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:
- None of the funds made available in this Act may be used for --
- the creation of a human embryo or embryos for research purposes;
or
- 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)).
- 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 -
- apply to research conducted or supported by the Secretary;
- involve living human fetuses in utero; and
- 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
- 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).
- "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).
- "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.
- George W. Bush, "Stem Cell Science and the Preservation of Life," Op-Ed,
The New York Times, August 12, 2001 at 13.
- 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").
- 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).
- "National Institutes of Health Guidelines for Research Using Human
Pluripotent Stem Cells," 65 Fed. Reg. 51976-81 (August 25, 2000) at 51980.
- 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).
- 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").
- 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.
- 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.
__________________________________
Office of General Counsel
United States Conference of
Catholic Bishops
3211 4th Street, N.E., Washington, DC 20017-1194 (202)
541-3000
June 03, 2003 Copyright © by United
States Conference of Catholic Bishops