Question 4 (Human Subjects) on the face sheet of new and renewal grant applications (PHS-398 packets) that include activities involving human subjects must be checked in the “yes” box. If an exemption applies, the exemption number must be indicated. In such a case, an expedited review by the IRB chairman may be in order. Information submitted with the grant should justify this claim. Exemptions are defined in the federal regulations issued 6/18/91, and are reproduced below:
Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from these regulations...:
- Research conducted in established or commonly established or commonly accepted educational settings, involving normal educational practices, such as
- research on regular and special instructional strategies, or
- research on the effectiveness of, or the comparison among instructional techniques, curricula or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
- Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
- any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability or reputation.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:
- The human subjects are elected or appointed public officials or candidates for public office; or
- federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate or otherwise examine:
- Public benefit or service programs;
- procedures for obtaining benefits or services under those programs;
- possible changes in or alternatives to those programs or procedures; or
- possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies,
- if wholesome foods without additives are consumed or
- if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture."
Non-Exempt Human Research
Research that involves human subjects and that is being submitted to DHHS or any other federal agency, must be certified in one of two ways. New applications or competing renewals must indicate either the approval date OR an indication that the approval is pending on the PHS 398 face page (Question 4). If a proposal is marked as “pending”, follow-up certification must be submitted on OPTIONAL FORM 310 ("Protection of Human Subjects Assurance Identification/ Certification/Declaration") or on a revised face page. Provisions for delayed certification required for a grant application submitted with a pending human subjects designation is the responsibility of the Principal Investigator. When the IRB Project Approval Request (IPAR) has been approved, the IRB Chairperson should be provided with the name and address of the individual at NIH who is to receive the follow-up certification.
Grace is Granted
NIH will allow new grant applications a grace period of 60 days from the application's deadline for the investigator to receive and document Institutional Review Board approval. Although not all federal funding agencies allow this grace period, contact with the funding agency will verify one way or the other. When "pending" approval is indicated on the face page of a grant, the IPAR forms should be submitted to the Fisk IRB as soon as possible. Emergency approval cannot be issued for routine IPAR’s submitted to the IRB with insufficient time to meet a deadline mandated by the investigator or a granting agency
Grace is NOT Granted:
Investigator-initiated AIDS research submitted to NIH for "expedited" funding review does not qualify for the 60-day grace period. These applications must be submitted with an IRB approval date. The proposal may be rejected or deferred if IRB approval does not appear on the face page.
A grace period is not given when submitting non-competing (Type 5) funding applications. Non-competing applications must be submitted with IRB approval (See the NIH Guide, Vol. 20, No. 30, August 2, 1991 for details). It is important that non-competing proposals are routinely reviewed in a timely manner so that IRB approval is not lost.
Regardless of sponsorship, no research involving human subjects may be performed by Fisk faculty without IRB approval. This is irrespective of the source of subjects or site of performance. If you are in doubt as to whether your research qualifies for an exemption or IRB approval is required, call the OSP. This form is submitted through the OSP.
IRB Project Approval Request Form
Research involving human subjects in any manner and those projects that do not fall in the exempt category, require the completion and submission of an IPAR to the IRB for review and approval. Information required will include a description of the project, methods you will use to minimize the risk to the subjects and methods that will be used to obtain informed consent. This form will be submitted through the OSP.
Applications and Proposals Lacking Definite Plans for Involvement of Human
"Certain types of applications for grants, cooperative agreements or contracts are submitted to departments or agencies with the knowledge that subjects may be involved within the period of funding, but definite plans would not normally be set forth in the application or proposal. These include activities such as...research training grants where the activities involving subjects remain to be selected; and projects in which human subjects involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. These applications need not be reviewed by an IRB before an award may be made."
If definite plans for human subjects research are not indicated in your proposal, state this in Section E. Human Subjects of the Research Plan as follows: "Plans for human subjects are not definite at the time of this grant application. If certification has not already been filed, record of IRB review and approval of research involving human subjects will be provided before the activity begins. This is in accord with 45 CFR 46.118."