NOT-OD-19-137: Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research

Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research

Notice Number: NOT-OD-19-137

Key Dates
Release Date: August 23, 2019

Related Announcements
NOT-OD-20-053
NOT-OD-19-128
NOT-OD-21-111

Issued by
Office of The Director, National Institutes of Health (OD)

Purpose

The purpose of this Notice is to inform NIH extramural applicants and recipients of the publication of Frequently Asked Questions (FAQs) regarding proposed use of human fetal tissue obtained from elective abortions (HFT) in extramural applications for grants, cooperative agreements and R&D contracts and to provide additional clarification of specific changes to competing grant and cooperative agreement application instructions that were published in NOT-OD-19-128 on July 26, 2019.

The specific changes to competing application instructions implemented in NOT-OD-19-128 and clarified in this Notice apply only to human fetal tissue obtained from elective abortions (herein referred to as HFT). The specific changes to competing grant and cooperative agreement application instructions outlined in NOT-OD-19-128 and clarified below will be incorporated into forthcoming application guide updates.

Clarification of Specific Changes to Competing Application Instructions

For grant and cooperative agreement applications submitted for due dates on or after September 25, 2019, NIH will require applicants to address HFT requirements as outlined in NOT-OD-19-128. This Notice clarifies the Other Attachments required to be attached to the R&R Other Project Information Form and clarifies instructions in the R&R Budget Form and PHS 398 Research Plan Form.

Applications that do not address all of the required information in NOT-OD-19-128, including the clarified instructions under Revised Language below, will be administratively withdrawn and not reviewed.

Current language:

For multi-project applications, the information should be provided in the component where the research involving HFT is conducted.

G.300 R&R Budget Form
- Added language under section F.8-10. Other: If HFT (as defined in NOT-OD-19-128) are included in the proposed application, regardless of whether costs will be incurred, it must be noted as a line item here. The line item must be titled Human Fetal Tissue Costs. If no cost will be incurred (i.e. donated tissue), enter 0 in the Funds Requested column. Details regarding HFT should be specified in the Budget Justification, pursuant to the instructions.

G.400 PHS 398 Research Plan Form

Under the introductory part of 3. Research Strategy section: New section titled Note for Applications Proposing the Use of Human Fetal Tissue: If HFT use is proposed, you will include specific information in the Research Strategy attachment. This information should be provided regardless of whether Human Subjects research is proposed or not. HFT is defined per NOT-OD-19-128. See specific instructions below in Section 3. Approach.
Within 3. Research Strategy - subsection 3: Approach added a new bullet point for this information:
- Use the specific heading: Human Fetal Tissue Research Approach
- Describe the proposed characteristics, procurement, and procedures for the research use of HFT. The description should be sufficiently detailed to permit meaningful evaluation by NIH.
- Justify the use of HFT in the proposed research by indicating the following:
  - Why the research goals cannot be accomplished using an alternative to HFT?
  - What methods were used (e.g. literature review, preliminary data) to determine that alternatives could not be used?
  - Results from a literature review used to provide justifications
  - Plans for the treatment of HFT and the disposal of HFT when research is complete
  - Description of planned written, voluntary, informed consent process for cell/tissue donation, or description and documentation of process if cells/tissue were already obtained. Include a sample of the IRB approved consent form with the application or during the JIT process. The informed consent for use of HFT from elective abortion requires language that acknowledges informed consent for donation of HFT was obtained by someone other than the person who obtained the informed consent for abortion, occurred after the informed consent for abortion, and will not affect the method of abortion; no enticements, benefits, or financial incentives were used at any level of the process to incentivize abortion or the donation of HFT; and to be signed by both the woman and the person who obtains the informed consent. Include an assurance letter
  - Information must be submitted by the applicant Institution in a letter assuring the HFT donating organization or clinic adheres to the requirements of the informed consent process and documentation that HFT was not obtained or acquired for valuable consideration. Name the PDF formatted letter HFTComplianceArssurance.pdf and attach it in the Other Attachments section of the Research & Related Other Project Information form. Applications proposing HFT research that do not include this assurance will be administratively withdrawn and not reviewed.

