protocol review What’s in store for a whistleblower?

oshua Richmond knew that the Distressed by the impending loss of his Is Richmond both a whistleblower and procedure he performed on a rat job and possibly revealing himself as the the target of a reprisal even though he Jwas not approved by Great Eastern letter writer, Richmond began reading. The denied writing the letter? Is there a conflict University’s IACUC. He had reminded school’s IACUC policy manual stated that between the OLAW statement which Dr. Paul Levine, his graduate studies the identity of a whistleblower would remain assigns responsibility against reprisals to the mentor, that they needed IACUC approval confidential if that was the preference institution or state, and the Guide, which before initiating the procedure, but Levine of the whistleblower, but the policy said is incorporated into the PHS Policy3,4 and became irate, as he often did, and told nothing about protection from reprisals. appears to expect an institution to provide him to do what he was told to do or find Nevertheless, he was somewhat heartened protection from reprisals? Should Richmond another lab to work in. That was not to find that the Guide for the Care and tell the whole truth and look for another a desired option for Richmond, so he Use of Laboratory Animals stated that lab? How should the IACUC deal with performed the procedure. “The process [of reporting concerns] these issues? ❐ Still bothered by the incident after a few should include a mechanism for anonymity, months had passed, Richmond wrote an compliance with applicable whistleblower Jerald Silverman ✉ anonymous letter to the IACUC, relating the policies, nondiscrimination against the University of Massachusetts Medical School, noncompliance. When the IACUC began its concerned/reporting party, and protection Worcester, MA, USA. investigation, the rat was long gone. When from reprisals.”1 Richmond told the IACUC ✉e-mail: [email protected] confronted with the accusation, Levine that Levine obviously imposed a reprisal denied the claim and demanded to know against him, but the IACUC chair opined Published online: 27 May 2020 who his accuser was because the university’s that the Guide was only referring to https://doi.org/10.1038/s41684-020-0551-z bylaws specified that a faculty member reprisals against a known whistleblower. accused of wrongdoing had a right to know The IACUC chair was also concerned References 1. Institute for Laboratory Animal Research. Guide for the Care his or her accuser. Richmond denied writing with the comment in the Guide about and Use of Laboratory Animals. 8th edn. (National Academy the letter but eventually admitted that he protection from reprisals because a Press, Washington, DC. 2011). performed the procedure. Levine did not document from the federal Office of 2. Ofce of Laboratory Animal Welfare, National Institutes of Health. Reporting Noncompliance. https://olaw.nih.gov/guidance/ think Richmond was the whistleblower, Laboratory Animal Welfare (OLAW), stated reporting-noncompliance.htm assuming that would be too obvious; that “OLAW may withhold identifying 3. Public Health Service. Policy on Humane Care and Use of however, because Richmond was the only information to protect whistleblowers, Laboratory Animals. (US Department of Health and Human person working for him, he told Richmond but protection from reprisal for Services, Washington, DC. 1986, amended 2002). 4. Ofce of Laboratory Animal Welfare, National Institutes of Health. to find another mentor, as he was no longer whistleblowers must be addressed at the What Investigators Need to Know About the Use of Animals. welcome in his laboratory. institutional and/or state level.”2 https://grants.nih.gov/grants/olaw/InvestigatorsNeed2Know.pdf

