PRIVILEGED AND CONFIDENTIAL — ATTORNEY-CLIENT COMMUNICATION NOT FOR DISTRIBUTION WITHOUT AUTHORIZATION OF GENERAL COUNSEL
MEMORANDUM
Date: November 26, 2024
From: Renata Vasquez, Partner, and Nadia Petrov, Associate Calderwood & Harkness LLP One Federal Place, Suite 3200 Boston, MA 02110
To: Elena Graff, General Counsel, Thornwick Medical Research Institute Grace Okenwa, Vice President, Human Resources, Thornwick Medical Research Institute
Re: Implementation of Recommended Corrective Actions — Grievance Investigation Concerning Dr. Marcus Ellender, Director of Biomedical Engineering Laboratories
C&H Matter No.: 1029-00002
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I. Introduction and Purpose
This memorandum follows the delivery of our Final Investigative Report dated November 22, 2024 (the "Final Report"), which Calderwood & Harkness LLP ("C&H") provided to Thornwick Medical Research Institute ("TMRI") in connection with the investigation of five formal employee grievances concerning the conduct of Dr. Marcus Ellender, Director of Biomedical Engineering Laboratories. The Final Report set forth our factual findings, legal analysis, and six recommended corrective actions in Section VI thereof.
Additionally, this memorandum follows the presentation made earlier today, November 26, 2024, to the Board Governance & Compliance Committee of the TMRI Board of Directors. That presentation was chaired by Committee Chair Raymond Alcott, and was attended by Dr. Constance Liu-Hartwell, Chair of the Board, and Teresa Dwight, Chair of the Audit & Risk Committee, among other Committee members. During that session, the Committee reviewed the principal findings and recommendations of the Final Report and authorized TMRI management to proceed with the implementation of the six corrective actions, subject to receipt of detailed legal guidance from outside counsel.
We confirm that the investigation has been closed as completed as of today's date. All witness interviews have concluded, documentary evidence collection is complete, and no further investigative steps are contemplated at this time.
The purpose of this memorandum is to provide TMRI with detailed, actionable legal guidance on implementing each of the six recommended corrective actions set forth in Section VI of the Final Report. For each corrective action, we address the legal basis, documentation requirements, recommended process and timeline, and associated risks. This memorandum is intended to serve as a comprehensive implementation roadmap that TMRI's internal stakeholders may reference as they execute each step.
As a threshold matter, we remind TMRI that C&H represents TMRI as the employer entity in this matter and does not represent any individual employee, officer, or director in their personal capacity. The attorney-client privilege attaching to the Final Report, this memorandum, and all related communications belongs to TMRI, and only TMRI — through its authorized representatives — may waive that privilege. Any decision to disclose privileged materials to third parties, including regulators, insurers, or litigation adversaries, should be made only after careful consideration and with the involvement of the General Counsel and, where appropriate, consultation with C&H.
All legal analysis and recommendations herein are governed by the laws of the Commonwealth of Massachusetts, except where federal statutes or regulations are specifically referenced.
We recommend that TMRI coordinate all implementation steps through Elena Graff, General Counsel, and Grace Okenwa, Vice President of Human Resources, to ensure consistency, proper documentation, and preservation of privilege. C&H remains available for ongoing consultation as needed throughout the implementation process and can be reached directly through the undersigned attorneys.
II. Summary of Investigation and Findings
To provide context for the corrective-action implementation guidance that follows, we briefly recapitulate the key facts and findings of the investigation as set forth in the Final Report.
Background and Timeline
The investigation was formally opened on September 10, 2024, following a referral from Grace Okenwa's office to Elena Graff. The referral was prompted by the filing of five formal grievances between August 12, 2024 and September 4, 2024, by the following TMRI employees:
1. Dr. Yuna Sakata, Research Scientist, Biomedical Engineering Laboratories (grievance filed August 12, 2024);
2. Trevor Hollins, Senior Laboratory Technician, Lab B-2 (grievance filed August 19, 2024);
3. Dr. Priya Chandrasekaran, Postdoctoral Research Associate, Lab B-3 (grievance filed August 22, 2024);
4. Miguel Ferreira, Laboratory Technician, Lab B-4 (grievance filed August 28, 2024); and
5. Sandra Nix, Research Associate, Lab B-2 (grievance filed September 4, 2024).
The respondent, Dr. Marcus Ellender, serves as Director of Biomedical Engineering Laboratories, overseeing Labs B-1 through B-4 and directly or indirectly supervising approximately 24 research and technical personnel. Dr. Ellender has been employed by TMRI since 2016 and has served as Director since 2019. He was placed on paid administrative leave effective September 18, 2024, following consultation between Elena Graff, Grace Okenwa, and C&H.
Substantiated Findings
The investigation examined four categories of alleged misconduct. Our findings, as detailed in the Final Report, are summarized below.
