Clinical Research

Research answers scientific questions about the cause, treatment, and natural history of some diseases and helps us find new and better ways to treat the people who suffer from these diseases.

Clinical trials are part of research. They help us find out if a promising new treatment is safe for patients. Clinical trials are conducted in phases for assessing the right dosage, safety and effectiveness. Only after passing rigorous review by the Food and Drug Administration (FDA), which usually includes analysis of randomized, controlled studies, can a drug be approved for use in the treatment of illness. After FDA approval, "post-marketing" drug research and monitoring may show evidence of safety or treatment issues that require revised labeling, new indications, or other treatment options.

Medical research is more than the development of new drugs, though. The goal of medical research is to understand the processes of normal and abnormal human biology and the diseases affecting people, and to improve the health and welfare of the population.

Medical research must undergo review to make sure that safety, effectiveness and confidentiality issues are addressed. Research subjects have clearly defined rights. Therefore, all research must be approved prior to its initiation. Committees that are brought together to review human research proposals, or clinical trials, are called Institutional Review Boards (IRBs).

Institutional Review Board

An Institutional Review Board is a committee of scientific and lay members. Its purpose is to protect the rights and welfare of research participants and to ensure that each subject is fully informed about the study in which he or she is participating. This is done through the careful review of any research proposal brought before the Board. If the research proposal is approved, IRB oversight includes follow-up review to ensure that the research study team complies with all applicable regulations and good clinical practice standards.

All research proposals are reviewed by the IRB for risks and benefits. This includes the research protocol, its scientific value, the safety of procedures and treatments to be administered during the study, methods for protecting subjects' confidentiality, and the information that will be included in the informed consent document. A consent form must be signed in order for a patient to be admitted into a study.

Past information known about the research proposal is also reviewed. All information to be shared with the public is reviewed. If the research proposal is approved by the IRB, the researcher is required to request IRB re-approval for the study at least yearly. Such re-approval requests must describe the progress of the research project, any changes to the project, any changes to the consent form, any pertinent new information, and any problems or unexpected or serious adverse events encountered in the study.

No research involving people may be undertaken without IRB review and approval.  Stamford Hospital IRB reviews study proposals that are done on the premises of the hospital or that involve any patients being treated at the hospital. The Board may also be asked to review other proposals brought to them by research investigators in the community. Many hospitals and universities, like Stamford Hospital , have IRBs. Committee members are volunteer faculty, physicians, nurses, and non-scientific (lay) individuals. Membership must include both affiliated and non-affiliated (independent) individuals.

Patients may call the IRB with any questions they may have about research in general, their rights as a study subject, or the conduct of any particular study.

Stamford Hospital IRB may be reached at 203-276-5551.

IRB Policies and Procedures

Stamford Hospital IRB operates within the principles of the Belmont Report ¹ and applicable FDA and DHHS guidelines² for human research. Investigators may obtain a copy of the Stamford Hospital IRB Policies and Procedures by contacting the IRB office at 203-276-5551.

1) Belmont Report: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (DHHS), April 18, 1979
2) United States Code of Federal Regulations: Title 45 Part 46; Title 21 Part 50; Title 21 Part 56