Protect the gatekeeper

his scenario investigates to GEU’s IACUC reporting the allegation; he every effort should be made to keep it whistleblower protection for reporting then later denied doing so when confronted. that way. The regulatory agencies seem to Tnoncompliance issues in an animal Richmond likely denied writing the letter want whistleblower protection, and the research setting. Here, Richmond is an in order to keep his job, but, as no one else research institution should have a policy institutional laboratory employee that was involved with the procedure, he had to or Standard Operating Procedure in place performed an animal research procedure leave the lab once Levine knew that no one to protect whistleblowers; otherwise, without Great Eastern University’s else could have reported the noncompliance. whistleblowers may not come forward (GEU) Institutional Animal Care and Therefore, Richmond appeared to be a due to fear of retaliation. Use Committee’s (IACUC) approval, as whistleblower and a target of reprisal. Ultimately, Richmond shouldn’t have instructed by his mentor Dr. Levine. As As Richmond was let go from Levine’s conducted the animal procedure in the first “conducting research animal activity lab, there seems to be a conflict with the place. He should tell the whole truth and without the IACUCs approval is a serious Office of Laboratory Animal Welfare look for another lab to work in. There will noncompliance with the Animal Welfare Act (OLAW) and the Guide’s statements that be other labs in which to seek employment, and Regulations,”1 Richmond never should whistleblowers should be protected from and hopefully they’ll be fully compliant. The have performed the procedure without retaliation by the state or institution. OLAW IACUC meanwhile has the responsibility IACUC approval in the first place, but he assigns responsibility against reprisals to investigate any animal concerns raised risked losing his job with Levine’s lab if he to the institution or state, and the Guide by whistleblowers. Institutional and refused to conduct the experiment. expects an institution to provide protection IACUC contact information should be After some time passed, and in good from reprisals2,3. If individuals report posted throughout all research facilities faith, Richmond anonymously sent a letter allegations of wrongdoing anonymously, so anyone that has questions or concerns

LAB ANIMAL | VOL 49 | JUNE 2020 | 153–155 | www.nature.com/laban 153 protocol review can report them. Contact information Research employee protections matter Published online: 27 May 2020 should include the IACUC Chair Person, and should be established. Any individual https://doi.org/10.1038/s41684-020-0554-9 Attending Veterinarian, other institutional working in these environments and witness veterinarians, and animal care managers wrongdoing should be willing to come References and supervisors. Any allegations of forward without fear of retaliation. The 1. Code of Federal Regulations. Title 9, Chapter 1, Subchapter a – animal-related wrongdoing made whistleblower is the gatekeeper in the Animal Welfare: Part 2 regulations (§2.31). 2. Public Health Service. Policy on Humane Care and anonymously should be kept that way as workplace and should be protected. ❐ Use of Laboratory Animals. (US Department of Health best as possible. The research institution and and Human Services, Washington, DC. 1986, amended IACUC should have a plan in place to shield Jefrey Etue ✉ 2002). 3. Ofce of Laboratory Animal Welfare. What Investigators whistleblowers that in good faith come University of Kentucky, Lexington, KY, USA. Need to Know About the Use of Animals. https://grants.nih.gov/ forward with concerns. ✉e-mail: [email protected] grants/olaw/Investigatorsneed2Know.pdf

The problem with a murky whistleblower policy

hile OLAW cannot guarantee refine OLAW’s expectations, stating “The If the IACUC does not already have one, protection from reprisals, OLAW process should include a mechanism for a written policy on how non-compliances Wdoes refer to the Guide 1(p. 24), anonymity, compliance with applicable are dealt with would be advantageous. which states that “mechanisms for reporting whistleblower policies, nondiscrimination The IACUC should also consult with their concerns should be posted in prominent against the concerned/reporting party, and legal department to revise the university’s locations in the facility and on applicable protection from reprisals.” We assume that bylaws, as they are in direct conflict with institutional website(s) with instructions on Great Eastern University has an Assurance a federal mandate. On a slightly separate how to report the concern and to whom. on file with OLAW. Because of this, they note, the PI needs to be trained from Multiple points of contact, including senior are bound by the principles in the Guide, Human Resources on appropriate employee management, the IO, IACUC Chair, and AV, and therefore, should have “protection termination practices. ❐ are recommended.” from reprisals” documented in their Richmond did the right thing by whistleblower policy. Christine Boehm1 ✉ and Kristina Pugh2 reporting the noncompliance to the IACUC. The IACUC needs to revisit their policy 1Texas Tech University Health Science Center at El Levine is using ‘guilt by association’ to on whistleblowers to include protection Paso, El Paso, TX, USA. 2William Beaumont Army punish Richmond, as only Levine and from reprisals and ensure it is consistent Medical Center, El Paso, TX, USA. Richmond knew about the noncompliance. with the rest of OLAW and the Guide’s ✉e-mail: [email protected] Richmond told the whole truth when he recommendations. To protect anonymous admitted to performing the procedure. reporters, outlining examples of reprisal, Published online: 27 May 2020 There is nothing inherently wrong with such as termination of employment of lab https://doi.org/10.1038/s41684-020-0552-y anonymity, so admitting that he reported the members without adequate justification, noncompliance is not necessary. Richmond will help avoid similar situations in References 1. Institute for Laboratory Animal Research. Guide for the Care has seen his employer’s true colors. We the future. The investigation into and Use of Laboratory Animals. 8th edition (National Academies would encourage him to find a lab that is non-compliance in Levine’s studies should Press, Washington, D.C., USA, 2011). more ethical, as well as aware of current continue, but it may proceed as post legal and appropriate HR practices. approval monitoring. Considering this Disclaimer As OLAW is not the employer, they investigator’s temperament and willingness This information represents the views of the author. The information or content presented does not represent would not be able to guarantee there to overlook one area of non-compliance, it the official position or policy of the U.S. Army Medical were no reprisals at the institutional is not unreasonable to think there may be Department, the Department of Defense or the U.S. level. However, the Guide does further other protocol non-compliances. Government.

