Part 2 – Approval Procedures

The IRB’s first and foremost job is the approval and oversight of research ethics. This module will outline some of the considerations to the oversight of IRBs.

 

Laws governing research with human subjects

The regulatory document for human research ethics is the Federal Law 45 CFR 46. This has five parts, and part A, which covers the most of the legislation regarding research with human subjects, is known as “Common Rule.” This is approved and held by the majority of federal agencies, and has a 2018 revision that some organizations have affirmed and others have yet to sign. It is important to know which rule the agency falls under. The provision of Common Rule have been covered at length in the previous modules.

Four additional parts cover other human research concerns. Part B covers pregnant women, human fetuses and neonates (primarily for medical research), part C covers research with prisoners, D research with children, and E provides information on IRB registration.

It is important to note that these laws only apply to research that is federally funded. However, many institutions will follow by these regulations as well as their provisions are generally very applicable to most research settings.

Finally, Common Rule is not “the end all” of regulations. Agencies may have their own specific policies, as well as other state, local or institutional policies that may need to be abided by. Research involving any sort of drugs must also follow FDA regulations as well.

 

Approval forms and processes
As covered in previous modules, there are three types of approval for a proposed study: exempt, expedited and full review.

Exempt studies follow under narrow purviews as described in previous modules and as a rule do not involve compromising private information about subjects and poses no more than minimal risk (defined as “the amount of discomfort expected in every day life or from a routine doctor’s visit”). Information gathered by these studies must have direct and indirect identifiers removed. These studies may be deemed exempt by an IRB member or group of IRB members outside of a normal meeting and do not need to follow Continuing Review unless required specifically.

Expedited studies involve minimal risk to the subjects but may involve information that has direct or indirect identifiers attached to it. These studies require limited review by an IRB Member but are also excused from continuing review.

Full review studies are necessarily those that involve more than minimal risk to subjects and or involve vulnerable populations. These must be approved by the majority of an IRB at a convened meeting. All decisions and rulings for any of the three types must be provided to the researcher in writing.

For partial review, this is generally done by the IRB chair or a designate and involves a full and careful review by that individual of the study protocols. If at this point they rule that it meets the criteria for exempt or expedited review, they may notify the researcher in writing of this ruling and then notify the IRB of the approval as well. If it is deemed unsafe or not meeting the requirements of exempt or expedited review, the reviewer may defer the decision to a full board meeting. It is important to note that only a fully convened board can deny research proposals: a reviewer can only defer the research to the full board with the recommendation it be denied if they are unwilling to approve it.