Department of Health and Human Services 
 
OFFICE OF INSPEC TOR GENERAL   
 
 
 
   
OHRP S I P
  HOULD  NFORM  OTENTIAL 
C H T C
OMPLAINANTS OF  OW  HEY  AN 
S W P  
EEK  HISTLEBLOWER  ROTECTIONS
OEI-01-15-00351 
September 2017   
 
 
  AT A GLANCE   
 
   
THIS REPORT 
  OHRP relies on information from 
This report highlights the implications of the Office for 
complainants to identify 
Human Research Protections (OHRPs) not providing 
noncompliance with protections for 
information on whistleblower protections to complainants 
human subjects.  
who disclose alleged noncompliance with protections for 
 
human subjects. 
  However, fear of reprisals may 
 
prevent potential complainants from 
reporting suspected noncompliance  BACKGROUND 
with protections for human subjects.  OHRP receives and responds to alleged violations of 
  protections for human subjects in research conducted or 
  OHRP reported that it often gets  supported by the Department of Health and Human 
Services (HHS).1  Sources of allegations can include human 
requests from complainants for 
subjects (i.e., individuals who volunteer to participate in 
whistleblower protections, and 
research), employees of research institutions, and 
sometimes complainants choose not 
advocates for human subjects.  To address allegations of 
to report suspected noncompliance 
noncompliance, OHRP may conduct a for-cause compliance 
because OHRP cannot offer such 
evaluation, or it may contact a research institution directly 
protections. 
to resolve a dispute.2  If OHRP identifies noncompliance 
 
with regulations protecting human subjects, it can take a 
  We found evidence of a fear of 
variety of actions, including (1) requiring the institution to 
reprisal in four of the five closed  take corrective action, (2) restricting or suspending 
for-cause compliance evaluations  research at the institution, and (3) recommending that an 
that we reviewed.  institution or investigator be debarred from receiving 
  Federal funds for research.  
  OHRP should inform potential 
Information from complainants can be an invaluable 
complainants of how they can seek  resource in ensuring protections for human subject 
whistleblower protections.  volunteers.  Employees of research institutions (e.g., 
  researchers or study coordinators) with insider knowledge 
  OHRP should request that HHS  of the circumstances can help identify noncompliance in 
consider the adequacy of  human subjects research earlier than other complainants 
whistleblower protections for  or OHRP oversight activities.  Such information allows 
complainants who make disclosures  OHRP to address any noncompliance, hold institutions 
accountable, minimize risk to human subject volunteers, 
to OHRP about human subjects 
and ensure public confidence in federally funded research.  
protections. 
However, when employees are considering whether to 
 
disclose information about potential noncompliance, they 
 
may fear reprisal, such as demotion, suspension, or termination.  For such complainants, information 
 
regarding whistleblower protections may encourage disclosures of noncompliance. 
 
WHIST LEBLOWER PROTECTIONS 
 
Under certain circumstances, employees at research institutions with HHS-funded grants or contracts 
may be entitled to relief commonly called whistleblower protections. 3  Such protections may be 
available if an HHS contractor, subcontractor, grantee, or subgrantee takes a prohibited employment 
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action (e.g., termination) against an employee for making a protected disclosure.  For the employees 
disclosure to be considered protected, it must meet the following two criteria:  
1.  The disclosure is information that the employee reasonably believes is evidence of a substantial 
and specific danger to public health or safety, or a violation of law, rule, or regulation related to 
the HHS contract or grant. 
2.  The disclosure must be made to specific individuals and entities, such as the Office of Inspector 
General (OIG); the officials of the grant-awarding agency (e.g., the National Institutes of Health) 
who are responsible for grant oversight and management; or a relevant employee of the 
contractor, subcontractor, grantee, or subgrantee who has the responsibility to investigate 
employee misconduct.4   
A disclosure to officials of a regulatory oversight agency such as OHRP does not qualify as a protected 
disclosure for the purposes of whistleblower protections.  
Once an employee has made a protected disclosure, the research institution may not take a prohibited 
employment action because of the employees disclosure.  If the employee believes that the research 
institution has taken a prohibited employment action as a result of the protected disclosure, the 
employee may submit a complaint to HHS OIG.5  Following an investigation, a whistleblower may be 
entitled to relief such as job restoration; reversal of suspension; back pay; and reasonable and 
foreseeable consequential damages, such as medical costs and attorney fees.6  Generally, for 
a complainant to receive whistleblower protections, (1) the complainant must make a protected 
disclosure; (2) the complainants employer must have knowledge of the complainants protected 
disclosure; (3) a specific prohibited action must have been taken against the complainant; and 
(4) the complainant must prove that the protected disclosure was a contributing factor in the action 
taken against the complainant.7  However, a complainant is not entitled to relief if the employer 
demonstrates by clear and convincing evidence that it would have taken the employment action in the 
absence of the disclosurefor instance, that it took the action because of the complainants poor 
performance.8 
This report is a companion to our report entitled OHRP Generally Conducted Its Compliance Activities 
Independently, But Changes Would Strengthen Its Independence (OEI-01-15-00350).  In the evaluation 
that produced that report, we found that OHRP appeared to independently carry out compliance 
activities for protecting human subjects but that certain factors may have limited or appear to limit 
OHRPs ability to operate independently.  
METHODOLOGY  
In our companion work, we analyzed a variety of data to understand how OHRP receives and responds 
to potential noncompliance with HHS regulations for protecting human subjects.  For this review, we 
used data obtained through the same data-collection methodology as the companion report and took 
the following actions: 
1.  We analyzed data on OHRPs activities from its Compliance Activity Tracking System 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 reviewed OHRPs administrative files from eight closed compliance evaluations and an 
open incident report.  Five of the eight compliance evaluations that we reviewed were 
for-cause evaluations and included documentation of the complaint reported to OHRP.  If the 
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complainant explicitly requested whistleblower protections or reported concerns of retaliation 
or adverse effects on his or her career, we considered that to be evidence of fear of reprisal. 
3.  We conducted interviews with OHRP staff, HHS officials outside of OHRP, and individuals with 
expertise in protections for human subjects. 
STANDARDS 
We conducted this study in accordance with the Quality Standards for Inspection and Evaluation issued 
by the Council of the Inspectors General on Integrity and Efficiency.  
 
