Information for ALL Research Volunteers

Why Do People Volunteer to Participate in Research as Subjects?
What Are My Rights as a Research Volunteer (Research Subject)?
What is Biomedical Research?
What is Socio-Behavioral Research?
What Is An Institutional Review Board?
Federal Oversight of Human Subject Research
Institutional Review Boards at Virginia Commonwealth University
The Belmont Report
Office of Human Research Protections (OHRP)

Why Do People Volunteer to Participate in Research as Subjects?
People generously volunteer their time to participate in research for a variety of reasons, which are sometimes quite unique to each individual. Some common reasons are listed below:

• As a community service, to help medicine/social science advance.

• To gain access to and benefit from medical treatments, before they become widely available.

• To help others in the future, who may have medical issues similar to yours, without expecting to personally benefit from having volunteered your time.

• The hope that a new medical treatment under study may be helpful in a disease, where other treatments have failed or where other treatments are not available.

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What Are My Rights as a Research Volunteer (Research Subject)?

• The United States Government regulates research that involves human subjects, so that their rights and welfare are protected.

• Your participation in research is voluntary. You should not be or feel coerced (or pressured) into participating in research.

• You may refuse to participate, or drop out of a research study anytime, without any negativity toward you and your decision.

• You should be given adequate information about the study, in a way you can understand fully, so that you can judge the risks and benefits of your participation.

• If you belong to any of the following vulnerable populations, you should be given extra protections from the risks of research: children [age <18 years]; pregnant women, fetuses, in vitro fertilization, mentally disabled persons, prisoners, and others who are likely to be vulnerable.

• If you are a child, or if your mental ability is impaired so that you are unable to make decisions on your own, the following individuals may join in decisions about your participation in research: Parent(s), Spouse, or Legal Guardian, and certain family members (who may serve as your legally authorized representative under VA State Law).

• If you have general questions about your rights as a research subject, please contact the administrative offices of the IRB, the VCU Office for Research Subjects Protection (ORSP). If you have more specific questions, or concerns about your participation, you may contact the VCU Office for Education and Compliance (OECO).

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What is Biomedical Research?
Biomedical research (also called clinical research, medical research, or a clinical trial) is a research study designed to answer specific questions about vaccines, new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs, existing drugs, or treatments are both safe and effective.

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What is Socio-Behavioral Research?
Socio-Behavioral research is social or behavioral research, which does NOT involve medical procedures or FDA-regulated products (prescription and over-the-counter medications, medical devices, or biologics). These research projects can involve surveys, observation, behavioral therapy, or other non-medical interventions.

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What Is An Institutional Review Board?
Institutional Review Boards (IRB's) act as advocates for human research subjects. IRB's have to be registered by the United States Government. IRB's work with researchers to make sure research projects are done safely and ethically. A Federalwide Assurance is a document that stands as an agreement between the U.S. Government and an Institution with an IRB. The VCU Federalwide Assurance can be found here .

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Federal Oversight of Human Subject Research
The U.S. Department of Health and Human Services (DHHS) and various offices and agencies, including the National Institutes of Health (NIH), the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) share oversight of human subject research.

Under federal regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research projects. The IRB assures that:

• Risks to subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

• Risks to subjects are reasonable in relation to anticipated benefits (if any) to subjects, and the importance of the knowledge that may be expected to result.

• Selection of subjects is equitable.

• Informed consent will be sought from each prospective subject or the subject's legally authorized representative and will be documented in accordance with, and to the extent required, by the Agency's informed consent regulations.

• Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

• There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

• Appropriate additional safeguards have been included in the study to protect the rights and welfare of subjects who are members of a vulnerable group.

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Institutional Review Boards at Virginia Commonwealth University
Virginia Commonwealth University has five (5) IRBs that are registered with U.S. Department of Health and Human Services Office for Human Research Protections (OHRP). Please click here for information about these IRBs.

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The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research can be found at http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm.

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The Office of Human Research Protections (OHRP), an agency in the Department of Health and Human Services that oversees federally-funded human subjects research, has a public outreach website available to answer questions and concerns about involvement in human subjects research. Find the site at: http://www.hhs.gov/ohrp/outreach/

In addition, OHRP provides an informational pamphlet entitled “Taking Part in Research: It’s Your Decision.” It provides information about issues to consider when thinking about participating in clinical trials and other research studies.
Find the pamphlet on the same website: http://www.hhs.gov/ohrp/outreach/

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