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'''National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research''' was the first public national body to shape [[bioethics]] policy in the [[United States]].
'''National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research''' was the first public national body to shape [[bioethics]] policy in the [[United States]].


⚫
Formed in the aftermath of the [[Tuskegee Study of Untreated Syphilis in the Negro Male|Tuskegee Experiment]] scandal, the commission was created in 1974 as Title II of the [[National Research Act]]. It was part of the [[United States Department of Health, Education, and Welfare]] (DHEW) until 1978.<ref>The President's Council on Bioethics. "Former Bioethics Commissions." The Bioethics Research Library at Georgetown University. The President's Council on Bioethics, 1998. Web. 19 Mar. 2012. <http://bioethics.georgetown.edu/pcbe/reports/past_commissions/></ref>
==History==
⚫
Formed in the aftermath of the [[Tuskegee Study of Untreated Syphilis in the Negro Male|Tuskegee Experiment]] scandal, the Commission was created in 1974 as Title II of the [[National Research Act]]. It was part of the [[United States Department of Health, Education, and Welfare]] (DHEW) until 1978.<ref>The President's Council on Bioethics. "Former Bioethics Commissions." The Bioethics Research Library at Georgetown University. The President's Council on Bioethics, 1998. Web. 19 Mar. 2012. <http://bioethics.georgetown.edu/pcbe/reports/past_commissions/></ref>


==Purpose==
== Goals ==
The commission had four goals that it needed to analyze:<ref>{{Cite web|url=https://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html|title=The Belmont Report|date=28 January 2010}}</ref>
The Commission had four goals that it needed to analyze: 1. the boundaries between biomedical and behavioral research and what the accepted and routine practices of medicine were, 2. assessing the risks and benefits of the appropriateness of research involving human subjects, 3. determining appropriate guidelines for how human subjects can be chosen for the participation in such research and 4. defining what informed consent is in each research setting.<ref>http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html</ref>
⚫
The Commission also had the task of making recommendations to the [[United States Secretary of Health, Education, and Welfare|Secretary of Health, Education, and Welfare]] and [[United States Congress|Congress]] for the protection of Human subjects.


1) the boundaries between biomedical and behavioral research and what the accepted and routine practices of medicine were
==Findings, Recommendations, and Reports==
⚫
The Commission has published numerous papers and recommendations over the proper treatment of research participants. These reports contained their recommendations,<ref>The Hastings Center. "Commission Recommendations." The Hastings Center Report 5.3 (1975): 45-46. JSTOR. Web. 19 Mar. 2012.</ref> the underlying deliberations and conclusions,<ref>The Hastings Center. "Deliberations and Conclusions ." The Hastings Center Report 5.3 (1975): 41-45. JSTOR. Web. 19 Mar. 2012.</ref> a dissenting statement and additional statement by commission members and summaries of materials presented to the Commission. An appendix was also included which contained complete text reports and papers prepared for the commission on the ethical, legal and medical aspects of the different research areas examined and other material reviewed by the commission in its deliberations. Such studies include:


2) assessing the risks and benefits of the appropriateness of research involving human subjects
===Research on the Fetus (1975)===

====Objective====
3) determining appropriate guidelines for how human subjects can be chosen for the participation in such research
One of the major issues facing the Commission was the nature and extent of research involving fetuses. With this in mind they were tasked with "conducting an investigation of research involving living fetuses, the purposes for which such research has been undertaken,

and alternative means for achieving such purpose." [http://bioethics.georgetown.edu/pcbe/reports/past_commissions/research_fetus.pdf]
4) defining what informed consent is in each research setting.
====Recommendations====

