Contracts, Grants, Cooperative Agreements, CRADAs and Guest Researchers

What is the Scope of the Protection of Human Subjects? 14.01.02. This subchapter applies to all research involving human subjects conducted or supported by NIST-Gaithersburg or NIST-Boulder. The term "research involving human subjects" is broad, encompassing the study of human behavior, reactions, and thought processes as well as the tangible study of the human body, tissues, organs, cells, and so on. "Research" means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this subchapter, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, human testing of computer software, research involving human cells or tissue, and in certain limited circumstances even employee surveys may fall within the scope of this subchapter. Research "conducted or supported" by NIST is broadly interpreted. In addition to research carried out by NIST employees and NIST contractors and funding recipients, the term includes activities of foreign and domestic guest researchers under their agreements with NIST, outside parties utilizing NIST facilities, and activities carried out jointly by NIST and other parties in shared facilities such as the Center for Advanced Research in Biotechnology (CARB) and JILA, and in CRADAs.

What are the Chief, Acquisition and Assistance Division Responsibilities? See 14.01.05c.

What are the Chief, Finance Division Responsibilities? See 14.01.05c.

What are the Director, Office of Technology Partnerships Responsibilities? See 14.01.05c.

What are the Director, Office of International and Academic Affairs Responsibilities? See 14.01.05c.

What is a " Protected Class"? NIST IRB is not authorized to review research involving the Protected Classes. For additional information concerning the "Protected Classes" review the NIST Administrative Manual 14.01.04 and 45 CFR Part 46 Subpart B (Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research); 45 CFR Part 46 Subpart C (DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects; and 45 CFR Part 46 Subpart D (DHHS Protections for Children Involved as Subjects in Research).

When is a Renewal Required? All projects approved by the NIST IRB require an annual renewal. The IRB Office will send notification to the Researcher or Principle Investigator three (3) months prior to the renewal date. Exemptions do not require renewals.

• The Chief, Acquisition and Assistance Division or Designee 14.01.06(4)- will contact contractors, grantees, and cooperative agreement funding recipients whose projects involve human subjects research at appropriate intervals to ensure that their projects are receiving continuing review by an appropriate IRB in accordance with their special award conditions and 15 CFR Part 27.

• The Director, Office of Technology Partnerships 14.01.06(4) - will contact organizations who have executed facilities use agreements involving human subjects research at appropriate intervals to ensure that their projects are receiving continuing review by an appropriate IRB in accordance with the continuing review procedures imposed by the IRB that certified the project.

What are Cooperative Research Projects 14.01.06(4)c? They are: CRADAs, 1525 Agreements, Cooperative Agreements where NIST participation rises to the level of NIST participation in the research, or other formal or informal cooperative research arrangements - Cooperative Research Projects are those projects covered by the Common Rule which involve more than one institution.

• Human Subjects Research Projects Conducted Under Certain ongoing Cooperative Research Arrangements, including CARB and JILA 14.01.06(6)d - When appropriate, the Deputy Director may enter into joint review arrangements, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort, as permitted by 15 CFR 27.114, for projects involving human subjects research that are conducted under ongoing cooperative research arrangements, such as CARB or JILA.

• Human subjects research conducted under a Foreign or Domestic Guest Researcher Agreement 14.01.06(6)e: (1) If a project involving human subjects research is to be conducted under a guest researcher agreement and the research is supported by NIST funding, the project must receive appropriate exemptions or approvals as described in paragraph a. of this section. (2) If a project involving human subjects research is to be conducted under a guest researcher agreement and the research is funded by another federal agency, the project must receive appropriate exemptions or approvals as described in paragraph b. of this section.

Human Subjects Computer Base Training (CBT) for NIST Staff

Protection of Human Subjects and Vertebrate Animals Used in Research - This is a presentation that Dr. Alan H. Cookson, NIST IRB Chairman and Mrs. Melissa Lieberman, Office of NIST Counsel gave on June 12, 2001.

Protection of Human Subjects in Research at NIST - This is a presentation that Dr. Alan H. Cookson, NIST IRB Chairman and Mrs. Melissa Lieberman, Office of NIST Counsel put together for the NIST scientists who are involved with or planning or approve human subjects research. This will also be used to meet the annual education requirements.