(1) Retaliation — Substantiated. The evidence established that Dr. Ellender reassigned Dr. Yuna Sakata from her role on NIH Grant No. 5R01-EB029174 within eleven (11) business days of her August 2, 2024 oral report to EHS Director Alan Murdoch regarding safety concerns in Lab B-4. An email from Dr. Ellender to Lab B-2 Supervisor Joanna Pratt, dated August 9, 2024, explicitly referenced Dr. Sakata's report and directed that she be moved to a different project assignment immediately. This email constitutes direct evidence of retaliatory motive. The reassignment was made without any documented performance-based justification and was inconsistent with TMRI's standard procedures for grant-personnel changes. We concluded that Dr. Ellender's conduct violated the Massachusetts whistleblower-protection statute, M.G.L. c. 149, § 185, and TMRI Anti-Retaliation Policy HR-2021-009.
(2) Hostile Work Environment — Substantiated in Part. Multiple witnesses corroborated a pattern of demeaning language directed at subordinate employees by Dr. Ellender, including repeated derogatory comments regarding the competence of junior researchers and technicians, as well as a pattern of unfavorable scheduling assignments concentrated among certain complainants. We substantiated these findings as violations of TMRI's Respectful Workplace Policy HR-2021-005. However, after a thorough review of the evidence, we found insufficient evidence to substantiate that the hostile conduct was motivated by a protected characteristic within the meaning of M.G.L. c. 151B, § 4, or Title VII of the Civil Rights Act of 1964, 42 U.S.C. § 2000e et seq. The substantiated policy violations nonetheless warrant corrective action as described below.
(3) Safety-Protocol Violations — Substantiated. Witness testimony from Karen Ashby (Senior Laboratory Technician, Lab B-4) and Derek Loomis (Laboratory Technician, Lab B-4) corroborated that on at least three occasions between March and July 2024, Dr. Ellender directed technicians to bypass required respiratory personal protective equipment ("PPE") during aerosol-generating procedures in Lab B-4. These directives were given verbally, and in at least one instance, Dr. Ellender stated words to the effect that the PPE requirements were "overkill" and "slowed down the workflow." Independently, the Haverford Safety Consulting Group, retained by C&H on behalf of TMRI in October 2024 and led by principal consultant Liam Garrett, CIH, CSP, conducted an environmental health and safety audit of Labs B-1 through B-4. Haverford's preliminary findings, received on October 28, 2024, identified nine (9) PPE-compliance deficiencies and three (3) biohazard-containment protocol violations. The substantiated safety-protocol violations constitute breaches of the Occupational Safety and Health Administration ("OSHA") PPE standards at 29 C.F.R. § 1910.132 et seq. and the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (the "NIH Guidelines").
(4) Falsification of Records — Substantiated. The evidence established that Dr. Ellender altered entries in laboratory notebooks related to a September 14, 2023 biohazard-containment breach in Lab B-2 involving BSL-2 materials. Additionally, safety-incident reports IR-2024-031 and IR-2024-038 contained narratives that were materially inconsistent with contemporaneous documentary evidence (including equipment-maintenance logs and electronic access records) and that falsely attributed equipment failures to operator error by Trevor Hollins. The alteration of laboratory notebooks is particularly concerning given the regulatory significance of such records in federally funded research settings, and the false attribution of fault to an individual employee compounds the misconduct by exposing that employee to unwarranted professional consequences.
Scope of Evidence
Over the course of the investigation, C&H conducted nineteen (19) interview sessions with fourteen (14) unique witnesses, including the five complainants, Dr. Ellender (who participated through his personal counsel, Rachel Whitmore of Hadley, Brennan & Morrow LLP), laboratory supervisors, and other personnel with knowledge of the relevant facts. We collected and reviewed one thousand two hundred forty-seven (1,247) documents, including emails, laboratory notebooks, safety-incident reports, personnel files, scheduling records, grant-administration documents, and internal communications.
The Final Report contains six recommended corrective actions, each of which is addressed in detail in the sections that follow.
III. Corrective Action No. 1: Termination of Dr. Ellender for Cause
A. Legal Basis and Handbook Authority
The TMRI Employee Handbook, at Section 9.2 ("Termination for Cause"), authorizes the termination of any employee for cause based on, among other enumerated grounds: (a) misconduct; (b) violation of TMRI policies, including safety protocols; (c) falsification or alteration of records; (d) retaliation against employees who report concerns through authorized channels; and (e) conduct that poses a risk to the health and safety of TMRI personnel or the integrity of TMRI's research programs.
The substantiated findings in the Final Report satisfy multiple independent grounds for termination for cause under Section 9.2. Specifically:
(i) Dr. Ellender's retaliatory reassignment of Dr. Sakata constitutes retaliation and misconduct under Section 9.2(a) and (d);
(ii) Dr. Ellender's pattern of demeaning conduct toward subordinates violates TMRI Respectful Workplace Policy HR-2021-005, constituting a policy violation under Section 9.2(b);
(iii) Dr. Ellender's direction that technicians bypass respiratory PPE during aerosol-generating procedures constitutes a safety-protocol violation under Section 9.2(b) and conduct posing a risk to health and safety under Section 9.2(e); and
(iv) Dr. Ellender's falsification of laboratory notebooks and safety-incident reports constitutes falsification of records under Section 9.2(c).
