At its most basic, research is an investigation. Researchers search and gather information, usually to answer a particular question or problem. Research can be medical, social or behavioral, and it almost always involves people like you.
Volunteers participate in medical research that provides better ways to diagnose, treat and prevent different diseases and conditions. Social and behavioral research explores how and why people behave certain ways in a given situation and how this may impact human health.
If you’ve ever taken medication or been treated for an illness, then you’ve received the benefits of medical research. Medical research helps people enjoy better health and lifestyles. Some studies may not benefit you as an individual, but taking part can help others in the future. With your help, researchers may be able to improve the health of a community or help a group with a particular disease or condition.
There are ethical guidelines that protect research participants and the integrity of science.
As a research participant, you have the right:
Before enrolling in a research study, it is a good idea to learn as much as possible about the study and your role as a participant.
Ask questions, use resources, such as the Internet, to search for information, and seek advice from family, trusted doctors, clergymen or friends. Speak to the research study team about what will be done and what your rights are as a participant. If you need help understanding what you were told about the research study, ask the investigators and research study team to explain it to you.
Your participation in a research study is completely voluntary, and you may drop out at any time.
When deciding whether to participate in a research study, you may want to ask the investigators and research study team some of the following questions:
What to do if you have concerns about research non-compliance
Allegations of research noncompliance with federal and state laws, rules and regulations and institutional policies and procedures are referred to the Office of Human Research Protection (OHRP). The Chairman of the Human Assurance Committee (HAC) may refer a study for review to OHRP. Should OHRP determine that the alleged practices appear to (1) cause injury or any other anticipated problems involving risks including but not limited to, physical, social, psychological, confidentiality, financial or emotional, to subjects or others or (2) constitute serious or continuing noncompliance with HAC Policies or Procedures, then the OHRP may recommend further action to the HAC Chairman.
The HAC Chairman may suspend the study pending a timely investigation and review. The Chairperson may recommend to the full HAC that the study should be terminated. The HAC has the authority to suspend or terminate protocols that are found to be non-compliant with federal and state laws, rules and regulations and institutional policies and procedures. Other sanctions imposed by the HAC and/or OHRP may include, but are not limited to, routine compliance audits, letters of reprimand and restrictions on serving as an investigator on human subjects protocols. Suspensions or terminations are reported to the appropriate institutional officials responsible for the federal wide assurance (FWA) and the human research protections program (HRPP)Serious or continuing noncompliance will require reporting to both sponsor and/or federal agencies.