Protections for Research Patients
There are several layers of oversight to assure that people participating in research are treated safely and ethically.
Protocol: Research studies are required to have a written protocol of what is going to be done. These documents are often over 100 pages in length and describe in detail all of the study procedures, medications that will be used, what outcomes will be measured and what safety precautions and tests are to be used. The protocol must be carefully followed. It assures that the study design has been carefully considered, and that things will not be forgotten during the course of the research.
Investigator’s Brochure: The investigator’s brochure (IB) is a description of what is known about a potential medication. It describes in detail the animal studies that have been done with a new medication, and also any human studies available. This is used to help determine whether there are any issues regarding safety with a medication.
Principal Investigator: The principal investigator (PI) is responsible for the safe and ethical conduct of the study. Their first responsibility is to the patient and the patient’s safety. They are responsible for assuring that participants are aware of the benefits and risk of a study as well as alternative treatments available outside of the study.
Primary Care Physician: The primary care physician should continue to be involved in the care of the patient, even if they are participating in research.
Institutional Review Board: The institutional review board (IRB) is responsible for overseeing the ethics of a study. The IRB must be independent of the principal investigator. They must have both medical experts and lay people included. They review the study protocol in detail, and monitor the study throughout its course to assure that subjects are treated ethically. They consider many aspects of a study including whether the study is answering a scientifically important question, whether the risks and benefits are acceptable, whether sufficient numbers of patients are being studied, whether the language of the consent form is appropriate, whether recruitment of research subjects is being handled ethically, that there is no coercion or discrimination in recruitment, protection of subjects rights and confidentiality, monitoring adverse outcomes during the study, and ethical conduct after the completion of the study. The IRB has the power to refuse to allow a study to begin, and also to halt the study at any time if there are ethics or safety issues.
Data Safety Monitoring Board: Larger studies have a data safety monitoring board (DSMB) that looks at the data through the course of the study. The DSMB can stop a study if there are safety issues. It can also terminate a study early if the scientific question is answered (positively or negatively) before the planned end of the study.
Food and Drug Administration: The food and drug administration (FDA) oversees the safety of medications prescribed in the United States. Similar agencies exist in other countries. The FDA must determine that a medication is both safe and effective before it can be sold in the US. However, neither safety nor effectiveness is required of food supplements and other over-the-counter health aids. Studies must be registered with the FDA prior to starting if the FDA is to use the data in determining whether a medication will be released to market. This assures that all studies (positive and negative) are known to the FDA. The FDA monitors the conduct of the study, the quality of the data, and the statistical analysis. The FDA also audits investigators to assure the proper conduct of a study.
Funding Source: The funding source (a pharmaceutical company, the National MS Society, the National Institute of Health) also oversees the study. It is in the best interest of the funding source to conduct a high quality study because questions about study design and conduct can lead to a medication being refused by the FDA. Also, ethical irregularities can also lead to a refusal by the FDA.
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