Human Fetal Tissue from Elective Abortions

NIH's Definition of Human Fetal Tissue (HFT) & Human Fetal Tissue (HFT) from Elective Abortions:
Per NIH GPS §4.1.14, “[h]uman fetal tissue (HFT) is defined as tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion or stillbirth. This definition does not include established human fetal cell lines. Research involving the transplantation of human fetal tissue must be conducted in accordance with applicable Federal, State, and local laws as well as the following NIH guidance.” Per NIH GPS §4.1.14.2, “HFT from elective abortions is defined as research involving the study, analysis, or use of primary HFT, cells, and derivatives, and human fetal primary cell cultures obtained from elective abortions… NIH requires additional documentation of the use of HFT from elective abortions in research… to ensure that it is utilized for research only when scientifically justifiable, and in the least amount possible to achieve the scientific outcomes.” Moreover, “[w]hen an application involving human fetal tissue research is submitted to NIH, the Authorized Organization Representative’s (AOR)'s signature certifies that researchers using these tissues are in compliance with section 498B of the PHS Act.” The statute specifically prohibits any person from “knowingly acquiring, receiving, or transferring any human fetal tissue for valuable consideration.”

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What a Central Sponsor Project Office (SPO) Reviewer needs to know when reviewing and submitting an NIH application or receiving and accepting an NIH award that contains HFT/HFT from Elective Abortions

Pre-Award: Review & Submission (Office of Contract and Grant Administration (OCGA) or Health Sciences Sponsored Pre-Award Project Office (HS SPPO)).

While reviewing an application, the SPO Reviewer will determine if HFT from Elective Abortions is involved (and allowable) in the application by noting the Human Fetal Tissue keyword was chosen in the PD Record as well as there are the required responses for Human Fetal Tissue from Elective Abortions in the required sections of the ASSIST or S2S application. The required sections are Research & Related (R&R) Cover; Cover Page Supplement; R&R Detailed Budget & Budget Justification; and Research Plan.

Note, the onus is on the Principal Investigator (PI) whether this is true HFT from elective abortions application or not. The SPO cannot make this determination on behalf of the PI at the time of submission or JIT.

Where and when the use of HFT is NOT allowed per GPS § 4.1.14.2:

Administrative supplements to add HFT research will not be allowed if not included in the parent award.
Complex grant mechanisms that include centers/cores with discretionary funds will not be allowed to expand existing HFT funding or to add HFT funded activities, including pilot projects. Additionally, other grant mechanisms that include centers with discretionary funds and Other Transaction Authority (OTAs) may not be used to support HFT research.
Training awards and individual fellowships may not propose research using HFT. This includes: T15, T32, T34, T35, T36, T37, T90/R90, TL1, TL4, F05, F30, F31, F32, F33, F37, F38, F99, K12, D43, D71.

If it is determined that HFT is involved (and allowable), then make sure all the required responses or items are listed below for, “What a Research Administrator needs to know about PD and ASSIST/S2S application” when working on an NIH application that contains HFT.

Be aware, per the GPS § 4.1.14.1, “the AOR's signature certifies [on the application, R&R Cover, Item 19] that researchers using these tissues are in compliance with § 498B of the PHS Act.”

Pre-Award: JIT (OCGA or HS SPPO)

If the informed consent sample form was not submitted at the time of submission in the application, then it will be required at JIT. Use of HFT with Elective Abortions does not call in itself for IRB review or approval. However, if there is a corresponding IACUC protocol in the application, then route as normal for a congruency review with the IACUC office; if there is a corresponding IRB protocol in the application, then request the IRB protocol # from the department and/or PI to verify the approval in the Kuali Compliance Module as well as have the PI attest in an email that the protocol is the correct one for the research being completed in the pending application.

Email language: "I confirm this/these IRB approval(s) is/are associated with this application/grant. This/these protocol(s) represents the research being performed in this application/grant."

Award (OCGA)

If a Notice of Award (NoA) with HFT/HFT from Elective Abortions is received, this is the trigger to route to the Research Compliance and Integrity Office (RCI) for review (rci@ucsd.edu). RCI will verify that the PI has documentation that the HFT was not obtained for valuable consideration.

Informed Consent is required by federal and state law (17 Cal. Code of Regs. § 100085), “for research involving the transplantation of human fetal tissue and for research with human fetal material associated with information that can identify a living individual,” per NIH GPS § 4.1.14. Documentation is required to establish that the 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 the informed consent will be signed by both the woman and the person who obtains the informed consent.
Administrative requirements and additional terms and conditions of the award are added when HFT is involved. For more information, see NOT-OD-19-128. This requirement includes an annual assurance required by NIH when HFT research is ongoing.

