United States General Accounting Office

GAO Report to the Chairmen and Ranking

Minority Members, Committee on Labor

and Human Resources, U.S. Senate, and

Committee on Commerce, House of

Representatives

March 1997 NIH-FUNDED

RESEARCH

Therapeutic Human

Fetal Tissue

Transplantation

Projects Meet Federal

Requirements

GAO/HEHS-97-61

GAO United States

General Accounting Office

Washington, D.C. 20548

Health, Education, and

Human Services Division

B-276018 

March 10, 1997

The Honorable James M. Jeffords

Chairman

The Honorable Edward M. Kennedy

Ranking Minority Member

Committee on Labor and Human Resources

United States Senate

The Honorable Thomas J. Bliley, Jr.

Chairman

The Honorable John D. Dingell

Ranking Minority Member

Committee on Commerce

House of Representatives

Therapeutic human fetal tissue transplantation is a promising area of

research that may have application for a broad range of diseases, such as

juvenile diabetes and leukemia. Current federally funded research projects

use fetal tissue—cells from electively aborted fetuses—to treat patients

with Parkinson’s disease. Although this research holds promise for

treating diseases, concerns have been raised about the acceptance of fetal

tissue transplantation; that is, some women might choose to conceive for

the sole purpose of aborting their fetuses, so that tissue could be provided

to treat family members or to supply fetal material for financial gain.

In March 1988, the Department of Health and Human Services (HHS)

imposed a moratorium on the use of federal funds for research projects on

therapeutic human fetal tissue transplantation until a panel, appointed by

HHS, could study the ethical issues involved.1 In the fall of 1988, the panel

concluded that the use of human fetal tissue in research is acceptable

public policy, but the moratorium remained until the President ordered it

lifted in January 1993. At the same time, the Secretary, HHS, directed the

National Institutes of Health (NIH) to develop interim guidelines for the

support and conduct of such research projects “to ensure that federal

funding of human fetal tissue transplantation research does not encourage

the choice of abortion.” In June 1993, the NIH Revitalization Act of 1993

(P.L. 103-43) was enacted, a part of which establishes the conditions under

which federally funded therapeutic human fetal tissue transplantation

research can take place.2

1

During the moratorium, private funding was used for therapeutic transplantation studies.

2

The NIH interim guidelines were withdrawn when P.L. 103-43 was enacted.

Page 1 GAO/HEHS-97-61 Fetal Tissue Transplantation
B-276018 

The NIH Revitalization Act of 1993 requires us to carry out a compliance

review of research on fetal tissue transplantation conducted or supported

by HHS. Specifically, the act requires that we (1) determine compliance

with informed consent and other documentation and (2) report on any

violations occurring in the acquisition of human fetal tissue for use in

transplantation.

To determine compliance with the requirements of the act, we met with

federal officials and with project personnel at two institutions awarded

grants for federally funded research on therapeutic human fetal tissue

transplantation. The federal officials gave us information from NIH’s Office

for Protection from Research Risks (OPRR),3

 Office of Science Policy, and

the National Institute of Neurological Disorders and Stroke (NINDS). This

information included project funding and status, as well as institutional

procedures for ensuring protection for human subjects.

We visited the project personnel at the University of Colorado Health

Sciences Center in Denver, Colorado, and the Mount Sinai Medical Center

in New York City, as well as its affiliated site at the University of South

Florida in Tampa, Florida.4

 We spoke with the principal investigators and

the chairs of the institutional review boards.5

 In addition, we examined

documents used for the research projects, including consent forms and

statements of the attending physicians. In reviewing such documents, we

were mindful of the confidentiality granted to the project participants and

of the integrity of the double-blind research methodology. These

double-blind research projects were designed so that neither the recipients

nor the researchers who evaluate the outcome of the transplant surgery

knew which patients were in the experimental group and which in the

control group. In our workpapers, we did not record the names of the

donors or recipients, nor any of the dates on which the transplantations

took place. We reviewed the relevant documents to ensure that the proper

number of forms were present and that consent had been obtained on or

before the dates that transplantations were performed.

3

OPRR has the responsibility for ensuring that institutions awarded grants for research on fetal tissue

transplantation comply with the act’s requirements for informed consent and other human subject

protection.

4

The University of South Florida is “affiliated” because it receives funding from Mount Sinai’s NIH

award. We needed to visit South Florida because it had relevant documents.

5

Institutional review boards are responsible for examining research proposals and ongoing studies in

order to ensure protection of human subjects from risks. These boards, composed mainly of scientists

at institutions doing the research, are required to report to the NIH any violations or unanticipated

problems involving risks to subjects.