#Therapeutic research directed toward the fetus may be conducted or supported, and should be encouraged, by the Secretary, DHEW, provided such research (a) conforms to appropriate medical standards, (b) has received the informed and non-dissenting consent of the mother and father, and (c)has been approved by existing review procedures with adequate provision for the monitoring of the consent process.
== Work ==
#Therapeutic research directed toward the pregnant woman may be conducted or supported, and should be encouraged, by the Secretary, DHEW, provided such research (a) has been evaluated for possible impact on the fetus, (b) will place the fetus at risk to the minimum extent consistent with meeting the health needs of the pregnant woman, (c) has been approved by existing review procedures with adequate provision for the monitoring of the consent process, and (d) the pregnant woman has given her informed consent.
⚫
The commission also had the task of making recommendations to the [[United States Secretary of Health, Education, and Welfare|Secretary of Health, Education, and Welfare]] and [[United States Congress|Congress]] for the protection of Human subjects. The commission produced their Reports and Recommendations on the following areas of research:
#Nontherapeutic research directed toward the pregnant woman may be conducted or supported by the Secretary, DHEW, provided such research (a) has been evaluated for possible impact on the fetus, (b) will impose minimal or no risk to the well-being of the fetus, (c) has been approved by existing review procedures with adequate provision for the monitoring of the consent process,(d) special care has been taken to assure that the woman has been fully informed regarding possible impact on the fetus, and (e) the woman has given informed consent. It is further provided that nontherapeutic research directed at the pregnant woman may be conducted or supported (f) only if the father has not objected, both where abortion is not at issue and where an abortion is anticipated.

