Current policies and requirements for research activities involving human subjects are set forth in the US Code of Federal Regulations, Title 45 Public Welfare, Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks, Part 46 Protection of Human Subjects.
Part 46 embodies the actual regulations governing activities with human subjects, and is usually referred to as the “Common Rule.” These regulations are supplemented by policies and regulations of other branches of government and the University.
The policies put forth in the Common Rule apply to all research with human subjects that is conducted, supported or otherwise subject to regulation by a Federal department or agency. At New York University, as at most other universities in the United States, the requirements of the Common Rule are applied to all research with human subjects carried out at NYU or by members of the University community.
The Common Rule, along with the body of precedent and interpretation based on it, establishes the requirements for approval of research with human subjects, including:
All these topics are presented in detail in other sections of this tutorial.
In order to implement the Common Rule, the University has an assurance on file with the Federal government that allows it to designate an Institutional Review Board (IRB) (known at NYU as the University Committee on Activities Involving Human Subjects and generally referred to as UCAIHS or the Committee), to oversee the review and approval process for research involving human subjects.
The Common Rule also:
Federal regulations as expressed in the Common Rule and administered by individual agencies, are not, however, the only source of policies and requirements for research involving human subjects.
State and local laws and policies must also be observed. One such regulation that has a considerable impact on research at the University is the requirement of the New York City Department of Education that all research involving public school personnel, students, or facilities must be approved by:
In addition, the University may institute policies affecting the requirements for approval that extend Federal, state or local requirements to nonfunded projects as well.
For example, effective October 1st, 2000, the National Institutes of Health requires that, for all NIH-funded projects:
Key personnel includes all individuals responsible for the design and conduct of the study and are labeled as such in the proposal.
As a matter of institutional, educational and research policy, the University has made the decision that all researchers and faculty sponsors involved with human subjects, whether the project is funded or not, must take and pass the educational tutorial developed and approved for the UCAIHS of which this section is part.
Completion of the tutorial is also required of researchers from other institutions who participate in projects involving human subjects that are based at the University unless their institution has a Federal Wide Assurance with an approved education program.
Next Chapter: Do you need to apply to the UCAIHS?