Research & Clinical Trial FAQ
What is Research?
Physicians, Scientists and others called ‘Investigators’ conduct research to add to our general knowledge about the world. Research is completed because Investigators and Scientists don’t know for sure what will work best for you. You may see the following terms that describe research: clinical trial, survey, experiment or protocol. Research is not the same as treatment.
If you agree to volunteer in research you may find that volunteers in research are sometimes referred to as ‘participants’, ‘volunteers’, ‘human subjects’ or ‘subjects’.
Is there a difference between a ‘clinical trial’ and research?
People often think of research as medical research or "clinical trials". However, there are different types of research including Clinical Trials.
A clinical trial is research study in human volunteers to answer specific health questions. The most commonly performed clinical trials evaluate new drugs, medical devices, biologics, or other interventions on patients in strict scientifically controlled settings, and are required for regulatory authority approval of new therapies (in the USA- it is the Food and Drug Administration - FDA).
However, research also includes research in non-medical departments such as Psychology, Business, Anthropology and Sociology. In these areas investigators may not be evaluating drugs or devices but may be evaluating different approaches, methods, or experiences to produce new knowledge about an area.
How is clinical research different from regular medical care?
When you receive medical care from your own doctor, s/he develops a plan of care just for you.
When you take part in a clinical research study, you and the investigator must follow a set plan called the “study protocol.”
The investigator usually can’t adjust the plan for you – but the plan includes steps to follow if you aren’t doing well.
How do I decide whether to take part in a research study?
If you are interested and seem to fit the study requirements, the research team will explain the research to you. They will give you a consent form to read. Then they will go over the consent form with you. They will describe what happens during the research study, the possible side effects, and other information you need to know about the research study.
The research team will give you time to ask questions. You should ask as many questions as you want. Here are some questions you may want to ask:
- What will happen to me in the research?
- Are there any risks to me if I participate?
- Will the research help me personally?
- What are my other options if I do not want to participate?
- Can I leave the study at any time?
- Will it cost me to participate in the research?
You usually don’t need to decide right away. You can take the consent form home, read it over, and think about it. You can also talk to friends, family, and your own doctor about the research.
The decision whether to take part is a voluntary decision that only you can make. You can decide not to take part in the research and your decision will not affect the care you receive at NYUMC or its affiliates.
If you have questions or concerns you may speak with the Investigator, research study team or you may contact the NYU School of Medicine Institutional Review Board (IRB) at 212-263-4110
What is an Institutional Review Board or IRB?
When investigators involve humans as subjects in their research, then they must receive prior approval from an Institutional Review Board or "IRB". An "IRB" is a group of individuals that has the authority to approve all research activities at an institution. According to federal regulations (45 CFR 46), IRBs must have at least five members, with at least one member who is not affiliated with the institution (a "community member"), and the board should represent varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.
What happens if I decide to take part in the research study?
You will be asked to sign the consent form. Your signature means that you volunteer to take part and understand what will happen.
You will then be asked to do what is required for the study.
Remember, you can ask questions or change your mind at any time.
I was a volunteer in a research study and now I have some questions about the research. Who should I contact?
For questions about the research, we suggest that you contact the "Responsible" or "Principal Investigator", whose contact information is listed on the consent document that you should have received when you agreed to participate. If you do not have this information, please contact the IRB office at the institution where the research was done.
Where can I learn more about the protections in place for research volunteers?
It's important that potential volunteers be fully informed about the research before they agree to participate (usually conveyed in the form of an informed consent document or similar information). Research participants should know that participation is voluntary, and they may discontinue involvement at any time.
We welcome you to use the resources on our education page, which include online seminars and useful links. See the Informational Resources below for more information.
Research Subjects Informational Resources:
- Cedars Sinai Medical Center - FAQs for Subjects
- Center for Information & Study on Clinical Research Participation (CISCRP)
- Center Watch Human Subjects Information Page
- Clinical Research Volunteer Program (CRVP) at NIH
- Clinical Trials.gov Information for the Public
- FDA's Q&A for Clinical Trials Participation
- OHRP International Compilation of Human Subject Research Protections
- OHRP Pamphlet: Becoming a Research Volunteer: It's Your Decision
- OHRP Research with Children FAQ
- OHRP Special Protections for Children as Research Subjects
- Western IRB - Research Subjects