FINDINGS  
FEAR OF REPRISAL MAY PREVENT POTENTIAL COMPLAINANTS FROM DISCLOSING ALLEGATIONS 
OF NONCOMPLIANCE TO OHRP   
OHRP reported that it often gets requests from complainants for whistleblower protections and that 
some complainants have chosen not to report suspected noncompliance to OHRP because it does not 
have the statutory authority to offer such protections.  OHRP relies primarily on allegations to learn 
about potential noncompliance with human subjects protections, and employees of research 
institutions are valuable sources of allegations.  Between 2007 and 2015, allegations from researchers, 
study coordinators, and other research institution staff were the source for about one-quarter of 
OHRPs closed for-cause evaluations. 
In addition, of the five closed OHRP compliance evaluations we reviewed that were prompted by 
complaints, four had evidence of a fear of reprisal.  In one instance, the documentation noted that the 
complainant indicated she was worried about raising the concern with the research institutions 
Institutional Review Board because other employees had been reassigned after doing so.  In another 
instance, documents showed that the complainant reported that she feared for her job and requested 
whistleblower protections.  In all instances, the complainants made their allegations despite their 
reported fears.  In two of these four compliance evaluations, OHRP found noncompliance and issued 
corrective actions.  
CONCLUSION AND RECOMMENDATIONS   
OHRPs effectiveness may be hampered if potential complainants at research institutions that conduct 
HHS-funded studies are unaware of whistleblower protections that may be available to them.  Fear of 
reprisal may prevent some individuals from coming forward with knowledge of noncompliance in 
protecting human subjects.  This raises concerns that some instances of noncompliance may go 
unreported and unresolved.  Although whistleblower protections are not available for complainants 
who make disclosures of noncompliance only to OHRP, protections may be available if complainants 
disclose such noncompliance to other entities, such as OIG or the HHS grant-awarding agency. 
Providing information about these available whistleblower protections could encourage complainants 
to come forward and thus help OHRP identify actual or potential problems.   
Therefore, we recommend that OHRP: 
  Inform potential complainants of how they can seek whistleblower protections  
OHRP should inform complainants of how they can potentially obtain whistleblower 
protections by reporting their allegations of noncompliance with human subject protections to 
entities such as OIG or the HHS awarding agency.  OHRP should post this information 
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prominently on its website and include it in routine outreach to research institutions.  OIG will 
provide technical assistance to OHRP via its Whistleblower Ombudsman on how potential 
complainants can make a protected disclosure.  Furthermore, OHRP should coordinate with the 
HHS grant-awarding agencies to ensure that they relay to OHRP any allegations they receive.  
  Request that HHS consider the adequacy of whistleblower protections for complainants who 
make disclosures to OHRP about human subjects protections  
Our work raises questions about the adequacy of current whistleblower protections for 
complainants who make disclosures of noncompliance with protections for human subjects. 
Elevating this issue would prompt HHS to consider whether a broad review of whistleblower 
protections is appropriate.  Furthermore, it could help HHS determine whether it should seek a 
legislative change that enables OHRP and other HHS entities that are not responsible for 
contract or grant oversight management to receive protected disclosures. 
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL RESPONSE  
The Office of the Assistant Secretary for Health (OASH) concurred with our recommendations.  
Regarding our first recommendation, it stated that OHRP will inform potential complainants of how 
they can seek whistleblower protections by concurrently reporting their allegations of noncompliance 
with human subject protections to entities such as OIG or the HHS awarding agency.  OHRP will post 
this information on its website and notify HHS grant-awarding agencies of how they can relay any 
allegations they receive to OHRP.  
Regarding our second recommendation, OASH will ask HHS leadership to consider the adequacy of 
whistleblower protections for complainants who make disclosures to OHRP about human subject 
protections.  OASH agrees that elevating this issue could help HHS determine whether it should seek a 
legislative change.   
OIG requests details on the efforts to implement these recommendations in OASHs final management 
decision.  We will monitor these efforts through our recommendations tracking process.  
For the full text of the agency comments received, see Appendix A. 
 
 
 
 
 
 
 
 
 
 
 
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APPENDIX A: AGENCY COMMENTS  
 
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ENDNOTES 
1 42 U.S.C.  289(b). 
2 OHRP, OHRPs Compliance Oversight Procedures for Evaluating Institutions (October 14, 2009). 
3 41 U.S.C.  4712(a).  P.L. No. 114-261 (December 14, 2016) made the pilot program permanent. 
4 Ibid.  Other eligible entities and individuals to which potential complainants may make disclosures include the 
Government Accountability Office; a Member of Congress or a representative of a committee of Congress; 
an authorized official of the U.S. Department of Justice or other law enforcement agency; and a court or grand 
jury. 
5 41 U.S.C. 4712(b)(1). 
6 41 U.S.C. 4712(c). 
7 41 U.S.C. 4712(c)(6). 
8 Ibid. 
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ACKNOWLEDGMENTS 
Chris Galvin served as the team leader for this study, and Kimberly Ruppert served as the lead analyst.  
Boston regional office staff who provided support include Lyncy Ha.  Central office staff who provided 
support include Clarence Arnold, Lucia Fort, Christine Moritz, and Melicia Seay.  
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. 
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