Tutorial Chapter 3: What are the current regulations concerning human subjects research?

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:

• categories of research that may receive Exempt Status
• procedures for working with minors and other protected populations
• the content and documentation of informed consent
• ongoing review policies.

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:

• establishes the functions and operations of the IRB and the criteria for IRB approval of research
• sets requirements for IRB membership to ensure diversity of its members, appropriate expertise, and inclusion of a nonscientist and a public member with no other association with the University
• identifies vulnerable subject populations
• establishes the categories of IRB approval and the ongoing requirements for each
• establishes the general requirements for informed consent and its documentation.

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:

• The University IRB and
• The IRB of the Department of Education, which is part of the Department's Division of Assessment and Accountability.

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:

• principal investigators, co-investigators and all key personnel complete a formal education program in the regulations governing research activities involving human subjects
• the University certify, in order than an award may be made, that the principal investigator and key personnel in the project have successfully received that education.

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.

Chapter Review

Question 1

Title 45 Public Welfare, Part 46 Protection of Human Subjects embodies all the regulations that make up the Common Rule.

• True
• False

Question 2

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.

• True
• False

Question 3

The Common Rule also (select all that are correct):

• identifies vulnerable subject populations
• establishes the categories of IRB approval and the ongoing requirements for each
• establishes the general requirements for informed consent and its documentation
• all of the above

Question 4

The New York City Department of Education requires that all research involving public school personnel, students, or facilities must be approved only by the University IRB.

• True
• False

Next Chapter: Do you need to apply to the UCAIHS?