#Nontherapeutic research directed toward the fetus in utero(other than research in anticipation of, or during, abortion) may be conducted or supported by the Secretary, DHEW, provided (a) the purpose of such research is the development of important biomedical knowledge that cannot be obtained by alternative means, (b) investigation on pertinent animal models and nonpregnant humans has preceded such research,(c) minimal or no risk to the well-being of the fetus will be imposed by the research, (d)the research has been approved by existing review procedures with adequate provision for the monitoring of the consent process, (e) the informed consent of the mother has been obtained, and(f) the father has not objected to the research.
*Research on the [[Fetus]] (1975) <ref>{{Cite web |title=Bioethics Research Library {{!}} Georgetown University Library |url=https://library.georgetown.edu/bioethics |access-date=2023-09-11 |website=library.georgetown.edu}}</ref>
#Nontherapeutic research directed toward the fetus in anticipation of abortion may be conducted or supported by the Secretary, DHEW, provided such research is carried out within the guideline for all other nontherapeutic research directed toward the fetus in utero. Such research presenting special problems related to the interpretation or application of these guidelines may be conducted or supported by the Secretary, DHEW, provided such research has been approved by a national ethical review body.
*Research Involving [[Prison]]ers (1976) <ref>{{Cite web |title=Bioethics Research Library {{!}} Georgetown University Library |url=https://library.georgetown.edu/bioethics |access-date=2023-09-11 |website=library.georgetown.edu}}</ref>
#Nontherapeutic research directed toward the fetus during the abortion procedure and nontherapeutic research directed toward the nonviable fetus ex-utero maybe conducted or supported by the Secretary, DHEW, provided (a)the purpose of such research is the evelopment of important biomedical knowledge that cannot be obtained by alternative means, (b) investigation on pertinent animal models and nonpregnant humans (when appropriate) has preceded such research, (c) the research has been approved by existing review procedures with adequate provision for the monitoring of the consent process,(d) the informed consent of the mother has been obtained, and (e) the father has not objected to the research; and provided further that (f) the fetus is less than 20 weeks gestational age, (g) no significant procedural changes are introduced into the abortion procedure in the interest of research alone, and (h) no intrusion into the fetus is made which alters the duration of life. Such research presenting special problems related to the interpretation or application of these guidelines may be conducted or supported by the Secretary, DHEW, provided such research has been approved by a national ethical review body.
*Research Involving [[Child]]ren (1977) <ref>{{Cite web |title=Bioethics Research Library {{!}} Georgetown University Library |url=https://library.georgetown.edu/bioethics |access-date=2023-09-11 |website=library.georgetown.edu}}</ref>
#Nontherapeutic research directed toward the possibly viable infant may be conducted or supported by the Secretary, DHEW, provided (a) the purpose of such research is the development of important biomedical knowledge that cannot be obtained by alternative means, (b) investigation on pertinent animal models and nonpregnant humans (when appropriate) has preceded such research, (c) no additional risk to the well-being of the infant will be imposed by the research,(d) the research has been approved by existing review procedures with adequate provision for the monitoring of the consent process, and (e) informed consent of either parent has been given and neither parent has objected.
*[[Psychosurgery]] Report and Recommendations (March 1977) <ref>{{Cite web |title=Bioethics Research Library {{!}} Georgetown University Library |url=https://library.georgetown.edu/bioethics |access-date=2023-09-11 |website=library.georgetown.edu}}</ref>
#Until the Commission makes its recommendations regarding review and consent procedures, the review procedures mentioned above are to be those presently required by the Department of Health, Education, and Welfare. In addition, provision for monitoring the consent process shall be required in order to ensure adequacy of the consent process and to prevent unfair discrimination in the selection of research subjects, for all categories of research mentioned above. A national ethical review, as required in Recommendations (5) and (6), shall be carried out by an appropriate body designated by the Secretary, DHEW, until the establishment of the National Advisory Council for the Protection of Subjects of Biomedical and Behavioral Research. In order to facilitate public understanding and the presentation of public attitudes toward special problems reviewed by the national review body, appropriate provision should be made for public attendance and public participation in the national review process.
⚫
*Disclosure of Research Information Under the [[Freedom of Information Act (United States)|Freedom of Information Act]] (April 1977) <ref>{{Cite web |title=Bioethics Research Library {{!}} Georgetown University Library |url=https://library.georgetown.edu/bioethics |access-date=2023-09-11 |website=library.georgetown.edu}}</ref>
