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OHRP generally conducted its compliance activities independently, but changes would strengthen its independence

Series Title(s):
Report in brief
Contributor(s):
United States. Department of Health and Human Services. Office of Inspector General. Office of Evaluation and Inspections, issuing body.
Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, July 2017
Language(s):
English
Format:
Text
Subject(s):
Human Experimentation -- standards
Patient Rights
Research Subjects
Ethics Committees, Research
Guideline Adherence
Human Experimentation -- ethics
Humans
United States
United States. Department of Health and Human Services.
United States. Department of Health and Human Services. Office for Human Research Protections.
Genre(s):
Technical Report
Abstract:
Why OIG Did This Review. Protecting the rights of human subjects--individuals who volunteer to participate in research--is critical to ensuring the safety of these volunteers and public confidence in research conducted or supported by the Department of Health and Human Services (HHS). The Office for Human Research Protections (OHRP) enforces compliance with HHS regulations for protecting human subjects. Congress and others have raised questions about OHRP's independence, and Congress requested that the Office of Inspector General (OIG) review OHRP procedures and make recommendations to strengthen protections for human subjects and ensure OHRP's independence. How OIG Did This Review. We analyzed data on OHRP's compliance activities for 2000 through 2015. We administered a survey to research institutions that were the primary subjects of OHRP compliance evaluations about their experiences with OHRP. We also reviewed documents from eight compliance evaluations that had been closed. Finally, we interviewed OHRP staff, other HHS officials, and individuals with expertise in protections for human subjects. What OIG Found. According to our review, OHRP appeared to carry out its compliance activities for protecting human subjects while maintaining its independence from the HHS agencies that fund the research and the institutions conducting the research. OHRP decided how to use its resources and, over time, initiated fewer compliance evaluations while increasing its use of other mechanisms in response to allegations. OHRP determined the scope of its evaluations and what methods to employ. Furthermore, OHRP was able--with some delays-- to access the information it needed to conduct its compliance evaluations. Lastly, OHRP maintained its determinations, changing only 1 finding in 492 evaluations since 2000, a record consistent with operating independently. However, certain factors may limit or appear to limit OHRP's ability to operate independently. For instance, stakeholders have varying interpretations as to whether OHRP's role is oriented more toward enforcing compliance or toward setting broader policy. In addition, OHRP is under the Assistant Secretary for Health while the research agencies it oversees are directly under the Secretary, and OHRP's budget is set by HHS, rather than by the Office of Management and Budget or by Congress. Lastly, OHRP's practice of not reporting publicly on all of its compliance activities may give the appearance of limited oversight and independence. What OIG Recommends. We recommend that HHS address factors that may limit OHRP's ability to operate independently. To accomplish this, HHS could (1) issue guidance that clarifies OHRP's role, (2) evaluate OHRP's position within HHS, and (3) evaluate the sufficiency of OHRP's resources and consider ways to elevate the prominence of its budget, such as including OHRP's budget as a line item in the President's budget. HHS should also foster a shared understanding for OHRP's independence by considering seeking statutory authority for OHRP's independence. We also recommend that OHRP post the following on its website: (a) a description of its approach to oversight and (b) data (in aggregate) regarding its compliance activities. The Office of the Assistant Secretary for Health provided HHS's response and said it would consider our recommendation to address factors that may limit OHRP's ability to act independently as part of a comprehensive review of HHS's structures and functions that is underway. OHRP concurred with our recommendation to make information about its oversight activities available on its website.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (28 pages))
Illustrations:
Illustrations
NLM Unique ID:
101737781 (See catalog record)
Series Title(s):
Report in brief
Contributor(s):
United States. Department of Health and Human Services. Office of Inspector General. Office of Evaluation and Inspections, issuing body.
Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, July 2017
Language(s):
English
Format:
Text
Subject(s):
Human Experimentation -- standards
Patient Rights
Research Subjects
Ethics Committees, Research
Guideline Adherence
Human Experimentation -- ethics
Humans
United States
United States. Department of Health and Human Services.
United States. Department of Health and Human Services. Office for Human Research Protections.
Genre(s):
Technical Report
Abstract:
Why OIG Did This Review. Protecting the rights of human subjects--individuals who volunteer to participate in research--is critical to ensuring the safety of these volunteers and public confidence in research conducted or supported by the Department of Health and Human Services (HHS). The Office for Human Research Protections (OHRP) enforces compliance with HHS regulations for protecting human subjects. Congress and others have raised questions about OHRP's independence, and Congress requested that the Office of Inspector General (OIG) review OHRP procedures and make recommendations to strengthen protections for human subjects and ensure OHRP's independence. How OIG Did This Review. We analyzed data on OHRP's compliance activities for 2000 through 2015. We administered a survey to research institutions that were the primary subjects of OHRP compliance evaluations about their experiences with OHRP. We also reviewed documents from eight compliance evaluations that had been closed. Finally, we interviewed OHRP staff, other HHS officials, and individuals with expertise in protections for human subjects. What OIG Found. According to our review, OHRP appeared to carry out its compliance activities for protecting human subjects while maintaining its independence from the HHS agencies that fund the research and the institutions conducting the research. OHRP decided how to use its resources and, over time, initiated fewer compliance evaluations while increasing its use of other mechanisms in response to allegations. OHRP determined the scope of its evaluations and what methods to employ. Furthermore, OHRP was able--with some delays-- to access the information it needed to conduct its compliance evaluations. Lastly, OHRP maintained its determinations, changing only 1 finding in 492 evaluations since 2000, a record consistent with operating independently. However, certain factors may limit or appear to limit OHRP's ability to operate independently. For instance, stakeholders have varying interpretations as to whether OHRP's role is oriented more toward enforcing compliance or toward setting broader policy. In addition, OHRP is under the Assistant Secretary for Health while the research agencies it oversees are directly under the Secretary, and OHRP's budget is set by HHS, rather than by the Office of Management and Budget or by Congress. Lastly, OHRP's practice of not reporting publicly on all of its compliance activities may give the appearance of limited oversight and independence. What OIG Recommends. We recommend that HHS address factors that may limit OHRP's ability to operate independently. To accomplish this, HHS could (1) issue guidance that clarifies OHRP's role, (2) evaluate OHRP's position within HHS, and (3) evaluate the sufficiency of OHRP's resources and consider ways to elevate the prominence of its budget, such as including OHRP's budget as a line item in the President's budget. HHS should also foster a shared understanding for OHRP's independence by considering seeking statutory authority for OHRP's independence. We also recommend that OHRP post the following on its website: (a) a description of its approach to oversight and (b) data (in aggregate) regarding its compliance activities. The Office of the Assistant Secretary for Health provided HHS's response and said it would consider our recommendation to address factors that may limit OHRP's ability to act independently as part of a comprehensive review of HHS's structures and functions that is underway. OHRP concurred with our recommendation to make information about its oversight activities available on its website.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (28 pages))
Illustrations:
Illustrations
NLM Unique ID:
101737781 (See catalog record)