Teachers 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 Services' (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. You can see more information about this by visiting our Training & Certification page.
The federal agency responsible for oversight of human subjects research is the Office for Human Research Protections (OHRP). Its website contains a wealth of materials covering the full spectrum of issues in human subjects protections, including the DHHS regulations known as 45 CFR Part 46, and the Belmont Report.
The federal Office of Research Integrity (ORI) oversees the responsible conduct of research at institutions that receive federal funding.
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 health 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 (COC) for their project. Among other benefits, a COC prevents investigators, research teams, and/or data from being subpoenaed. Thus, a COC 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 COC.
As a major professional and research institution, Teachers College's mission is to engage in a vast number of research activities. Thus, sometimes it can be difficult to decide whether or not a particular project involving human subjects requires IRB review.
The federal regulations define a human subject as a living individual about whom a researcher 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 that 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 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 researchers with specific guidance about whether or not their project requires IRB review. When in doubt, always contact the IRB office.