Each of these grounds, standing alone, would be sufficient to support termination for cause. Taken together, they present an exceptionally strong basis for the termination decision.
We note that Dr. Ellender is an at-will employee of TMRI. Under the well-established at-will employment doctrine in the Commonwealth of Massachusetts, either the employer or the employee may terminate the employment relationship at any time, with or without cause, subject to certain public-policy exceptions. See, e.g., Jackson v. Action for Bos. Cmty. Dev., Inc., 403 Mass. 8, 9 (1988). However, notwithstanding the at-will nature of the relationship, we strongly recommend that TMRI document the for-cause basis for the termination decision for three important reasons. First, thorough documentation will be essential in defending against any potential wrongful-termination or related claims that Dr. Ellender may assert. Second, TMRI's Employment Practices Liability Insurance ("EPLI") carrier, Meridian Indemnity Group, will likely require documentation of the basis for the adverse employment action in the event of a coverage claim. Third, because Dr. Ellender is the named Principal Investigator on two active NIH R01 grants totaling $4.8 million in awarded funding, demonstrating that the personnel action was based on documented institutional findings will be relevant to TMRI's ongoing compliance obligations to the National Institutes of Health.
B. Documentation Requirements
We recommend that Elena Graff and Grace Okenwa jointly prepare a formal termination letter for Dr. Ellender, to be executed by Dr. Philip Astbury, Chief Executive Officer of TMRI. The termination letter should include the following elements:
(i) A statement that Dr. Ellender's employment is being terminated for cause, effective as of the date specified in the letter;
(ii) A reference to the internal investigation conducted by outside counsel and the substantiated findings in each of the four categories of misconduct (retaliation, hostile work environment, safety-protocol violations, and falsification of records);
(iii) Identification of the specific TMRI Employee Handbook provisions and institutional policies that Dr. Ellender's conduct violated, including Section 9.2, TMRI Anti-Retaliation Policy HR-2021-009, and TMRI Respectful Workplace Policy HR-2021-005;
(iv) Identification of the regulatory standards that Dr. Ellender's conduct violated, including OSHA PPE requirements at 29 C.F.R. § 1910.132 et seq. and the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules;
(v) The effective date of termination;
(vi) Instructions regarding the return of all TMRI property, including identification badges, access cards, electronic devices, and any research materials, data, or laboratory notebooks in Dr. Ellender's possession; and
(vii) Information regarding final-pay obligations, COBRA continuation coverage, and any other applicable post-termination matters.
The termination letter should be direct, factual, and measured in tone. It should not include inflammatory language or characterizations beyond what is necessary to document the for-cause basis. It should not attach or incorporate the Final Investigative Report itself, as doing so could constitute a waiver of privilege in certain circumstances. Rather, the letter should reference the investigation and its findings in general terms.
We further recommend that TMRI maintain the complete investigative file — including the Final Investigative Report, all witness interview summaries and memoranda, documentary evidence, the Haverford Safety Consulting Group preliminary findings, and this memorandum — in a secure, restricted-access location. These materials should be maintained separately from Dr. Ellender's general personnel file and should be accessible only to authorized individuals (i.e., Elena Graff, Grace Okenwa, and members of the Board Governance & Compliance Committee). This approach preserves the attorney-client privilege and work-product protections applicable to these materials while ensuring that they remain available in the event of future litigation or regulatory inquiries.
C&H is prepared to provide a draft termination letter for TMRI's review upon request.
C. Severance Considerations
Given that the termination is for cause based on substantiated misconduct, TMRI is under no contractual or policy-based obligation to provide severance pay or benefits to Dr. Ellender. The TMRI Employee Handbook does not mandate severance in for-cause terminations, and no separate severance arrangement or employment agreement exists for Dr. Ellender.
For context, Dr. Ellender's total annual compensation consists of a base salary of $247,000 plus a research-leadership stipend of $38,000, for a total annual compensation of $285,000 (exclusive of benefits). He has been on paid administrative leave since September 18, 2024, and has continued to receive his full salary during that period.
We advise against providing any severance payment or continuation of pay beyond the date of termination unless TMRI obtains a comprehensive release agreement from Dr. Ellender in return. Given the nature and severity of the substantiated misconduct, any gratuitous severance payment could undermine TMRI's position in subsequent proceedings and could be construed as inconsistent with the for-cause determination.
If, however, TMRI elects to offer a separation agreement in exchange for a general release of claims — which may be a reasonable risk-mitigation strategy depending on TMRI's assessment of the likelihood that Dr. Ellender will pursue affirmative claims — we recommend that any such agreement include the following provisions:
(a) General Release of Claims. A broad release of all known and unknown claims, including claims under federal and state employment-discrimination statutes, common-law tort and contract claims, and any claims arising out of or related to Dr. Ellender's employment or the termination thereof.