Post-Award (OCGA or HS SPPO)

Progress Report (RPPR): Per NOT-OD-19-128, continued use of HFT will require justification for the ongoing scientific necessity for the use of HFT in the annual RPPR. This would include B. Accomplishments, and H. R&R Budget and Budget Justification.

As with JIT, if there is a corresponding IACUC protocol in the progress report, then verify as normal that the protocol is still valid on IACUC's protocol website; if there is a corresponding IRB protocol in the application, then request the IRB protocol # from the department and/or PI to verify the approval in the Kuali Compliance Module as well as have the PI attest in an email that the protocol is the correct one for the research being completed in the pending progress report.

Email language: "I confirm this/these IRB approval(s) is/are associated with this application/grant. This/these protocol(s) represents the research being performed in this application/grant."

What a Research Administrator needs to know about PD and ASSIST/S2S application when working on an NIH application or receiving an award that contains HFT/HFT from Elective Abortions

PD Record

PD Record: Basic: Proposal Details: Keyword: Select “Human Fetal Tissue.” This is for reporting purposes as well as to inform the Central SPOs that research is being done on campus with HFT/HFT from elective abortions.

Basics: S2S Opportunity: Forms: make sure to include the necessary forms in the application after you have selected your S2S Opportunity ID.

ASSIST & S2S: Single-Project

21. Cover Letter: Include a statement in the cover letter if the proposed studies involve human fetal tissue obtained from elective abortions (HFT), regardless of whether or not Human Subjects are involved and/or there are costs associated with the HFT.

ASSIST: upload under R&R Cover, 21. Cover Letter
S2S: upload under Proposal Attachments: RRSF424_Cover_Letter and indicate as Final.

Cover Page Supplement: Question 4: Does the proposed project involve human fetal tissue from elective abortions? If “Yes,” then provide the HFT Compliance Assurance & provide the HFT Sample IRB Consent Form.

ASSIST: There are two additional documents that are required to be included in the application if HTF from elective abortions is involved:

The applicant must provide a letter, signed by the Program Director IPD)/PI, assuring the HFT donating organization or clinic adheres to the requirements of the informed consent process and documenting that HFT was not obtained or acquired for valuable consideration. This form is called the HFT Compliance Assurance Sample IRB Consent Form and the PDF file name MUST be named exactly HFTComplianceAssurance.pdf.
The applicant must provide a blank sample of the IRB-approved consent form. The PDF-formatted form must be a blank sample. This sample form is called the HFT Sample IRB Consent Form and the PDF file name MUST be named exactly HFTSampleIRBConsentForm.pdf.

S2S: Questionnaire: PHS 398 Cover Page Supplement v5.0:Follow the above guidelines for ASSIST and complete the form.

To add the two required documents to the application, users must go to Attachments: Proposal: add the two documents and select the appropriate description: HFTComplianceAssurance or HFTSampleIRBConsentForm to each of the attachments. Both attachments MUST appear with that naming convention if HFT from elective abortions Research is applicable.
After these two steps have been completed, you can go to Basics: S2S Opportunity: Forms: select PHS398_CoverPageSupplement_5_0-V5.0 on the right side to create a PDF of just this form to verify it has been completed correctly for HFT, plus verify both required files have been attached correctly, using the required naming convention.

Other Project Information: 1. Human Subjects

ASSIST: Users should indicate “No” for Human Subjects if the application only includes HFT from elective abortions. This was determined using NIH’s Decision Tool: Am I Doing Human Subjects Research?
S2S: Key Personnel: Contact PI: Research Questions: Question 1: Note, the location is slightly different in PD S2S, then in ASSIST. Users should indicate “No” for Human Subjects if the application only includes HFT from elective abortions. This was determined using NIH’s Decision Tool: Am I Doing Human Subjects Research?

R&R Budget: F. Other Direct Costs: no matter the size of the budget, a detailed budget is REQUIRED when you are using HFT/HFT from Elective Abortions, even if the direct costs are in all years total less than $250,000.00 per year. Additionally, you MUST use a specific line item just for HFT.

ASSIST: Do not include these costs in Materials and Supplies. You must create a line item for titled Human Fetal Tissue Costs and enter the related costs. If the researchers are using donated or existing HFT where there is no cost, the line item still must be included, and the value would be indicated as $0.00. Note, that this line-item cost cannot be combined with any other costs.
S2S: Do not include these costs in Materials and Supplies. To add this required HFT line item, users must select Other Category Type, then Human Fetal Tissue in Category, and finally Human Fetal Tissue in Object Code. Once you add this object to your budget, it will map to the RR Budget forms as a separate unique line 9 in Other Direct Costs labeled Human Fetal Tissue Costs.

