- Office for Human Research Protections
The Office for Human Research Protections OHRP is a small office within the United States Department of Health and Human Services that deals with ethical oversight of clinical research conducted by the department, mostly through the National Institutes of Health . The office s primary duty is the implementation of 45CFR46, a set of regulations for Institutional Review Boards that directly mirrors the U.S. Food and Drug Administration regulation that covers clinical research conducted by pharmaceutical companies as well as other regulations under the aegis of the common rule. Institutions that conduct United States Department of Health and Human Services Department of Health and Human Services sponsored research must have a Federal Wide Assurance FWA , an agreement with OHRP regarding ethical oversight. OHRP also provides education for IRBs, gives guidance on research ethics, and advises the Secretary on issues of medical ethics . See also Human experimentation in the United States Institutional Review Board Medical ethics Declaration of Helsinki External links http www.hhs.gov ohrp about facts index.html OHRP Fact Sheet official http www.hhs.gov ohrp HHS agencies US gov stub Category Clinical research ... more details
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- National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Those Institutionalized as Mentally Infirm 1978 http videocast.nih.gov pdf ohrp research mentally ... 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 ... External links http www.hhs.gov ohrp archive irb irb introduction.htm THE HISTORY OF THE HUMAN SUBJECTS ... Commissions http www.hhs.gov ohrp archive nationalcommission.html Reports of the National Commission ... more details
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- Belmont Report
known as the Common Rule. The Office for Human Research Protections OHRP was also established within HHS. ref http www.hhs.gov ohrp Office for Human Research Protections OHRP ref Today the Belmont ... http www.hhs.gov ohrp humansubjects guidance belmont.html The Belmont Report U.S. Health & Human Services website http videocast.nih.gov pdf ohrp belmont report.pdf Belmont Report, original version, 30 September 1978 http www.hhs.gov ohrp archive documents 19790418.pdf Belmont Report, Federal Register ... more details
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- Justice (ethics)
Justice is a concept in research ethics which refers to fair selection of research participants . Justice describes the ideal distribution of risks and benefits when scientists conducting clinical research are recruiting volunteer research participants to participate in clinical trials . The concept gives guidelines on how scientific objectives and not membership in either a privileged or vulnerable population should determine which members of which communities should meet inclusion criteria to participate in research in order to most equability share the risks and benefits of the research. Defining research justice The most commonly recognized source for drawing attention to the importance of justice is the Belmont Report , ref cite book last King first Ruth R. Faden, Tom L. Beauchamp, in collaboration with Nancy M.P. title A history and theory of informed consent year 1986 publisher Oxford University Press location New York isbn 0 19 503686 7 pages 216 edition first ref which used the term justice to describe a set of guidelines for the selection of research subjects. ref citation title The Belmont Report url http www.hhs.gov ohrp humansubjects guidance belmont.html work Ethical Principles and Guidelines for the Protection of Human Subjects of Research accessdate 4 March 2012 author The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research date April 18, 1979 ref This is a critical safeguard to making clinical research ethical. ref cite doi 10.1001 jama.283.20.2701 ref References reflist External links http www.hhs.gov ohrp humansubjects guidance belmont.html the Belmont Report , a United States guideline Research participant rights Category Medical ethics Category Human subject research Category Justice Category Ethical principles ... more details
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- Common Rule
The Common Rule is a rule of ethics regarding biomedical and behavioral research involving human subjects in the United States . These regulations governing Institutional Review Board s for oversight of human research came into effect in 1981 following the 1975 revision of the Declaration of Helsinki , and are encapsulated in the 1991 revision to the U.S. Department of Health and Human Services Title 45 CFR 46 Public Welfare Subparts A, B, C and D. Subpart A The Common Rule is the baseline standard of ethics by which any government funded research in the US is held, and nearly all academic institutions hold their researchers to these statements of rights regardless of funding. ref cite web url http www.hhs.gov ohrp humansubjects guidance 45cfr46.htm title Code of Federal Regulations Title 45 Public Welfare CFR 46 last U.S. Department of Health and Human Services accessdate 2008 10 21 ref References Reflist External links http ori.hhs.gov education products ucla chapter2 page04b.htm government page on Common Rule Category United States Department of Health and Human Services Research participant rights med stub ethics stub ... more details
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- Cooperative Human Tissue Network
of Human Research Protections OHRP in the United States Department of Health and Human Services Department of Human and Health Services DHHS , http www.hhs.gov ohrp humansubjects guidance reposit.htm. ... OHRP of the United States Department of Health and Human Services DHHS . The Assurance documents ... OHRP guidance for tissue repositories. Investigators at institutions that DO NOT have an IRB may ... more details
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- Research participant
A research participant , also called a human subject or an experiment, trial, or study participant or subject , is a person who participates in human subject research by being the target of observation by researchers. Rights of research participants Researchers who conduct human subject research should afford special rights to research participants. ref cite book last Coleman first Carl H. title The ethics and regulation of research with human subjects year 2005 publisher LexisNexis location Newark, NJ isbn 978 1583607985 ref Research participants should expect the following to be the target of Beneficence ethics beneficence to experience Justice ethics research justice to get respect for persons to have privacy for research participants Further reading cite book last Speid first Lorna title Clinical trials what patients and healthy volunteers need to know year 2010 publisher Oxford University Press location Oxford isbn 978 0199734160 . This is a layman guide to research participant rights. References reflist External links http www.hhs.gov ohrp education brochures index.html explanation of rights from the United States government http www.yale.edu hrpp participants rights.html example list of rights from Yale University Research participant rights Category Human subject research ... more details
