Research Ethics Highlight: Clarifying Consent
The Belmont Report (1979) chose the principles of
- respect for persons,
- beneficence, and
- justice
as essential for ethical human subjects research.
Respect for persons is often broken down into respect for autonomy and protection of vulnerable populations. Both autonomy and protection have largely been operationalized through the informed consent process.
Ethics discussions1,2,3 of informed consent have highlighted three major requirements for valid consent:
- Information:
- Participants should know the purpose, procedures, risks, benefits, and other details of the research. That information lets them decide whether participation aligns with their goals and values.
- Comprehension or understanding:
- Participants should be able to understand this information. They should also have the opportunity to ask questions about the study and communicate their choice to participate or not participate.
- Voluntariness:
- Participants should be free to choose whether to be in the study without coercion or undue influence. This might include options to skip questions or procedures that are part of the research and/or to withdraw from the study at any point, so long as appropriate safety measures are in place.
The informed consent process should be just that: a process, not merely a form participants must sign before the research activities can begin. Study teams should provide enough time for discussion and make sure participants actually understand the essential elements of the research. They must also have procedures in place to ensure that participants do not feel pressured in any way to sign the form before they are ready.
Fortunately, you don’t have to start from scratch when considering how to properly inform and consent people who might want to participate in your research! The VCU IRB’s template consent forms help researchers determine what is necessary to disclose to participants. The HRP-502 offers a full consent template in a question-and-answer format. The HRP-502a adds a HIPAA authorization section for researchers accessing medical records or other Protected Health Information. The HRP-502b adds VCU-approved language for informing participants about the payments they will receive.
These templates can be found in VIRBs under the Library tab:
We also recommend a few best practices for informed consent:
- The reading level of the document should be no higher than that of the target population.
- The average reading level in the U.S. is about an 8th-grade level.
- You can use features in Word to make sure your informed consent document is written at the appropriate reading level.
- Under the “Review” tab, click “Editor” → “Insights” → “Document stats”:
- The 2018 revisions to the Common Rule apply a reasonable person standard to informed consent. This means that investigators should consider what an ordinary person might want to know about this study. Applying this standard may help investigators decide which risks and benefits should be disclosed and how best to communicate them.
- For complex studies, there may be a lot of risks that could be overwhelming to your potential participant. Can you group them into categories by how likely the risks are to occur, how severe they may be, or another relevant factor that helps with comprehension?
- Consider using comprehension checks during the informed consent process.4
- Ask a potential participant to share their understanding of the risks, benefits, procedures, and alternatives to research. This promotes comprehension and provides opportunities for the study team to clarify miscommunications before the research begins.
- Additional protections are in place for participants who are not able to make decisions for themselves. This may include minors or adults with impaired capacity or decision-making ability. A Legally Authorized Representative (LAR), such as a parent or guardian, may be able to offer consent on their behalf.
- The VCU HRPP has guidance on these vulnerable populations in HRP-416: Children and HRP-417: Cognitively Impaired Adults.
- These documents can be found in the VIRBs Library under the “Checklists” tab. Study teams do not need to fill out or upload these documents with their VIRBs submission–the IRB will do that during its review process. However, it may be helpful to consult these documents if you plan to work with those populations.
Tips to reduce the reading level in consent forms:
- Use short sentences.
- Keep sentences focused on a single point.
- Use words with fewer syllables.
- Use bulleted or numbered lists when 3 or more items are included in text.
- Use plain language, swapping complex medical terms with familiar, everyday words.
- Write directly to the reader using the second person (“you”) instead of the passive voice (for example, “We will send you results” instead of “A summary of results will be sent”).
- Use italics, bold, or all-caps to emphasize important points, but NOT all at once. In other words, DO NOT do this: THIS IS IMPORTANT.
References:
Note: There are hundreds–if not thousands–of excellent bioethics articles that discuss informed consent! We cite just a few that investigators can use as a jumping-off point for digging further into this literature.
1 Emanuel, E. J., Wendler, D., & Grady, C. (2000). What makes clinical research ethical? Journal of the American Medical Association 283(20): 2701–11. DOI: 10.1001/jama.283.20.2701.
2 Millum, J., & Bromwich, D. (2021). Informed consent: what must be disclosed and what must be understood? American Journal of Bioethics 21(5):46–58. DOI: 10.1080/15265161.2020.1863511.
3 Applebaum, P. S., Lidz, C. W., & Klitzman, R. (2009). Voluntariness of consent to research: a conceptual model. Hastings Center Report 39(1):30–39. https://doi.org/10.1353/hcr.0.0103
4 King, W. T., & Heubi, J. E. (2014). Comprehension testing in informed consent. AJOB Empirical Bioethics 5(3):39–54. https://doi.org/10.1080/23294515.2014.894153
Categories Education & Training, Research Ethics Highlight