Department of Health and Human Services	

 
 
OFFICE OF 

 
  INSPECTOR GENERAL 

 
 
OHRP G C I
    ENERALLY  ONDUCTED  TS 

C A
OMPLIANCE  CTIVITIES 

 
I , B C
NDEPENDENTLY   UT   HANGES 

  W S I
OULD  TRENGTHEN   TS 

 
I  
NDEPENDENCE 

 
 
 
 
 
 
 
 
 
 
 
Daniel R. Levinson 
	 
Inspector General
	 
 
July 2017 

OEI-01-15-00350 
  
Report  in  Brief  
   
July 2017    
OEI011500350   
 
Why OIG Did This Review  OHRP Generally Conducted Its Compliance Activities 
Protecting  the rights of human   Independently, But Changes Would Strengthen Its 
subjectsindividuals who volunteer 
Independence   
to participate in researchis critical 
Key Takeaway 
to ensuring the safety of  these 
volunteers and public confidence in   What OIG Found  According to  our review, OHRP 
research conducted  or supported by  According to our review, OHRP appeared to carry  appeared to independently  
out its compliance activities for protecting  human  carry out its compliance  
the Department of Health and 
subjects while maintaining its independence  from  activities for protecting human 
Human Services (HHS).  The Office for 
the HHS agencies that fund the research and the  subjects. However, varying 
Human Research Protections (OHRP) 
institutions conducting the research.  OHRP  interpretations of OHRPs role, 
enforces compliance  with HHS 
decided how to use its resources and, over time,  its placement within HHS, and 
regulations for protecting  human  
initiated fewer  compliance evaluations while  the way its budget  is set may 
subjects.  Congress and others have  increasing its use of other mechanisms in response  limit its ability  to operate 
raised questions about OHRPs  to allegations.  OHRP determined the scope  of its  independently.  In  addition, 
independence, and Congress  evaluations and what methods to employ.   OHRPs practice of not 
requested that the Office of  Furthermore, OHRP was ablewith some delays  reporting  publicly on all of its  
Inspector General (OIG) review OHRP  to access the information it  needed to conduct its  compliance  activities may give 
compliance evaluations.  Lastly, OHRP  maintained  the appearance of limited 
procedures and make 
its determinations, changing only 1 finding in   oversight and independence.   
recommendations to strengthen 
492 evaluations since 2000, a record consistent  We recommend that HHS 
protections for human subjects and 
with operating independently.   address factors that may limit  
ensure OHRPs independence.  
OHRPs ability  to operate 
However, certain factors may limit or appear to 
How OIG Did This Review  independently.  
limit OHRPs ability to operate independently.  For  
We analyzed data on OHRPs  instance, stakeholders have  varying interpretations 
compliance activities for 2000  as to whether OHRPs role is oriented more  toward enforcing compliance or toward 
through 2015. We administered a  setting broader policy. In addition, OHRP is  under the Assistant Secretary for Health while 
survey to research institutions that  the research agencies it oversees are directly under the Secretary, and OHRPs budget  is 
set by HHS, rather than by the Office of  Management and Budget or by Congress.  Lastly, 
were the primary subjects  of OHRP  
OHRPs practice of not reporting publicly on all of its compliance  activities may give the 
compliance evaluations about their 
appearance of limited oversight and independence.  
experiences  with OHRP.  We also 
reviewed documents from eight  What OIG Recommends   
compliance evaluations that had  We  recommend  that HHS  address factors that may limit OHRPs ability to operate  
been closed. Finally, we interviewed  independently. To accomplish this, HHS could (1) issue guidance that clarifies OHRPs 
OHRP staff, other HHS officials, and  role, (2) evaluate OHRPs position within HHS, and  (3) evaluate the sufficiency of  OHRPs  
resources and consider ways to elevate the prominence of its budget, such as including 
individuals with expertise in  
OHRPs budget  as a line item in the Presidents budget.  HHS  should also foster a shared 
protections for human subjects.   
understanding for OHRPs independence by considering seeking statutory authority for 
OHRPs 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 HHSs response and  said it would consider our recommendation to address 
factors that may limit OHRPs ability to act independently as part of a comprehensive 
review of HHSs structures and functions that is underway.  OHRP concurred with our 
recommendation to make information about its oversight activities available on its 
website.   
 
   
   
TABLE OF CONTENTS 
 
Objective ......................................................................................................1 

Background ..................................................................................................1 

Methodology ................................................................................................5 

Findings........................................................................................................7 

According to our review, OHRP  appeared to independently carry 
out its compliance activities for protecting human subjects ............7 

However, certain factors may limit or appear to limit OHRPs
	 
ability to operate independently .....................................................12 

Conclusion and Recommendations ............................................................17 
	
Agency Comments and Office of Inspector General Response .....19 

Appendixes  ................................................................................................20 

A: Detailed Methodology  ..............................................................20 

B: Trends in OHRP  Compliance Activity Data from 2000 to 

2015................................................................................................23 

C: Examples of Editorials, Letters, and Articles Responding to 

OHRPs Determination in SUPPORT, in Chronological Order  ....25 

D: Agency Comments  ....................................................................27 

Acknowledgments......................................................................................28 

 
 
 
   
   
OBJECTIVE  
To determine the extent to which the Office for Human Research 
Protections (OHRP) independently initiates, conducts, and makes  
determinations about compliance evaluations.  
BACKGROUND   
Protecting the rights of human subjectsindividuals who volunteer to 
participate in researchis 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).  Federal agencies 
that fund research help to ensure human subjects are protected, and OHRP  
provides guidance and enforces compliance with HHS regulations for 
protecting human subjects.1  Congress and others have raised questions 
about OHRPs 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 
its independence.2  For purposes of this study, we consider independence 
for OHRP  to be characterized by the ability to decide how to fulfill its 
mission to protect human subjects independently from  the HHS agencies  
that fund the research and the institutions that conduct the research.         
Regulations to Protect Human Subjects 
A human subject is a living individual about whom  an investigator  
conducting research obtains (1) data through intervention or interaction 
with the individual or (2) identifiable private information.3  Biomedical 
and behavioral research activities that involve human subjects range from 
(for example) ingesting an experimental drug to providing a blood sample, 
participating in a focus group, or completing a survey.  Research involving 
human subjects has provided substantial benefits, but it has not been 
 
1 42  U.S.C. 289(b); 65 Fed. Reg. 37136 (June 13, 2000). 
2 Explanatory  Statement  submitted by Mr.  Rogers of  Kentucky,  Chairman of the House  
Committee on Appropriations regarding the  House Amendment to the Senate  
Amendment  on H.R.  83.  Congressional  Record  160:151 (Dec. 11, 2014) p.  H9839 
accompanying the Consolidated and Further Continuing Appropriations  Act, 2015,  
P.L. No. 113-235 (Dec. 16, 2014).   
3 45 CFR   46.102(f).  The Food and Drug  Administration (FDA) defines a  human 
subject as an individual (who may be healthy or a patient)  who is or becomes 
a participant in research, either as a  recipient of the test article or  as a control, 21 CFR 
 56.102(e).  
OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              1  
Strengthen Its Independence  (OEI-01-15-00350)    
   
