This page is for research participants.
Investigators, sponsors, and/or site staff are encouraged to review and/or offer these resources to participants who are deciding to join or have joined a study.
Sections on this page:
Deciding whether or not to receive individual results
When you participate in a study, data will be collected that you might find interesting or helpful. Data that are about you personally are called “individual results.”
This guide can help you think about whether you wish to receive your individual results from the research study. The types of individual results you might be able to get depend on the study and what data are being collected.
There are a few reasons why you might want to get your individual results:
- They could be helpful to your medical care now or in the future
- They might be interesting
- They signify the appreciation of the study doctors for your being in the study
There are also reasons why you might not want to get your individual results:
- They could be upsetting
- They could prompt additional questions for you to consider about your health
- You just might not be interested
As you decide whether to receive your results or not, you might want to consider:
- How important are these results to me?
- What value do these results have to me?
- Could these results help me?
- Could these results hurt me?
- Am I likely to be upset or confused about the results and, if so, what can I do?
Many of these and other questions can be answered by the study doctor and/or their staff. A list of questions for you to consider is given below to help facilitate a conversation about results when deciding whether to join a study or receive results.
Know that some studies may not be able to or choose to return individual results to participants. This should be discussed with the study staff when you are deciding whether or not to participate in a study.
Considering Genetic Results
In the case of genetic results, there are a few more things to think about. Genetic information is passed on to and shared by family members. Therefore, genetic results might affect not only you individually but also your immediate family members and perhaps even influence the decision to have children.
The decision to receive genetic results about yourself is complicated and will require time, thoughtfulness and, often, advice. Make sure to ask your study team whatever questions you have when you’re considering joining a study and whether a genetics counselor is available for you to talk to.
The following online resources may help guide this decision but should not replace talking to your study doctors and, if available, genetic counselors. Note that the number of resources is increasing, and the ones listed below do not imply endorsement or preference among them or others.
- Genomics Advisor, a decision support tool designed to help patients who have had their exome or genome sequenced and are being offered to learn about any incidental or secondary results.
- Genetic Support Foundation, an online resource with information related to a variety of genetic topics:
- General Health.
- Gene Test or Not, An online tool to help you decide whether or not to get tested to learn your genetic risk for late-onset Alzheimer’s disease. This tool guides users through these four questions, which could be applied to other therapeutic areas as well:
- Family history
- The usefulness of the information
- Timing with life circumstances
- Advantages and disadvantages
Discussing genetic results with family members
It can be difficult to process new genetic information about yourself. Often, genetic information about you will also be relevant to your family members. This possibility is something that should be addressed during the informed consent process when joining a study. Your study doctor and site staff can help explain what impact the information may have on your family members as well.
Each genetic result will have unique details and implications. You should ask the study doctor or site staff about how best to have this conversation with family members.
The CDC has prepared an example letter template for sharing BRCA1/BRCA2* results with family members (*these are genes related to Breast and Ovarian Cancer).
Questions to ask about individual results
Below are some questions to ask the study doctor and/or study staff about your individual results. Other questions about the research study may come up, and you should feel free to ask about anything.
Remember, joining a research study is an important personal decision, and participating in a study is your choice. Be informed. Ask questions. Get answers.
- What kinds of results will you share with me? If you are not sharing any results with me, can you tell me why?
- What happens if you find out something serious or other information about my health?
- Do I have a choice about which findings you share with me? What if I don’t want to know?
- Can I change my mind later about receiving these results?
- How can these results help me?
- Will you tell me about results that might affect my health or a member of my family’s health?
- Could results/findings affect my family planning decisions?
- Could you learn something new about my family history?
- Will you be able to make sure any findings are correct?
- Who can I talk to about these findings?
- Are my research data placed in my regular medical records?
- How will you protect my privacy?
- Who will pay for my follow-up care and treatment if a new medical issue is uncovered as part of the study?
- Will there be future research on any of my samples? Will I learn any of those results?