rulemaking, is a federal administrative regulation that advanced through the proposed rule and public comment stages of the rulemaking process and is published in the Federal Register with a scheduled effective date.

For which types of studies must consent forms be posted on a public web site?

The revised Common Rule requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form be posted on a publicly available federal website within a specific time frame.

What is broad consent?

Broad consent is an alternative to study-specific consent, not a waiver of consent. In general, broad consent must be obtained before the storage, maintenance, or secondary research use of identifiable private information or identifiable biospecimens occurs.

What specific consent means?

Specific consent means consent provided directly to the government entity seeking information, including, but not limited to, when the government entity is the addressee or intended recipient or a member of the intended audience of an electronic communication.

What is the common rule human subjects protection?

The Common Rule is a short name for “The Federal Policy for the Protection of Human Subjects” and was adopted by a number of federal agencies in 1991. The Common Rule applies to human subjects research conducted, supported or otherwise subject to regulation by the VA.

What is the importance of the final rule?

The Final Rule creates a new requirement for U.S. institutions engaged in multi-site (more than one) cooperative research to use a sIRB for that portion of the research that takes place within the U.S., with certain exceptions. This requirement becomes effective three years after publication (20 January 2020).