This type of review is conducted for studies that entail greater than minimal risk to subjects. It is carried out by a fully convened IRB committee. According to federal regulation, minimal risk means that “The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” [45CFR26.102(f)]
This type of review is for studies that involve minimal risk to subjects. The review is performed by the IRB chair or an experienced designee. One example is a project that collects biological specimens for research purposes via noninvasive means (such as hair and nail clippings in a non-disfiguring manner). The Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) has a list of activities that fall under the category of minimal risk. Please note that use of the term “expedited” does not necessarily translate into a speedier review by the IRB.
Regulations specify several research activities that are considered exempt from review (45CFR46.101b). An example would be a minimal risk survey that cannot be linked to subjects through any form of identifiers. Due to the potential for conflict of interest, it is important to note that someone other than the investigator must make the determination of whether or not a study meets the criteria for exemption. Typically, this determination should be made by an IRB member. Contact your IRB office to determine the local procedures for exemption in your institution.
In assessing the type of review your research project may require, a useful tool to have on hand is a group of decision charts published by the DHHS. This will guide you through a list of questions to determine which review category is appropriate for your particular study (see sidebar for resources). Also, communicating with the IRB office to confirm that you are completing the correct forms for submission can save you time later.
Documents Needed for IRB Review
Typically, IRBs include a list of documents required for review submissions on their website. The documents may vary according to the type of research involved. The website will also have a template consent form containing standard language.
Examples of documents that may be required to be submitted with each new full-board review submission include an IRB application, detailed study protocol, subject consent form, data collection tools, grant/contract application, Investigator Brochure, recruitment advertisements, subject questionnaires, and Financial Interest Disclosure forms.
In addition, funding and accreditation agencies have adopted policies that mandate human research protection education for all study personnel. Many institutions utilize the Collaborative Institutional Training Initiative (CITI) course for this purpose. This contains various training modules and a certificate is issued upon successful completion of the course. Most IRBs will not issue final approval of a project until they have verified that all study personnel have completed this training.
The Full Board IRB Review Process
For full IRB review, the board will need all of the required documentation to assess that the study meets the federal criteria for approval. Many IRBs operate on a primary reviewer system whereby 1 or more IRB members are assigned a protocol based on the member’s education, background, and expertise. If no member has the appropriate expertise, an outside consultant is usually called upon. Some IRBs invite the investigator to the convened meeting to present their new protocols and answer any questions that might arise.
Much of the committee’s discussion is typically focused on weighing the risks involved with the study versus the potential for benefit to subjects. Risks include not only physical risks but also psychological and social risks. Recommended changes to the consent form are also discussed. If significant concerns are raised by the IRB, the protocol may be tabled or disapproved.
During the meeting, the IRB will determine the length of approval. This is based on the risks associated with the study and cannot exceed 1 year. The IRB may shorten the approval period for higher- risk protocols.
At the conclusion of the discussion, an IRB member makes a motion, it is seconded by another member, and then all members vote for or against approval or may abstain from voting. Members with a conflict of interest are required to leave the meeting room during the discussion and cannot participate in the vote.
IRB Approval Timeline
Oncology fellows need to be aware that once an application is submitted to the IRB it may take up to a month to be reviewed, although the time frame depends on the particular institution. Ask your local IRB for its average turn around time. This may vary according to review category and deadlines for submission. Since projects cannot be initiated until IRB approval is received, it is imperative to take this interval into consideration when developing a timeline for the implementation of any given research project.