October 27th, 2015

There is a variety of reasons that an individual chooses to participate in a research study – altruistic motivation, the desire for more closely monitored care from their physician, to access innovative technology, or because of the respect they have for their surgeon. Our staff at OCRI encounters these patients on a day-to-day basis, as well as patients who are not as interested in participating in research for equally valid reasons. However, a common reason we sometimes hear from patients for choosing not to participate is that they do not want to be a “guinea pig”. While the ultimate decision to be included in a research study lies with the patient, it is important to us that every patient that is approached about participating in research understands that our intention is to make sure that they are protected. To ensure the protection of every patient’s rights in research, there are many systems of checks and balances to ensure that patients are safe and that the research being conducted is ethical and beneficial.

Prior to 1947, there were no set of formalized documents guiding the conduct of research, sorely diminishing any standard of patient rights and resulting in “open-season” for some researchers to set their targets on and abuse uneducated and unwilling patients. After World War II, the Nuremburg Code set new standards. It was now imperative that patients participate in research voluntarily, with their consent and with full understanding of what they are consenting to, and that those conducting the research could assure the patient that the benefits of the research outweigh any risks. After the Nuremburg Code established this set of regulations, there were several other publications that furthered the cause for patient rights – the Declaration of Helsinki (1964) and the Belmont Report (1979).

To make certain that all patients are being protected, research involving human subjects must be submitted to an independent ethics committee or Institutional Review Board (IRB) prior to commencing research activities. The IRB “[safeguards] the rights, safety, and well-being of all trial subjects” by reviewing all documents involved with study conduct, such as: study protocols, consent forms, study procedures, advertisements, and questionnaires. The IRB is also the first-line of contact for a patient if they have a concern with a study they are participating in. IRB review is an ongoing process, and any new study information or changes to the study must also be submitted for their approval.

Patient data and study conduct are also continuously monitored by the study sponsor (the entity supplying the materials for research). The study sponsor reviews all documentation at the study site to verify that the study personnel is conducting research according to the protocol and collecting data from patients that have participated in the informed consent process and consented to trial participation. In some cases, a random audit will be conducted by the Food and Drug Administration (FDA) to review the same types of documentation.

In addition to the checks and balances above, OCRI also has the Research Advisory Committee (RAC) made up of OrthoCarolina physicians and the OCRI Executive Director. Among other responsibilities, RAC meets every other month to evaluate research proposals, to approve research policies and procedures, and to oversee regulatory and ethical issues.

Both OrthoCarolina physicians and OCRI are committed to the advancement of orthopedic treatments, improvement of quality of life for patients, and education of the medical community, as well as the continued education of all our patients and research participants. Rest assured that whether your decision is to participate in research or not to participate in research, your decision is respected by all OrthoCarolina and OCRI staff. We hope that you will feel more comfortable with research knowing the means taken to protect you and to ensure your safety while participating in research.