(b) Cooperation Clause. A commitment by Dr. Ellender to cooperate with TMRI in connection with any subsequent regulatory inquiries, investigations, audits, or legal proceedings related to matters within his knowledge, including but not limited to inquiries by OSHA, NIH, or the TMRI Institutional Biosafety Committee.
(c) Mutual Non-Disparagement. Mutual obligations not to make disparaging statements about the other party, subject to carve-outs for legally compelled testimony and communications with governmental agencies.
(d) Confidentiality. Obligations not to disclose the terms of the separation agreement, the existence or findings of the investigation (to the extent not already publicly known), or any proprietary or confidential TMRI information.
(e) Compliance with the Older Workers Benefit Protection Act ("OWBPA"). Dr. Ellender is 51 years of age. Any release of claims under the Age Discrimination in Employment Act, 29 U.S.C. § 621 et seq., must comply with the requirements of the OWBPA, 29 U.S.C. § 626(f), including: (i) a clear and specific written waiver referencing ADEA claims; (ii) advice that Dr. Ellender consult with an attorney; (iii) a twenty-one (21) day consideration period before execution; and (iv) a seven (7) day revocation period following execution. The separation agreement and the severance payment would not become effective until the expiration of the revocation period without revocation.
C&H is available to draft or review any separation agreement should TMRI determine that this approach is appropriate.
D. Process and Timeline
We recommend that TMRI schedule the termination meeting within five to seven (5–7) business days following receipt of formal Board authorization to proceed, which we understand was granted during today's Governance & Compliance Committee session. Based on today's date, this would place the meeting in the window of approximately December 3–5, 2024.
The termination meeting should be conducted in person at TMRI's offices and should be attended by Grace Okenwa (or her designee) and one additional member of TMRI's senior management, such as the CEO, Dr. Philip Astbury. We do not recommend that Elena Graff attend the meeting in her capacity as General Counsel, as her presence could create complications regarding privilege in the event the meeting is later the subject of testimony. However, Elena Graff should be immediately available by telephone or in an adjacent office in case legal questions arise during the meeting.
Dr. Ellender's personal counsel, Rachel Whitmore of Hadley, Brennan & Morrow LLP (75 Ashbury Asset Advisors, Suite 1400, Boston, MA 02109), should be notified of the termination decision in writing simultaneously with, or immediately following, the termination meeting. This notification is not legally required but is consistent with professional courtesy and may reduce the likelihood of a disruptive initial response. The notification to Ms. Whitmore should be factual and brief, stating that Dr. Ellender's employment has been terminated for cause and enclosing a copy of the termination letter.
In coordination with the termination meeting, TMRI's Human Resources and Information Technology departments should execute the following logistical steps:
• Retrieval of all TMRI-owned property, including laptop computers, mobile devices, laboratory access cards, identification badges, and keys;
• Immediate revocation of Dr. Ellender's access to all TMRI information systems, including email, network drives, laboratory information management systems (LIMS), and grant-management platforms;
• Deactivation of Dr. Ellender's building-access badge and any associated security credentials;
• Issuance of Dr. Ellender's final paycheck, including accrued and unused vacation time, on the date of discharge, in compliance with M.G.L. c. 149, § 148, which requires Massachusetts employers to pay all wages earned by a discharged employee on the date of discharge.
We emphasize the importance of strict compliance with the final-pay requirement under M.G.L. c. 149, § 148. Massachusetts courts have consistently held that an employer's failure to pay all wages (including accrued vacation, if the employer's policy treats vacation as earned compensation) on the date of discharge triggers mandatory treble damages under M.G.L. c. 149, § 150. See Wiedmann v. The Bradford Grp., Inc., 444 Mass. 698 (2005). TMRI should calculate Dr. Ellender's final pay, including any accrued vacation, in advance of the meeting and have a final paycheck or direct-deposit confirmation prepared and available for delivery at the meeting.
E. Risk Assessment
We have assessed the potential legal risks associated with Dr. Ellender's termination and summarize our analysis below.
Wrongful Termination. Dr. Ellender may assert a claim for wrongful termination, potentially alleging that the termination was pretextual or that it violated an implied contract of continued employment. Under Massachusetts law, implied-contract claims can be based on representations in employee handbooks, but only where the handbook language creates a reasonable expectation of continued employment or specific termination procedures. See O'Brien v. New England Tel. & Tel. Co., 422 Mass. 686, 691–92 (1996). We have reviewed the TMRI Employee Handbook and note that it contains a clear and conspicuous at-will disclaimer. The strength of the documented for-cause basis further mitigates this risk.
Breach of Implied Contract. Related to the above, Dr. Ellender could argue that TMRI's past practices created an implied promise of progressive discipline before termination. However, the TMRI Employee Handbook expressly reserves TMRI's right to terminate employment at any time without prior warning or progressive discipline, and the severity of the substantiated misconduct (including safety-protocol violations and falsification of records) would support termination even under a progressive-discipline framework.
