Community/Research Participant Corner
Are you interested in participating in a research study or learning more about research at Stony Brook? This site will provide you with many answers to questions and direct you to other sites that may further clarify any questions you may have regarding research studies.
Stony Brook University is one of 94 institutions in the country designated a “Very High Research University” by the Carnegie Foundation. Both medical and non-medical research is conducted regularly at Stony Brook.
In order to protect human participants in research, the Office of Research Compliance (ORC) works with the IRB (Institutional Review Board), a committee responsible for reviewing and overseeing all research conducted at Stony Brook that involves human participation. Together they assure all the federal rules and regulations are followed in order to protect human participants.
The ORC welcomes your questions. You can contact our office at: 631-632-9036. The ORC periodically provides presentations to the community.
As an additional effort to protect research subjects, if you are already a research participant, the ORC welcomes input and concerns regarding our Research Compliance program. To express a concern, offer input or if you wish to report possible noncompliance, please email Judy Matuk, Assistant VP for Research Compliance, at firstname.lastname@example.org. You may also submit your concerns, questions or complaints anonymously, by posting to Stony Brook University on this website: http://www.solvanon.com/ These postings are reviewed and serve as one mechanism to investigate concerns/complaints regarding human subject research, investigators, and even the IRB process.
What is a Research Study?
A research study is a very careful way of looking at something and collecting data about what is being looked at. It can be something as simple as asking questions, giving a survey or looking at a particular behavior. On the other hand, it can be more complicated and may look at a specific disease. When a researcher is looking at a disease or at a treatment for a health problem, the research study is frequently called a clinical trial.
What is a research subject?
A research subject is a person who decides to participate in a research study. This is completely voluntary. You are helping the researcher look at the questions he/she wants to study. You can quit the study any time you want to.
What is a protocol?
All research studies follow a protocol. A protocol is like a cookbook. It tells the researcher what can and cannot be done when he/she is conducting the study. All this is done to protect the research subject and this protocol is reviewed by the Institutional Review Board (IRB).
Can anyone be in a research study?
Each study has a list of who can and cannot be included in that study. This is written in the protocol. In order to protect research subjects only people who qualify can be in the study.
What is a PI?
The PI, or Principal Investigator, is the person who conducts the research study. The PI is also the person who is responsible for making sure everything is done properly. Along with the PI, there may be other persons who help with the study. For example, if it is a medical study, there may be a nurse involved in conducting the study. There are also people who look at all the data that is collected in the study and other individuals involved in operating the study.
What is an IRB?
The Institutional Review Board (IRB) is made up of a group of people such as scientists, doctors and some community people. The IRB looks at every protocol or research study before it is conducted on any people. Because some research studies involve risk, the IRB looks at the study to make sure the risks are justified and minimized. In addition, the IRB wants to make sure the Principal Investigator follows all the rules the federal government has set up to protect human subjects who so kindly volunteer to participate in a research study.
What is an Informed Consent?
If you decided to volunteer in a research study, the facts of the study will be given to you in a consent form. This is to help you understand exactly what will happen to you in the research study. It is designed to help you make up your mind about participating, or not participating, in the study. The informed consent will outline all the rights you have as a volunteer in a research study.
Giving a research subject a consent form to read is a helpful process because it gives you enough time to ask as many questions you want to about your voluntary participation in the study. You will be told about all the risks, any benefits that may exist and even alternative options to the study.
After reading the consent you can make your final decision about participating in the proposed study.
- Office of Human Subjects Protections (ORHP)
- Center for Information & Study on Clinical Research Participation
- Association for the Accreditation of Human Research Protection Programs, Inc.(AAHRPP)
- National Institutes of Health (NIH)
- Are Clinical Studies for you?
- Frequently asked Questions on Research:
- A Participant’s Guide to Mental Health Clinical Research
- Patient Information Publications; Partners in Research; Volunteer Patients
- Clinical Center Patients’ Bill of Rights
Trials.gov; A service of the US National Institutes of Health; Understanding Clinical
- Center for Disease Control and Prevention (CDC)
- US Food and Drug Administration (FDA)
- Department of Veterans Affairs
- The Joint Commission