Respect for participants is integral to ethical and effective clinical research. CT:IQ has previously developed a range of outputs targeted towards promoting respectful research practices, including the InFORMed Project, Beyond the Form, and Clinical Research Data Sharing Frameworks. This project builds upon these outputs to articulate the broader elements of respect for clinical research participants throughout the research life cycle. This includes, but is not limited to, through ongoing and dynamic consent.
BACKGROUND
Respect in clinical research
‘Respect’ has been a foundational principle of clinical research ethics since publication of the 1979 Belmont Report, which defined respect as entailing
"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. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy."
Beyond the traditional focus on autonomy, respect for participants also entails broader obligations to ‘regard individuals’ rights, needs, interests and feelings’,[1] which scholars have identified as including:
- Upholding human dignity, human rights and fundamental freedoms
- Kind, patient and ongoing interactions with the study team
- Protecting participants’ privacy and confidentiality
- Not increasing burden of participation without a valid reason.
What is ‘Respect by Design’?
‘Respect by Design’ seeks to promote a systemic approach to ensuring that individuals’ rights, safety and wellbeing are foundational requirements for every clinical research design decision. The title is an adaptation of the well-known ‘Quality by Design’, which has been in existence since the 1990s as a means of proactively designing quality into pharmaceutical products.[2] CTTI has developed a comprehensive toolkit to help implement Quality by Design principles into clinical trials.
Examples of Respect by Design in clinical research may include the following
- Developing valid clinical research questions designed with consumer input.
- Designing clinical research protocols that do not unnecessarily increase burdens on participants.
- Developing and implementing systems that allow participants to set and update their consent preferences.
- Collecting information on participants’ surrogate decision‑makers in case their capacity changes during the research project.
- Ensuring fair and transparent participant payment and reimbursement.
- Re‑consenting participants when circumstances change and reaffirming their choices is the right thing to do.
- Following‑up with participants as appropriate after the trial finishes.
- Clarifying future use and access to participants’ samples and data.
SCOPE
The proposed project will develop:
- A list of the key elements of Respect by Design, through a consensus-based process with Australian clinical research sponsors, sites, consumers, and ethicists.
- A high-level white paper on strategies for incorporating Respect by Design principles in Australian clinical research.
- Links to helpful resources in Australia and internationally for operationalising Respect by Design.
The project seeks to:
- Raise awareness by sponsors, sites, and review bodies of the meaning of Respect by Design and its associated elements
- Give high-level guidance on the implementation of Respect by Design principles in common research elements.
[1] Kraft, Stephanie A., et al. "Demonstrating ‘respect for persons’ in clinical research: findings from qualitative interviews with diverse genomics research participants." Journal of Medical Ethics 47.12 (2021): e8-e8.
[2] Yu, Lawrence X., et al. "Understanding pharmaceutical quality by design." The AAPS journal 16.4 (2014): 771-783.