Page 2 GAO/HEHS-97-61 Fetal Tissue Transplantation
B-276018 

We conducted our review from October 1996 to December 1996 in

accordance with generally accepted government auditing standards.

Results in Brief In general, the requirements of the act are being complied with. The act’s

documentation requirements—pertaining to informed consent of donors

and “donees” (recipients) and compliance statements made by institutions,

researchers, and attending physicians—were met. HHS did not submit

annual reports on the program’s activities, however, as required by the act.

But the agency did submit a combined report on January 29, 1997,

describing the activities from fiscal years 1993 through 1995.

There have been no reported violations in the acquisition of human fetal

tissue for use in transplantation, according to NIH and our verification

efforts.

Background Between fiscal years 1993 and 1996, NIH awarded over $6 million for five

extramural projects involving therapeutic human fetal tissue research.

Two projects—at the University of Colorado Health Sciences Center and

the Mount Sinai Medical Center—involved actual transplantation of fetal

tissue. These projects accounted for about $5.9 million of the funds. Both

were funded by NINDS, which expects to continue funding these projects in

fiscal year 1997. The remaining three projects—at Yale University School

of Medicine, University of Colorado Health Sciences Center, and Columbia

University College of Physicians and Surgeons—totaling about $280,000,

were funded through NIH’s National Center for Research Resources (NCRR)

grants at General Clinical Research Center (GCRC) sites. For these three

projects, funds were not spent to transplant fetal tissue, but to clinically

observe Parkinson’s patients before and after transplant surgery. (For

more detailed funding information, see app. I).

No intramural projects involving therapeutic human fetal tissue

transplantation have been funded. At the time of our review, no new

projects on therapeutic human fetal tissue transplantation were being

proposed for funding by January 1997.

Page 3 GAO/HEHS-97-61 Fetal Tissue Transplantation
B-276018 

Ongoing Projects

Have Complied With

the Requirements of

the Act

The act contains the following eight requirements for research on human

fetal tissue transplantation:

(1) Informed consent of the donor: The woman providing the tissue

must make a signed written statement, declaring that she is donating fetal

tissue for research, without any restrictions on, or awareness of, who the

tissue recipient will be.

(2) Attending physician statement: The physician responsible for

obtaining the tissue from the woman involved must make a signed written

statement declaring that

• in the case of tissue obtained through an induced abortion, consent for the

abortion preceded consent for the tissue donation, the timing of the

abortion was not solely for purposes of obtaining the tissue, and the

abortion was performed in accordance with state law;

• the woman gave informed consent, as described in (1) above; and

• the donor was given full disclosure of any interest the physician has in the

research use of the tissue and any known medical risks and privacy risks

associated with the tissue donation.

(3) Principal researcher statement: The individual with the principal

responsibility for conducting the research must make a signed written

statement indicating awareness that the tissue obtained is human tissue,

that it may have been obtained through a spontaneous or induced abortion

or a stillbirth,6

 and that it was donated for research purposes. The

statement also must indicate that the researcher

• has provided such information to others with responsibilities for the

research,

• will obtain written acknowledgment from the tissue recipient of the

receipt of such information, and

• has not been involved in the timing of, or method used, in the abortion.

(4) Informed consent of the recipient: The individual to be a recipient

of a transplantation of tissue must provide written acknowledgment, as

described in (3) above.

6

Due to concerns about the quality of the tissue, only tissue obtained from induced abortions is used in

research on therapeutic human fetal tissue transplantation.

Page 4 GAO/HEHS-97-61 Fetal Tissue Transplantation
B-276018 

(5) Availability of statements for audit: The head of each agency or

entity conducting the research must certify to the Secretary of HHS that the

required statements (1 to 4) will be available for audit by the Secretary.

(6) Compliance with state law: The recipients of funding for research

on fetal tissue transplantation must agree to conduct research in

accordance with applicable state law.

(7) HHS annual report: HHS is required to submit annual reports to the

House Committee on Commerce and the Senate Committee on Labor and

Human Resources, describing the fetal tissue transplantation activities

carried out during the preceding fiscal year and discussing whether those

activities were carried out in accordance with the law.

(8) Tissue purchase and donation restrictions: The purchase of

human fetal tissue is prohibited. In addition, donated tissue can not be

transplanted into a recipient specified by the donor, such as a relative of

the donor, nor can a person acquiring tissue pay costs associated with the

abortion. Violators are subject to fines or imprisonment or both.