#Research on the Dead Fetus and Fetal Tissue. The Commission recommends that use of the dead fetus, fetal tissue and fetal material for research purposes be permitted, consistent with local law, the Uniform Anatomical Gift Act and commonly held convictions about respect for the dead.
#The design and conduct of a nontherapeutic research protocol should not determine recommendations by a physician regarding the advisability,timing or method of abortion.
#Decisions made by a personal physician concerning the health care of a pregnant woman or fetus should not be compromised for research purposes, and when a physician of record is involved in a prospective research protocol, independent medical judgment on these issues is required. In such cases, review panels should assure that procedures for such independent medical judgment are adequate, and all conflict of interest or appearance thereof between appropriate health care and research objectives should be avoided.
#The Commission recommends that research on abortion techniques continue as permitted by law and government regulation.
#The Commission recommends that attention be drawn to Section 214(d)of the National Research Act (P.L. 93-348) which provides that:
''"No individual shall be required to perform or assist in
the performance of any part of a health service program
or research activity funded in whole or in part by the
Secretary of Health, Education, and Welfare if his
performance or assistance in the performance of such
part of such program or activity would be contrary to
his religious beliefs or moral convictions."''
#No inducements, monetary or otherwise, should be offered to procure an abortion for research purposes.
#Research which is supported by the Secretary, DHEW, to be conducted outside the United States should at the minimum comply in full with the standards and procedures recommended herein.
#The moratorium which is currently in effect should be lifted immediately, allowing research to proceed under current regulations but with the application of the Commission's Recommendations to the review process. All the foregoing Recommendations of the Commission should be implemented as soon as the Secretary, DHEW, is able to promulgate regulations based upon these Recommendations and the public response to them.
===Research Involving Prisoners===
*Research Involving [[Prison]]ers (1976) [http://bioethics.georgetown.edu/pcbe/reports/past_commissions/Research_involving_prisoners.pdf]
===Research Involving Children===
*Research Involving [[Child]]ren (1977) [http://bioethics.georgetown.edu/pcbe/reports/past_commissions/Research_involving_children.pdf]
===Psychosurgery: Report and Recommendations===
*[[Psychosurgery]] Report and Recommendations (March 1977) [http://bioethics.georgetown.edu/pcbe/reports/past_commissions/psychosurgery.pdf]
===Disclosure of Research Information===
⚫
*Disclosure of Research Information Under the [[Freedom of Information Act (United States)|Freedom of Information Act]] (April 1977) [http://bioethics.georgetown.edu/pcbe/reports/past_commissions/Disclosure_of_Research_Information.pdf]
===Research Involving Institutionalized Participants===
*Research Involving Those Institutionalized as Mentally Infirm (1978) [http://videocast.nih.gov/pdf/ohrp_research_mentally_infirm.pdf]
*Research Involving Those Institutionalized as Mentally Infirm (1978) [http://videocast.nih.gov/pdf/ohrp_research_mentally_infirm.pdf]
===Ethical Guidelines for the Delivery of Health Services by DHEW===
*Ethical Guidelines for the Delivery of Health Services by DHEW (1978) <ref>{{Cite web |title=Bioethics Research Library {{!}} Georgetown University Library |url=https://library.georgetown.edu/bioethics |access-date=2023-09-11 |website=library.georgetown.edu}}</ref>
*Ethical Guidelines for the Delivery of Health Services by DHEW (1978) [http://bioethics.georgetown.edu/pcbe/reports/past_commissions/ethical_guidelines_health_services_min.pdf]
*Appendix to Ethical Guidelines for the Delivery of Health Services by DHEW (1978) <ref>{{Cite web |title=Bioethics Research Library {{!}} Georgetown University Library |url=https://library.georgetown.edu/bioethics |access-date=2023-09-11 |website=library.georgetown.edu}}</ref>
===Appendix to Ethical Guidelines for the Delivery of Health Services by DHEW===
*Appendix to Ethical Guidelines for the Delivery of Health Services by DHEW (1978) [http://bioethics.georgetown.edu/pcbe/reports/past_commissions/Appendix_ethical_guidelines.pdf]
===Institutional Review Board===
*[[Institutional review board|Institutional Review Board]]s (1978) [http://videocast.nih.gov/pdf/ohrp_institutional_review_boards.pdf]
*[[Institutional review board|Institutional Review Board]]s (1978) [http://videocast.nih.gov/pdf/ohrp_institutional_review_boards.pdf]
===Implications of Advances in Biomedical and Behavioral Research===
*Special Study Implications of Advances in Biomedical and Behavioral Research (1978) [http://videocast.nih.gov/pdf/ohrp_special_study.pdf]
*Special Study Implications of Advances in Biomedical and Behavioral Research (1978) [http://videocast.nih.gov/pdf/ohrp_special_study.pdf]
⚫
*The Belmont Report: Ethical Principles and Guidelines for Protection of Human Subjects of Biomedical and Behavioral Research (1979) [https://web.archive.org/web/20040405065531/http://ohsr.od.nih.gov/guidelines/belmont.html]
===The Belmont Report===
⚫
*The Belmont Report: Ethical Principles and Guidelines for Protection of Human Subjects of Biomedical and Behavioral Research (1979) [http://ohsr.od.nih.gov/guidelines/belmont.html]


