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Comments on Proposed HHS Regulations on the Protection of Pregnant Women, Unborn Children and Neonates in Research

 

August 31, 2001


Irene Stith-Coleman, Ph.D.
Office of Human Research Protections
Department of Health and Human Services
200 Independence Avenue SW
Room 733-E
Washington, D.C. 20201

Dear Dr. Stith-Coleman:

On behalf of the United States Conference of Catholic Bishops ("Conference"), I offer the following comments on a proposal to revise federal regulations governing research on pregnant women and human fetuses and neonates ("Proposal") published at 66 Fed. Reg. 35576 (July 6, 2001).

Interest of the United States Conference of Catholic Bishops

The Conference is a nonprofit corporation organized under the laws of the District of Columbia. All active Catholic bishops in the United States are members of the Conference. The Catholic Church, the largest religious denomination in the United States, has over 63 million adherents in over 19,000 parishes throughout the country. The Conference advocates and promotes the pastoral teaching of the bishops in such diverse areas as education, family life, health care, social welfare, immigration, civil rights, and the economy. The Conference participates in rulemaking proceedings of importance to the Catholic Church and its people in the United States. Rulemaking that concerns the protection of unborn human life and the ethical integrity of medicine is of paramount concern to the Conference.

In the Conference's view, the dignity and inviolability of human life at every stage of development is a foundational principle of any truly civilized society. The core ethical norms protecting human research subjects, affirmed in the Nuremberg Code and many subsequent documents, reflect this principle. The right not to be subjected to harmful experimentation without one's express and informed consent is an innate human right, belonging to each and every member of the human family by his or her very nature as a human being. Thus it does not belong to government to recognize this right for some human subjects and not for others, or to set aside protection of this right in given cases in the name of expanded knowledge or the good of society. Laws or regulations which fail to give full recognition to this fundamental right do not succeed in nullifying the right in question, but only call into question their own moral legitimacy. It is in light of this moral conviction that we offer the following comments.
Comments

The draft Proposal would revise regulations on protection of human research subjects that have governed federally funded research with little change since 1975 (Subpart B of 45 CFR Part 46, 45 CFR §46. 201 et seq.). A revision of these regulations was proposed as a Final Rule by the Clinton Administration on January 17 (the "January rule"), but suspended and further revised by the Bush Administration.

Generally the Bush Administration's revisions to the January rule are welcome improvements. These revisions recognize the child who has left the womb alive as a newborn child ("neonate"), setting aside the contradictory phrase "fetus ex utero" used in these regulations since 1975. The Proposal also gives greater recognition than the January rule to the valid role of both father and mother in deciding whether to consent to research that may benefit their unborn son or daughter.

However, in key respects these revisions do not go far enough. The Proposal:

(i) fails to incorporate important policy decisions made on this issue by Congress and the Executive Branch in recent years;

(ii) retains certain features of the January rule which may weaken protections for the fetal research subject as compared with the longstanding 1975 regulations; and

(iii) retains features of the original 1975 regulations that are even more unwarranted and morally controversial than the longstanding problem of terminology regarding "fetuses ex utero."

I. Statutory and Executive Guidance not Reflected in the Proposal

A. In vitro fertilization and human embryo research

The title of the proposed Subpart B of 45 CFR Part 46 retains the 1975 regulations' reference to in vitro fertilization: "Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research, and Pertaining to Human In Vitro Fertilization" (emphasis added).

Oddly, however, the Proposal provides no guidance whatever on human in vitro fertilization. We believe this omission should be cured in conformity with the Dickey Amendment which has been a part of federal statutory law since 19961, so that the federal government will fund no research in which a human embryo is created for research purposes or is destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero.

Some background on this issue may be helpful. Subpart B of the 1975 regulations addressed human in vitro fertilization, by providing that no research involving this procedure or embryos created thereby could be conducted with federal funds absent the approval of an Ethics Advisory Board. 45 CFR § 204(d) (1976). Promulgation of a substantive policy on such embryo research was seen as premature at that time, because even the technical feasibility of producing children by this procedure was not known until 1978. In 1979 an Ethics Advisory Board did conclude that some research in this area may be "ethically defensible" but declined to recommend funding for any such research,2 and no Administration from that time to 1994 decided to pursue such funding.

