Your Rights As a Study Participant
Joan P. Packenham, Ph.D.
If you have any problems or questions about your participation in a study or about your rights as a research participant, or about any research-related injury, you can contact the study researcher or the NIEHS Office of Human Research Compliance at 919-541-4265.
Rights and Protection for Children
Children (aged 18 and younger) get special protection as research subjects. Almost always, parents must give legal consent for their child to take part in a clinical study.
When researchers think that a study's potential risks are greater than minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical studies.
Bill of Rights
As a study volunteer at the NIEHS Clinical Research Unit in Durham NC, you are protected by the Clinical Research Unit Patients' Bill of Rights. As a study volunteer at the NIH Clinical Center in Bethesda MD, you are protected by the Clinical Center Patients' Bill of Rights. This document is adapted from the one made by the American Hospital Association for use in all hospitals in the country. The bill of rights concerns the care you receive, privacy, confidentiality, and access to medical records.
Your participation in any Clinical Center research study is voluntary. For every study in which you intend to participate, you will receive a document called "Consent to Participate in a Clinical Research Study" that explains the study in language you can understand. A member of the research team will discuss the protocol with you, explain its details, and answer your questions. Reading and understanding the protocol is your responsibility. Take your time to understand and discuss the study protocol with family and friends or physician. You will not be hurried into making a decision, and you will be asked to sign the document only after you understand and agree to the commitment. At any time after signing the protocol, you are free to change your mind and decide not to participate further. This means that you are free to withdraw from the study completely, or to refuse particular treatments or tests without loss of benefits or privileges to which you are otherwise entitled. Sometimes, however, this will make you ineligible to continue the study. If you are no longer eligible or no longer wish to continue the study, you will return to the care of the doctor who referred you to NIH.
Confidentiality and Privacy
When results of an NIH research study are reported in medical journals or at scientific meetings, the individuals who take part in a study are not named or identified. The NIH will not release any information about your research involvement without your written permission. if you sign a release of information form for an insurance company, the NIH will give the insurance company information from your medical record. This information might affect (either favorably or unfavorably) the willingness of the insurance company to sell you insurance.
To help us protect your privacy, researchers obtain a Certificate of Confidentiality (CoC). The researchers can use this Certificate to legally refuse to disclose information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if there is a court subpoena. The researchers will use the Certificate to resist any demands for information that would identify you.
However, you should also know that there are several circumstances in which the Certificate does not provide protection. These include when information:
- will be used for auditing or program evaluation internally by the NIH; or
- must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA);
- is necessary for your medical treatment and you have consented to this disclosure;
- is for other research
In addition, identifiable, sensitive information protected by this Certificate cannot be admissible as evidence or used for any purpose in any action, suit, or proceeding without your consent.
You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, medical care provider, or other person obtains your written consent to for us to disclose the research information, then the researchers will not use the Certificate to withhold that information.
The Certificate of Confidentiality will not be used to prevent disclosure to state or local authorities of events such as:
The protections of the Certificate apply to all copies of identifiable, sensitive information. Therefore, if an NIH researcher shares a copy of your identifiable, sensitive information with any other researcher or institution (whether a collaborator on this study, or researcher conducting secondary research in the future) that party must agree that s/he is also subject to the disclosure restrictions under the Certificate of Confidentiality described above.
Federal Privacy Act
Additionally, the Federal Privacy Act protects the confidentiality of your NIH medical records. However, you should know that the Act allows release of some information from your medical record without your permission, for example, if it is required by the Food and Drug Administration (FDA), members of Congress, mandatory health reporting to state or local authorities, law enforcement officials, auditing or monitoring for quality purposes, or authorized hospital accreditation organizations.
Please note: The study consent form will provide additional information on how your privacy and confidentiality are protected. Please make sure you read and understand the information contained within the consent form. Ask questions if you do not understand.
Institutional Review Board
Institutional review boards (IRBs) help provide oversight for clinical studies. An IRB is an independent committee created by the institution that sponsors a study. IRB members are doctors, statisticians, and community members.
The IRB is the advocate of the volunteer subject. The primary purpose of the IRB is to protect the rights and welfare of the human subjects. Informed consent is an important component. As in any medical research facility, all new protocols produced at NIH must be approved by an institutional review board before they can begin. The IRB will only approve protocols that deals with medically important questions in a scientific and responsible way.
Are There Risks Involved in Participating in Clinical Research?
Please note that participating in clinical studies is considered research. Risks are involved in clinical research. This is no different than routine medical care and activities of daily living. In thinking about the risks of research, it is helpful to focus on two things: the degree of harm that could result from taking part in the study, and the chance of any harm occurring. Most clinical studies pose risks of minor discomfort, lasting only a short time. Some volunteer subjects, however, experience complications that require medical attention. The specific risks associated with any research protocol are described in detail in the consent document, which you are asked to sign before taking part in research. In addition, the major risks of participating in a study will be explained to you by a member of the research team, and they will answer any questions you have about the study. Before deciding to participate, you should take your time and carefully weigh these risks. You may not receive any direct benefit as a result of participating in research, but the knowledge developed may help others.