Questions Before Joining

You are allowed to ask anything

NIH says that if you are thinking about a clinical trial you should feel free to ask any question or raise any issue at any time. The Office for Human Research Protections publishes a printable list of 36 questions in six groups to help people decide whether to volunteer. The questions below are drawn from that list and from NIH’s own guidance, grouped the way OHRP groups them.

About the research

• What is the research about, and why is it being done?
• What do the researchers hope to learn, and who might benefit?
• Who is funding the study, and who has reviewed and approved it?
• Why are you — or your child — specifically being asked to take part?
• What kind of study is this? Is it a clinical trial? How many groups are there, is assignment random, and will any group get a placebo?
• When is the study expected to finish, and how will the findings be shared — would you be told personally?

What would happen

• What would you have to do — which tests, procedures or medications?
• Would you have to travel, and how long would participation last?
• Does the study involve a new or untested intervention that is considered experimental? Would you be told whether you received it?
• Would you be given the results of any tests done in the study?
• If your child’s doctor is also a researcher on the study, who would look out for your child’s best interests as a patient?
• How would being in the study affect daily life and current medical care? Can your child keep seeing their regular doctors and taking their regular medications?

Risks, privacy and money

• How much do the researchers know about the risks? Does the intervention have FDA approval or oversight?
• What are the short- and long-term risks, discomforts or side effects, and what is being done to minimize them?
• How would biological samples, test results and other personal information be used or shared?
• How would identifiable private information be protected, and what could happen if it were disclosed?
• Would participating cost anything — for tests, procedures or the study drug — and would insurance cover it?
• If you or your child were harmed, who would pay for medical care?
• Are travel, child-care or other study-related costs covered? If compensation is offered, how much and when?

Personal considerations

• Would you or your child personally benefit, and how?
• How much time do you have to think it over before deciding?
• If your doctor is the researcher and you decline, would that affect your current care?
• Whom do you contact with questions about participating — and whom do you contact with concerns about the research itself?
• What happens if you volunteer now but decide to quit later?

Tips NIH suggests for the conversation

• Take a family member or friend along for support and to help ask questions or record answers.
• Plan what to ask and write questions down in advance — but do not hesitate to ask new ones.
• Write down the answers so they are available when you need them.
• Ask about recording the conversation, even if you also take notes.
• Tell your regular health care provider if you enroll, so they can coordinate care.