All federally funded human subjects research, and at many institutions, all human subjects research, must be approved by an Institutional Review Board (IRB). The IRB is an independently functioning committee charged with reviewing human subjects research to ensure that participants are protected according to accepted ethical standards and regulatory requirements. IRBs can be based within an institution (such as a university or hospital) or can be an independent IRB that reviews studies for a variety of institutions and research groups. All IRB operate according to federal regulations.
Some researchers, especially those new to human subjects research, can find the process of obtaining IRB approval daunting. As IRB reviewers, we can assure you that the IRB firmly believes in the benefits of research but knows that these benefits can only be fully realized if the research is compliant and done in a manner that protects research participants. This 2-part Blog series is based on the many years of experience of the Learn eCORE founders, Drs. Ann Hardy and Sherry Mills, in conducting ethical reviews of research and offers key tips for IRB submissions and to highlight some common errors seen during IRB review process. While IRBs all have their own procedures, all are following the same basic regulatory requirements described in the 2018 Basic HHS Policy for the Protection of Human Research Subjects, often referred to as the revised Common Rule. Almost all federal agencies that support human subjects research follow the Common Rule.
In these blogs, the term” IRB Application” refers to an IRB-specific form, completed by an investigator, describing the study for which IRB approval is being sought. This may be done within a larger electronic IRB management system or may use a simple document template. We use the term “IRB Submission” to refer to all the study materials that must be submitted for IRB review, such as the IRB application, consent documents, and other related study materials.
Key Tips for IRB Submissions:
1. Your IRB is a great resource for help in preparing your submission. Make sure to review any materials they have developed for investigators before starting your submission. If investigators have specific questions, contact the IRB staff directly. IRBs generally are very willing to work with investigators to improve the quality of IRB submissions.
2. Understand the criteria IRB members use to determine whether a proposed research study is acceptable:
The Common Rule lays out specific criteria that all IRBs must use to approve proposed research studies
(section 46.111). Researchers should become familiar with these criteria. Think of this as being told exactly what topics will be on a test. Once researchers understand exactly what IRBs are looking for, it is much easier to craft a successful IRB submission. Unfortunately, many researchers are not aware that these criteria exist. This can result in their submission being returned simply for missing one of these key components. IRB submission requirements may vary in format and process across IRBs, but all are gathering information that the IRB needs to determine if these regulatory criteria are satisfied. Researchers can use these criteria as a checklist for an IRB application. Criteria for approval can be found in section 46.111 of the regulations.
The Common Rule also describes specific requirements of informed consent, including:
a. General requirements about consent in 46.117 (a) regarding the process, including the new requirement that informed consent begin with presentation of key information needed to help a person decide about whether to participate in a research study
b. Basic elements of consent in 46.117(b) that describes information that must be addressed in all consent forms
c. Additional Elements of consent in 46.117(c) are only needed when appropriate for a particular study.
Some IRBs have used these requirements to create consent form templates. For researchers that do not have a template, we suggest using these requirements as a starting point for creating your consent document and/or using them as a checklist to ensure all are covered before submitting your consent documents to the IRB.
3. Be prepared to describe the entire study from participant recruitment through to what happens when the study ends. Regardless of the format of an IRB submission, the IRB will need to know it all the details of a study, such as:
a. Who is being recruiting and how are potential participants found and made aware of the study?
b. Describe any screening of potential participants.
c. Provide details on all research procedures. Be sure to distinguish research procedures from procedures that are separate from the research, such as standard health care procedures (standard of care) provided to everyone regardless of the research
d. Most IRBs want to review everything that participants will see, such as flyers and other recruitment announcements, emails, data collection forms, referrals to be given, etc., so be prepared to provide electronic versions of these.
e. What happens when the study ends? For example:
i. Will results be shared with participant?
ii. What happens to the data?
iii. Could participants be asked to participate in future research?
f. Identify all potential risks and possible benefits associated with being in the research (to study participants or to society in general). Remember that risks are more than physical and can include psycho-social and legal/social risks. Specifically discuss how participant privacy and the confidentiality of research data will be maintained.
Learn eCORE has created an IRB submission Toolkit that describes these and other tips and includes a useful checklist. Click here to get your copy of this useful tool.
Both versions of the Learn eCORE human subjects research training courses teach about IRB’s and the regulatory requirements for IRB approval.