McLaren Health Care
Research Participant Corner

Research Participant Corner

WELCOME!

Research has led to important discoveries that make our lives better. By taking part in a research study, you can contribute to the better understanding of how a treatment or intervention works in people of different ethnic backgrounds and genders. Research may also help to improve medical procedures in the future. At McLaren, we are committed to protecting the rights and welfare of those who choose to volunteer in research.

This page was designed to help current and potential research volunteers in the decision making process. You will find basic information about research and your rights as a research participant.

The Research Integrity department welcomes your questions, concerns, complaints, and suggestions. You can contact our office at (248) 484-4950.

To learn more, click on any of the boxes below:

Why Volunteer?

Information that may help you in deciding whether or not to participate in research

Basic Information on Research

Research Terms

This document translates some medical terms into words that may be easier to understand

FAQs

Answers to questions frequently asked by those participating in, or considering participating in research.

History

Information on some historical milestones in human research protections.

Historical Milestones in Research

Reporting Concerns

Who do I call if I have questions or concerns about being in a research study?

We understand that, if you or a loved one are currently participating in a research study, or have participated in one in the past, you may have questions or concerns. To address those questions / concerns related to participation in a research study, you are encouraged to contact your research doctor. Their contact information is listed in the informed consent form.

You may also contact the McLaren Healthcare Corporation Institutional Review Board (248) 484-4950; or by email at hrpp@mclaren.org.

Frequently Asked Questions

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

p>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

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.

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).

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

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