Institutional Review Board (IRB)

The importance of patient participation in and protection during clinical research

In selecting HSS for your orthopedic and rheumatologic care, you are entering a hospital with a rich tradition of innovation and education that has long established HSS as an internationally recognized center of excellence for musculoskeletal health care. If your doctor asks you to consider enrollment in a research study (clinical trial) as part of your care, you can be assured that this request is in keeping with the HSS mission of delivering healthcare of the highest quality.

Your participation in clinical research is a valuable contribution to medical science. It is the essential road to discovery of new and better health care, and it is the way that doctors and researchers translate new knowledge into safe and effective practices and procedures in medicine and surgery. As the leading academic center in musculoskeletal medicine, HSS is dedicated to the highest standards of clinical care, education, and research. Research is the engine that drives this academic excellence and the best patient care possible.

While most patients understand the importance of research and are inclined to participate, it is natural to have some concerns about joining a clinical trial. It is at this moment that the essential process of informed choice begins. Among those questions that may come up are:

• What exactly will I be asked to do?
• What is the risk, and how may I or others with my condition possibly benefit from the study?
• Will I be told everything I need to know, in language I can clearly understand?
• Will my privacy be protected?
• Will I have time to think it over, perhaps discuss with my family, before deciding?
• Can I back out later if I’m not comfortable continuing with what is required?

For these concerns, and many more, you have a strong advocate protecting your rights and interests: the Hospital for Special Surgery Institutional Review Board (IRB).

Clinical research regulations and guidelines

Many of the protections for patients involved in clinical research may seem obvious and intuitive, but other areas of concern have emerged as the result of historical abuses. The guiding principles that are the core of research participant safeguards emerged after World War II, resulting in the Nuremberg Code of 1948, a foundation of five basic human protections in clinical research:

1. Voluntary, informed consent of the subject is required.
2. Benefit of research should outweigh its risk.
3. Research must be conducted by qualified scientists.
4. Scientists will do no harm, no death, no disabling injury.
5. Subjects are at liberty to withdraw at any time.

The Nuremberg Code standards coupled with subsequent experience and more insightful ethical values have resulted in eight fundamental principles that guide clinical research at HSS:

1. The risks of a study must be minimized through sound research design and methodology
2. Risks must be reasonable relative to the anticipated benefits of the study
3. The selection of research subjects must be equitable (equal and fair) and without bias
4. Informed consent must be obtained
5. The consent language agreed to, and the process for obtaining consent, must be carefully documented
6. Research subject privacy and confidentiality must be adequately protected
7. The ongoing safety of research subjects must be adequately monitored
8. Vulnerable subjects, such as children, must be adequately protected

The informed consent process

One of the most important requirements imposed by the IRB in research involving patients is the informed consent process. More than a written document that requires a patient’s signature, informed consent is a process that requires the proper setting, time, diligence, and clear explanation in obtaining consent.

The consent must be written in language that is clear and easily understood. It is important that the research candidate have time to read and understand the consent form, and to have all questions answered by an investigator or qualified hospital staff. The consent document must contain enough information about the research and its risks and benefits to allow the patient to make an informed decision regarding participation. Language and culture must be taken into consideration and, when necessary, translated consent documents must be used or an impartial translator/interpreter provided. Consent documents should include the following eight basic elements:

1. Describe the study fully.
2. Point out foreseeable risks or discomforts.
3. Explain anticipated benefits.
4. Explain alternatives.
5. Describe how confidentiality will be maintained.
6. Describe compensation, if any.
7. Provide contacts who will share more information or discuss concerns.
8. Explain that participation is voluntary and that the subject may withdraw at any time.

Clinical trials and HIPAA: “The privacy rule”

“The Privacy Rule,” known as HIPAA, the “Health Insurance Portability and Accountability Act,” became effective in April, 2003. It was established to protect the privacy of health information that you would expect to remain confidential, e.g., your medical record. The IRB must uphold HIPAA protection when considering how researchers may gain access to, use, and safeguard protected health information (PHI) necessary to conduct research. Patient information gained in the course of standard medical care cannot be reviewed or disseminated to anyone other than the patient’s physician without specific authorization by the patient, obtained at the time of written consent.

Everyone at HSS is dedicated to the highest standards of clinical research research that improves the lives of our patients. The HSS IRB is made up of knowledgeable and dedicated scientists and lay members who serve as an ethics review board for this research. When you agree to participate in a research study at HSS, you can rest assured that the Institutional Review Board is maintaining a constant vigilance to protect your rights, safety, and privacy.