Human Subjects: What research participants should know !
Humans are an important part of testing new ideas, new products, and new techniques. All of these advances in science and make life better, safer, healthier and more productive for everyone. Humans, however, can be vulnerable in this process. Jargon, sophisticated language, and complex or scientific concepts can make people who like to help advance research feel at a disadvantage. In the unfamiliar world of research it is easy to feel confused or fearful about asking questions or saying, "I still don't exactly understand." Other individuals may have serious health worries or be afraid due to life threatening diagnoses. Because of these circumstances might be willing to agree to participate in a study without giving fully informed consent to the requirements of the study.
The Federal Government heavily regulates all universities and scientific organizations that are involved with the administration or coordination of research activities. The Department of Health and Human Services (DHHS), i.e., the Federal Policy, and the regulations of the Food and Drug Administration (FDA), is the agency that has this mandate. In a place like a University there is a campus organization that is responsible for implementing, regulating and policing this effort. They are usually called an Institutional Review Board (IRB). This is the administrative body established to protect the rights and welfare of human subjects (including patients) who are recruited to participate in research activities. The IRB has the authority to approve, require modifications in, or disapprove all research activities involving humans that fall within its jurisdiction. The jurisdiction of a University IRB is defined by its binding commitment (Assurance # M-1259) with the DHHS.
All of the regulations to protect human subject proceed from this commitment. These regulations specifically discuss which institutions, locations, funding streams, and personnel are under the regulation of the regulating IRB. The regulation in this commitment must be carefully and rigorously followed. Universities and research organizations are in jeopardy of loosing ALL of their Federal research funds if the IRB is found to be lax or careless in regulating even just one research study. The press has publicized recent problems at major universities that brought potential financial ruin due to careless attitudes toward caring for the protection of human subjects.
There is a specific unit within the DHHS called the Office for Protection from Research Risks (OPRR) that implements and oversees IRB compliance. (This agency has a website that makes it very easy to learn more about this topic.) ( It checks for compliance with the Federal Policy and provides instruction and guidance on ethical issues related to human subject research. A University's Research Conduct and Compliance Office is responsible for establishing and administering institutional policies and procedures through which their University conforms to both the Federal Policy and the FDA regulations that govern the protection of human subjects participating in research (human research subjects).
The purpose of a University IRB is to assure both in advance and by periodic monitoring, that appropriate steps are being taken to protect the rights and welfare of human research subjects. (For an example of a University IRB website and the resources it may include take a look at the University of Pittsburgh's IRB.) To accomplish this purpose, the IRB uses a group deliberation process to review and approve research protocols and related materials (e.g., informed consent documents, investigator brochures).
The focus of the process is to ensure that:
Definition of Research
The other issue that arises is what exactly is research. The University Institutional Review Board (IRB) is required to review and approve all research activities involving human subjects prior to their implementation. There is sometimes a question of whether a planned activity is "research" and, therefore, requires IRB review and approval. The DHHS Federal Policy defines research as "a systematic investigation, including research development, testing and evaluation, designed to develop or to contribute to generalizable knowledge." Specific criteria that can be used to determine whether a planned activity is research include:
Innovative or newly introduced clinical procedures or therapies do not require IRB review and approval except when they involve "research" as defined by the above criteria. (An innovative clinical practice is an intervention designed solely to enhance the well being of an individual patient or client. The purpose of an innovative clinical practice is to provide diagnosis, preventative treatment, or therapy to particular individuals.) It is recommended that the introduction of innovative procedures or therapies into clinical practice (i.e., independent of a research activity approved by the IRB) be reviewed with the applicable department chairperson and the Office of Risk Management prior to their implementation.
Scientific Review Committees
Even before a research study goes to the IRB for approval, the research protocols (including the informed consent document(s)) must be reviewed by an appropriate and formally constituted scientific review committee. This process assures the IRB that the specific aims and/or design of the research protocol are sound. Scientific committee review of the research protocol addresses such issues as scientific merit; research subject availability; resource utilization; compliance with applicable federal, state, and University policies; and readability and submission format. Submission of the research protocol (or substantial modifications to the protocol) to the IRB shall be accompanied by a letter or other notification (i.e., signed by the chairperson of the scientific review committee or if no scientific review committee is established, the responsible administrator of the department, school, or multidisciplinary center/institute to whom the principal investigator reports) indicating that the scientific review committee found the research protocol and consent form(s) acceptable for IRB submission.
All IRB-approved research protocols must be submitted annually (or sometimes more frequently) for renewal approval. If substantial changes have been made in the course of the time period, then evidence that a scientific committee has reviewed the proposal and approved the changes must accompany the annual renewal.
The bottom line for research study participants is that the IRB by which is regulating and approving the research study you are involved in has your best interest at heart. It is required that a consent form offer you the phone number and contact information so you can easily and confidentially reach the specific IRB office. Don't be afraid to ask questions or to questions unresolved issues. People who act as research study participants deserve to be treated fairly and carefully and with respect for the contribution that they are making to science.
Last Updated: 3-2-2006
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Please note: This information is provided a archival information from the Rehabilitation Engineering Research Center on Wheeled Mobility from 1993 to 2002.