without cases of abuse. A few highly publicized cases of such abuse led 
to the development of a regulatory framework to protect human subjects.4  
The Federal Policy for the Protection of Human Research Subjectsalso 
known as the Common Ruleestablishes the basic regulatory provisions 
for assurance of compliance, Institutional Review Boards (IRBs), and 
informed consent.5  The Common Rule was published in 1991 and is 
followed by 18 Federal departments and agencies.  A Federalwide  
Assurance (FWA) is a written statement that commits a research 
institution to comply with all Common Rule requirements for protecting 
human subjects.  To receive an FWA, research institutions must use an 
IRB that protects human subjects by approving proposed research, 
disapproving it, or recommending modifications to it.6   In addition, 
informed consent must generally be obtained from human subjects under 
circumstances that give subjects the opportunity to decide whether to 
participate in the research and that minimize the possibility of coercion or 
undue influence.7  Federal agencies are responsible for reviewing research 
proposals that involve human subjects and awarding Federal funds only to 
research that meets these requirements for protecting human subjects.8    
In 2015, HHS published a Notice of Proposed Rulemaking proposing the 
first substantial revision to the Common Rule in 25 years.9 HHS 
published the final rule on January 19, 2017.10   Revisions to the Common 
Rule include new requirements for informed consent, new categories of 
research that are exempt from  IRB review, and a requirement for the use 
of a single IRB in research conducted by multiple institutions.  
The Office for Human Research Protections 
OHRP provides leadership and maintains regulatory oversight of human 
subjects research supported or conducted by HHS.11  OHRP also develops 
guidance and educates researchers, IRBs, and research institutions on 
complying with HHS regulations.  
 
4 P.L. No. 93-348 (July 12, 1974) created the National Commission  for the Protection of 

Human Subjects in Biomedical and  Behavioral Research.  This  commission was charged
	 
with identifying the basic ethical principles that should underlie the conduct of 	

biomedical and behavioral  research involving  human subjects. 

5 The Common Rule is codified at 45  CFR pt. 46,  subpart A. 
  
6 45 CFR   46.109(a). 
	
7 45 CFR   46.116.  HHS regulations have additional  protections  for vulnerable 

populations, such as pregnant  women and prisoners, and require the registration of IRBs. 
	
8 45 CFR    46.120, 46.122. 
	
9 76  Fed. Reg. 44512 (July 26, 2011); 80  Fed. Reg. 53933 (Sept. 8, 2015). 

10 82 Fed. Reg. 7273  (Jan. 19, 2017). 
	
11 OHRP, About OHRP: Mission.  Accessed at www.hhs.gov/ohrp  on March 28, 2017. 
	   
OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              2  
Strengthen Its Independence  (OEI-01-15-00350)    
   
History and Organizational Structure. In 2000, the Secretary of HHS 
moved OHRP  from the National Institutes of Health (NIH), where it was  
part of the Office of the Director, to the Office of the Assistant Secretary 
for Health (OASH), which is within HHSs Office of the Secretary.12 HHS 
made this change to minimize the appearance of a conflict of interest  
between an agency that funds research and the office that ensures the 
protections of human subjects in that research.13  No law mandates that 
OHRP be independent from other components of HHS or limits OHRP  
from receiving input from them.14  
In 2017, OHRP  consisted of the Office of the Director and 3 divisions with 
a total of 22 staff.15  Four staff in the Division of Compliance Oversight 
are responsible for responding to allegations of noncompliance with HHS 
regulations and other compliance activities.16    
Jurisdiction. OHRP oversees research involving human subjects that is 
supported by HHS or covered by an applicable FWA.17, 18  Research is 
covered by an applicable FWA when an institution voluntarily applies 
HHS regulations to all its research, regardless of funding source.19  Most 
research that OHRP oversees is funded by NIH.20  OHRP shares oversight 
of human subjects protections with FDA when HHS-funded research is 
associated with an application for approval of a product such as a drug or 
medical device.21  If OHRP receives allegations regarding research that is 
conducted or supported solely by a non-HHS Federal agencyfor 
example, the Veterans Health AdministrationOHRP may refer those 
allegations to that agency. 
 
12 65 Fed. Reg. 37136  (June 13, 2000).  
13 OIG,  Report of OIG Review of Allegations of Interference in  OHRP Compliance 

Determination for SUPPORT (OIG-12-14-04), September 2014. 	

14 Ibid. 
	
15 OHRP, About OHRP: Staff Listing. Accessed at http://www.hhs.gov/ohrp/about-
ohrp/staff/index.html on March 28, 2017.  
   
16 One of the four staff members is a temporary fellow until June 2018. 

17 OHRP, OHRPs Compliance Oversight Procedures for Evaluating  Institutions, 

October 14, 2009. 

18 Research may be exempt from  HHS regulations if it is determined  to meet the criteria 

for an exemption category  (e.g., research conducted  in educational settings involving	
 
normal educational activities).  

19 Federal regulations for  protecting human subjects  also apply  to research that  is 
	
conducted outside the United States but is funded or supported by a department  or agency  
covered by the Common Rule. 

20 Presidential  Commission for  the Study  of Bioethical Issues,  Moral Science: Protecting 

Participants in Human  Subjects Research, June 2012. 

21 FDA  has its  own requirements for protecting human subjects in  clinical trials 

associated with an application for product  approval.  FDAs  regulations can be found at 

21 CFR pts. 50 and 56.   

OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              3  
Strengthen Its Independence  (OEI-01-15-00350)    
   
OHRPs Compliance Oversight Procedures 
OHRP has procedures in place to evaluate potential noncompliance with 
HHS regulations for protecting human subjects.22  OHRP has considerable 
discretion in this process, allowing it to prioritize and shape its 
evaluations.23  In addition, OHRP  may use mechanisms other than 
compliance evaluations to address allegations of noncompliance, such as 
contacting a research institution directly to resolve a dispute regarding 
reimbursement to a study participant.  As part of its compliance activities,  
OHRP  also receives and reviews mandatory incident reports from  research  
institutions. 
For-Cause Compliance Evaluations. OHRP may conduct for-cause 
compliance evaluations upon receipt of a complaint or allegation of 
noncompliance.  In such an evaluation, OHRP requests that the institution 
conduct its own investigation of the potential noncompliance, provide 
a written response with supporting documentation, and develop 
a corrective action plan if any noncompliance is revealed.  OHRP reviews 
the institutions investigation and may request additional information, 
conduct interviews or site visits, or consult experts.   
Not-For-Cause Compliance Evaluations.  In the absence of a complaint, 
OHRP may also conduct a not-for-cause compliance evaluation at 
an institution.  OHRP selects institutions for these evaluations on the basis 
of various factors, such as an institutions volume of HHS-supported 
research.  OHRP reviews documents and may conduct interviews or site 
visits, or consult experts. 
Compliance Evaluation Outcomes.  After conducting its evaluation, 
OHRP provides the institution with a determination letter specifying its 
findings.  If OHRP finds no evidence of noncompliance, it may still 
recommend improvements to the institutions policies.  If OHRP identifies 
noncompliance with regulations regarding the protection of human 
subjects, it can take a variety of actions, including (1) requiring the 
institution to take corrective action; (2) restricting or suspending research 
at the institution; and/or (3) recommending that an institution or 
investigator  be debarred from  receiving Federal funds for research.  If 
institutions or complainants disagree with OHRPs determination, they 
may request that OHRPs director reconsider the results of the 
 
22  42  U.S.C.  289(b). 	

23 OHRP, OHRPs Compliance Oversight Procedures for Evaluating  Institutions, 

October 14, 2009.  

OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              4  
Strengthen Its Independence  (OEI-01-15-00350)    
   
evaluation.24  OHRP publicly posts its determination letters from 
compliance evaluations on its website.  
Mandatory Incident Reports from Institutions (Incident Reports).  HHS 
regulations require that institutions have written procedures to ensure that 
the following types of incidents pertaining to research are promptly 
reported to OHRP: (1) any unanticipated problems involving risks to 
subjects or others; (2) any serious or continuing noncompliance; and 
(3) any suspension or termination of IRB approval.25  
Prior OIG Work 
Recent OIG work evaluated the extent to which OHRP  followed its  
procedures during a for-cause evaluation of the Surfactant, Positive 
Pressure, and Oxygenation Randomized Trial (SUPPORT).  In its 
evaluation of SUPPORT, OHRP  issued a compliance determination that 
the informed-consent document used in the study was inadequate.   
OHRPs determination received significant attention in the media and 
research community.  Although OIG determined that OHRP  followed its 
procedures, it found that those procedures are broadly drawn and allow for 
substantial discretion in how OHRP  carries out its evaluations.26   
Subsequent OIG work found that NIH encouraged OHRP  to reverse its 
determination following OHRPs evaluation of SUPPORT and that NIH 
provided input on OHRPs correspondence to the research institution.27   
OHRP  reaffirmed its determination, but it also suspended corrective 
actions for this particular case and committed to providing guidance to the 
research community.  OIG found no law, regulation, or written policy that 
prohibits or restricts the kind of consultation that occurred between OHRP  
and NIH. 
METHODOLOGY  
For purposes of this study, we consider independence for OHRP  to be 
characterized by the ability to decide how to fulfill its mission to protect 
human subjects.  This includes OHRPs ability to obtain the information it 
needs and to make determinations without interference from other entities, 
 
24 As of June 2016, OHRP was developing dispute resolution procedures for its  
evaluations. 

25 OHRP, Guidance on Reporting Incidents to OHRP.   Accessed at 

http://www.hhs.gov/ohrp/compliance-and-reporting/guidance-on-reporting-incident/ on 

March  28, 2017. 

26 OIG,  Memorandum Report: The Office for Human Research Protections Evaluation of 
 
the Surfactant, Positive Pressure, and Oxygenation  Randomized Trial 

(OEI-01-14-00560), September 2014. 

27 OIG,  Report of OIG Review of Allegations of Interference in  OHRP Compliance 

Determination for SUPPORT (OIG-12-14-04), September 2014. 	

OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              5  
Strengthen Its Independence  (OEI-01-15-00350)    
   
most notably from  the HHS agency that funded the research or from the 
research institution conducting the research.28    
To determine the extent to which OHRP  independently initiates, conducts, 
and makes determinations about compliance evaluations, we used five 
main sources of data.   
1. 		 We analyzed data on OHRPs activities from  its Compliance Activity 
Tracking System  (CATS) for 2000 through 2015.  Data included 
descriptions  of the allegations that OHRP received; the dates when 
OHRP received the allegations; the sources of the allegations; 
the dates when OHRP opened and closed compliance activities; and 
the outcomes of those compliance activities.   
2. 		 We administered an online survey to  research institutions that were the 
primary subjects of a for-cause or not-for-cause OHRP compliance 
evaluation closed from  2010 through 2015.  The survey covered the 
research institutions experiences with OHRP and the extent to which 
they thought OHRP operated independently during its evaluations.  
3. 		 We reviewed documents from  eight closed compliance evaluations and 
an open incident report.  
4. 		 We conducted interviews of OHRP staff, HHS officials outside of  
OHRP, and individuals with expertise in protections for human 
subjects.  
5.		  We reviewed our memorandum report, The Office for Human 
Research Protections Evaluation of the Surfactant, Positive Pressure, 
and Oxygenation Randomized Trial (OEI-01-14-00560), issued in 
September 2014.  
See Appendix A for a detailed methodology.  
Limitations 
We did not independently verify the data that we received from OHRP, 
nor did we independently verify other self-reported data from research 
institutions, relevant Government agencies, and individuals with expertise 
in protections for human subjects.  We also did not assess the 
appropriateness of OHRPs responses to allegations or of its 
determinations in its compliance evaluations.   
Standards 
This study was conducted in accordance with the  Quality Standards for 
Inspection and Evaluation issued by the Council of the Inspectors General 
on Integrity and Efficiency.  
 
28  OIG does not  consider  consultation with experts  or with the entity being reviewed  to 
constitute interference.  
 
OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              6  
Strengthen Its Independence  (OEI-01-15-00350)    
   
FINDINGS  
According to our review, OHRP appeared to 
independently  carry  out its compliance activities for 
protecting human subjects 
Given that no law establishes OHRPs independence and that OHRP has 
considerable discretion in conducting evaluations, OHRP could appear 
vulnerable to interference.  However, our review found that OHRP has 
been largely able to make decisions about its compliance evaluations, 
obtain the information it needs, and maintain its determinations without 
interference.  
OHRP independently decided how to use its resourcesover 
time, initiating fewer compliance evaluations while increasing 
its use of other mechanisms in response to allegations   
According to OHRP, it has the final say on whether to initiate a 
compliance evaluation.  OHRP  explained that it decided over the years to 
initiate fewer compliance evaluations both to better leverage its limited 
resources and to focus the evaluations on broad policy issues in 
protections for human subjects.  Between 2000 and 2015, OHRP  received 
an average of 123 allegations of noncompliance each year (see Exhibit 
B-1 in Appendix B).  In 2000, OHRP  conducted 60 compliance 
evaluations in response to allegations, compared to an average of 5 such 
compliance evaluations over the last 5 years (2011 through 2015).  (See 
Exhibit 1.)  Of note, the percentage of allegations that OHRP  determined it 
did not have jurisdiction to investigate increased from 10 percent in 2006 
to 54 percent in 2015.29    
One example of OHRPs leveraging its resources is its decision to limit 
compliance evaluations for multisite  studies to the lead institution.  In 
these instances, OHRP copies the other institutions on its determination 
letters.  OHRP said that in this way, it was both more efficient and 
achieved the same impact as separate but similar evaluations.  OHRP used 
this approach when it addressed allegations it received about SUPPORT,  
conducting its evaluation at the University of Alabama, Birmingham, but 
also sending its determination to the other 22 institutions involved in the 
research.  
The SUPPORT evaluation also reflected OHRPs interest in focusing 
compliance evaluations on broader policy issuesin this case, 
 
29  When  appropriate,  OHRP forwarded  an allegation outside its jurisdiction  to the  
appropriate funding  entity or research institution.  
 
OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              7  
Strengthen Its Independence  (OEI-01-15-00350)    
   
determining and communicating risks in standard-of-care research 
designed to compare the effectiveness of treatments.30   Another policy 
issue that OHRP  addressed through a compliance evaluation involved 
determining whether certain types of research are exempt from IRB 
review.     
Although it conducted fewer compliance evaluations, OHRP reported that 
it increased its use of other mechanismsfor example, contacting the 
research institution directlyto address allegations of noncompliance.  
For example, OHRP worked directly with a research institution to resolve 
a complaint about a surgeon performing experimental orthopedic surgeries 
without IRB approval.  The research institution substantiated the 
complaint and required the surgeon to complete additional training and 
withdraw a publication about the research.  OHRP accepted these  
corrective actions but never opened a compliance evaluation or  issued 
a determination letter.    
Exhibit 1: For-Cause Compliance Evaluations Conducted by  
OHRP by Close Year, 20002015 
100 
 s 
on 80 
ati
u
al
v 60 
e
e  
s
u
a
c 40 
r-
o
f f
o
er  20 
b
m
u
N
0 
 
Source: OIG analysis of OHRP CATS data, 2016.  
Finally, in addition to responding to allegations of noncompliance, OHRP  
responded to mandatory incident reports from institutions, which have 
nearly tripled since 2000 (see Exhibit 2 and Exhibit B-2 in Appendix B).  
Although OHRP  reviewed several hundred of these each year, it decided 
 
30 The term  standard of care refers to treatments that are commonly  used in health care 
for a given type of disease or medical condition.  Diseases and medical conditions may 
have multiple standards  of care.  Standard-of-care research aims to determine the more 
effective  treatment by comparing  treatments within the standards of care. 
 
OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              8  
Strengthen Its Independence  (OEI-01-15-00350)    
   
to initiate a compliance evaluation in response to an incident report in only 
a few cases, such as in cases involving the death of a human subject.  
OHRP  said that the increased volume of incident reports might be the 
result of its issuing more guidance and education about incident reports to 
research institutions.  
Exhibit 2: Number of Incident Reports Reviewed by  OHRP by 
Close Year, 20002015   
1200 
s  
t 1000 
r
o
p
e
R 800 
t 
n
e
d
ci 600 
n
f I
o
r  400 
e
b
m
u 200 
N
0 
 
Source: OIG analysis of OHRP CATS data, 2016.  
 
When OHRP initiated compliance evaluations, it determined 
the scope of the evaluations and what methods to employ   
OHRP  used its discretion to determine the scope of each compliance 
evaluation. For example, OHRP  focused each evaluation on the 
compliance concerns specific to the allegation and research study.  OHRP  
conveys the focus of its compliance evaluations in its initial inquiry letters 
to the respective research institutions,  and it copied the corresponding 
HHS funding agency on these letters.   This practice indicates that OHRP  
did not expect research institutions and HHS funding agencies to provide 
it with input regarding the scope and focus of its evaluations.    
OHRP  also used its discretion to determine what methods to employ in 
carrying out its compliance evaluations.  OHRP  can review records, 
conduct a site visit, or engage experts, among other methods, and OHRP  
selected methods according to the needs and priority of the evaluations.  
For example, site visits are resource-intensive, spanning 2 12 days and 
involving four to six OHRP staff.  OHRP  reported that it conducts site 
visits for most of its not-for-cause evaluations, which are broad reviews of 
institutions  systems of protections for human subjects.  OHRP  stated that 
OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              9  
Strengthen Its Independence  (OEI-01-15-00350)    
   
it conducts site visits during for-cause evaluations only if it has difficulty 
resolving the allegation. OHRP  typically engages experts for its site visits.   
The experiences reported by research institutions that were the subjects of 
OHRP compliance evaluations support that OHRP conducted its 
evaluations independently. For example, no institutions disagreed with 
statements that OHRP maintained its independence from the agency that 
funded the research or the research institution itself.  Furthermore, 
institutions agreed that OHRP possessed the necessary expertise and was 
thorough and fair in conducting its evaluations (see Exhibit 3). 
Exhibit 3: Research Institution Responses to Statements About Working With OHRP 
Strongly Agree or Agree  Neither Agree nor Disagree  Disagree Strongly or Disagree  Dummy
OHRP maintained its independence from the agency  that funded the research during its evaluation. 
OHRP maintained its independence from this institution during its evaluation. 
OHRP possessed the expertise to conduct its evaluation. 
OHRP was thorough in conducting its evaluation at this institution. 
OHRP was fair in conducting its evaluation at this institution. 
0%  20%  40%  60%  80%  100% 
Source: OIG survey of research institutions that were the subjects of OHRP compliance evaluations between 2010 and 2015.  
 
OHRP was ablewith some delaysto access the information 
it needed to conduct its compliance evaluations 
OHRPs ability to obtain  the information necessary to carry out its 
evaluations is critical for ensuring their quality and thoroughness, but also 
for supporting OHRPs independence and effective oversight.  If OHRP 
did not receive the full information it needed from those involved in the 
allegations, it may be vulnerable to producing biased results. OHRP 
reported thatwith some delaysit received what it needed from  HHS 
funding agencies and research institutions. 
OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              10  
Strengthen Its Independence  (OEI-01-15-00350)    
   
HHS funding agencies generally responded to OHRPs routine requests 
for information, such as requests for research protocols and 
informed-consent documents.  OHRP  said that HHS funding agencies 
sometimes took several months to respond to OHRPs request, which 
OHRP  considered to be a delay, or directed OHRP  to obtain information 
directly from the research institution.  When OHRP  faced these 
challenges, it continued to remind the funding agency of its request until it 
obtained the information it needed. 
HHS funding agencies told us that working with OHRP during its 
compliance evaluations is a collaborative and positive experience.  One 
agency reported that it provided answers to OHRPs questions about 
technical aspects of the research and the agencys procedures.  Two HHS 
funding agencies reported that they accompanied OHRP onsite visits to 
research institutions.  In these instances, the agencies reported that OHRP  
planned and led the site visit while the HHS funding agency staff observed 
and asked additional questions.     
OHRP also reported that it faced few challenges in obtaining information 
from research institutions during its compliance evaluations.  However, 5 
of 45 research institutions that were the subjects of an OHRP compliance 
evaluation reported difficulties fulfilling OHRPs request for hard copies 
of documentation.  These institutions reported that OHRP requested 
voluminous documentation and that it was a challenge to compile and 
send documents to OHRP. Research institutions reported that OHRP most 
  
commonly requested IRB documents, protocols, membership information, 
and meeting minutes, as well as approved informed-consent documents.  
One institution suggested that it would be more efficient to send OHRP 
the documentation electronically.     
OHRP maintained its determinations, changing only 1 finding 
in 492 evaluations since 2000, a record consistent with 
operating independently 
OHRP has almost always maintained its findings after conducting its 
compliance evaluations.  After an evaluation, OHRP communicates its 
findings to the research institution in a determination letter, which is later 
made public on OHRPs  website.  A single determination letter often 
contains multiple findings.  Since 2000, OHRP has conducted 
492 compliance evaluations.  OHRP told us that during this time it 
reversed only one finding after issuing a determination letter. In this 
instance, the research institution provided additional evidence that 
prompted OHRPs reversal.   
OHRP also maintained its determinations when challenged.  OHRP 
reported that out of its 492 compliance evaluations since 2000, 3 had 
OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              11  
Strengthen Its Independence  (OEI-01-15-00350)    
   
