A primary purpose of informed consent is to allow competent individuals to decide for themselves whether or not to participate in research. This process involves three elements: 1) disclosing information to potential participants; 2) ascertaining that they understand the information; and 3) ensuring that their agreement to take part is voluntary.25
Current regulatory and procedural frameworks, however, tend to emphasize disclosure requirements, which can lead to complicated consent documents that contain an overwhelming level of detail.26
Failure to attend to the importance of comprehension and voluntariness may undermine the basic ethical principle of respect for persons and the goals of informed consent.
In actuality, as Wendler and Grady27
point out, investigators do not need to disclose, nor do potential participants need to understand, all there is to know about research. Not only is there too much to know, but much of this information is not needed to give valid informed consent. Rather, the extent and nature of the information disclosed should focus on what a reasonable person needs to make an autonomous decision.26,28
In this study, we gathered data from multiple stakeholders to begin addressing calls to simplify and refocus consent forms—in this case, a biorepository consent form. Starting with a model form that was developed based on federal regulations and best practice guidelines, we sought input to ensure that a further simplified form would contain the information most important for prospective participants to know about taking part in a biobank. Between the different stakeholder groups, we found significant differences in both the number of sentences identified as containing important information, as well as in the topics of the sentences that were identified as being important. One explanation may be the diverse motivations that exist across the three groups.
A likely motivation among research participants is to understand efficiently the choice being presented to them. In other words, they want to spend as much time as necessary, but no more, obtaining information and making a decision about taking part in research. This might explain why in our study they selected fewer sentences on average when compared to the other groups. Participants are of course ideally situated to provide input on what they would like to know in order to make a knowledgeable and voluntary decision. The National Bioethics Advisory Commission recommended in multiple reports that prospective participants can provide valuable insights into the type of information other potential subjects might want to learn by involving them in the design of studies and the informed consent process.2,26,29,30
Researchers’ goals include maximizing enrollment of eligible participants within the constraints of ethically acceptable approaches to recruitment and consent. At the same time, they are likely motivated by a desire to minimize delays in the IRB review process and may see adherence to IRB template language with the fewest possible study-specific additions or deletions as the path of least resistance. Informally, one researcher in our study commented that she found it challenging to remain true to the instruction to highlight sentences containing information she considered most important for prospective participants to know because, as she went through the form, she instead found herself thinking, “The IRB expects to see this, the IRB wants to see that.” Therefore, although research teams have first-hand experience with obstacles to the informed consent process, such as those raised by lengthy, complex forms, they may perceive little incentive to bring these matters to the attention of the IRB.
IRB representatives in particular confront several potentially conflicting mandates:
- Protect research participants. The purpose of IRB review is to ensure that appropriate steps are taken to protect the rights and welfare of research participants. To approve a study, the IRB must determine that risks to subjects are necessary, minimized, and reasonable in relation to anticipated benefits; that selection of subjects is equitable; that informed consent is obtained and documented appropriately (when required); and that adequate provisions are made to ensure subjects’ safety and to protect privacy and confidentiality (45 CFR 46.111[a]).
- Ensure regulatory compliance. Although IRBs are broadly charged with ethical review, they are ultimately held responsible primarily for procedure and documentation.26 Avoiding adverse enforcement action by a federal oversight agency can be a compelling source of motivation for IRBs,31 leading to excessively cautious interpretations and undermining efforts to streamline IRB practices—and all without enhancing participant protections.32
- Guard against institutional liability. As noted by the Institute of Medicine, consent forms have been “...hijacked as ‘disclosure documents’ for the risk management purposes of research organizations,” with the interests of the institution overwhelming the interests of the participant.33 A common refrain we heard in general conversation with IRB representatives was, “We like the idea of a simpler form, but the lawyers require us to have all this language.”
A strength of our study was that our consent form was written below an 8th
grade reading level, making it accessible to research participants as well as to the other stakeholders. Our sample size was relatively small, which limited our power to detect, for example, differences between IRB representatives and researchers in the number of sentences identified as important. However, we believe our data effectively demonstrate the widely divergent opinions of these three groups—potentially due to differing mandates—regarding the importance of various items of information in a consent form. These differences could frustrate efforts to move simplified forms into actual use, despite continued calls for such forms and ongoing projects aimed at developing them.34
This applies not just to biobanking consent forms, but to those used for other kinds of research that involve more risk and where the need for simpler forms that participants actually read and understand is arguably even greater.
Thus, reconciling these differences is a critical area for future endeavor. This resolution should be in the direction of ensuring that the focus of the informed consent process and form is on informing and protecting research participants. A simplified biobanking form should include the basic elements required by federal regulations for the protection of human research subjects, as well as additional topics recommended as best practice for biobanking (e.g., participant access to research results, development of commercial products). This information should be conveyed in clear, straight-forward language, with the level and types of detail guided by data such as those presented here concerning what participants most want to know. Research is needed to identify innovative ways of providing additional details for those participants who desire them, such as supplemental brochures and ‘Frequently Asked Questions.’ Finally, tools are needed that can be used during the consent process to ensure voluntariness and assess comprehension of the most important information.