When the Board reviews the risk in a study, they rely on guidance provided in the Belmont Report and in the federal regulations regarding IRB review. Providing a protocol that demonstrates your ability to work with participants as well as an understanding of IRB regulations will go a long way in helping the Board to make a good decision about your protocol.
Foundation for Risk Review
When the IRB reviewer looks at the risk in a study, he or she tries to determine what the best and worst case scenarios will be based on the information provided in the protocol. This assessment is based on the experience of the primary reviewer, secondary reviewer, and the entire Board (if the protocol requires full board review) and the ethical concepts that are the foundation for the IRB process. Two documents (among others), the Belmont Report and Code of Federal Regulations 45 part 46, canonize these concepts. The federal regulations provide a rule structure while the Belmont Report provides an analytical framework for decision-making, creating a balance between social code and individual judgment.
Belmont Report
At the core of the Belmont Report are three concepts that govern the ethical deliberations of the IRB:
- Respect for Persons: Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.
- Beneficence: Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being.
- Justice: Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of "fairness in distribution" or "what is deserved."
At least one (if not more) of these concepts drives the more practical requirements of the IRB, such as providing informed consent (respect for persons and beneficence), making an assessment of risks and benefits (justice, respect for persons, and beneficence), and selection of subjects (justice).
Federal Regulation’s guidance on risk
According to the federal regulations CFR 45, when the Board reviews a protocol, they are required to determine if the study is minimal risk; if the study is not minimal risk, the Board analyzes if the study minimizes the risks according to good scientific practice. The Board will also weigh the benefits versus the risks. In addition, the Board will evaluate the study’s recruitment and consent procedure. The Board will review the data collection and storage procedures to make sure that confidentiality is protected and the data are properly stored. All of these elements combined can give the Board a summary of the level of risk in a study, from which they can make recommendations and ultimately make a decision regarding approval. The federal regulations also describe how the Board is supposed to be constructed and how the meetings should be run, as well as the administrative functions of the IRB-SBS.
Explaining Risk in a Protocol
The Board will need to know the various harms that might be encountered by participants, the likelihood that the harm will occur, and how you will both reduce the potential for harm and assist participants who have experienced harm as the result of participating in the study. Regardless of the risk level in your study, it is important that you accurately describe this information in your protocol. Consider the following checklist before you submit your protocol for review and check out the iProtocol Risk & Benefits section.
- Clearly outlined recruitment and consent procedure: From the IRB’s perspective, one of the best ways to protect a participant is to ensure that a participant is able to protect themselves. Ultimately, the person that will make the best decision about a tolerable level of risk is the individual consenting to participate. The Board and the researchers work together to create the kind of environment where this is possible, allowing participants to act out of their own best interests. Some participants are not able to sign a consent form because of their age and/or mental competency. Please see Vulnerable Participants and Risk-Sensitive Populations for more information.
- Identify all risks in the study: The Board will review a study for possible “red flags”, elements in the study that will likely cause concern for a participant. For example, questions about personal behaviors such as sexuality, drug use, political views, etc, may make a participant uncomfortable and should be specified in the consent form. Possible injuries, potential emotional distress, or offensive material should be included as well. Be particularly sensitive regarding children and provide ample information to parents about what their child will do. The consent form should inform participants about all of the probable risk factors; don’t include improbable, ridiculous, and/or outlying risk factors that will only stress a participant. Some participants, because of their lifestyle, relationships, health conditions, etc, may be more susceptible to risk and need extra precautions. Please see Vulnerable Participants and Risk-Sensitive Populations for more information.
- Describe what you will do to minimize risks: The Board will not allow unnecessary risk and will want assurance that you have minimized risk in the study. One of the benefits of the review is that the Board members may have suggestions of ways you can reduce risk in your study, providing alternative, safer methods for collecting the same data.
- Include a detailed plan for an undesirable event: If something goes wrong, what will you do? The Board wants to know that you are prepared to handle a situation should it arise. For example, if a participant indicates that they are suicidal on a questionnaire, how will you handle this situation? In your protocol, you need to develop a plan that is specific to your study and will best benefit your participants. If you need help, consult with a faculty advisor, colleague, and contact our office. Should an incident occur, our office is required to follow specific procedures in the event of an unexpected event; for more information, please see Unexpected Adverse Events.