determinations that were challenged by some in the research community 
who encouraged OHRP to reverse its decisions.  These determinations 
addressed broad policy issues, such as communicating risks in 
standard-of-care research and determining whether research is exempt 
from IRB review.  In each of these cases, OHRP maintained its 
determinations, but revised its corrective actions.  For example, in its 
determination regarding SUPPORT, OHRP suspended its call for 
corrective actions and instead committed to providing guidance on how to 
communicate risks to human subjects enrolled in research comparing 
different treatments within the standard of care.    
However, certain factors may  limit or appear to limit 
OHRPs ability  to operate independently 
In considering OHRPs independence, we also looked at the extent to 
which OHRP is able to decide how to fulfill its mission to protect human  
subjects.  We considered potential risks of interference from other Federal 
agencies and from  entities outside Government.  We also considered how 
resources are allocated to OHRP and how this may affect its capacity to 
fulfill its mission.   
Varying interpretations of OHRPs rolewhether it is oriented  
more toward enforcing compliance or toward setting broader 
policymay limit OHRPs ability to operate independently  
The lack of agreement among stakeholders regarding OHRPs role in 
enforcing protections for human subjects may undermine OHRPs ability 
to act independently.  OHRP bases its decisions and actions in part on how 
it defines its role in protecting human subjects.  Likewise, stakeholder 
reactions to OHRPs actions can depend on how those stakeholders 
perceive and interpret OHRPs role.  We found that the recent public 
discourse on the different interpretations of OHRPs role may have 
prompted OHRP to act less decisively and more cautiously.  As a result, 
OHRP may miss opportunities to take action that could further its mission 
to strengthen protections for human subjects.   
In 2013, the varying interpretations of OHRPs role played out publicly in 
a series of editorials, letters, and articles published in high-profile 
peer-reviewed medical journals.  (See Appendix C for examples.)   This 
discourse addressed OHRPs determination in SUPPORT, which sparked 
controversy regarding how OHRP considered research risks that exceeded 
the specifics of that particular trial.  For example, one article,  coauthored 
by the director of NIH, documented not only NIHs disagreement with 
OHRP on SUPPORT, but also NIHs fundamental difference with OHRP 
OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              12  
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as to how the regulations should be interpreted.31  Likewise, others claimed 
that OHRP overreached in its conclusion that SUPPORT investigators 
violated Federal regulations.32  Conversely, some articles supported 
OHRPs determination and its role in clarifying regulations and guiding 
IRB decisions. For example, one article by physicians and bioethicists 
agreed with OHRPs determination by stating it was justified and did not 
overreach.33    
The varying interpretations of OHRPs role can be represented along 
a continuum between a focus on enforcing compliance and shaping policy. 
(See Exhibit 4.) Stakeholders favoring OHRPs role in ensuring  
compliance emphasize that OHRP should react to allegations of 
noncompliance by confirming that institutions fulfill specific regulatory 
requirements, such as those for IRB membership and review of research.34   
This interpretation tends to view OHRPs monitoring of IRB operations as 
appropriate, but not OHRPs evaluating of IRB decisions.35  
In contrast, those favoring OHRPs role in shaping policy emphasize that 
OHRP should prevent violations of protections for human subjects by 
clarifying regulations and guiding IRBs in their decisions.36  This 
interpretation may call for OHRP to review research protocols and 
informed-consent documents earlier, and it focuses more on prospective 
improvement.   
 
31 Kathy L. Hudson, Alan E. Guttmacher, and Francis S. Collins, In Support of	
 
SUPPORTA  View From  the NIH.  The New England Journal  of Medicine, June 20, 

2013.  Accessed  at http://www.nejm.org/doi/full/10.1056/NEJMp1306986 on March  28, 

2017. 

32 Benjamin S. Wilfond et al.,  The OHRP and SUPPORT.  The New England Journal 
 
of Medicine,  June 20, 2013.  Accessed  at 

http://www.nejm.org/doi/full/10.1056/NEJMc1307008 on March  28, 2017. 

33  Ruth Macklin et al., The OHRP and SUPPORTAnother View.   The New England 

Journal of Medicine, July 11, 2013.  Accessed at 

http://www.nejm.org/doi/full/10.1056/NEJMc1308015 on March  28, 2017. 

34 Benjamin S. Wilfond et al.,  The OHRP and SUPPORT.  The New England Journal 
 
of Medicine,  June 20, 2013.  Accessed  at 

http://www.nejm.org/doi/full/10.1056/NEJMc1307008 on March  28, 2017. 

35 Ruth Macklin et al., Informed Consent and Standard  of Care: What  Must  Be 

Disclosed.  The American Journal  of Bioethics, November 12, 2013.  Accessed at 

http://dx.doi.org/10.1080/15265161.2013.849303 on February 28, 2017. 

36 Daniel D. Federman et al., Responsible Research: A Systems Approach to Protecting 

Research Participants.   National Academies Press, 141-143, 2002.  Accessed  at 

https://www.ncbi.nlm.nih.gov/books/NBK43563/pdf/Bookshelf_NBK43563.pdf on 

March  27, 2017. 

OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              13  
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Exhibit 4: OHRPs Role: A Continuum of Interpretations 

                        
OHRP defines its role as more on the policy side of the continuum.  
OHRP sees its role as educational and its compliance evaluations as 
opportunities to strengthen human subjects protections in future research.  
Furthermore, OHRP told us that it is looking for opportunities to clarify 
regulations and to guide research institutions in their decisions earlier in 
the process, before they enroll human subjects in research. 
However, OHRP appears to be less decisive in implementing this vision of 
its role.  For example, in response to an incident report, rather than directly 
requesting documentation from  NIH (such as research protocols and 
informed-consent documents) before human subjects were enrolled, 
OHRP went to OASH for permission to do so.  As of April 2017, OHRP 
had yet to obtain this documentation.  In another example, OHRP reported 
that it sent OASH its proposed response to an allegation for OASHs 
review because the study was controversial and NIH had not yet provided 
some of the information that OHRP requested.  Lastly, some stakeholders 
told us that they thought OHRP may be hesitating to address certain policy 
issues in an attempt to avoid the type of controversy that its SUPPORT 
decision generated. 
Finally, HHSs language describing OHRPs mission may contribute to 
the lack of agreement regarding OHRPs role.  The HHS budget 
justification describes OHRPs mission as one that includes ensuring the 
interests of the research it oversees, while OHRPs stated mission focuses 
OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              14  
Strengthen Its Independence  (OEI-01-15-00350)    
   
solely on protecting human subjects involved in HHS research.37, 38   The 
differences in how OHRPs mission is described across HHS may 
influence stakeholder perceptions of OHRPs role. 
OHRPs position in the HHS hierarchy and HHSs control over 
its resources may limit its ability to operate independently 
OHRP is under the Assistant Secretary for Health, whereas the agencies 
that fund researchsuch as NIHare directly under the Secretary of 
Health and Human Services.  This means that OHRP is at a lower level in 
the HHS organizational hierarchy than the research-funding agencies and 
may face greater pressure in arguing its decisions because it does not have 
an equal voice with those agencies.  In fact, OASH noted that OHRP, as 
a small agency, often punches above its weight. 
Furthermore, HHS determines OHRPs resources.  HHS allocates OHRPs 
annual budget from  Congresss appropriations to HHS for general  
departmental management.  This means that OHRPs budget is not 
directed by the Office of Management and Budget or by Congress.   
OHRPs budget has generally been flat, averaging about $6.9 million 
annually since 2000.  Currently, 4 staff in OHRPs Division of 
Compliance oversee more than 13,000 research institutions, whereas in 
previous years, as many as 8 staff fulfilled this role.39  Meanwhile, the 
number of research grants that NIH awards is growingfrom about  
30,000 in fiscal year (FY) 2000 to 34,206 in FY 2015.40, 41  OHRP reported 
that in addition to its oversight, its priority has been finalizing revisions to 
the Common Rule, which means that its resources have been focused on 
this task.  Some stakeholders and one research institution reported that 
they considered OHRP to be understaffed and underresourced. For 
example, a respondent from  the research institution said that he did not 
feel that OHRP has enough staff to fulfill its obligations.  
 