Coming clean o maintain public trust in the welfare especially since the broader institution Great Eastern University has a valid OLAW and ethical treatment of animals also does not seem to have any such assurance on file, it would clearly state Tused in biomedical research, it is policy. The Office of Laboratory Animal that they are in compliance with the Guide imperative that institutions have policies Welfare (OLAW) assigns responsibility such that nondiscrimination against the that explicitly forbid reprisal against against reprisals to the institution, and the concerned/reporting party and protection whistleblowers for reporting noncompliance IACUC is the delegated authority to make from reprisals is enforced1,2. and humane concerns. In the case of recommendations and develop policies Because Richmond did not identify Joshua Richmond, it is unfortunate that the specific to its areas of animal care program himself as the whistleblower, such a policy IACUC’s policy did not address reprisal, oversight, consistent with the Guide. If may still not have helped him, as Levine

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could claim any number of acceptable A WoRD fRom oLAW reasons to terminate him. The lack of evidence and witness accounts regarding the In response to the issues posed in this only individual willing or able to provide exchange between Richmond and Levine scenario, the National Institutes of information about an animal welfare issue make this a ‘he said/he said’ situation. Health - Office of Laboratory Animal even at institutions with effective reporting With proper training and awareness, Welfare (NIH-OLAW) provides the structures for animal welfare concerns. Richmond should have reported the conflict following clarification: Whistleblowers should use the to the IACUC as soon as it happened, In this scenario, a graduate student institution’s internal reporting structure to before performing the procedure, so that under duress from his mentor performs report animal welfare concerns but may resolutions could have been made to prevent an unapproved procedure on a rat. also call OLAW to either make a report noncompliance. At present, Richmond Subsequently, the student reports the or receive anonymous consultation. Once should identify himself as the whistleblower noncompliance anonymously to the an incident has been reported to the to the IACUC so he can at least provide IACUC. Then, the mentor, assuming the IACUC and the institution has verified a witness account of the interaction that student was the whistleblower, retaliates. that a noncompliance has occurred, an Levine is denying and be afforded protection During its investigation of the unapproved authorized individual at the institution from reprisal. activity, the IACUC uncovers the mentor’s must contact OLAW promptly with a Richmond’s relationship with Levine reprisal and must decide a course of action. preliminary report3. If reprisals are reported is already beyond repair, and the ethical The PHS Policy requires the IACUC to OLAW’s Division of Compliance murkiness of the mentor’s philosophy as an agent of the institution to review Oversight, the institution will be asked to is not a nurturing and welcoming place concerns involving the care and use of reaffirm their reporting policy for animal to learn. Richmond should reconsider animals at the institution1. Although welfare concerns and clearly state that the hostile working environment in the the PHS Policy does not have explicit the policy complies with the institution’s laboratory and anticipated mentorship whistleblower protections, OLAW expects Animal Welfare Assurance with OLAW value from a researcher who is clearly institutions to vigorously enforce both and the Guide.5 It is important to note that not adhering to IACUC authority, who is institutional and state protections for the source of a whistleblower complaint to