⚫
These reports contained their recommendations,<ref>The Hastings Center. "Commission Recommendations." The Hastings Center Report 5.3 (1975): 45-46. JSTOR. Web. 19 Mar. 2012.</ref> the underlying deliberations and conclusions,<ref>The Hastings Center. "Deliberations and Conclusions ." The Hastings Center Report 5.3 (1975): 41-45. JSTOR. Web. 19 Mar. 2012.</ref> a dissenting statement and additional statement by commission members and summaries of materials presented to the commission. An appendix was also included which contained complete text reports and papers prepared for the commission on the ethical, legal and medical aspects of the different research areas examined and other material reviewed by the commission in its deliberations.
==Result==


The commission established limits on Biomedical research such that pregnant women and their fetus' were not harmed by researchers or exposed to any form of risk. The commission further established that the health of a pregnant woman or her fetus could not be compromised under any circumstance for the purposes of research no matter how minute the perceived risk may be. Furthermore, the commission suggested lifting the [[moratorium]] imposed on abortion research at that time under the condition that no inducements were offered to subjects to undergo an abortion for the purpose of research. However research on a dead fetus or dead fetal tissue was approved. Lastly, non-therapeutic research upon a pregnant woman or fetus was approved only under the extenuating circumstance that important biomedical knowledge could not be obtained through any other means and that permission was granted to researchers by the subject.<ref>The Hastings Center. "Commission Recommendations." The Hastings Center Report 5.3 (1975): 45-46. JSTOR. Web. 19 Mar. 2012.</ref>
The commission established limits on Biomedical research such that pregnant women and their fetuses were not harmed by researchers or exposed to any form of risk. The commission further established that the health of a pregnant woman or her fetus could not be compromised under any circumstance for the purposes of research no matter how minute the perceived risk may be. Furthermore, the commission suggested lifting the [[moratorium (law)|moratorium]] imposed on abortion research at that time under the condition that no inducements were offered to subjects to undergo an abortion for the purpose of research. However research on a dead fetus or dead fetal tissue was approved. Lastly, non-therapeutic research upon a pregnant woman or fetus was approved only under the extenuating circumstance that important biomedical knowledge could not be obtained through any other means and that permission was granted to researchers by the subject.<ref>The Hastings Center. "Commission Recommendations." The Hastings Center Report 5.3 (1975): 45-46. JSTOR. Web. 19 Mar. 2012.</ref>


The Commission was succeeded by the [[President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research]].
The commission was succeeded by the [[President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research]].


==See also==
==See also==
* [[Human experimentation in the United States]]
* [[Human experimentation in the United States]]
* [[Biomedical Ethical Advisory Committee]]
* [[Advisory Committee on Human Radiation Experiments]]
* [[Advisory Committee on Human Radiation Experiments]]
* [[National Bioethics Advisory Commission]]
* [[National Bioethics Advisory Commission]]
Line 78: Line 46:


==External links==
==External links==
*[http://www.hhs.gov/ohrp/archive/irb/irb_introduction.htm/ THE HISTORY OF THE HUMAN SUBJECTS PROTECTION SYSTEM]
*[https://www.hhs.gov/ohrp/archive/irb/irb_introduction.htm/ THE HISTORY OF THE HUMAN SUBJECTS PROTECTION SYSTEM]
*[http://bioethics.georgetown.edu/pcbe/reports/past_commissions/ Former Bioethics Commissions]
*[http://bioethics.georgetown.edu/pcbe/reports/past_commissions/ Former Bioethics Commissions]
*[http://www.hhs.gov/ohrp/archive/nationalcommission.html/ Reports of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research]
*[https://www.hhs.gov/ohrp/archive/nationalcommission.html/ Reports of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research]


{{DEFAULTSORT:National Commission For The Protection Of Human Subjects Of Biomedical And Behavioral Research}}
{{DEFAULTSORT:National Commission For The Protection Of Human Subjects Of Biomedical And Behavioral Research}}
[[Category:Medical ethics]]
[[Category:Human subject research in the United States]]
[[Category:Clinical research]]
[[Category:Medical research]]
[[Category:United States national commissions]]
[[Category:United States national commissions]]
[[Category:Ethics commissions]]
[[Category:Ethics commissions]]
[[Category:Clinical research ethics]]
[[Category:Clinical research ethics]]
[[Category:1974 establishments in the United States]]

Latest revision as of 19:58, 11 September 2023

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was the first public national body to shape bioethics policy in the United States.

Formed in the aftermath of the Tuskegee Experiment scandal, the commission was created in 1974 as Title II of the National Research Act. It was part of the United States Department of Health, Education, and Welfare (DHEW) until 1978.[1]

Goals[edit]

The commission had four goals that it needed to analyze:[2]

1) the boundaries between biomedical and behavioral research and what the accepted and routine practices of medicine were

2) assessing the risks and benefits of the appropriateness of research involving human subjects

3) determining appropriate guidelines for how human subjects can be chosen for the participation in such research

4) defining what informed consent is in each research setting.