In 1993, Congress enacted legislation that nullified section 204(d). NIH Revitalization Act, Pub. L. No. 103-43, §121(c). This allowed the Clinton administration to propose funding a wide range of harmful human embryo experiments; however, Congress blocked such funding in 1995 by enacting the Dickey Amendment as a rider to the annual Labor/HHS appropriations bill. Every year since then, Congress has filled the policy vacuum left by the 1993 repeal of section 204(d) by specifically choosing to protect the human embryo outside the womb to the same extent as the 1975 regulations protect the unborn child inside the womb.

Congress's attempt through the Dickey Amendment to correct a glaring loophole or deficiency in the existing regulations on fetal research is clear by the terms of the amendment. Its current version reads:

  1. None of the funds made available in this Act may be used for --
    1. the creation of a human embryo or embryos for research purposes; or
    2. research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR §46.208(a)(2) and Section 498(b) of the Public Health Service Act (42 USC §289g(b)).

  2. For purposes of this section, the term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR §46 as of the date of enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.
In our view, it is time for these regulations to mirror the Dickey Amendment and begin treating the human embryo outside the womb as a human subject, as Congress has chosen to do for the past five years.

This would be in full accord with President Bush's announced policy on human embryo research. In his nationally televised speech of August 9, the President said that each human embryo has "the unique genetic potential of an individual human being," and acknowledged his "important obligation" as Chief Executive "to foster and encourage respect for life in America and throughout the world." Finally, he announced his opposition to "providing taxpayer funding that would sanction or encourage further destruction of human embryos that have at least the potential for life," noting that approval for such funding would require "crossing a fundamental moral line."3 This Administration should incorporate into its regulations on human research the principle that this line should not be crossed. As President Bush added in a subsequent opinion column, in which he affirmed the value of human life even in its earliest stages: "Seeking noble ends by any means is unacceptable when life itself is in the balance."4

This correction can be made in either of two ways: by amending the definition of "fetus" at §46.202(c), so that federal protections begin at the onset of embryonic development instead of at implantation; or by adding a definition of "embryo" based on that found in the Dickey Amendment, and inserting a separate provision on equal protection for the human embryo outside the womb as compared with the fetal subject inside the womb.

B. Equal protection for the unborn child slated for abortion

In 1985 Congress permanently amended the Public Health Service Act to clarify the risk standard for research involving the unborn child. This statutory provision, codified at 42 USC §289g(b), states:

(b) Risk standard for fetuses intended to be aborted and fetuses intended to be carried to term to be same

In administering the regulations for the protection of human research subjects which -
  1. apply to research conducted or supported by the Secretary;
  2. involve living human fetuses in utero; and
  3. are published in section 46.208 of part 46 of title 45 of the Code of Federal Regulations;
or any successor to such regulations, the Secretary shall require that the risk standard (published in section 46.102(g) of such part 46 or any successor to such regulations) be the same for fetuses which are intended to be aborted and fetuses which are intended to be carried to term.
Congress stated that this policy must be followed in implementing the 1975 regulations "or any successor to such regulations."5 It would therefore be a serious abdication of responsibility for the Executive Branch to implement a thorough revision of the 1975 regulations without explicitly incorporating this important clarification.

Without this clarification, the Proposal's requirement that nontherapeutic research involving the unborn must pose no more than "minimal risk" to the child contains a potential loophole. "Minimal risk" is defined in terms of the risks "ordinarily encountered in daily life" (45 CFR 46.102(i)). This might be construed by some to mean that federally funded researchers may do virtually any harm to a child intended for abortion, because that child's "daily life" will soon involve a violent death.6 As will be seen below, in Part III of these comments, even some federally funded researchers have acted on the misguided theory that children who may soon face an abortion can be treated by the government as lacking the dignity of other unborn children. The regulations should erect a clear barrier against such abuses, in accord with the clear statutory guidance provided by Congress.

C. Regulating research involving fetal tissue

The 1975 regulations included a brief provision stating simply that research involving a "dead fetus" or "fetal material" must be conducted in accord with state or local laws. 45 CFR §46.210. The Proposal lacks even this provision, substituting instead a provision dealing only with "the dead neonate" and "neonatal material." Proposed §46.206 (66 Fed. Reg. at 35580). It is unclear whether this narrowing of the provision's scope was intentional -- but surely using the term "neonate" to describe an unborn child who, due to an abortion, was dead before leaving the womb is not common usage.

