During the public comment phase, NIH received approximately 50,000 comments. These ranged from suggestions that there is no need for any such federal guidelines to contentions that the research was in violation of the U.S. Department of Health and Human Services (DHHS) appropriations law prohibiting research involving human embryos. Comments came from a wide variety of persons and entities, including private citizens, members of Congress, religious organizations, and scientific societies. See “Summary of Public Comments on Draft Guidelines,”National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells (visited October 6, 2000) <http://www.nih.gov/news/stemcell/stemcellguidelines.htm>.
2.
“National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells,”65Fed. Reg.51,975, Aug. 25, 2000; BNA's Health Law Reporter, 9 (2000): At 1350 [hereinafter cited as Guidelines].
3.
See, e.g., “Testimony on Pluripotent Stem Cell Research Guidelines” (reporting testimony of two National Institutes of Health directors before the Senate Appropriations Subcommittee on Sep. 7, 2000) (visited October 6, 2000) <http://www.ninds.nih.gov/about_ninds/testimony_stemcell_090700.htm>.
4.
Id.
5.
See, for example, Ethical Issues in Human Stem Cell Research, Executive Summary of the National Bioethics Advisory Commission (September 1999) (visited October 11, 2000) <http://bioethics.gov/stemcell_exec_intro.htm>.
For further discussion of stem cell research and potential applications, see “Statement of Harold Varmus, M.D., Director, National Institutes of Health” before the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies, December 2, 1998 (visited Oct. 6, 2000) <http://nih.gov/news/stemcell/statement.htm>.
8.
See the “Scope of Guidelines and General Issues” section of the Guidelines, supra note 2.
9.
See Guidelines, supra note 2.
10.
Id.
11.
The Guidelines list more than 15 procedural directives for the conduct of funded research. These are summarized in the text above or may be read in full in the Guidelines themselves. See Guidelines, supra note 2.
12.
There also must be a clear separation of the decision to undergo fertility treatment from the decision to donate excess embryos for research.
13.
Standard procedural safeguards include institutional review board (IRB) scrutiny and the provision of documentation and assurances of compliance.
14.
See Guidelines, supra note 2.
15.
See BivenM., “Administrative Developments: NIH Backs Federal Funding for Stem Cell Research,”Journal of Law, Medicine & Ethics, 27, no. 1 (1999): At 96–97.
16.
Id.
17.
Id.
18.
The main issue is whether the embryo is a fully realized human with accompanying rights or a potential human whose full rights begin at some point later in pregnancy or at birth.
19.
See, for example, Senate Health Appropriations Subcommittee Hearings, April 26, 2000. See also “Testimony on Pluripotent Stem Cell Research Guidelines, September 2000,” reporting the testimony of two NIH directors before the Senate Appropriations Subcommittee, September 7, 2000 (visited October 6, 2000) <www.ninds.nih.gov/about_ninds/testimony_stemcell_090700.htm>.
20.
Opponents often characterize proponents' arguments as “utilitarian” at best and have compared stem cell research to medical experiments conducted by the Nazis in World War II, as in this comment by Senator Sam Brownback (R-KS): “… like what happened in World War II. [The Nazis figured that] these people are going to be killed, why not experiment on them ….” See Senate Health Appropriations Subcommittee Hearings, April 26, 2000. See also IrvingD., “Stem Cell Research: Some Pros and Cons,”Canadian Physicians for Life (visited Oct. 11, 2000) <http://physiciansforlife.ca/stemcell1.html>.
21.
Certain additional research areas are also defined as ineligible. See Guidelines, supra note 2.