37 HHS,  FY 2017 General Departmental  Management: Justification  of Estimates for 
Appropriations Committee. Accessed at http://www.hhs.gov/sites/default/files/fy2017-
budget-justification-gdm.pdf on April 5, 2017.  OHRPs mission  is to  assure that the 
well-being of volunteers is strongly protected and ensure that any  harm, real  or perceived,  
does not  negatively  impact the pool  of volunteers for  scientific studies and clinical 
research trials, delay the outcome of study  results or prevent  them altogether.   
38 OHRP, Education &  Outreach. Accessed at https://www.hhs.gov/ohrp/education-and-
outreach/index.html on March 28, 2017.  
   
39 OHRP, History: OHRP History. Accessed at  http://www.hhs.gov/ohrp/about-
ohrp/history/index.html on  March 28, 2017.     

40 NIH,  NIH Budget Summary. Accessed at 
http://archive.hhs.gov/budget/fy01budget/hhs2000.pdf, on March 28, 2017.  
41 HHS,  HHS FY2016 Budget in Brief. Accessed at 
https://www.hhs.gov/about/budget/budget-in-brief/nih/index.html, on March 28, 2017. 
OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              15  
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OHRPs practice of not reporting publicly on all of its 
compliance activities may give the appearance of limited 
oversight and independence 
OHRP does not publicly report much of its oversight activity, which may 
make it appear to stakeholders and the public that OHRP plays  a smaller 
role or is less active in protecting human subjects than it actually is.  
The decrease in determination letters over the years may increase 
stakeholders concerns that OHRP is being prevented from  conducting 
evaluations. OHRP makes public only its final determination letters from  
its compliance evaluations, and these letters do not reflect the extent or 
breadth of OHRPs compliance activities.  OHRP also does not report 
publicly on the number of allegations it receives or on how it assesses 
these allegations to determine whether to initiate an evaluation.   
Furthermore, stakeholders are likely unaware of OHRPs increasing 
workload of incident reports.  OHRP does not publicly report information 
on the volume of incident reports it receives (which has nearly tripled 
since 2000) or on how it assessed and responded to these reports.  One 
stakeholder, whose institution submitted about 30 incident reports to 
OHRP each year, questioned the benefit of reporting and the extent to 
which OHRP reviews such reports.  In fact, OHRP reviews each incident 
report and decided whether to obtain more information or to accept the 
research institutions corrective actions.  OHRP told us that it has 
considered posting this information publicly on its website; however, it 
has no timeline to do so and was concerned that the media might take the 
data out of context.  OHRP recently published this information in 
a peer-reviewed journal.42   
   
 
42 Kemnique Ramnath, Sarita Cheaves, Lisa Buchanan, Kristina Borror, and Marinna 
Banks-Shields, Incident Reports and Corrective Actions Received by  OHRP.  
IRB: Ethics &  Human Research, November-December 2016.  Accessed at 
http://www.thehastingscenter.org/irb_article/incident-reports-corrective-actions-received-
ohrp/ on March 28, 2017.  
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CONCLUSION AND RECOMMENDATIONS  
OHRP plays  an important role in the system  for protecting human subjects 
by providing leadership in the protection of the rights, welfare, and 
well-being of volunteers involved in research supported or conducted by 
HHS.  OHRP oversees a system  that relies on IRBs and research 
institutions, as well as the funders of research, to protect human subjects 
through a review of the ethics and merits of any particular study.  Given 
the potential for volunteers to experience risks, a robust oversight system  
is important in ensuring their protections.  Congress requested that OIG 
make recommendations to strengthen protections for human subjects and 
to ensure OHRPs independence. 
Because no law or mandate makes OHRP independent, its independence 
relies on a shared understanding across HHS that such independence is 
important for ensuring that human subjects are protected.  OHRP does 
have latitude in how it operates, and its independence is apparent in its 
ability to decide how and when to respond to allegations of 
noncompliance.  However, at a time when the research community must  
adjust to a revised Common Ruleits first major revision in 25 years 
and research continues to evolve, stakeholders disagree on the 
fundamental scope of OHRPs oversight role.  The differences in how 
OHRPs mission is described across HHS may contribute to this lack of 
agreement among stakeholders.  In addition, OHRPs resources and 
placement in HHS can mean the office does not have an equal voice with 
the HHS agencies that fund research.  These factors may affect OHRPs 
independence or the appearance of its independence.  
Therefore, we have recommendations for both HHS and for OHRP:  
HHS should address factors that may limit OHRPs ability to 
operate independently  
In light of Congresss request to OIG for recommendations to ensure 
OHRPs independence, it is vital that there be a shared understanding 
across HHS that OHRPs independence contributes to a robust system of  
protections for human subjects.  Absent that understanding and 
commitment to OHRPs independence, the office and its mission could be 
marginalized.  Therefore, HHS should address the factors that limit or 
appear to limit OHRPs ability to operate independently.  HHS could do 
this by: 
	   Issuing guidance that clarifies (for stakeholders and the public) 
OHRPs role;  
	   Evaluating OHRPs position within HHS, including (1) whether to  
place OHRP at the same hierarchical level within HHS as the 
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Strengthen Its Independence  (OEI-01-15-00350)    
   
research agencies it oversees and (2) the potential advantages and 
disadvantages of such a change; and 
 	  Evaluating the sufficiency of OHRPs resources to carry out its  
mission and exploring with the Office of Management and Budget 
and congressional appropriators ways to elevate the prominence of 
OHRPs budgetfor example, by including it as a line item  in the 
Presidents budget. 
Finally, HHS should consider seeking statutory authority for OHRPs 
independence. 
 
