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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. The Commission was tasked with studying the ethical principles underlying biomedical and behavioral research on [[Human subject research|human subjects]] and to make 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:
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>


== Goals ==
⚫
*Research on the [[Fetus]] (1977) [http://bioethics.georgetown.edu/pcbe/reports/past_commissions/research_fetus.pdf]
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>
*Research Involving [[Prison]]ers (1976) [http://bioethics.georgetown.edu/pcbe/reports/past_commissions/Research_involving_prisoners.pdf]
*Research Involving [[Child]]ren (1978) [http://bioethics.georgetown.edu/pcbe/reports/past_commissions/Research_involving_children.pdf]
*[[Psychosurgery]] Report and Recommendations (1977) [http://bioethics.georgetown.edu/pcbe/reports/past_commissions/psychosurgery.pdf]
⚫
*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 Those Institutionalized as Mentally Infirm (1978)
*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) [http://bioethics.georgetown.edu/pcbe/reports/past_commissions/Appendix_ethical_guidelines.pdf]
⚫
*[[Institutional review board|Institutional Review Board]]s (1978)
⚫
*Implications of Advances in Biomedical and Behavioral Research (1978)
⚫
*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]
*New Directions: The Ethics of Synthetic Biology and Emerging Technologies [http://bioethics.gov/cms/sites/default/files/PCSBI-Synthetic-Biology-Report-12.16.10.pdf]


1) the boundaries between biomedical and behavioral research and what the accepted and routine practices of medicine were
⚫
These reports contained their recommendations, the underlying deliberations and conclusions, 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.


2) assessing the risks and benefits of the appropriateness of research involving human subjects
⚫
The Commission was succeeded by the [[President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research]].

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 ==
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:

*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>
*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>
*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>
*[[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>
⚫
*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 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 (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 (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>
⚫
*[[Institutional review board|Institutional Review Board]]s (1978) [http://videocast.nih.gov/pdf/ohrp_institutional_review_boards.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]

⚫
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.

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]].


==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]]
* [[President’s Council on Bioethics]]
* [[President's Council on Bioethics]]


==References==
==References==
{{Reflist}}
{{Reflist}}

⚫
*[http://pediatrics.aappublications.org.myaccess.library.utoronto.ca/content/62/2/131.abstract Research Involving Children: Recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research]


==External links==
==External links==
*[https://www.hhs.gov/ohrp/archive/irb/irb_introduction.htm/ THE HISTORY OF THE HUMAN SUBJECTS PROTECTION SYSTEM]
*[http://www.bioethics.gov/reports/past_commissions/index.html Information about former Bioethics commissions]
⚫
*[http://bioethics.georgetown.edu/pcbe/reports/past_commissions/ Former Bioethics Commissions]
⚫
*[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: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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