ATRI's Research Participant Advisory Board recently met and celebrated the publication of a new paper titled "Disclosing Individual Results in Dementia Research: A Proposed Study Participant’s Bill of Rights." The "Bill of Rights" is a call to action for researchers in Alzheimer’s disease and related dementias (ADRD) to proactively design clinical studies that provide the option for research participants to learn their individual research results if they choose, and in a manner that ensures study integrity.
STUDY PARTICIPANT BILL OF RIGHTS
- I have the right to receive my individual results, collected in the course of my research participation if I so choose; I can also ask how to receive them. This may be done in person or by telehealth, and either alone or with a person of my choosing.
- I have the right to exercise this right in an informed manner, including receiving information on validated decision-making tools if they are available, knowing who can access my results, how the law does or does not protect me after receiving my results. In order to protect myself, I may need to finish any care, legal and financial planning in advance of receiving my results.
- I have the right to be told what my test results mean, in easy-to-understand terms and with sensitivity, compassion, and patience. This information should also be provided in writing, so that I may review it later.
- I have the right for my questions to be answered to the best of the researcher’s knowledge and to take all the time I need to process the information I received.
- I have the right to be contacted or decline to be contacted to check on my well-being after receiving a result suggesting increased risk of dementia, and to be referred to additional resources for more information and support related to my health and well-being.
- I have the right to decide what actions I take after receiving my test results, such as pursuing medical and/or psychological care, engaging in legal or financial planning, and informing my family and friends of my results.
- I have the right to turn my results into action for my own well-being and the betterment of others, by exploring additional research studies I may qualify for.
- The above rights should apply regardless of my cognitive status.
The purpose of the “Bill of Rights” is to recognize the personal preferences of research participants and to urge sponsors and scientists to proactively fund and design studies that accomplish these goals in a safe and effective manner, without compromising the validity and integrity of the scientific work. This poses a paradigm shift and a new opportunity for research participant engagement as part of protocol design and development.
These rights are proposed as a starting point for a larger discussion that will ultimately improve the process of sharing clinical results with research participants.
“…I would ask that you share the Research Participant's Bill of Rights with those in your circles of influence. Thank you ALL for your advocacy and for your commitment to dementia research Together we are making a difference. I have such hope!” - RPAB member and co-author, Cynthia Huling Hummel, pictured above.