Defamation. Dr. Ellender may allege that statements made in connection with the termination — whether to him directly, to his counsel, or to TMRI personnel — are defamatory. We recommend that all communications regarding the termination be limited to factual statements supported by the investigation findings, and that TMRI personnel refrain from discussing the reasons for Dr. Ellender's departure with anyone who does not have a legitimate need to know. TMRI's qualified privilege to communicate the reasons for an employment action to appropriate internal stakeholders provides a defense, provided statements are made in good faith and without malice. See Correllas v. Viveiros, 410 Mass. 314, 319 (1991).
Overall Assessment. C&H assesses the risk of a successful claim by Dr. Ellender as low, given the thoroughness of the investigation, the strength of the documentary evidence (including the August 9, 2024 email and the falsified incident reports), and the multiple independent grounds for termination under TMRI policy. Nonetheless, we recommend that TMRI maintain privilege over all investigative materials and provide timely notice to its EPLI carrier, as discussed in Section IX below, to preserve all available protections.
IV. Corrective Action No. 2: Referral of Safety Violations to IBC and OSHA
A. Institutional Biosafety Committee (IBC) Referral
TMRI, as a recipient of NIH funding for research involving recombinant or synthetic nucleic acid molecules, is required under the NIH Guidelines to maintain an Institutional Biosafety Committee. The IBC is responsible for reviewing and overseeing research involving recombinant or synthetic nucleic acid molecules conducted at TMRI, including review of biohazard-containment practices and incident reporting.
Based on the investigation findings, we recommend that TMRI notify its IBC of the following matters:
(i) The September 14, 2023 Biohazard-Containment Breach in Lab B-2. The investigation established that a containment breach involving BSL-2 materials occurred in Lab B-2 on September 14, 2023, and that Dr. Ellender subsequently altered laboratory notebooks related to this incident. To the extent this incident was not previously reported to the IBC in its full scope — or was reported on the basis of incomplete or inaccurate information — the IBC must be informed of the corrected facts.
(ii) Systematic Circumvention of Biohazard-Containment Protocols. The Haverford Safety Consulting Group's preliminary EHS findings, received October 28, 2024, identified three (3) distinct biohazard-containment protocol violations across Labs B-1 through B-4. These violations appear to reflect a pattern of noncompliance directed or condoned by Dr. Ellender, rather than isolated incidents attributable to individual laboratory personnel.
We recommend that Elena Graff and Alan Murdoch, EHS Director, jointly prepare a written referral to the IBC incorporating the relevant findings from the Final Report and from Haverford's preliminary EHS findings. The referral should provide the IBC with sufficient factual detail to evaluate the incidents but should be drafted with care to avoid unnecessary disclosure of privileged legal analysis. C&H can assist in reviewing the referral for privilege concerns.
The IBC should be asked to evaluate whether additional corrective measures are needed at the laboratory level — including, for example, enhanced containment protocols, equipment upgrades, additional training for laboratory personnel, or temporary suspension of certain procedures pending remediation. The IBC should also be asked to evaluate whether any of the biohazard incidents are required to be reported to the NIH Office of Biotechnology Activities ("OBA") under the NIH Guidelines. Section IV-B-2-b of the NIH Guidelines requires that certain significant incidents involving recombinant or synthetic nucleic acid molecules be reported to OBA within specified time frames. The IBC is best positioned, in consultation with the Biological Safety Officer, to make this determination.
B. OSHA Reporting Obligations
We have reviewed the applicable OSHA mandatory-reporting requirements under 29 C.F.R. § 1904.39, which require covered employers to report to OSHA within twenty-four (24) hours any work-related incident resulting in in-patient hospitalization, amputation, or loss of an eye, and within eight (8) hours any work-related fatality.
Based on our review of the evidence developed during the investigation, no single incident appears to have resulted in an outcome triggering the mandatory reporting thresholds under 29 C.F.R. § 1904.39. There is no evidence that any employee suffered in-patient hospitalization, amputation, loss of an eye, or death as a direct result of the PPE-protocol bypass or the biohazard-containment violations.
However, the pattern of directed PPE-protocol bypass during aerosol-generating procedures in Lab B-4 over a period of approximately five months (March through July 2024), combined with the nine (9) PPE-compliance deficiencies and three (3) biohazard-containment protocol violations identified by Haverford, raises a more nuanced question: whether TMRI should proactively self-report to OSHA's Boston Area Office as a matter of sound institutional risk management. Proactive self-reporting can, in some circumstances, demonstrate good faith and may result in more favorable treatment in the event of a subsequent OSHA inspection or enforcement action. Conversely, self-reporting can trigger an OSHA investigation that may not otherwise occur, with attendant costs and potential citations.
We recommend that TMRI take the following interim steps before making a final determination regarding OSHA self-reporting:
(i) Consult with Haverford's principal consultant, Liam Garrett, CIH, CSP, to finalize the EHS audit report covering Labs B-1 through B-4. The preliminary findings received October 28, 2024 should be supplemented with any additional data or analysis needed to produce a final, comprehensive audit report.
