Introduction to Human Research Subject Protection at UNC

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Protecting Human Research Subjects at UNC: An IntroductionA Lot of Research at UNC-Chapel Hill Involves People

Last year, over one million people took part in more than 5300 different research studies at UNC-Chapel Hill. Who are these research participants, who is studying them and why?

Many of UNC’s scientists study people—their health, behavior, and culture—everything that defines us as being human. Much of our research looks at health or disease and takes place in our schools of dentistry, medicine, nursing, pharmacy, and public health. But our researchers also study human social behavior in such varied fields as anthropology, education, exercise and sport science, journalism, political science, information technology, psychology, sociology, and social work.

All Human Subjects are Volunteers

The people whom our scientists study are called “human subjects,” and all are volunteers.  Some study participants agree to take new drugs being developed to treat disease or other medical conditions, while others agree to answer survey questions, or to be observed under controlled conditions. We study all sorts of people: those who are healthy, as well as those who are having problems with their health; participants may be children, teenagers, or adults of any age. Some human subjects are paid modestly or are reimbursed for their travel to take part in research. But most receive nothing except the satisfaction of helping us learn more about ourselves.

Risk in Research Participation

Most research studies involve little or no risk for research participants. But because we cannot predict what we will learn from research, some studies present subjects with varying degrees and kinds of risk. UNC-Chapel Hill has an obligation to minimize risks to our research participants, and we take this obligation very seriously. To evaluate and minimize risk to human subjects, we have created review committees, called Institutional Review Boards.

Institutional Review Boards

Before anyone is allowed to take part in a research study, each project is carefully reviewed by a panel of experts and community members. This panel is called an Institutional Review Board, or IRB for short.

There are six IRBs at UNC-Chapel Hill made up of authorities on every subject we study, such as cancer, heart disease, psychology or education. None of these experts has anything to do with the research projects they review. In addition, each IRB includes community members who do not work at UNC-Chapel Hill. These community members bring a lay perspective to the review process and help us apply community standards to the research we conduct.

Federal Regulations

Research subjects have rights that are guaranteed by federal law, and IRBs are charged with ensuring that researchers respect these rights. Scientists may not put human subjects at risk unless that risk is outweighed by the potential benefit of the research. And whether the risk of participation is large or small, scientists must inform subjects about the nature of the research and what will be expected of them during the study.

Informed Consent

Before a scientist can obtain information from or about a human subject, the researcher must explain the study fully, and the volunteer must indicate that he or she understands. Usually the volunteer will sign an “informed consent statement.”  As part of this process, a researcher is required to tell each subject:

  • What the researcher hopes to learn by doing the study.
  • What will occur during the study, especially what the subject will experience.
  • How long the research study will last—at each visit and over the entire study.
  • What risks or discomforts a subject might experience during the study.
  • What potential benefits might be gained from the research, either for the subject or society at large.
  • What alternatives to the proposed research procedures might be available to a subject (this usually applies to medical studies).
  • How private information about a research participant will be safe-guarded, so as to protect the subject’s privacy, reputation or legal standing.
  • Whether a subject might be paid, or reimbursed for travel for participating in the study; and whether the researcher might pay for medical expenses if a subject were to be injured during the study.
  • How to contact the research team or the IRB with questions about the study or one’s rights as a human subject.
  • That participation in the research is voluntary; and that a research subject may withdraw from a study at any time, without penalty.

Vulnerable Subjects

Federal regulations additionally provide special protections for those whose decision-making capacity has not matured (children), or may be diminished because of aging or illness, or is restricted (prisoners). Therefore, IRBs require that parents give permission for their children to participate in research. Legally authorized representatives must provide consent on behalf of those who have limited mental abilities. Prisoners may serve as subjects only if researchers can assure the IRB that their participation is truly voluntary. And in most cases, pregnant women may not take part in research studies because of potential harm to their baby.

Why IRBs are Needed

In the first half of the last century, a number of scientific studies were conducted on subjects without their permission or consent. A few of those studies caused great harm and suffering. Since then, society has recognized the need to set standards for the ethical conduct of research. In the United States, this led to the Federal Government writing a rule setting high standards for the protection of human subjects.

While it is impossible to remove all risk from research participation, IRBs now use accepted ethical standards to judge the safety and value of research. They also help researchers learn how to design studies that maximize benefits while minimizing possible harm. In addition, IRBs make sure that those who participate do so voluntarily and with a full understanding of what is expected of them.