This collection and the collection submitted under 1880-0537 are disapproved for the following reason. Under the requirements of the Paperwork Reduction Act of 1995, a collection of information must provide the least burdensome approach to meet its purposes. This collection fails to take the least burdensome approach possible for the collection's intended purpose. The process proposed by ED is unduly cumbersome and burdensome, and does not conform with the process used by NIH and PHS. For example, ED's approach would be to supplement as part of the application a lengthy set of instructions that is followed by a short form to be filled out by the applicant. In contrast, PHS and NIH build that information into their application form and instructions, capturing the institutional official signature, exempt status and number, MPA number (if applicable) and IRB number, and review status. In addition, respondents would find it very difficult to navigate the processes proposed by ED for both the Instructions to Applicants/Offerors and the Compliance Form, particularly given that they create a separate procedure that researchers must learn and follow. Furthermore, ED has failed to demonstrate why the Department's proposed process warrants a significant deviation from that used by HHS. OMB recommends that ED reexamine the approaches used by other agencies, particularly those used by HHS as well as NSF, and revise their form accordingly. As part of this revision, ED shall consider replacing the 424 form used currently by the Department as a face sheet for all grant applications to conform with that used by PHS and NIH. Before revising the forms, ED shall consult widely with interested parties, including the grants management office within the Department, researchers who will be subject to reporting, and the Human Subjects Research Subcommittee run out of NIH which includes representation from agencies across the Federal government. In its next submission, ED shall include evidence of this consultation as well as evidence of concurrence from HHS on the approach chosen. Finally, OMB recommends that this subcommittee reevaluate the appropriateness of a model approach for use by all agencies.
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The instructions to grant applicants notify applicants of the Federal requirements for the protection of human subjects in research and require them to provide certain information on any planned research activities involving human subjects. The instructions to contract offerors instruct offerors to provide certain information about planned research activities involving human subjects.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
U.S. Department of Education Protection of Human Subjects in Research Instructions to Applicants/Offerors