IRB Considerations for Conducting Patient Recruitment
Recruitment is the first interaction potential participants have with a research study and can set the tone for everything that follows. Regulatory agencies even consider recruitment to be part of the informed consent process. This is why institutional review boards (IRBs) carefully review recruitment strategies. Recruitment isn’t just about hitting enrollment numbers, it’s about making sure people are invited into research studies fairly, with accurate information and without pressure.
How can researchers ensure they are effectively recruiting participants? This blog outlines IRB regulations and best practices for researchers to abide by.
Ethical Considerations
With ethical roots in The Belmont Report, published by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1976 in response to wrong doings in research, IRBs review recruitment strategies to ensure:
- Respect for persons: From the very first contact, people are given accurate information, the freedom to choose and protection if they are vulnerable
- Justice: People are recruited in a way that is inclusive, fair and not based on convenience, vulnerability or bias
IRBs look to ensure eligible populations have a fair opportunity to participate in research regardless of race, gender or socioeconomic status. They must also ensure no vulnerable population or easily accessible groups – such as prisoners or low-income communities – are targeted unless the research specifically benefits them.
Undue Influence
Undue influence occurs when participants are offered an excessive, unwarranted, inappropriate or improper reward for participation. A common example of undue influence in recruitment is participant payment – over emphasizing payment or using excessively high payments to recruit participants. These approaches could cause someone to ignore or downplay study risks because the potential payments are too good to pass up. This is especially concerning when research takes place in low-income settings.
However, just because payment is offered, it doesn’t mean it’s ethically concerning – even if it motivates potential participants to take part in a study. The concerning part is offering something so enticing, people compromise their evaluation of the potential participation risks.
Coercion
Coercion happens through an overt or implied threat of harm or negative consequences – typically used to compel someone to participate in research. One example of a potentially coercive recruitment strategy is when supervisors approach their direct reports to take part in a study. In this case, the individual who is recruiting is in a position of authority over the potential participant rejecting them could have real or perceived negative impacts, such as a bad performance evaluation.
With this in mind, there are ways to design research involving employees and/or students that mitigates the risks of coercion. This may include involving a third party in the recruitment process to remove the threat of coercion.
Regulatory Requirements
Before participants are enrolled in a study, they must undergo a process called informed consent: This is a process where researchers outline the study, what participation will involve and potential risks and benefits to participating.
Federal regulations require IRBs to review informed consent as part of their review process. Regulatory agencies have specified that recruitment is the first step in the informed consent process. As such, IRBs have an obligation to ensure both the recruitment methods and materials used to enroll participants are reviewed and approved. This includes initial use of recruitment material as well as any changes to them once the study is underway.
Examples of recruitment material needing IRB approval includes (but is not limited to):
- Websites
- Radio ads
- Phone scripts
- Direct mail
- Social media
- Podcast scripts
- Television scripts and graphics
- Posters
- Print advertisements
- Email copy
It’s important to note: When it comes to seeking IRB approval, there is no asking for forgiveness. There is only asking for permission. Failure to gain approval for any recruitment materials can result in study delays or potentially findings of investigator non-compliance. Sabai IRB established Recruitment Guidelines to help researchers design recruitment materials aligning with both IRB and federal agency requirements.
Best Practices for Recruitment Materials
When designing recruitment materials and talking to participants, everything must be conveyed in such a way that is clear and understandable for prospective participants. Especially with recruitment materials, a few guidelines to follow are:
- Simple: The brief description of the research should be short and easy to read. Avoid using jargon and acronyms, and be mindful of tone as you are creating materials.
- Accurate: Clearly state this material is for a research study. Do not imply it’s an FDA-approved medical treatment. Outline what’s expected of participants and who may be eligible.
- Accessible: Include time commitment and compensation involved without over-emphasizing payments. Include different messaging delivery modes to connect with a variety of participants.
- Compliant: Be aware of the IRB’s and FDA’s Guidance for Recruitment. Design materials in alignment of both of these guidelines. Avoid promises of free treatment and implications of favorable outcomes, exaggerated benefits or false claims about FDA approvals or labeling.
Staying Patient-centric During Recruitment
Our mission at Sabai is to protect the rights, safety and welfare of human research participants as they participate in research. Our patient-first approach is top of mind as we review recruitment methods and materials. As a central IRB, we know what an IRB must review and approve, we understand ethical considerations when it comes to reviewing research and we work to make sure researchers are staying compliant.
Whether you’re launching a new study or refining your recruitment strategy, we are here to ensure your approach is ethical, inclusive and compliant. Partner with us to strengthen your trial design and protect your participants every step of the way.