Work[edit]

The commission also had the task of making recommendations to the Secretary of Health, Education, and Welfare and Congress for the protection of Human subjects. The commission produced their Reports and Recommendations on the following areas of research:

  • Research on the Fetus (1975) [3]
  • Research Involving Prisoners (1976) [4]
  • Research Involving Children (1977) [5]
  • Psychosurgery Report and Recommendations (March 1977) [6]
  • Disclosure of Research Information Under the Freedom of Information Act (April 1977) [7]
  • Research Involving Those Institutionalized as Mentally Infirm (1978) [1]
  • Ethical Guidelines for the Delivery of Health Services by DHEW (1978) [8]
  • Appendix to Ethical Guidelines for the Delivery of Health Services by DHEW (1978) [9]
  • Institutional Review Boards (1978) [2]
  • Special Study Implications of Advances in Biomedical and Behavioral Research (1978) [3]
  • The Belmont Report: Ethical Principles and Guidelines for Protection of Human Subjects of Biomedical and Behavioral Research (1979) [4]

These reports contained their recommendations,[10] the underlying deliberations and conclusions,[11] a dissenting statement and additional statement by commission members and summaries of materials presented to the commission. An appendix was also included which contained complete text reports and papers prepared for the commission on the ethical, legal and medical aspects of the different research areas examined and other material reviewed by the commission in its deliberations.

The commission established limits on Biomedical research such that pregnant women and their fetuses were not harmed by researchers or exposed to any form of risk. The commission further established that the health of a pregnant woman or her fetus could not be compromised under any circumstance for the purposes of research no matter how minute the perceived risk may be. Furthermore, the commission suggested lifting the moratorium imposed on abortion research at that time under the condition that no inducements were offered to subjects to undergo an abortion for the purpose of research. However research on a dead fetus or dead fetal tissue was approved. Lastly, non-therapeutic research upon a pregnant woman or fetus was approved only under the extenuating circumstance that important biomedical knowledge could not be obtained through any other means and that permission was granted to researchers by the subject.[12]

The commission was succeeded by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.

See also[edit]

References[edit]

  1. ^ The President's Council on Bioethics. "Former Bioethics Commissions." The Bioethics Research Library at Georgetown University. The President's Council on Bioethics, 1998. Web. 19 Mar. 2012. <http://bioethics.georgetown.edu/pcbe/reports/past_commissions/>
  2. ^ "The Belmont Report". 28 January 2010.
  3. ^ "Bioethics Research Library | Georgetown University Library". library.georgetown.edu. Retrieved 2023-09-11.
  4. ^ "Bioethics Research Library | Georgetown University Library". library.georgetown.edu. Retrieved 2023-09-11.
  5. ^ "Bioethics Research Library | Georgetown University Library". library.georgetown.edu. Retrieved 2023-09-11.
  6. ^ "Bioethics Research Library | Georgetown University Library". library.georgetown.edu. Retrieved 2023-09-11.
  7. ^ "Bioethics Research Library | Georgetown University Library". library.georgetown.edu. Retrieved 2023-09-11.
  8. ^ "Bioethics Research Library | Georgetown University Library". library.georgetown.edu. Retrieved 2023-09-11.
  9. ^ "Bioethics Research Library | Georgetown University Library". library.georgetown.edu. Retrieved 2023-09-11.
  10. ^ The Hastings Center. "Commission Recommendations." The Hastings Center Report 5.3 (1975): 45-46. JSTOR. Web. 19 Mar. 2012.
  11. ^ The Hastings Center. "Deliberations and Conclusions ." The Hastings Center Report 5.3 (1975): 41-45. JSTOR. Web. 19 Mar. 2012.
  12. ^ The Hastings Center. "Commission Recommendations." The Hastings Center Report 5.3 (1975): 45-46. JSTOR. Web. 19 Mar. 2012.

External links[edit]

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