When it comes to conducting scientific research and turning clinical trials into cures for Alzheimer’s disease and related dementias (ADRD), it's not just about collecting data and analyzing results. We understand that there’s a deeper responsibility to ensure that study participants are treated with respect and given accurate information about the study they're participating in. We understand the importance of creating a safe and transparent environment for participants, and we hope that our commitment to that mission shines through in every aspect of our work.
To that end, ATRI recently celebrated the release of a new paper titled “Disclosing Individual Results in Dementia Research: A Proposed Study Participant’s Bill of Rights.” The proposed Bill of Rights was crafted by a committee of study participants, representatives of dementia advocacy organizations, and other stakeholders in dementia research for the Advisory Group on Risk Education for Dementia (AGREEDementia). It was co-written by Sarah Walter (Alzheimer’s Therapeutic Research Institute) and Angela Taylor (Lewy Body Dementia Association), with significant contributions from Alzheimer's Clinical Trials Consortium advisory board member Cynthia Huling Hummel. The framework developed by the Multi-Regional Clinical Trials (MRCT) Return of Individual Research Results provides a useful context for researchers to plan their studies and disclosure.
The purpose of the Study Participant Bill of Rights is to empower research participants and urge trial sponsors and scientists to fund and design studies that accomplish their goals, while also taking ethical considerations into account. The adoption of the Participants Bill of Rights would be a paradigm shift as, at present, study participants are not informed of their own test results, even though studies have shown that many participants want to know their results, even if the results are not definitive.
The Bill consists of eight individual rights covering many facets of the clinical studies process. Each right is aimed at ensuring that research participants are able to make informed decisions about their participation in studies and that they have access to their individual results (if they so choose).
When you participate in research, you should have certain rights that protect you and ensure that you receive the information you need to make informed decisions. For example, you have the right to receive written information about the tools used to make decisions during the research process. You also have the right to know who can access your results and how the law protects your privacy.
It's important that participants understand what their test results mean, and that the information is presented to them in a way that is easy to understand. You have the right to ask questions and take as much time as you need to process the information you receive, and you should feel empowered to make decisions about your own well-being based on the information you learn.
If a person chooses to participate in research, they have the right to be contacted (or to decline to be contacted) and for someone to check on their well-being after receiving a result suggesting an increased risk of dementia. A participant should also be referred to additional resources for more information and support related to their health and well-being.
When a participant receives their test results, they should have the right to decide what actions to take. This includes pursuing medical or psychological care, engaging in legal or financial planning, and informing their family and friends of their results. These rights allow them to use their results to make a positive impact on their own health.
Lastly, all of these rights should apply regardless of cognitive status, meaning that those living with Mild Cognitive Impairment (MCI) or dementia are also entitled to these rights. This recognizes the importance of patient autonomy and informed decision-making, even in cases where cognitive decline may be present.
These rights are proposed as a call to action for a larger discussion which will ultimately help clinical trial participants make more informed decisions. There should of course be stipulations made for certain situations in which providing data would harm the validity of the study. We encourage researchers to design studies that allow for more transparency and encourage funders to support studies that engage with the participants at this level.
The growing industry of genetic testing by for-profit companies shows that the public does have an interest in obtaining information of this kind. But unfortunately, that information is typically provided to participants without all of the proper contexts. That’s a mistake that researchers cannot and should not make in clinical trials. Researchers should provide data to participants in a way that contextualizes results, in order to not create any unwarranted fear. Similarly, patients need to be informed of any potential risks of knowing such information.
While there is currently no federal Patient Bill of Rights, the creation of a Study Participant Bill of Rights would not be unprecedented. In 1973 the American Hospital Association adopted a “Patient's Bill of Rights”, which was later turned into the “The Patient Care Partnership”. The rights were developed with the expectation that hospitals and healthcare institutions would support these rights in the interest of delivering effective patient care.
The implementation of the Bill of Rights in research would mark a significant shift, granting individuals greater agency and control over their involvement in clinical studies. By recognizing the personal preferences of research participants and ensuring that they have access to their individual results, researchers will be better able to build trust with study participants.
Please share the Study Participant Bill of Rights with those in your circle of influence; together, we can a difference in the fight against Alzheimer’s disease and related dementias.