OHRP should post the following on its website:  
(a) a description of its approach to oversight and (b) data 
(in aggregate) on the  full array  of its compliance activities 
This information would provide context for interpreting OHRPs 
responses to allegations of noncompliance as well as provide more 
insights to OHRPs role in receiving incident reports.  OHRP should post 
information including, but not limited to, the numbers of allegations and 
incident reports it receives and data on its actions.  OHRP could present 
these data in  aggregate to mitigate any privacy or confidentiality concerns.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              18  
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AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL  
RESPONSE 
OASH provided HHSs response and neither concurred nor nonconcurred 
with our recommendation that HHS should address factors that may limit 
OHRPs ability to operate independently.  OASH said that HHS would 
consider our recommendation as part of a comprehensive review of HHSs 
structure and functions, known as Reimagine HHS, which is underway 
and may identify revisions to OHRPs organizational location, mission, 
and budget. 
OHRP concurred with our recommendation that it post a description of its 
approach to oversight and data (in aggregate) on the full array of its 
compliance activities.  OHRP stated that it will post additional information 
on its website within the next few months regarding the full array of its 
compliance activities.  
OIG supports OHRPs and OASHs efforts to enhance the system of  
protections for human subjects.  OIG requests details on their efforts and 
the results of their efforts in its final management decision.  We will 
monitor these efforts through our recommendations-tracking process.  
For the full text of the comments received, see Appendix D.  
OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              19  
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APPENDIX A  
Detailed Methodology   
Scope 
This study assessed the extent to which OHRP  independently initiated, 
conducted, and made determinations about compliance evaluations  
between 2000 and 2015. To look for trends, we analyzed data provided by 
OHRP on allegations it received and compliance activities it conducted 
from January 1, 2000, through December 31, 2015.  We did not assess the 
appropriateness of OHRPs responses to allegations or its determinations 
in its compliance evaluations.   
OHRP Compliance Evaluation Data 
We requested and obtained from  OHRP all data on its compliance 
activities from its Compliance Activity Tracking System.  Data included 
descriptions  of the allegations that OHRP received; the dates when OHRP 
received the allegations; the sources of the allegations; the dates when 
OHRP opened and closed compliance activities; and the outcomes of those 
compliance activities.  We conducted a trend analysis on OHRPs  
compliance activities for  which allegations had been received  and/or 
compliance activities had been opened or closed between January 1, 2000, 
and December 31, 2015.  After consulting OHRP, we considered for-cause  
evaluations and activities categorized as No Action to represent 
allegations, because these are the two possible outcomes for each 
allegation that OHRP receives.  We determined the number of allegations  
using the dates they were received.  We determined the number of 
mandatory incident reports (from  institutions), for-cause evaluations, and 
not-for-cause evaluations by year using the dates they were closed. We 
also determined the percentage of for-cause evaluations for each type of 
allegation source, such as research participant, researcher, or anonymous 
complainant.  In addition, we requested and received from  OHRP its 
budget and staffing data over this time period and analyzed the data for 
trends. 
Survey of Research Institutions  
OHRP provided us with the contact information for the current Signatory 
Officials at all institutions that had been subject to any OHRP compliance 
evaluation closed between January 1, 2010, through December 31, 2015.  
We administered an online survey to 48 research institutions between 
February 11, 2016, and March 22, 2016.  We asked questions to learn  
about research institutions experiences with OHRP and the extent to 
which they thought OHRP operated and made decisions independently 
during its respective evaluations.  We analyzed survey responses by 
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categorizing  and counting responses.  We received responses from 
45 institutions, a 94-percent response rate. 
OHRP Files on Specific Compliance Evaluations  
From our analysis of data from  OHRPs compliance evaluations and 
responses to our survey of research institutions, we selected eight closed 
compliance evaluations that OHRP conducted between 2010 and 2015.  
We selected these evaluations on the basis of the type of compliance 
evaluation, the duration of the evaluation, the location of the research 
institution, the presence of involvement from  the HHS agency funding the 
research, and the survey responses from  research institutions.  We 
requested and obtained from  OHRP the administrative files for these 
compliance evaluations.  OHRP also provided us with an open incident 
report to review.  We reviewed files to learn how OHRP initiated and 
conducted its evaluations and how OHRP collaborated with relevant  
Federal entities and research institutions.  We conducted this review at the 
OHRP offices in Rockville, MD. 
Interviews  
We conducted interviews by telephone or in person.  
OHRP.  We conducted structured onsite interviews with staff in OHRPs 
Compliance Division and in OHRPs Office of the Director to learn about 
how they responded to allegations of noncompliance and conducted 
compliance evaluations.  We asked about the factors that contributed to 
the trends in OHRPs responses to allegations of noncompliance from  
2000 through 2015. We also asked about OHRPs policies and procedures 
for its compliance evaluations and any challenges it faced in conducting 
such evaluations independently.  In addition, we asked how OHRP worked 
with relevant Federal Government entities and research institutions during 
their compliance evaluations and other activities. 
Relevant Government entities. We conducted nine structured interviews 
with representatives from relevant HHS entities (e.g., NIH, FDA, OASH, 
and the Office of Research Integrity) to learn about OHRPs interactions  
with these entities.  We reviewed selected administrative files of OHRP 
compliance activities to identify representatives  of  relevant Government  
entities that had direct involvement with a compliance evaluation.  We 
interviewed multiple representatives from  NIH, including its policy 
divisions (e.g., its Office of Science Policy) and two NIH institutes.  We 
asked about policies and procedures for working with OHRP and the 
extent to which the representatives were involved with OHRPs 
compliance evaluations.  We also asked about challenges these entities 
faced during OHRPs compliance evaluations and whether OHRP 
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operated independently or made decisions independently during 
evaluations.  We had a 100-percent response rate to our request for 
interviews.  
Individuals with expertise in human subjects protections. We conducted 
structured interviews  with five individuals with expertise in human 
subjects protections. We  identified these five individuals through 
research, literature, and individual recommendations.  They represented 
a patient advocacy group, a teaching hospital, and research institutions. 
We asked about OHRPs independence and compliance activities and 
about opportunities to enhance protections for human subjects in future 
research. 
Prior OIG Work 
We reviewed our memorandum report, The Office for Human Research 
Protections Evaluation of the Surfactant, Positive Pressure, and 
Oxygenation Randomized Trial (OEI-01-14-00560), issued in 
September 2014.  This OIG work (discussed on page 5) evaluated the 
extent to which OHRP  followed its procedures during the for-cause  
evaluation of SUPPORT.    
 
 
   
OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              22  
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APPENDIX B  
Trends in OHRP Compliance Activity Data from 2000 to 2015 
Exhibit B-1: Allegations OHRP Received From 2000 to 2015 
Allegations For Allegations For
Which OHRP  Which OHRP Did 
Initiated a  Not Initiate a 
Year  Total  Compliance Compliance
Received  Allegations  Evaluation  Evaluation 
2000  147  91  56 
2001  112  42  70 
2002  109  30  79 
2003  119  32  87 
2004  119  18  101 
2005  154  43  111 
2006  121  16  105 
2007  128  15  113 
2008  99  9  90 
2009  135  5  130 
2010  146  8  138 
2011  125  7  118 
2012  126  8  118 
2013  134  3  131 
2014  142  5  137 
2015  54  6  48 
Source: OIG analysis of OHRP CATS  data, 2016. 
   
OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              23  
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Exhibit B-2: OHRP Compliance Evaluations and Incident Reports  
from 2000 to 2015 
For-Cause  Not-For-Cause  Mandatory 
Year  Compliance Compliance Incident Reports
Closed  Evaluations  Evaluations  From Institutions 
2000  60  0  294 
2001  86  0  227 
2002  94  1  230 
2003  36  3  303 
2004  36  4  186 
2005  14  4  194 
2006  48  1  379 
2007  11  4  749 
2008  18  4  1044 
2009  11  3  1110 
2010  6  6  744 
2011  8  3  591 
2012  7  5  1142 
2013  4  2  1128 
2014  4  4  1156 
2015  3  2  815 
Source: OIG analysis of OHRP CATS  data, 2016. 
   
OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              24  
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APPENDIX C   
Examples of Editorials, Letters, and Articles Responding to 
OHRPs Determination in SUPPORT, in Chronological Order  
1.	 	 Jeffrey  M. Drazen, Caren G. Solomon, and Michael F. Greene, Informed 
Consent and SUPPORT.  The New England Journal of Medicine, May  16, 
2013. Accessed at http://www.nejm.org/doi/full/10.1056/NEJMe1304996 on 
March 28, 2017.  
2.	 	 David Magnus and Arthur L. Caplan, Risk, Consent, and SUPPORT.  The 
New England Journal of Medicine, May 16, 2013.  Accessed at 
http://www.nejm.org/doi/full/10.1056/NEJMp1305086 on March 28, 2017.  
3. 		 Michael Carome and Sidney Wolfe, Public Citizen: The SUPPORT Study  
Was Even Worse Than We Thought.  The Hastings Center, May  21, 2013.  
Accessed at http://www.thehastingscenter.org/public-citizen-the-support-
study-was-even-worse-than-we-thought/ on June 15, 2017.  
4.		  Sidney  Wolfe, The SUPPORT Study and the Standard of Care.  The 
Hastings Center, May  21, 2013.  Accessed at 
http://www.thehastingscenter.org/the-support-study-and-the-standard-of-
care/ on May  30, 2017.  
5. 		 Kathy  L. Hudson, Alan E. Guttmacher, and Francis S. Collins, In Support  of 
SUPPORTA View From the NIH.  The New England Journal of 
Medicine, June 20, 2013.  Accessed at 
http://www.nejm.org/doi/full/10.1056/NEJMp1306986 on March 28, 2017.  
6. 		 Benjamin S. Wilfond et al., The OHRP and SUPPORT.  The New England 
Journal of Medicine, June 20, 2013. Accessed at 
http://www.nejm.org/doi/full/10.1056/NEJMc1307008 on March 28, 2017.  
7.		  Lois Shepherd, Dozens of Bioethicists Air Views on SUPPORT Study  
Controversy.  The Hastings Center, July 1, 2013. Accessed at 
http://www.thehastingscenter.org/dozens-of-bioethicists-air-views-on-
support-study-controversy/  on June 15, 2017.   
8.		  Jon F. Merz and Nancy M. P. King, Re: US Study Criticized for 
Experimentation With Premature Infants.  BMJ, July 9, 2013.  Accessed at 
http://www.bmj.com/content/347/bmj.f4198/rr/653401 on May  30, 2017.  
9.		  Ruth Macklin et al., The OHRP and SUPPORTAnother View. The New 
England Journal of Medicine, July  11, 2013.  Accessed at 
http://www.nejm.org/doi/full/10.1056/NEJMc1308015 on March 28, 2017.  
10.  Subject to Question. Nature, August 22, 2013. Accessed at 
http://www.nature.com/polopoly_fs/1.13573!/menu/main/topColumns/topLef 
tColumn/pdf/500377a.pdf  on June 15, 2017.  
11.  Elliott M. Weiss and Steven Joffe, Promoting Informed Decision Making 
for Comparative Effectiveness Randomized Trials.  Journal of the American 
Medical Association, September 2015.  Accessed at 
http://archpedi.jamanetwork.com.ezproxyhhs.nihlibrary.nih.gov/article.aspx? 
articleid=2344552 on April 4, 2017.  [Note: This link  works only  for HHS 
users.] 
12.  Jeffrey  M. Drazen, Caren G. Solomon, Stephen Morrissey, and 
Michael F. Greene, Support for SUPPORT.  The New England Journal of  
OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              25  
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Medicine, October 8, 2015.  Accessed at 
http://www.nejm.org/doi/full/10.1056/NEJMe1511158 on March 28, 2017.  
13.  Clyde J. Wright and Ola D. Saugstad, OHRP and SUPPORT:  	Lessons in 
Balancing Safety and Improving the Way We Care for Patients.  Journal of 
Pediatrics, November 2013.  Accessed at 
http://dx.doi.org/10.1016/j.jpeds.2013.08.061 on March 28, 2017. 
14.  Gregory  E. Kaebnick, Ongoing Controversy  Over SUPPORT.  	The 
Hastings Center, January 19, 2015.  Accessed at 
http://onlinelibrary.wiley.com/doi/10.1002/hast.405/full on May 30, 2017.  
15.  Chana A. Sacks and Celestine E. Warren, Foreseeable Risks?  Informed 
Consent for Studies within the Standard of Care.  The New England Journal 
of Medicine, January 22, 2015.  Accessed at 
http://www.nejm.org/doi/full/10.1056/NEJMp1415113  on March 28, 2017.  
16.  Scott Y. Kim and Franklin G. Miller, Varieties of Standard-of-Care 
Treatment Randomized Trials: Ethical Implications.  Journal of the 
American Medical Association, March 3, 2015. Accessed at 
http://jamanetwork.com/journals/jama/article-abstract/2091465 on April 4, 
2017.  
17.  John D. Lantos, Vindication for Support.  T	 he New England Journal of 
Medicine, October 8, 2015.  Accessed at 
http://www.nejm.org/doi/full/10.1056/NEJMp1510876 on March 28, 2017.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              26  
Strengthen Its Independence  (OEI-01-15-00350)    
   
APPENDIX D 
Agency Comments 
 
 
 
OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              27  
Strengthen Its Independence  (OEI-01-15-00350)    
   
ACKNOWLEDGMENTS  
This report was prepared under the direction of Joyce Greenleaf, Regional 
Inspector General for Evaluation and Inspections in the Boston regional 
office, and Kenneth Price, Deputy Regional Inspector General.  
Chris Galvin served as team leader for this study, and Kimberly Ruppert 
served as lead analyst.  Other Office of Evaluation and Inspections staff  
from the Boston regional office who conducted the study include Lyncy 
Ha.  Central office staff who provided support include Clarence  Arnold, 
Lucia Fort, Christine Moritz, and Melicia Seay.  
We would also like to acknowledge the contributions of other Office of 
Evaluation and Inspections regional office staff, including 
Russell Hereford, who has since retired. 
 
OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would                                              28  
Strengthen Its Independence  (OEI-01-15-00350)    
Office of Inspector General
http://oig.hhs.gov  
 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95452, as  
amended, is  to protect the integrity of the Department of  Health and Human Services  
(HHS) programs, as  well  as the health  and welfare of individuals served by those programs.  
This statutory mission is carried  out through a nationwide network of audits, investigations,  
and inspections conducted by the following operating components: 
Office of Audit Services 
The Office  of  Audit Services  (OAS) provides auditing services  for HHS, either by  conducting  
audits  with its own audit resources or by  overseeing  audit work done by others.  Audits  
examine the performance of HHS programs and/or its grantees and contractors in carrying  
out their respective responsibilities and are intended  to provide independent assessments of 
HHS programs and operations.  These assessments help reduce waste, abuse, and  
mismanagement and promote economy and efficiency  throughout  HHS. 
Office of Evaluation and Inspections 
The Office  of  Evaluation and Inspections (OEI)  conducts national evaluations to  provide 
HHS, Congress, and the public with timely, useful, and reliable information on significant 
issues.  These evaluations focus on preventing fraud,  waste, or abuse  and promoting  
economy, efficiency, and effectiveness of departmental programs.  To promote impact, OEI 
reports also present practical recommendations for improving program operations.  
Office of Investigations 
The Office of Investigations (OI) conducts criminal, civil, and administrative investigations  
of fraud and misconduct  related to HHS programs, operations, and individuals.  With  
investigators working in all 50 States and the District of Columbia, OI  utilizes its resources 
by actively  coordinating with the Department  of Justice  and other Federal, State, and local 
law enforcement authorities.  The investigative efforts of OI often lead to  criminal 
convictions, administrative sanctions,  and/or  civil monetary  penalties.  
Office of Counsel to the Inspector General 
The Office of Counsel to the  Inspector  General (OCIG) provides general legal services to 
OIG, rendering  advice and opinions on HHS programs and operations and  providing all  
legal support for OIGs  internal operations.  OCIG represents  OIG in all civil and 
administrative fraud and  abuse cases involving HHS programs, including False Claims Act, 
program exclusion, and civil monetary penalty cases.  In  connection with these cases, OCIG 
also negotiates and monitors corporate integrity agreements.  OCIG renders advisory 
opinions, issues compliance program  guidance, publishes fraud alerts, and provides other  
guidance  to  the health care industry concerning the anti-kickback statute and other  OIG  
enforcement authorities.