Frequently Asked Questions

What is Research?

Research can be defined as a systematic investigation conducted in order to reach new or better conclusions. Researchers (also referred to as “investigators”) are physicians, scientists and others that conduct research to add to our general knowledge about the world. In medicine, research studies are conducted in order to identify the best treatment for various medical conditions.

The following terms may be used to describe research:

  • Clinical trial
  • Survey
  • Experiment
  • Protocol

    The following terms may be used to describe research volunteers:+

  • Participants
  • Volunteers
  • Human subjects
  • Subjects
Is there a difference between a "clinical trial" and "research"?

Research is simply a study that is done to answer a question. A clinical trial is a type of medical 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 is also conducted in non-medical departments such as Psychology, Business, Anthropology and Sociology. In these areas, investigators may be evaluating different approaches, methods, or experiences to produce new knowledge about an area.

How is clinical research different from regular medical care?

Medical care you receive from your own doctor is based on a care plan s/he hasdeveloped just for you.

When you take part in a clinical research study, you and the investigator (doctor) must follow a set plan called the "study protocol." The plan cannot usually be adjusted for you – however,the plan includes steps to follow if you aren't doing well.

How do I decide whether or not 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 and give you a consent form to read. Then they will go over the consent form with you, describing what happens during the research study, the possible side effects, and other information you need to know.

The research team will give you time to ask questions. You should ask as many questions as you want. For example:

  • 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 and read it over. You may also want to discuss the research with friends, family, and your own doctor.

The decision whether to take part is a completely voluntary decision that can only be made by you. If you decide not to take part in the research,your decision will not affect the care you receive at McLaren Healthcare Corporation facilities.

If you have questions or concerns you may speak with the investigator, research study team or you may contact the McLaren Healthcare Corporation Institutional Review Board (IRB) at 248-484-4950or email at hrpp@mclaren.org

What is an Institutional Review Board or IRB?

When research involves humans as subjects, the investigator must receive prior approval from an Institutional Review Board or "IRB". An IRB is a group of individuals that has the authority to approve or disapprove all research activities at an institution. The McLaren Health Care Corporation Institutional Review Board (MHC IRB) is charged with assuring that all human subject research, regardless of sponsorship, conducted at the McLaren Health Care facilities complies with the federal regulations (45 CFR 46) of the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), the Belmont Report, State and Local Laws and MHC policies and procedures.

According to federal regulations (45 CFR 46), an IRB must have at least five members and should represent varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. At least one member of the IRB must have no affiliation with the institution (i.e. a community member).

What happens if I decide to take part in the research study?

You will be asked to sign the consent form. This means that you volunteer to take part, you have read the consent form, and you 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 question. Who should I contact?

For questions about the research, we suggest that you contact the 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, or wish to speak to someone outside of the research team, please contact the IRB office at (248) 484-4950.

Where can I learn more about the protections in place for research volunteers?

You may contact the McLaren Health Care Institutional Review Board (MHC IRB) office at (248) 484-4950, or via email at hrpp@mclaren.org.