Policy GuidanceTeachers College's agreement with the Federal Government that allows it to conduct research involving human subjects is known as a Federal Wide Assurance (FWA). In that agreement, Teachers College agrees to abide by the Department of Health and Human Service's (DHHS) regulations for the protection of human research subjects, 45 CFR Part 46. Those regulations are based largely on the Belmont Report, a statement of ethical principles in human subjects protections published in 1979. The terms of the FWA at Teachers College apply to all research conducted by its faculty, staff and students, funded or unfunded. This includes doctoral research.
The FWA also requires Teachers College to provide comprehensive, ongoing training in human subjects protections for all investigators and research staff. This training is currently available online through CITI, provided by the Collaborative Institutional Training Initiative. In order to register for the training, go to the CITI website: http://www.citiprogram.org [See more information about this by clicking on the Training and Certification tab].
Public Responsibility in Medicine and Research (PRIM&R) is an organization of researchers, ethicists and IRB professionals committed to improving human subjects protections and all other aspects of the responsible conduct of research. They hold ongoing conferences and workshops and are an important resource to the research community.
Investigators who will be collecting private, identifiable heath information (PHI) as part of their research are subject to the privacy requirements of the Health Insurance Portability and Accountability Act (HIPAA). Click here for more information on HIPAA.
Certain projects that gather highly sensitive data may wish to obtain a federal Certificate of Confidentiality for their project. Among other benefits, a Certificate of Confidentiality prevents you, your research team, and/or your data from being subpoenaed and thus is most appropriate for projects where a breach of confidentiality could lead to legal difficulties for a subject. A project need not be federally funded to be awarded a Certificate of Confidentiality.
Finally, Teachers College, as part of its mission as a major professional and research institution, engages in a vast number of activities, and sometimes it can be difficult to decide whether or not a particular project is a research project involving human subjects that requires IRB review.
The federal regulations define a human subject as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. --- 45 CFR 46.102(f)(1),(2)
Research is defined as a means of a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for the purposes of this policy, whether or not they are supported under a program which is considered research for other purposes.
Therefore, both the nature of the specific activities to be carried out and their purpose need to be considered. For example, a program evaluation meant to assess the effectiveness and make improvements in a local environment is not considered research, because the activity is not designed to lead to generalizable knowledge. The IRB office can provide you with specific guidance about whether or not your project requires IRB review. When in doubt, always contact the IRB office.