(ii) Review the final Haverford audit report to assess whether any incidents meet the OSHA recordkeeping requirements under 29 C.F.R. Part 1904, including the general recording criteria at 29 C.F.R. § 1904.7 (requiring recording of work-related injuries and illnesses meeting certain severity thresholds).
(iii) Assess whether any employees who worked in Lab B-4 during the March–July 2024 period have reported or are experiencing any health effects that could be attributable to the PPE-protocol bypass, and ensure that any such effects are evaluated and documented.
If, upon completion of these steps, TMRI determines that self-reporting is advisable, or if OSHA independently initiates an inquiry or inspection relating to TMRI's laboratories, C&H is available to assist with the preparation and coordination of TMRI's response.
C. Timeline
We recommend the following timeline for this corrective action:
• IBC Referral: Within ten (10) business days of the date of this memorandum (i.e., by approximately December 10, 2024).
• OSHA Assessment: Completion of Haverford's final EHS audit report within thirty (30) calendar days of the date of this memorandum (i.e., by approximately December 26, 2024), with a reporting determination to be made promptly thereafter.
V. Corrective Action No. 3: Notification to NIH Grants Management Regarding PI Change
A. Background on Active NIH Grants
Dr. Ellender is currently the named Principal Investigator ("PI") on two active NIH R01 research grants:
These two grants represent a substantial component of TMRI's externally funded research portfolio. Upon Dr. Ellender's termination, the PI designation for each grant will need to be changed, as the named PI will no longer be affiliated with the grantee institution. If TMRI is unable to designate a qualified replacement PI, the grants may need to be relinquished, placed on hold, or transferred to another institution — any of which could result in significant disruption to ongoing research programs and loss of substantial funding.
B. NIH Notification Requirements
Under the NIH Grants Policy Statement ("GPS"), a change in PI is a significant event that requires prior approval from the relevant NIH Institute or Center ("IC"). The grantee institution must notify the Grants Management Specialist ("GMS") assigned to each grant and submit a formal Prior Approval Request through the eRA Commons system. The Prior Approval Request must include:
(i) Identification of the proposed successor PI, including the individual's curriculum vitae, biosketch (in NIH format), and other credentials demonstrating that the successor possesses the qualifications and expertise necessary to lead the funded research;
(ii) A justification for the PI change — which, in this case, may be described as an institutional personnel change without disclosing the details of the investigation, absent a specific inquiry or request from NIH;
(iii) A description of any planned modifications to the research plan or scope of work resulting from the change in PI; and
(iv) Updated budget justifications, if applicable.
If no suitable replacement PI is identified within a reasonable period, TMRI may need to request a temporary suspension or no-cost extension of the grants, or may need to initiate the process for relinquishing the grants. In some circumstances, the NIH may agree to transfer the grants to another institution at which a qualified PI is located, though such transfers are complex and require the agreement of both the relinquishing and receiving institutions.
C. Recommended Steps
We recommend the following steps to manage the PI-change process effectively:
Immediate Identification of Successor PI Candidates. TMRI should immediately begin identifying potential successor PIs for each of the two grants. This process should involve Dr. Philip Astbury (CEO), relevant department heads, and any senior investigators who are familiar with the scope and methodology of the funded research. The identification of qualified candidates is a scientific and institutional judgment that falls outside the scope of C&H's legal representation, but we note that the selection should be guided by the NIH's criteria for PI qualifications, including relevant expertise, track record, and institutional commitment.
Preparation and Submission of Prior Approval Requests. Once successor PIs are identified, TMRI's grants-administration office should prepare and submit Prior Approval Requests to the appropriate NIH ICs for each grant. The requests should describe the PI change as resulting from an institutional personnel action. We recommend that TMRI not volunteer the details of the investigation in the Prior Approval Requests; however, if the NIH GMS or program officer inquires about the circumstances, TMRI should respond truthfully and should consult with C&H before providing information that could implicate privileged materials.
Interim Expenditure Controls. Pending the formal designation of successor PIs and NIH approval of the PI changes, we recommend that TMRI suspend all discretionary expenditures under both grants. Ongoing obligations that are necessary to maintain the integrity of existing research (e.g., animal care, maintenance of cell cultures, data-storage fees) should continue, but new expenditures for equipment, personnel, or travel should be held in abeyance. TMRI's grants-administration office should implement appropriate spending controls to ensure compliance during the transition.
Timeline. We recommend that TMRI initiate contact with the relevant NIH ICs and GMSs within ten (10) business days of Dr. Ellender's termination, to provide informal notice of the anticipated PI change. A formal Prior Approval Request should be submitted within thirty (30) days of termination, or as soon as a successor PI has been identified, whichever comes first. If a successor PI cannot be identified within thirty days, TMRI should request a temporary suspension or no-cost extension to preserve the grants while the search continues.
D. Institutional Risk
The combined remaining funds of approximately $3,100,000 under these two grants represent a significant portion of TMRI's research-funding portfolio. TMRI's approximately $62 million annual operating budget includes substantial reliance on extramural research funding, and the loss of these grants would affect not only the specific research programs they support but also the employment of research personnel, institutional overhead recovery, and TMRI's competitive position in the biomedical-engineering research community.
