Becoming a Research Volunteer: It's Your Decision

Should I participate in a research study?

People participate in research for a variety of reasons. Common reasons to participate in a research study include: Many people volunteer for research because they want to contribute to research efforts that may help others in the future.

The lack of a generally accepted therapy or the partial effectiveness of available therapies.

Participating in a research study might offer a new alternative to "standard" treatment before it will be available to the general public.

Research has led to important discoveries that make our lives better. Some examples include:

• Improved medical procedures
• New drugs to treat cancer, diabetes, and other diseases
• Vaccines
• Ultrasound, X-ray machines, and diagnostic tests
• Ways to stop smoking

This booklet will help you understand your rights as a research volunteer and help you decide if you should participate.

What is a research study?

A research study is an organized activity that is done to determine an answer to a question or problem. Scientists perform research studies because they do not know for sure what works best to help patients. A study may be done to determine the best way to treat or prevent an illness. A study may use a survey to help understand health needs, problems, or feelings.

One specific type of research study is called a clinical trial. A clinical trial is a study of a medical treatment in human participants. The medical treatment can be a drug; a surgical device such as an artificial hip; a medical device such as an insulin pump; or a surgical technique. The purpose of a clinical trial is to answer questions about safety and effects. Clinical trials are used to decide whether the best treatments are being used or to help the Food and Drug Administration (FDA) decide whether or not to approve a treatment for use.

Are there any benefits and/or risks to being in a research study?

Research studies that are well-designed and well-done may be beneficial because participants:

• Play an active role in their own health care.
• Gain access to new research treatments before they are widely available.
• Help others by contributing to medical research.

As is the case with most medical treatments, there are risks to participating in research. Some risks may include:

• There may be unpleasant, serious or even life-threatening side effects to the treatment.
• The treatment may not be effective for an individual participant.
• The research study may require more time and attention than would routine clinical treatment, including trips to the study site, more treatments, longer hospital stays, or complicated drug therapies.
• Experimental treatments must be evaluated for both immediate and long-term side effects.

Who pays for clinical research?

Mayo Clinic sponsors certain research studies initiated by physicians as part of an ongoing commitment to clinical research. Additional funding may come from the federal government (via the National Institute of Health), voluntary health agencies such as the National Multiple Sclerosis Society, private industry (via pharmaceutical and biotech companies), or from philanthropic private donations to Mayo that are earmarked for research. If research studies involve routine clinical care, your insurance company may also be asked to cover some of the costs.

What are my rights if I take part in a study?

• The decision to take part in a study is entirely your decision. No one can make you participate.
• You can stop at any time. Your medical care at Mayo Clinic now, or in the future, will not be affected by your decision.
• Mayo Clinic and/or the study sponsor can end your participation in a study at any time if it is in your best interest; if you do not follow the study rules; or if the study is stopped.
• You will be told of important new findings or any changes in the study.
• Your confidentiality is protected: data from the study may be published, but your name and other identifying information will not be sent outside of Mayo without written permission unless the law allows it.

What should I consider before participating in a research study?

You should know as much as possible about the study and feel comfortable asking the research members of the health care team questions about it, the care expected while in a study, and the cost of the trial. The following questions might be helpful for you to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

• What is the purpose of the study?
• Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
• Who is going to be in the study?
• What kinds of tests and treatments are involved?
• How do the possible risks and benefits in the study compare with my current treatment?
• How long will my participation in the trial last?
• Will hospitalization be required?
• Will results of the study be provided to me?
• Who will pay for the treatment?
• Will I be reimbursed for other expenses?
• What type of long-term follow up care is part of this study?
• Who will be in charge of my care?
• How will I know that the treatment is working?
• How might this trial affect my daily life?

What is informed consent?

Federal rules mandate that study participant informed consent be obtained and properly documented before a participant is enrolled in a study. In most cases the participant must sign and date a detailed informed consent form. Informed consent forms are written in understandable language. Mayo Clinic is committed to making sure that every research participant has a good understanding of their study. An informed consent form provides details about:

• The purpose of the study
• Which clinical procedures and laboratory tests will be used
• How long the study will last
• Whether you will be asked to allow biological samples to be stored for future research, such as blood and tissue samples
• The risks and benefits of the study
• Treatments other than the experimental one that are currently available for your illness
• The dollar amount, if any, you will receive for participation
• Compensation for study-related injury
• Expected costs of tests and procedures and who will pay for them
• Confidentiality of health information
• Whom to contact with questions

How is the safety of the study participant protected?

The ethical and legal codes that govern medical practice also apply to research. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. All studies follow a carefully controlled protocol, which is a study plan that details what researchers will do in the study. As a study progresses, researchers report the results at scientific meetings, to medical journals, and to other government agencies. Individual participants' names will remain confidential and will not be mentioned in these reports. Every research study at Mayo Clinic must be approved and monitored by Mayo’s Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits.

What is an Institutional Review Board (IRB)?

An Institutional Review Board (IRB) is a group of people such as doctors, nurses, pharmacists, scientists, ethicists, and people from the local community who ensure that human research is well-planned and ethical. An IRB is used to ensure the rights and welfare of people participating in research studies both before and during their participation. These impartial review panels perform the job of risk and benefit assessment, ensuring that the risks are both minimized and fairly disclosed to study participants. IRB’s are monitored by the FDA to protect and ensure the safety of participants in medical research.

Mayo Clinic’s Institutional Review Board (IRB)

Here’s how Mayo’s IRB ensures your protection:

• It approves and monitors all research conducted at Mayo Clinic to ensure the research complies with federal regulations and the protocol.
• The IRB is completely independent of any other committee or governing body within the institution.
• The IRB is composed from a large pool of Mayo Clinic experts, as well as nonscientific members from a variety of areas that have included ethicists, clergy members, psychologists, and college counselors among others.
• Every protocol is reviewed by the chair of the IRB, a scientist or physician, and one of the non-scientific members before it is discussed at a meeting and voted upon.
• Every protocol must be approved by the IRB before the study can begin.
• If an IRB member has a personal interest, or is an investigator in a particular study, he or she is excused from the room when the study’s protocol vote is taken.
• All protocols involving human studies are reviewed at least once each year.