At the University of Minnesota, research participant safety is a priority. Legally authorized representatives (LARs) play an important role in making sure that the rights of research participants are protected.
LARs make decisions on behalf of a person not capable of making their own decisions. To be an LAR, you must be (in order of priority) the person’s:
- Health care agent*
- Adult child
- Adult sibling
*Person named by an individual in a healthcare power of attorney to make health decisions for them when they do not have the capacity to make such decisions.
Benefits & Risks
LARs consider the benefits and risks of a research study before making a decision for another person.
The research team can help LARs to understand what the risks and benefits of the research are, how likely they are to happen, and if there are alternative treatments available.
Benefits are good things that might happen because of the research study.
Indirect benefits are those that help others, such as learning new things that lead to better treatments in the future.
Direct benefits are those that help the participant as a result of receiving an experimental drug, device, or other intervention. Relief from pain is an example of a direct benefit. Free medical care, exams, or testing are not considered direct benefits.
Risk means the chance of harm. Risks could include side effects, pain, or other problems, discomforts, or inconveniences that might happen due to participating in the research study.
As an LAR, you will be asked to serve in the role for as much of the research study as needed. This might mean making all of the decisions from the beginning to the end, or only making some decisions if the person you represent has the capacity to make decisions at times.
Assisting a family member in decision-making can be difficult. The following are some ways to think about and decide if the person you are representing should start, continue, or stop participation in a research study.
If the person you are representing has clearly stated their wishes about research participation (for example, in a health care directive), you should follow their stated wishes.
If you know the person’s beliefs, views, and preferences, and there is no health care directive, you can make a decision based on what you think the person would do if they were capable of deciding.
Example: Participating in the research study has a small chance of slowing the person’s disease but requires participants to visit the clinic several times a week for long periods of time. You know that the person values the activities at their assisted living center and will likely miss out on those activities. What do you think the person would do if they could decide?
If you do not know the person’s beliefs, views, and preferences, you can make decisions based on what you think is best for them.
Example: Participating in the research study has a small chance of slowing a person’s disease, but the experimental drug is known to have side effects such as periods of depression and confusion. You don’t know what the person would prefer. What do you think is in the best interest of the person?
Assent & Dissent
The research team will assess the capacity of the person you are representing throughout the study. Maintaining the dignity of the person is of primary importance.
If the person can understand some of the information about the research study, such as what they will be asked to do, the research team will ask the person to indicate their feelings about participating. Indicating willingness to participate is called assent.
Indicating unwillingness to participate is called dissent. The research team will respect the person’s feelings and may consult with you to help determine whether continued participation in the study is appropriate.
Assent and dissent can be expressed verbally or nonverbally (for example, a smile or frown).
Questions & Concerns
If you or a loved one are in a study and have questions for the researcher, contact them directly. Their contact information is located in the materials you received about the research study.
To share feedback privately about your or a loved one’s research experience:
- Call the Research Participants’ Advocate Line: 612-625-1650
- Submit feedback online