FAQs

Frequently Asked Questions

A clinical research study follows a carefully controlled protocol, which is a plan that details what research physicians will do in the study. Researchers may also report the results of the study at scientific meetings, in medical journals, and to various government agencies.

Privacy

All participants’ names remain confidential and will not be mentioned in these reports without the consent of the participants, except as required by law.

What is a clinical study?

A clinical study is designed to test the effects of a medication, medical treatment or device on a group of volunteers. A group of professionals called the Institutional Review Board or IRB carefully review study activities.

Who can be in a clinical study?

People with the condition being studied as well as healthy people can volunteer to participate in clinical studies. Each study has specific requirements for participants. The Principal Investigator conducting the study will review the volunteer's medical history and study requirements to determine eligibility. Study procedures, benefits and known risks will be explained to the volunteer prior to participating in the study.

What are the benefits of volunteering?

Increases the participants understanding of the condition and allows the participants to meet other people who have the same problem, which strengthens the participants support network.

Participants receive study related medical care such as examination, medication, laboratory work and treatment at no cost.

Participants are giving back to the community by helping researchers find new treatments and/or medications as well as helping the researchers uncover new information about the condition and therapies.

What happens if I decide to participate?

All subjects must first go through the Informed Consent process. In this process, the research study – its purpose, duration, required procedures, key contacts, and any possible benefits and risks – is explained in detail in an informed consent form, and all of your questions regarding study participation are answered by the research physician. This process ensures that you understand what participation involves. As a potential participant, you must then decide whether or not you want to participate. Your signature and date of your informed consent on this form make it an important study document. You may withdraw from the research study at any time. Very often, a reason for withdrawal will be asked, but you are not required to provide a reason. The clinical study staff performs study related examinations at the beginning of a research study and monitors you throughout the research study. The clinical study staff provides specific instructions for participation and follows the research study protocol. The procedures you may receive depend on the research study protocol and the disease or condition being researched.

How am I protected?

Governmental regulatory agencies have rules for conducting clinical research studies. For example, all clinical research studies must be approved by an ethics committee or institutional review board (IRB). Ethics committees or IRBs must: Help ensure that appropriate steps are taken to protect the rights, welfare, and anonymity of all people who voluntarily participate in clinical research studies. Review and approve the research study protocol, all written information provided to participants, and methods of recruitment of research physicians and subjects. Review the conduct of a clinical research study and the reporting of unexpected or unknown side effects.