In any case, federal policy on use of fetal tissue for human transplantation was established by statute through the NIH Revitalization Act of 1993. 42 USC §§289g-1, 289g-2. Like President Bush, we have repeatedly stated our opposition to federal funding of any research using fetal tissue from induced abortions. However, these statutory requirements at least define important restrictions on such research -- for example, researchers may only obtain such tissue from a dead fetus, after an abortion was performed by others for unrelated reasons; the timing, method and manner of the abortion may not be modified solely to meet the needs of the research; etc. We see no reason why such restrictions, enacted by Congress after the 1975 regulations were published, should not now be explicitly incorporated into the revised regulations.

The 1993 statute explicitly applied only to use of fetal tissue for transplantation into humans, failing to address other possible uses for such tissue. However, this vacuum was filled by the Clinton Administration in its guidelines governing research on embryonic stem cells and embryonic germ cells.7 The guidelines extended the statutory restrictions cited above to any research using pluripotent stem cells from fetal tissue, even if such tissue was not currently intended for use in human transplantation. Because the Clinton guidelines are likely to be formally rescinded to allow implementation of the somewhat different Bush Administration policy on stem cell research, this one policy choice should be incorporated into the final version of the Proposal on fetal research: All federally funded research using fetal tissue should at least abide by the restrictions which statutory law requires when fetal tissue is used in human transplantation research.

II. Lingering Deficiencies of the Clinton Administration's January Rule

The Proposal has corrected some but not all of the ways in which the January rule would have weakened longstanding protections for the fetal research subject:

A. Exemptions from the regulations

Section 46.201(b) of the Proposal states: "The exemptions at §46.101(b)(1) through (6) are applicable to this subpart."

The incorporation of some of these exemptions is potentially troublesome. Subsection (4) of section 46.101(b) provides that the regulations do not apply to research "involving the collection or study of ... 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." Might this not be construed to mean that researchers have carte blanche to use fetal tissue with no regulatory scrutiny -- indeed, that there is no barrier even to the researcher being involved in an abortion?

Subsection (6) of section 46.101(b) provides that the regulations do not apply to certain taste and food quality evaluation and consumer acceptance studies if a food is consumed that contains an ingredient at or below the level, and for a use, found to be safe, or an agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or other specified agencies. Might this not be construed to mean that if food is found to be generally safe, it then escapes further regulatory scrutiny and may be used in research on pregnant women, without any particular inquiry into whether such research is safe for pregnant women and their unborn children in particular?

Researchers who wish to use fetal tissue, or to test a food ingredient by using pregnant women as research subjects, should not be exempt from the requirements of Subpart B. For this reason, we believe that the exemptions created under subsections (4) and (6) of section 46.101(b) should not be applicable to Subpart B without limitation, and that the proposed section 46.201(b) should be reviewed and revised accordingly.

B. Protective vs. permissive language

The 1975 regulations were written in language that precludes funded research unless certain specified conditions are met.8 The Proposal, following the January rule, is written in a language which explicitly permits funded research if certain conditions are met.9 In our view, preclusive language is more accurate than permissive language in capturing and conveying the regulatory intent. The obvious problem with using permissive language is that it does not prohibit anything. The point of the regulations, of course, is to prohibit funded research that fails to meet particular requirements; otherwise the regulations have little purpose or meaning.

This difference is more than a matter of style. In our view, innocent human subjects have a presumptive right not to be subjected to risk of harm by government for the sake of benefit to others. The burden should rest on proponents of federally funded research to show that such risk will be kept to a minimum and that informed consent is obtained from subjects as appropriate.

Since prohibitive language is clearer than permissive language in expressing this intent, we believe the Proposal, following the structure of the regulations that were in place prior to January 2001, should be revised to use preclusive instead of permissive language.

C. Minimizing the risk of potentially therapeutic research

The 1975 regulations permitted funded research with greater-than-minimal risk to the fetus if (i) the purpose of the activity was to meet the health needs of the particular fetus or the pregnant woman, (ii) the fetus would be placed at risk only to the minimum extent necessary to meet those health needs, and (iii) the research was the least possible risk for achieving the objectives of the activity. 45 CFR §§ 46.207(a) and 46.208(a) (setting out requirements (i) and (ii)); 46.206(a)(2) (setting out requirement (iii)).

In its subsections 46.204(b) and (c), the Proposal follows the January rule in dropping requirement (ii).