R&R Budget: Budget Justification: Details regarding procurement and costs are required. The user must document the quantity, type(s), and source(s) of the HFT, stage of fetal development, as well as a certification that valuable consideration has not been provided for the acquisition of HFT. This information must be included if costs for the HFT are assigned to the grant or if the HFT is acquired under the grant at no cost. The HFT justification must be clearly labeled in the budget justification attachment.

ASSIST: The user would upload under Year 1 of the Detailed Budget in the application, Item L. Budget Justification.
S2S: The user would upload under Attachments: Proposal. Select Budget Justification as the document type.

Research Plan: 3. Research Strategy: the PI MUST justify the need for use of HFT for the research proposed, under the Approach heading. The description must include an additional subheading titled Human Fetal Tissue Justification. 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. Furthermore, the PI must justify the use of HFT in the proposed research by indicating the following:

Why the research goals cannot be accomplished by 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.
Additional note for both ASSIST & S2S: you must still follow the page limits for the FOA you are responding to.

ASSIST & S2S Multi-Project: follow instructions for Single Project applications, with slight deviations listed below.

SF424 R&R Form: 21. Cover Letter: Include a statement in the cover letter if the proposed studies involve human fetal tissue obtained from elective abortions (HFT), regardless of whether or not Human Subjects are involved and/or there are costs associated with the HFT.
Cover Page Supplement: Question 4: Overall Component: Does the proposed project involve human fetal tissue from elective abortions? If the use of HFT is proposed in any Component, then you must answer Yes here.
R&R Budget: F. Other Direct Costs & Budget Justification:

ASSIST: HFT should be included only in each project/core budget where research involving HFT is conducted (even if there is no HFT cost) – ensure that each project/core lists HFT as a separate line item in Section F.8-10 "Other" titled Human Fetal Tissue Costs. Do not include these costs in Materials and Supplies. Budget Justification: the instructions stated above for a Single Project application should be followed.
S2S: Parent (Overall) and Children (Projects/Cores): HFT should be included only in each project/core budget where research involving HFT is conducted (even if there is no HFT cost) – ensure that each project/core lists HFT as a separate line item in Section F.8-10 "Other" titled Human Fetal Tissue Costs. Do not include these costs in Materials and Supplies. Budget Justification: the instructions stated above for a Single Project application should be followed.

Research Plan: 3. Research Strategy: HFT should be included only in each project/core where research involving HFT is conducted.

ASSIST: the instructions stated above for a Single Project application should be followed.
S2S: Parent (Overall) and Children (Projects/Cores): the instructions stated above for a Single Project application should be followed.

R&D Contracts

Refer to specific solicitations published on or after September 25, 2019, for proposal instructions regarding the use of HFT.

JIT: eRA Commons

If not HFT was not disclosed at the time of submission of the application, then you must provide a sample of the IRB-approved informed consent form at JIT.
Once the JIT has been submitted, then you will need to update the KR IP record and add the keyword for Human Fetal Tissue.

Award/NoA Received

Was the informed consent document submitted at the time of the application, or is it still pending? May have to work with OCGA, RCI, and the PI once the NoA has been issued.

Post Award

Informed Consent and acquisition of HFT. Are the policies and regulations being followed in making sure this is coming only from elective abortions? Is the documentation secure and stored?
See NOT-OD-19-128 for the administrative requirements and terms and conditions of the award that are added when HFT is involved. This includes the requirement of documentation from the HFT donating organization assuring adherence to the requirements of the informed consent process and documentation that HFT was not obtained or acquired for valuable consideration. The NIH awardee will acquire this assurance for each year of the award HFT research is conducted for the life of the award and maintain this documentation in accordance with the NIH Record Retention and Access Policy (NIH GPS § 8.4.2).
Progress Report (RPPR): Per NOT-OD-19-128, continued use of HFT will require justification for the ongoing scientific necessity for the use of HFT in the annual RPPR. This would include B. Accomplishments, and H. R&R Budget and Budget Justification.

What a PI needs to know about PD and ASSIST/S2S applications when working on an NIH application that contains HFT or receiving an award that contains HFT

If they do not have an assistant and their Research Administrator (RA) does not assist them with their ASSIST or S2S application, then after their PD record is complete, then they need to follow the guidelines for ASSIST or S2S, under, “What a Research Administrator needs to know about PD and ASSIST/S2S application” when working on an NIH application that contains HFT. Pay close attention to the following sections above

R&R Budget: F. Other Direct Costs, including the Budget Justification.
Research Plan: 3. Research Strategy.

Note, the onus is on the PI whether this is true HFT from elective abortions at the time of submission for the application.