We therefore recommend that TMRI treat the NIH PI-change notification as a high-priority implementation item and engage its grants-administration office without delay. C&H is available to consult on the legal aspects of the NIH notification, including privilege considerations and the appropriate scope of disclosure to NIH.
VI. Corrective Action No. 4: Mandatory Anti-Retaliation and Supervisory-Conduct Training
A. Scope of Training
We recommend that TMRI implement mandatory anti-retaliation and supervisory-conduct training for all laboratory directors and supervisors across the institute. Based on information provided by TMRI, this encompasses approximately eighteen (18) individuals occupying supervisory roles over laboratory and research personnel.
The training curriculum should comprehensively address the following topics:
(i) TMRI Anti-Retaliation Policy (HR-2021-009). A detailed review of the policy, including its scope, definitions of protected activity, and the prohibition on adverse employment actions in response to safety reporting, grievance filing, participation in investigations, and whistleblower activity. The training should include specific reference to the protections afforded under M.G.L. c. 149, § 185, the Massachusetts whistleblower-protection statute, which prohibits retaliation against employees who report or threaten to report violations of law to a supervisor or public body, or who participate in investigations, hearings, or inquiries conducted by a public body.
(ii) TMRI Respectful Workplace Policy (HR-2021-005). A thorough review of the expectations for supervisory conduct, including the prohibition on demeaning, belittling, or abusive language directed at subordinates; the requirement for equitable treatment in scheduling, assignment, and professional-development decisions; and the obligation to foster a work environment that is respectful, inclusive, and free from harassment and intimidation.
(iii) OSHA Rights and Protections. An overview of employees' rights under the Occupational Safety and Health Act of 1970 and applicable OSHA standards at 29 C.F.R. § 1910, including the right to report safety hazards without fear of retaliation, the right to access safety-related information, and OSHA's anti-retaliation provisions. The training should also reference applicable Massachusetts workplace-safety statutes, including M.G.L. c. 149, § 6, which provides additional protections for employees who report unsafe working conditions.
(iv) Proper Handling and Documentation of Safety-Incident Reports and Lab-Notebook Entries. Given the falsification findings in the Final Report, the training should specifically address the legal and institutional requirements for accurate, contemporaneous, and unaltered documentation of safety incidents and laboratory procedures. Supervisors should be instructed that they are prohibited from directing, encouraging, or condoning the alteration of safety reports or laboratory records, and that such conduct may result in termination and potential personal liability.
(v) Reporting Obligations and Mechanisms. A review of the channels available to TMRI employees for reporting safety concerns, policy violations, and other workplace issues, including direct reporting to supervisors, reporting to the EHS office, reporting to Human Resources, and the forthcoming anonymous-reporting mechanism discussed in Section VII below. Supervisors should be reminded of their obligation to escalate reports received from subordinates and to refrain from any adverse action against employees who utilize these reporting channels.
B. Training Provider and Format
We recommend that TMRI engage an external training provider to design and deliver the training program. The use of an external provider is advisable for two reasons. First, it ensures independence and credibility — the training will carry greater weight if it is delivered by a professional training organization rather than by internal TMRI personnel who may be perceived as having institutional biases. Second, an external provider can bring specialized expertise in employment law, workplace safety, and adult-education methodology that may exceed internal capabilities.
C&H can provide referrals to qualified external training providers with experience in the biomedical and laboratory-research sectors. Several providers in the Greater Boston area have established programs specifically tailored to academic and research institutions.
We recommend that the training be delivered through live, interactive sessions rather than solely through pre-recorded online modules. Live sessions allow for real-time questions, discussion, and the exploration of nuanced scenarios that are particularly relevant to TMRI's laboratory environment. The training should incorporate scenario-based exercises drawn from realistic laboratory contexts (without directly referencing the specifics of the current investigation, which remain privileged) to ensure that participants can apply the principles to their daily supervisory responsibilities.
Attendance at the training should be mandatory for all individuals within the identified population of approximately eighteen supervisory personnel. TMRI should document attendance through sign-in sheets or electronic attendance records, and confirmation of each individual's completion of the training should be placed in the individual's personnel file.
C. Timeline
The training should be completed within ninety (90) calendar days of the date of this memorandum — i.e., by approximately February 24, 2025. Grace Okenwa's Human Resources department should be responsible for coordinating the engagement of the external training provider, scheduling the training sessions, and ensuring that all required personnel attend. Given holiday schedules and the availability of external providers, we recommend that the engagement and scheduling process begin promptly.
VII. Corrective Action No. 5: Revision of Safety-Incident Reporting Procedures
A. Current Deficiencies
The investigation revealed significant structural deficiencies in TMRI's existing safety-incident reporting procedures that facilitated the misconduct at issue and may have delayed the identification of unsafe conditions. Two principal deficiencies warrant attention.
