The IRB (Institutional Review Board) process is the critical oversight and approval foundation when embarking upon a research study. This article presents the most important things to know about the IRB application process before moving forward and offers some tips for expediting the process.
What is an IRB?
The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) have established regulations for the protection of human subjects involved in research. An IRB is an FDA regulated committee whose purpose is to review and ensure compliance and ethical conduct in medical research settings involving human participants. The main purpose of these regulations is to establish consistent requirements for researcher compliance, documentation, informed consent, operation of the IRB committee itself, and record keeping. Once an application is reviewed and approved, monitoring is conducted through audits, reviews, and site visits by federal investigators to ensure continued compliance. There are additional regulations pertaining to certain vulnerable populations (i.e. children, pregnant women, and prisoners). A researcher, usually the Principal Investigator, will submit an application packet to the board prior to engaging in any research involving human subjects. If, however, the study fulfills criteria for exemption from a formal IRB application, a shortened application may be submitted. The board then has the authority to approve, reject, or require modification to the proposed research protocol. The overarching purpose of this organization is to protect the safety, privacy and welfare of human participants in research settings.
Keynote: The IRB is the crucial oversight of all human subject research. It is individual to each institution and as such, many of the individual documents and forms required may vary between different IRB committees, however, the basic requirements remain the same.
Do I need to complete an IRB?
First, determine whether the study is in fact research. The Federal Policy for the Protection of Human Subjects (Common Rule) defines research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge…”
Second, determine whether human subjects are involved. The Common Rule defines a human subject as “…a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”
If both of these criteria are met, the study requires IRB committee approval.
What is the basic structure of IRB review process?
The IRB committee will review an application for research approval and perform a risk vs. benefit analysis, evaluate the proposed informed consent, selection of subjects, and how the researcher plans to ensure privacy and confidentiality of protected health information, among other requirements.
Risk vs. Benefit Analysis
“Risks to research subjects posed by participation in research should be justified by the anticipated benefits to the subjects or society.”- Department of Health and Human Services IRB Guidebook
Because there is inherent risk in any treatment plan, the IRB must first distinguish the risk of participation from the risk of a patient continuing with the patient’s current therapy plan. In addition, they must consider patients who are dependent on the proper treatment who may be placed on a placebo during the course of a study. They must account for all risks, whether it is physical, psychological, or economic. Then they determine what measures must be taken to minimize the risk of participation in the study, identify the anticipated benefits of the research in question, and determine whether the risks are justified given the potential benefits to the patients themselves and to society. A few questions considered by the IRB when conducting a risk/benefit analysis (From the HHS IRB Guidebook):
- Are both risks and anticipated benefits accurately identified, evaluated, and described?
- Are the risks greater than minimal risk? Has the IRB taken into account any special vulnerabilities among prospective subjects that might be relevant to evaluating the risk of participation?
- If the research involves the evaluation of a therapeutic procedure, have the risks and benefits of the research interventions been evaluated separately from those of the therapeutic interventions?
- Has due care been used to minimize risks and maximize the likelihood of benefits?
- Are there adequate provisions for a continuing reassessment of the balance between risks and benefits? Should there be a data and safety monitoring committee?
The informed consent process is more than a simple consent signature on a disclosure form. It is meant to represent an open dialogue between the researcher and participant in which the participant not only understands the process they are embarking upon but are also able to ask questions to further clarify the information if needed. The participant has the right to revoke consent and disenroll from a study at any time.
The informed consent process rests on three main tenets:
- Complete disclosure of the study details
- Comprehension on the part of the subject
- Voluntary participation
A comprehensive, and ethical informed consent process is a vital requirement of all research involving human subjects. It assures that human subjects not only willingly consent to participate in the research study but that that they are “informed”- that they both know and understand what their involvement will entail, and the potential risks and benefits of participation. Informed consent also requires that the participant have the capacity to make an educated decision, and that they are not under any duress or persuasion in the process. Furthermore, informed consent must be properly documented, usually in the form of a written document.
Though informed consent may seem like a fairly simple requirement to meet, according to the Department of Health and Human Services, studies show that ensuring adequate comprehension and true voluntary choice may not be so easy to achieve. Often, the full nature of the study may not be properly conveyed, resulting in failure of the subjects to understand what their participation entails. In addition, special considerations must be taken for vulnerable populations such as children or persons who may be unable to comprehend the information.
Keynote: The Informed Consent form is usually specific to each IRB and will have areas that are generic and must be included, but will also have sections individual to each proposed study protocol that the researchers must fill in.
Under federal regulations, it is the duty of the IRB committee to determine that the selection of the proposed research participants is fair and equitable, ensuring that the risks and benefits of participation in the research will be equally distributed. These regulations arose out of studies such as the Tuskegee Syphilis experiment where the participants were solely of a minority population who were economically disadvantaged. Therefore, the selection of the patients is evaluated by the IRB to establish “whether some classes (e.g., welfare patients, racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position or their manipulability, rather than for reasons directly related to the problem being studied.”- National Commission for the Protection of Human Subjects.
Privacy and Confidentiality
Research participants have the right to be aware of how their personal and private health information is accessed, stored, shared, and reported during the course of a research study. The IRB committee will review the researcher’s confidentiality plan to determine that all information gathered under the patient’s consent is necessary to accomplish the intended research, that identifiers are systematically removed, and that there are adequate safeguards to protect that information from unauthorized disclosure.
Keynote: Data storage in secure locations whether physically in locked filing cabinets in locked offices, or through digital locations, must be through approved locations that the IRB has deemed as secure. A breech in participant personally identifiable information is a reportable event.
Ongoing Monitoring and Review
The researcher must present a plan for collection, storage, and analysis of data. This is important because the preliminary data may highlight a need to make changes to the study design. Also, as the study progresses, periodic analysis will allow the research team to make changes that may enhance the value of the data collected or even lead them to prematurely terminate the study if it becomes clear that there is an increased risk to patients than previously thought.
What else do I need to know about the IRB process?
While institution-dependent, there may be a cost involved in filing an IRB application. Often business and industry-related studies that take place place at universities or academic hospitals may have a fee to cover administrative costs of managing the study review process. As many business-related studies tend to be more complex, they may require more IRB resources to complete the proper review and prevent bias. Again, this fee is entirely dependent upon the research site in question.
Certain studies may be eligible for an expedited review process if they are determined to involve minimal risk to human subjects. This topic is bettered reviewed in a later post.
Who can help me complete my IRB application?
Colony Health employs and maintains many personnel and resources with access to a variety of institutions. We can provide the guidance needed to navigate the IRB process at many locations as well as individualized guidance based on the specifics of your planned study.
More information about Institutional Review Boards can be found at:
FDA Regulatory Site: http://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm
Department of Health and Human Services:
Office for Human Research Protections (OHRP). IRB guidebook. www.hhs.gov/ohrp/irb/irb_guidebook.htm (accessed 2007 Feb 2).
- Byerly W. Working with the institutional review board. American Journal Of Health-System Pharmacy [serial online]. January 15, 2009;66(2):176-184 9p. Available from: CINAHL with Full Text, Ipswich, MA. Accessed April 18, 2016.
- Department of Health and Human Services. Office for Human Research Protections (OHRP). IRB guidebook. www.hhs.gov/ohrp/irb/irb_guidebook.htm (accessed 2007 Feb 2).
- Korenman, S.G., Teaching the Responsible conduct of Research in humans (RCRH) Common Rule, Office of Research Integrity, US Department of Health and Human Services https://ori.hhs.gov/education/products/ucla/chapter2/page00b.htm