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NIST Researcher or Principal Investigator

What are the Researcher or Principal Investigator's Responsibilities?14.01.05a. NIST employees and their appropriate line management, and guest researchers (foreign and domestic), their hosts, and their hosts' appropriate line management, are responsible for submitting to their OU Directors protocol descriptions for research projects they would like to conduct or support that involve human subjects.

How Do I Know Whether My Project Requires IRB Review? 14.01.05b. The National Institute of Standards and Technology requires that all research protocols involving human subjects be submitted through line management to the OU Director for determination whether the research involves Protected Classes of Human Subjects, is exempt from the requirement of IRB review, or requires IRB review.

How do I get Started? Review the procedures section of the NIST Administrative Manual Section 14.01.06 to help determine what type of review is required for your protocol.

What is an Exemption? Some projects may not require a full IRB review. Review the list of what is exempt under 15 CFR 27.101(b). If you think your protocol falls within one of the exemption categories, submit required documentation for your OU Director to make an exemption determination.
Sample Exemption Memorandum (NIST Administrative Manual 14.01 Appendix A) in a PDF format.

When is a Project Exempt? The only time a project is exempted is when the criteria for exemption is met under the policy 15 CFR 27.101(b).

When is a Full IRB Review Required? If the research project is expected to involve human subjects, the work will be performed at NIST, the protocol does not involve a Protected Class, and is determined not to be exempt.

What is an Expedited Review and When is it done? When research involves no more than minimal risk and involves only procedures listed in one or more of the categories listed by DHHS, the NIST IRB Chairperson may review the protocol under the expedited review procedures authorized by 15 CFR 27.110.

If My Protocol Requires IRB Review, What Must I Submit to the NIST IRB ? A sample submission package is located in the NIST Administrative Manual 14.01 Appendix B PDF format.

What is an Informed Consent Form and What are the Requirements? Review the general requirements for an informed consent form under 15 CFR 27.116.

What Documentation is Required for an Informed Consent Form? Review the documentation requirements under 15 CFR 27.117.
Requirements/Sample of an Informed Consent Form (NIST Administrative Manual 14.01 Appendix C) in PDF format.

How Do I Know My Human Subject Package is Complete and Ready to Proceed? For an Exemption checklist. For an Expedited or Full Review Checklist.

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) .

What if NIST Funds a Project Involving Human Subjects Under a Grant, Contract or a Cooperative Agreement? The NIST Administrative Manual 14.01.06b states that "NIST-funded or supported projects involving external research using human subjects, and research conducted at NIST under proprietary and non-proprietary facilities use agreements - If a research project is expected to involve human subjects, and the work involving human subjects will be performed outside NIST through either a grant, a contract, or a cooperative agreement used as the funding mechanism, or if a project involving human subjects will be performed at NIST by an outside organization under a facilities use agreement (either proprietary or non-proprietary), the NIST principal investigator must develop a package to be submitted through line management to the OU Director whose OU will fund the project, or in which the facility is located, for determination as to whether the human subjects involved fall into a class of subjects covered by 45 CFR Part 46, Subpart B, C, or D, and, if not, whether the project fits within an exemption to the Common Rule."

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

What Should I Do if Changes Occur During the Year? Any change to the protocol requires approval by the IRB Chairman in writing. Any work related to the said change(s) can not proceed until the IRB Chairman approves the change(s).

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.