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- Clinical research coordinator
ohrp humansubjects guidance 45cfr46.htm 46.116 outlines the elements of informed consent ... Regulation http www.hhs.gov ohrp humansubjects guidance 45cfr46.htm 46.116 46.116 General Requirements ... of Health and Human Services, http www.hhs.gov ohrp Office for Human Subjects Protections OHRP OHRP http www.hhs.gov ohrp irb irb guidebook.htm Institutional Review Board Guidebook http www.ed.gov ... more details
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- Experimentation on prisoners
refimprove date June 2010 Throughout history prisoners have been frequent participants in scientific, medical and social human subject research . The history of research involving prisoners has been exploitative and cruel, and many of the modern protections for human subjects evolved in response to the abuses in prisoner research. Research involving prisoners is conducted today, but prisoners are now one of the most highly protected groups of human subjects. ref OHRP Guidance on the Involvement of Prisoners in Research , http www.hhs.gov ohrp humansubjects guidance prisoner.htm ref Requirements of Research Involving Prisoners According to the Common Rule 45 CFR 46 , prisoners may only be included in human subjects research when the research involves no more than a minimal risk of harm. Prisoner Consent Prisoners can consent, although their consent cannot be said to be completely voluntary, due to their compromised and dependant status. Their status as imprisoned human subjects becomes even more ethically problematic when investigators offer incentives such as parole, phone calls, or objects that are normally unavailable to prisoners. Research to Improve Prison Conditions Empty section date July 2010 Historical Abuses Ancient History Herophilos of Chalcedon was reputed by Celcus, amongst others, to have vivisection vivisected prisoners received from the Ptolemaic dynasty Ptolemaic kings. Second Sino Japanese War and World War II In Japan , Unit 731 , located near Harbin Manchukuo , experimented with prisoner vivisection , dismemberment and induced epidemics on a very large scale from 1932 onward through the Second Sino Japanese war . With the expansion of the empire during World War II , many other units were implemented in conquered cities such as Nanking Unit 1644 , Beijing Unit 1855 , Guangzhou Unit 8604 and Singapore Unit 9420 . After the war, Supreme commander of occupation Douglas MacArthur gave immunity in the name of the United States to all members of the un ... more details
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- Guidelines for human subject research
referred to as the Common Rule. ref cite web title Regulations url http www.hhs.gov ohrp humansubjects ... web title Human Subjects Research 45 CFR 46 url http www.hhs.gov ohrp humansubjects guidance 45cfr46.html ... more details
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- Cancer and Leukemia Group B
, the Surgery Quality Assurance Committee, the PET Committee, and other sources. OHRP Assurances ... Research Protection OHRP . This office is responsible for assuring that the rights of patients participating .... The CALGB audit teams evaluate institutional performance with respect to OHRP regulations. Patient ... more details
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- Cardiovascular Cell Therapy Research Network
International Society for Stem Cell Research http www.hhs.gov ohrp outreach documents 3panelfinal.pdf Becoming a Research Volunteer OHRP DEFAULTSORT Cardiovascular Cell Therapy Research Network Cctrn ... more details
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- Adil Shamoo
Website http www.hhs.gov ohrp nhrpac shamoo.pdf US Department of Health and Human Services Bio ... more details
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- Philip Rubin
ohrp nhrpac nhrpac.htm and the Secretary s Advisory Committee on Human Research Protections SACHRP http www.hhs.gov ohrp sachrp , established to provide advice to the Secretary of Health and Human ... more details
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- Tuskegee syphilis experiment
ohrp policy ohrpregulations.pdf format PDF accessdate 2010 02 22 ref communication of diagnosis ... Report and the establishment of the Office for Human Research Protections OHRP . ref cite web publisher US Department of Health and Human Services url http www.hhs.gov ohrp humansubjects guidance 45cfr46.htm ... Office for Human Research Protections OHRP date 2005 06 23 accessdate 2008 12 04 ref It also led ... subjects in studies involving human subjects. The Office for Human Research Protections OHRP manages ... www.hhs.gov ohrp title Office for Human Research Protections publisher Department of Health and Human ... more details
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- Human subject research
System url http www.hhs.gov ohrp archive irb irb introduction.htm publisher Office for Human Research ... http www.hhs.gov ohrp humansubjects guidance belmont.htm Belmont Report http www.wma.net en 30publications ... more details
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- Dorothy Height
Subjects of Biomedical and Behavioral Research, which published http www.hhs.gov ohrp humansubjects ... more details
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- Brigham and Women's Hospital
Bent Brigham Hospital. ref name fz 1979 Belmont Report http www.hhs.gov ohrp humansubjects guidance ... more details
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- Declaration of Helsinki
the articles, the changes in which are outlined in this http www.hhs.gov ohrp nhrpac mtg12 00 h2000 ... local regulations such as the http www.hhs.gov ohrp humansubjects guidance 45cfr46.htm Common Rule in the US, in addition to the requirements of the FDA and Office for Human Research Protections OHRP ... Public Welfare http www.hhs.gov ohrp humansubjects guidance 45cfr46.htm CFR Title 45 Part 46 Protection ... more details
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- Arthur Krigsman
cite web last McNeilly first Patrick J. title Letter to Lenox Hill Hospital url http www.hhs.gov ohrp ... more details
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- Lahey Clinic
www.hhs.gov ohrp education archives OHRPRetreat2003.pdf Paper published by Lahey for the U.S. Department ... more details
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- Chelation therapy
for an investigation by OHRP after complaints about ethical concerns such as inadequate informed consent ... more details
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- Gender
ohrp humansubjects guidance 58fr39406.htm Guideline for the Study and Evaluation of Gender Differences ... more details
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