Research Subjects

Deciding to participate in a medical research study is an important decision.    Protecting human subjects shapes our behaviors each day.  It is our job.   We wanted to provide you with some information and resources as you consider entering a research study.  The following information will help you understand what a research study is, who conducts it, and why many people choose to participate.

What is clinical research?

Clinical research is medical research done to determine the safety and effectiveness of drugs, devices, or diagnostics for use in humans.  Click here to review a great resource, AAHRPP’s website. AAHRPP is an organization that accredits high-quality human research protection programs.

Who is a sponsor?

The person or organization who plans and initiates the research is the sponsor.  This can range from an individual person to a pharmaceutical or device company, a public institution like a university, or a government agency such as the National Institutes of Health (NIH).

Who conducts the research?

Usually a medical doctor called a Principal Investigator (PI) is the person who conducts a research study.   A team of researchers often helps the PI conduct the study.   You may hear titles such as sub-investigators, research nurses, and research coordinators used to describe other team members involved in the clinical research.   However, the PI is the person with ultimate responsibility for overseeing the study.  The PI must follow a protocol when executing the study.    The protocol is the roadmap that describes all the design and all the details of the study.    It is important to follow the protocol so that all the questions being studied in the study can be answered.

Why do people choose to participate in research studies?

If you are asked to join a study, remember that it is your choice.  We encourage you to make an informed decision, and talk to family members, other health care professionals, and the people associated with the study.   While people have a variety of reasons for joining research studies, many do it because they have a disease and are not completely helped by existing treatments or have side effects, others participate because they have a disease and they want to find a diagnostic or treatment that can help themselves or others, or, some people join studies because they have a particular passion in finding a cure for a disease.    There are also research subjects who participate in a study because they want the money that subjects receive.

It is a deeply personal decision to participate in a study, and you should remember that in clinical research there are no assurances that the drug, device or procedure will help you. Remember, no one can make you give up your legal rights or make you think that you are being asked to do so.

We hope you find these resources helpful:

Pearl IRB Policies

And for a list of valuable Industry Links and Resources, click here.