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RESEARCH PARTICIPANTS

Clinical research studies play an important role in discovering ways to understand, treat, and prevent medical problems.  Participants make it possible for the doctors and scientists of the clinical research center to accomplish these studies.

Clinical research studies include human volunteers in an effort to answer specific scientific questions. These carefully reviewed studies provide the information to understand health processes and develop treatments that work in people.

Research participants take an active role in research by helping doctors and scientists learn about various health problems and diseases. Knowledge gained through these research studies may help others live longer, healthier lives.

Before volunteering, participants should ask themselves:

• Do I have time to participate?

• Am I prepared to accept any possible risks or side effects associated with the study?

• Am I interested in what is being studied?

Informed Consent

Because  protecting rights and safety are so important, participation in a clinical research study is only possible if participants  first understand all the possible risks and benefits associated with the study.

Once participants understand the study aspects, and their subject rights, they will be invited to sign an informed consent form. This form contains a detailed description of the study. By signing the informed consent form participants indicate that they understand the  research study and agree to participate.

Subject Rights

Participants have the right to be told:

• the purpose of the study

• what will happen and how those procedures differ from standard practice

• about possible risks and/or side effects

• of any benefits that could result

• about other possible choices and their advantages/disadvantages

• what treatment is offered if complications occur

• that they can refuse to participate (and change their mind once the study has begun)

• that they are free from pressure when deciding whether to participate on the study

Participants should receive a copy of the signed and dated informed consent form.

In addition, participants should also have an awareness of what will be expected of them, what they might expect to learn from the study, and if they will receive compensation.

The Harvard-Thorndike Clinical Research Center is a Harvard Catalyst Research Unit
 and is funded by Grant UL1 RR 025758 from the NCRR, NIH
 Please send general questions about the CRC to the Administrative Manager.
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