performing unethical research, and who individuals who come forward with OLAW is not releasable under the federal belittles and intimidates others who may valid concerns regarding research animal Freedom of Information Act3,6. ❐ question his practices. A noncompliance welfare and research integrity as mandated of this magnitude requires reporting to by the Guide for the Care and Use of Patricia Brown ✉ OLAW, and the report should also go to Laboratory Animals2. OLAW disagrees Director, OLAW, OER, OD, NIH, HHS, Bethesda, the department chair. The chair, working with the IACUC chair’s interpretation of MD, USA. with the IACUC, could lend support to the Guide’s requirements for reporting ✉e-mail: [email protected] identifying a more welcoming research animal welfare concerns. Protection from environment for Richmond. While coming reprisals should be afforded to any person Published online: 27 May 2020 clean will not change the need for Richmond reporting a concern whether identified or https://doi.org/10.1038/s41684-020-0557-6 to find a new lab, it could salvage his anonymous. When anonymous complaints reputation, self-esteem, and possibly are made to the IACUC, it is important References 1. Ofce of Laboratory Animal Welfare, National Institutes of his research career while assisting the to have a feedback mechanism to inform Health. Public Health Service Policy on Humane Care and Use IACUC in holding Levine accountable for the complainant of the outcome. This may of Laboratory Animals. (US Department of Health and Human promoting noncompliance and punishing prevent those reporting anonymously Services, Bethesda, Maryland, USA, 2015). https://olaw.nih.gov/ policies-laws/phs-policy.htm thoughtful dialogue. ❐ who may feel the concerns have not been 2. Institute for Laboratory Animal Research. Guide for the Care acknowledged from reporting to oversight and Use of Laboratory Animals. 8th edition 23-23, (National Jon Reuter ✉ and Sara Hashway agencies or other outside parties. Academies Press, Washington, D.C., USA, 2011). University of Colorado Boulder, Boulder, While OLAW is not tasked specifically 3. Ofce of Laboratory Animal Welfare, National Institutes of Health. Reporting Noncompliance. https://olaw.nih.gov/ CO, USA. in the PHS Policy with determining if guidance/reporting-noncompliance.htm (2020). ✉e-mail: [email protected] retaliation has occurred, it takes allegations 4. Potkay, Steven & DeHaven, William OLAW and APHIS: Common Areas of Noncompliance. Lab Animal 2000 29 32-37. of retaliation seriously and in such cases https://olaw.nih.gov/sites/default/fles/LabAnimal.pdf (2020). carefully monitors institutional animal care 5. Ofce of Laboratory Animal Welfare, National Institutes Published online: 27 May 2020 and use programs for compliance with of Health. Domestic Assurance Sample Document, Part III. https://doi.org/10.1038/s41684-020-0553-x PHS Policy and the Guide, particularly Institutional Program for Animal Care and Use https://olaw.nih. gov/sites/default/fles/assursmp.htm#sectionIII (2020). regarding reporting policies related 6. National Institutes of Health. Public Health Service Policy on References to animal welfare concerns1–4. OLAW Humane Care and Use of Laboratory Animals - Frequently Asked 1. Ofce of Laboratory Animal Welfare, National Institutes of Health. Obtaining an Assurance. https://olaw.nih.gov/guidance/ considers whistleblower protections Questions. Institutional Reporting to OLAW, Question C.5. (US Department of Health and Human Services, Bethesda, obtaining-an-assurance.htm imperative to ensure effective institutional MD, USA, revised 2017). https://olaw.nih.gov/guidance/ 2. Institute for Laboratory Animal Research. Guide for the Care oversight. A whistleblower may be the faqs#report_5 (2020). and Use of Laboratory Animals. 8th edn. (National Academy Press, Washington, DC. 2011.)

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