In our view, it is important that requirement (ii) be reinstated. There is no good reason to drop this requirement, and every reason to restore it. If a research activity is of greater than minimal risk, and places the unborn child at risk beyond that necessary to meet the unborn child's health needs or those of the pregnant woman, that activity simply cannot be justified ethically. The broader and more ambiguous standard that such risk must be "the least possible for achieving the objectives of the research," as in §46.204(c) of the Proposal, is no adequate substitute. That standard would justify substantial or even lethal harm to the child solely for the sake of knowledge, as long as the experiment also had some potential benefit to the pregnant woman (even if that benefit could be achieved without posing this additional risk to the child).

Accordingly, the regulations should be revised to provide that no funded research posing greater-than-minimal risk to the fetus is permitted unless, among other requirements, the unborn child is placed at risk only to the minimum extent necessary to meet his or her health needs or those of the pregnant woman. Subsection 46.204(b) of the Proposal would then begin by requiring that "the risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus, and any such risk is the minimum necessary to provide this benefit."

D. Parental informed consent

While the Proposal is an improvement over the January rule, it does not go far enough in protecting the interest of parents in research posing some risk to their unborn children. First, proposed section 46.204 seems to require no one's consent ( not even the mother's) for research that poses no benefit to either mother or child. Presumably this was an oversight. Second, subsection 46.204(d) requires only the consent of the mother in cases where the research may be of benefit to the mother alone or to both mother and child. In our view, no research which presents a greater than minimal risk to the unborn child should generally be funded without the consent of both the mother and the father.

That fathers have an interest in the lives of their unborn children cannot be gainsaid. They are generally as interested as the mother in the health and well-being of their child, and are equally responsible, legally and financially, for the child's health care and for helping to alleviate or cope with any injury that may accrue to the child as the result of medical research or experimental treatment. Neither parent should be excluded from this decision-making process without the most serious of justifications.

III. The Authority to Waive Protections for the Unborn Child

Following the January rule, section 46.207 of the Proposal reiterates and actually broadens the authority of the Secretary to set aside protections for the fetal research subject in the womb in particular cases. This waiver clause can be used to nullify all the protections of section 46.204, effectively rendering this regulation into a mere optional guideline. (The reference to "neonates" in the heading and text of section 46.207 suggests that this section might be invoked to set aside protections for newborn children under section 46.205 as well.) Under the Proposal, if the Secretary thinks a given experiment would present a "reasonable opportunity" to gain important medical knowledge, these protections may be waived with only two conditions: (1) the Secretary, after consulting with a "panel of experts" that he or she chooses, thinks that the research will be "in accord with sound ethical principles"; and (2) informed consent is obtained from one or more parents for doing this harm to the unborn child. Proposal, §46.207(b)(2).

This is an egregious loophole. The "sound ethical principles" relevant to this research are the principles of the Nuremberg Code, reflected in section 46.204 itself (if this section is refined by the suggestions cited above). Ethically, researchers may not do substantial harm to a human subject who is incapable of giving informed consent, solely for the sake of medical knowledge. The importance of upholding this principle in the name of human dignity is greater, not lesser, in cases where researchers are tempted to set it aside in order to gain new knowledge. If the principle obtains only where there is no serious temptation to ignore it, it is not a principle at all.

The waiver clause in the 1975 regulations (45 CFR §46.211), though not as broad or open-ended as the corresponding section of the new Proposal, has always been the most controversial feature of these regulations. As far as we know the waiver has been invoked only once in the context of human fetal research, in 1979. This was done to allow testing of a prenatal diagnostic tool of uncertain risk to the unborn child, known as the fetoscope. Federally funded researchers approached low-income black and Hispanic women planning to have abortions in south central Los Angeles, and obtained their consent to try out the fetoscope on their unborn children to see how often the procedure itself caused miscarriages. They found that the fetoscope did induce a miscarriage in about 3% of cases, and this tool was soon supplanted in medical practice by safer and more useful techniques such as ultrasound imaging. In the meantime, the federal government effectively paid researchers to end the lives of some unborn children, on the grounds that their mothers would soon be having abortions in any case.10

When Congress learned of this experiment in the early 1980s its reaction was overwhelmingly negative, and it made several attempts to enact legislation to prevent such abuses in the future.11 Finally, through the Health Research Extension Act of 1985, it enacted the provision ensuring equal protection for the child intended for abortion that is discussed above. In the same legislation, Congress banned any use of the waiver clause for three years, and sought to appoint a Biomedical Ethics Advisory Committee that would study this issue and report back to Congress on whether there is any need for such a clause. Pub. L. No. 99-158, §2 (42 USC §289g (c)). That Board, however, ultimately disbanded amid disputes over membership and ideology. Congress later extended the ban on any use of the waiver for an additional two years, but it took effect again in 1990. Pub. L. No. 100-607, §157 (b). However, such was the controversy over this clause that we know of no instance in the last decade in which it was invoked or needed.