In general, the research projects we reviewed were in compliance with the

requirements of the act. See table 1 for a summary of our methodology and

findings, which verify compliance.

Page 5 GAO/HEHS-97-61 Fetal Tissue Transplantation
B-276018 

Table 1: GAO Verification of

Compliance With Requirements 

of the Act

Requirement of the act Methodology and findings

(1) Informed consent of donor

(2) Attending physician

 statement

(3) Principal researcher

 statement

(4) Informed consent of

 recipient

We checked for the inclusion of the required statements

on the forms used by the projects,a and verified that the

required forms were in the project files and were properly

executed. Documentation for both projects met the

requirements of the law.

(5) Availability of statements

 for audit

We checked whether the institutions involved in this

research had submitted institutional assurances to NIH

that covered the audit requirements. Each institution

involved had submitted such an assurance.

(6) Compliance with state law We checked whether the institutions involved in this

research had submitted institutional assurances to NIH

that covered the state law requirements. Each institution

involved had submitted such an assurance.

(7) HHS annual report We checked on HHS submission of reports to the

Congress. HHS was not in compliance with the annual

requirement. The agency submitted a combined report

covering fiscal years 1993-95 in January 1997.

(8) Tissue purchase and

 donation restrictions

We checked with NIH’s OPRR and the funded institutions’

institutional review boards. No violations had been

reported or detected.

aEach project had several participating institutions, but only one institution for each project was

listed as the funded institution.

We found that the two research projects on fetal tissue transplantation

adhered to the documentation requirements for the protection of human

subjects. Our examination of the four forms used by each of the two

projects conducting fetal tissue transplantation research indicated that the

requirements of the law were met. During our visits to the project sites, we

also verified that the forms had been appropriately executed for each

project. All of the forms that were required were present, signed, dated,

and witnessed.

To date, NIH’s OPRR has not performed audits on the two projects

conducting fetal tissue transplantation research because there have been

no complaints reported. According to OPRR, NIH funds approximately 15,000

studies involving human subjects and OPRR can only carry out about five

compliance site visits each year. Therefore, site visits tend to be made to

institutions with some indication of problems.

We also found that the Secretary, HHS, had not submitted annual reports to

your Committees as required. NIH prepared draft annual reports for fiscal

Page 6 GAO/HEHS-97-61 Fetal Tissue Transplantation
B-276018 

years 1993, 1994, and 1995 and forwarded them to the Secretary in May

1994, June 1995, and August 1996, respectively. HHS submitted a combined

report, covering fiscal years 1993 through 1995, on January 29, 1997.

Agency Comments A draft of this report was reviewed by NIH officials. They agreed with our

findings related to therapeutic human fetal tissue transplantation research.

Based on these officials’ technical comments, we changed the report

where appropriate.

We are sending copies of this report to other interested Members of

Congress, and will make copies available to others on request. Please call

me on (202) 512-7119 if you or your staff have any questions about the

issues discussed above. Other major contributors include Rosamond Katz,

Erwin Bedarf, Ann White, and Robert Crystal.

Bernice Steinhardt

Director, Health Services Quality

 and Public Health Issues

Page 7 GAO/HEHS-97-61 Fetal Tissue Transplantation
Appendix I 

NIH Funding of Award Institutions for

Research on Fetal Tissue Transplantation,

FYs 1993-96

Award institution

NIH

sponsor FY 1993 FY 1994 FY 1995 FY 1996a

Total NCRR

FYs 1993-96

Total NINDS

FYs 1993-96

Total FYs

1993-96

Yale University

School of Medicine $213,357

NCRR

(GCRC) $97,325 $76,693 $36,007 $3,332 $213,357 b

University of

Colorado Health

Sciences Centerc 3,855,445

NINDS d 1,019,956 1,326,627 1,507,573 b 3,854,156

NCRR

(GCRC) d d 1,289 d 1,289 b

Columbia University

College of

Physicians and

Surgeons 66,890

NCRR

(GCRC) d d 26,424 40,466 66,890 b

Mount Sinai Medical

Centerc,e 2,028,049

NINDS d d 952,070 1,075,979 b 2,028,049

Total $97,325 $1,096,649 $2,342,417 $2,627,350 $281,536 $5,882,205 $6,163,741

aOnly preliminary information was available for FY 1996.

bTotal not applicable here.

cThese funds were used for a research project involving transplant surgery.

dNo funding.

eThe University of South Florida was funded through this award.

Source: Office of Science Policy, NIH.

(108299) Page 8 GAO/HEHS-97-61 Fetal Tissue Transplantation
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