Here is UC San Diego IRB's Additional Consent Language for Human Fetal Tissue Collection. This document is divided into three sections: background, requirement, and guidance. The background explains the why, the requirement explains the what, and the guidance explains the how. Under the guidance section, please use the provided additional consent language in the participant's, person obtaining the consent, and if applicable, the witness's signature blocks for all HFT from elective abortions in the research informed consent documents. For questions on the use of the signature blocks, please write to the Office of IRB Administration at irb@ucsd.edu.

Please note per NOT-OD-19-128 & NOT-OD-19-137, “applications that do not address all of the required information, including the detailed budget as instructed [in both NOAs], will be administratively withdrawn and not reviewed.”

Additional Policies and Resources for HFT in NIH Applications

NIH Grants Policy Statement (GPS):

§ 2.3.7.11 Human Fetal Tissue from Elective Abortions: NIH requires applicants to address HFT requirements by providing a justification of the use of HFT, details regarding procurement and costs, and information about how the applicant will use HFT.
§ 4.1.14 Human Fetal Tissue Research: Human fetal tissue is defined as tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion or stillbirth.

When an application involving human fetal tissue research is submitted to NIH, the AOR's signature certifies that researchers using these tissues are in compliance with § 498B of the PHS Act.
Additional Information: Statute on Fetal Tissue Transplantation Research: Public Law 103.43.
NIH expects informed consent to have been obtained from the donor for any NIH-funded research using human fetal tissue.
When obtaining primary human fetal tissue for research purposes, NIH expects grantees and contractors to maintain appropriate documentation, such as an attestation from the health care provider or a third-party supplier, that informed consent was obtained at the time of tissue collection.

§ 4.1.14.2 Human Fetal Tissue from Elective Abortions: Human Fetal Tissue (HFT) from elective abortion is defined as research involving the study, analysis, or use of primary HFT, cells, and derivatives, and human fetal primary cell cultures obtained from elective abortions.

NIH Notices:

NOT-OD-15-143: Reminder of Legal Requirements Regarding the Acquisition and Use of Human Fetal Tissue for Research Purposes
NOT-OD-16-033: NIH Policy on Informed Consent for Human Fetal Tissue Research

Expectations to obtain informed consent from the donor for any NIH-funded research using HFT
When obtaining primary human fetal tissue for research purposes, NIH expects grantees and contractors to maintain appropriate documentation, such as an attestation from the health care provider or a third-party supplier, that informed consent was obtained at the time of tissue collection.

NOT-OD-19-128: Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research (from elective abortions)

Clarifies the definition of HFT as well as what is included in this type of research and what is not. Additionally, it clarifies HHS Requirements and review considerations regarding research by the NIH and involves the proposed use of human fetal tissue obtained from elective abortions (HFT) in extramural applications for grants, cooperative agreements and R&D contracts. HHS Requirements.

NOT-OD-19-137: Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research
NOT-OD-21-111: Update on Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research

Public Law: § 498B of the PHS Act: PROHIBITIONS REGARDING HUMAN FETAL TISSUE SEC. 498B:

PURCHASE OF TISSUE- It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if the transfer affects interstate commerce.
SOLICITATION OR ACCEPTANCE OF TISSUE AS DIRECTED DONATION FOR USE IN TRANSPLANTATION - It shall be unlawful for any person to solicit or knowingly acquire, receive, or accept a donation of human fetal tissue for the purpose of transplantation of such tissue into another person if the donation affects interstate commerce, the tissue will be or is obtained pursuant to an induced abortion, and —

the donation will be or is made pursuant to a promise to the donating individual that the donated tissue will be transplanted into a recipient specified by such individual;
the donated tissue will be transplanted into a relative of the donating individual; or
the person who solicits or knowingly acquires, receives, or accepts the donation has provided valuable consideration for the costs associated with such abortion.

CRIMINAL PENALTIES FOR VIOLATIONS:

IN GENERAL. Any person who violates subsection (a) or (b) shall be fined in accordance with title 18, United States Code, subject to paragraph (2), or imprisoned for not more than 10 years, or both.
PENALTIES APPLICABLE TO PERSONS RECEIVING CONSIDERATION. With respect to the imposition of a fine under paragraph (1), if the person involved violates subsection (a) or (b)(3), a fine shall be imposed in an amount not less than twice the amount of the valuable consideration received.

DEFINITIONS. For purposes of this section:

The term 'human fetal tissue' has the meaning given such term in section 498A(f).
The term interstate commerce' has the meaning given such term in section 201(b) of the Federal Food, Drug, and Cosmetic Act.
The term valuable consideration' does not include reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue.'

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