We believe the time has come to assure the American people that ethical limits on harmful human research will not be nullified in specific cases, simply because researchers feel that the research is too useful to be left undone. In this regard the federal government should set an important example of giving the highest priority to the life and dignity of the human subject, especially when human life is in its most vulnerable stages. We therefore urge that section 46.207(b)(2) of the Proposal be deleted. If a future Administration believes that any aspect of the regulations is unduly restrictive of potentially beneficial research, that case should be made and discussed as part of a genuine rule-making procedure that is open to public scrutiny and comment. In this way, ad hoc or ethically problematic rationales will not be incorporated into federal policy simply on a case-by-case basis.
Conclusion

This rule-making process affords an excellent opportunity for the Bush Administration to clarify and strengthen protections for human subjects, especially for those most in danger of having their human dignity and human rights ignored due to researchers' zeal for knowledge and medical benefits in the future. As history has taught us time and time again, this area of ethics and policy more than any other must be governed by the principle that a good end does not justify an evil means. We believe the changes proposed above will help to bring federal regulations more fully into accord with sound ethical norms, reassuring all Americans that no one in our society will be used by government as a mere object of the research enterprise.

Sincerely,

Mark E. Chopko
General Counsel
U.S. Conference of Catholic Bishops

Notes

  1. The current version of the Dickey Amendment can be found at Section 510 of the Labor/HHS appropriations bill for Fiscal year 2001, H.R. 5656 (enacted through Section 1(a)(1) of H.R. 4577, the FY ‘01 Consolidated Appropriations Act, Pub. L. No. 106-554).
  2. "Protection of Human Subjects; HEW Support of Human In Vitro Fertilization and Embryo Transfer: Report of the Ethics Advisory Board," 44 Fed. Reg. 35033-58 at 35055 (June 18, 1979).
  3. "Remarks by the President on Stem Cell Research," Office of the Press Secretary, The White House, www.whitehouse.gov/news/releases/2001/08/20010809-2.html.
  4. George W. Bush, "Stem Cell Science and the Preservation of Life," Op-Ed, The New York Times, August 12, 2001 at 13.
  5. Due to minor revisions in the regulations in subsequent years, the current successor to §46.102(g) is §46.102(i) (definition of "minimal risk").
  6. Disagreement on this point arose even among members of the advisory group that first crafted the 1975 regulations, as some members held that "risks to the fetus-to-be-aborted may be considered ‘minimal' in research which would entail more than minimal risk for a fetus-going-to-term." "Part 46 - Protection of Human Subjects: Fetuses, Pregnant Women, In Vitro Fertilization," 40 Fed. Reg. 33526, 33546 (August 8, 1975).
  7. "National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells," 65 Fed. Reg. 51976-81 (August 25, 2000) at 51980.
  8. E.g., 45 CFR §46.207 (providing that "[n]o pregnant woman may be involved as a subject in an activity covered by this subpart unless" certain specified conditions are met); §46.208 (providing that "[n]o fetus in utero may be involved as a subject covered by this subpart unless" certain specified conditions are met); 46.206 (providing that "[n]o activity to which this subpart is applicable may be undertaken unless" certain specified conditions are met).
  9. E.g., proposed section 46.204 ("[p]regnant women or fetuses may be involved in research if all of the following conditions are met"); proposed section 46.205 ("[n]eonates may be involved in research if all of the following conditions are met").
  10. See Statement of Ezra C. Davidson, Jr., M.D., in National Institutes of Health, Report of the Human Fetal Tissue Transplantation Research Panel, Vol. II (December 1988) at D82-89.
  11. In 1982, by a vote of 260 to 140, the House of Representatives approved a complete ban on funding nontherapeutic experiments on the unborn child "before or after induced abortion," but the underlying bill was not approved by the Senate. Cong. Record, September 30, 1982, H8081-91. In 1984 both chambers of Congress approved a ban on any use of the waiver clause for three years, but the underlying bill was vetoed for unrelated reasons. See Cong. Record, October 9, 1984, H11670-5. Those who opposed a ban on use of the waiver clause argued that such a ban was "unnecessary" because the waiver had never been used since 1979. Id. at 11672.

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