Revised language:

For multi-project applications, the budget information must be provided only in the G.300 R&R Budget Form of the component(s) where the research involving human fetal tissue obtained from elective abortions (HFT) is conducted.

G.220 R&R Other Project Information Form

Applicants must include two attachments in the Other Attachments section of the R&R Other Project Information form.
- HFT Sample IRB Consent Form. Provide a blank sample of the IRB approved consent form with the application. The PDF-formatted form must be a blank sample and named HFTSampleIRBConsentForm.pdf . Applications proposing HFT research that do not include this assurance will be administratively withdrawn and not reviewed.
  - The informed consent for use of HFT from elective abortion requires language that acknowledges informed consent for donation of HFT was obtained by someone other than the person who obtained the informed consent for abortion, occurred after the informed consent for abortion, and will not affect the method of abortion; no enticements, benefits, or financial incentives were used at any level of the process to incentivize abortion or the donation of HFT; and to be signed by both the woman and the person who obtains the informed consent.
- HFT Compliance Assurance. The applicant institution must provide a letter signed by the PD/PI assuring the HFT donating organization or clinic adheres to the requirements of the informed consent process and documentation that HFT was not obtained or acquired for valuable consideration. The PDF-formatted letter must be named HFTComplianceAssurance.pdf . Applications proposing HFT research that do not include this assurance will be administratively withdrawn and not reviewed.

G.300 R&R Budget Form
- Added language under section F.8-10. Other: If HFT (as defined in NOT-OD-19-128) are included in the proposed application, regardless of whether costs will be incurred, it must be noted as a single line item here. The line item must be titled Human Fetal Tissue Costs. If no cost will be incurred, enter 0 in the Funds Requested column. The line item must only be used for HFT costs and cannot include or be combined with any other costs. Details regarding HFT must be specified in the Budget Justification, pursuant to the instructions.

G.400 PHS 398 Research Plan Form

Under the form overview instructions, part of 3. Research Strategy section: New instruction section titled Note for Applications Proposing the Use of Human Fetal Tissue: If the use of HFT obtained from elective abortions is proposed, as defined per NOT-OD-19-128, you must include specific information in the Research Strategy attachment. This information must be provided regardless of whether Human Subjects research is proposed or not. See specific instructions below in Section 3. Approach.
Within 3. Research Strategy - subsection 3: Approach added a new bullet point for this information:
- In the Approach section of the Research Strategy use the specific heading: Human Fetal Tissue Research Approach
- Describe the proposed characteristics, procurement, and procedures for the research use of HFT. The description should be sufficiently detailed to permit meaningful evaluation by NIH and an ethics advisory board comprised of scientists, bio-ethicists and others as specified in section 492A of the Public Health Service Act.
- Justify the use of HFT in the proposed research by indicating the following:
  - Why the research goals cannot be accomplished using an alternative to HFT.
  - What methods were used (e.g. literature review, preliminary data) to determine that alternatives could not be used.
  - Results from a literature review used to provide justifications.
  - Plans for the treatment of HFT and the disposal of HFT when research is complete.
  - Description of planned written, voluntary, informed consent process for cell/tissue donation, or description and documentation of process if cells/tissue were already obtained.

FAQs

Answers to FAQs regarding proposed use of HFT in research have been posted at https://grants.nih.gov/grants/human-fetal-tissue-research-faqs.htm. We anticipate updating the FAQs page as needed and recommend that applicants check back for updates to the FAQs regularly until their submission date.

Inquiries

Please direct all inquiries to:

Office of Policy for Extramural Research Administration (OPERA)
Telephone: 301-435-0949
Email: grantspolicy@mail.nih.gov