First, the existing reporting process permitted supervisory override and alteration of safety-incident reports after submission. This structural vulnerability enabled the falsification of incident reports IR-2024-031 and IR-2024-038 by Dr. Ellender, who was able to alter the narrative content of reports prepared by subordinate personnel without detection. The absence of version control, audit trails, or independent review mechanisms meant that there was no safeguard against post-submission manipulation of these critical records.
Second, TMRI's existing reporting infrastructure did not provide laboratory personnel with a mechanism for reporting safety concerns anonymously or confidentially. Several witnesses indicated during the investigation that they had been reluctant to report safety concerns through normal channels because the reports would be visible to their direct supervisor — in this case, Dr. Ellender — who they feared would retaliate. This dynamic likely delayed the identification and remediation of the safety hazards in Labs B-1 through B-4 and contributed to the retaliatory environment that gave rise to the grievances.
B. Recommended Revisions
We recommend that TMRI implement the following revisions to its safety-incident reporting procedures:
Anonymous-Reporting Option. TMRI should implement a confidential hotline or web-based reporting platform that allows employees to report safety incidents, near-misses, and safety concerns without identifying themselves. Anonymous-reporting mechanisms are widely recognized as a best practice for research institutions and are consistent with OSHA's emphasis on protecting employees who raise safety concerns. Several commercial platforms (e.g., Brightwater Data Systems, Granite Harbor Services Inc.) provide turn-key solutions for institutional reporting that include web-based submission forms, telephone hotlines, and case-management dashboards. The anonymous-reporting mechanism should be clearly publicized to all TMRI employees, and its availability should be incorporated into new-employee orientation and the mandatory supervisory training discussed in Section VI.
Independent EHS Review. The revised procedures should require that all safety-incident reports be routed directly to the EHS Director, Alan Murdoch, or his designee, with simultaneous copies to the Vice President of Human Resources. This routing should occur before any supervisory sign-off or review. Under the revised workflow, the supervisor of the employee filing the report should have the opportunity to provide supplementary information or context, but should not have the ability to alter, edit, or suppress the original report as filed. The EHS Director should serve as the gatekeeper for all safety-incident documentation, with responsibility for ensuring the accuracy, completeness, and integrity of the reporting record.
Audit Trail and Version Control. TMRI should transition from its current paper-based or semi-electronic reporting process to a fully electronic incident-reporting system that incorporates version control, audit logs, and user-authentication features. Such a system would create a tamper-evident record of all submissions, edits, and reviews, making it virtually impossible for any individual to alter a report without detection. Several commercially available laboratory information management systems (LIMS) and environmental health and safety (EHS) management platforms include incident-reporting modules with these capabilities.
Periodic Review. TMRI's EHS audit reports — of which six (6) reports covering the period 2022–2024 were reviewed during the investigation — should be produced on a quarterly basis rather than on the current, less frequent schedule. Each quarterly EHS audit report should be reviewed by the Audit & Risk Committee of the Board of Directors, chaired by Teresa Dwight, as a standing agenda item. This level of Board-level oversight will ensure that safety trends and emerging concerns receive prompt institutional attention and that laboratory leadership is held accountable for compliance with safety protocols.
C. Policy Drafting
We recommend that Elena Graff and Grace Okenwa, in coordination with Alan Murdoch, draft a revised Safety-Incident Reporting Policy that incorporates the revisions described above. The revised policy should supersede the current reporting procedures and should be distributed to all TMRI employees with a signed acknowledgment of receipt required.
C&H is available to review the draft revised policy for legal sufficiency, including consistency with applicable OSHA regulations, NIH Guidelines, and Massachusetts workplace-safety statutes. We recommend a target completion date of sixty (60) calendar days from the date of this memorandum — i.e., by approximately January 25, 2025 — for the finalization and adoption of the revised policy.
VIII. Corrective Action No. 6: Individual Remediation for Affected Complainants
Each of the five complainants who filed grievances has been affected by Dr. Ellender's misconduct in distinct ways. The Final Report recommended that TMRI undertake specific remediation measures for each individual. We address each complainant below.
A. Dr. Yuna Sakata
Dr. Sakata was improperly reassigned from her role on NIH Grant No. 5R01-EB029174 on or about August 13, 2024, in retaliation for her August 2, 2024 oral report to EHS Director Alan Murdoch. This reassignment was the subject of the retaliation finding in the Final Report.
We recommend the following remediation steps:
(i) Restoration of Grant Role. Dr. Sakata should be restored to her role on NIH Grant No. 5R01-EB029174 as soon as practicable. This restoration should be formally documented and communicated to Dr. Sakata in writing. The restoration will also need to be coordinated with the NIH PI-change process described in Section V, as the successor PI will need to incorporate Dr. Sakata's role into the revised grant-management structure.
(ii) Personnel File Correction. Dr. Sakata's personnel file should be updated to reflect that the August 13, 2024 reassignment was determined to be retaliatory in nature and has been reversed. Any notation in her file suggesting that the reassignment was based on performance or other legitimate grounds should be removed or corrected.
(iii) Back-Pay and Compensation Review. TMRI should evaluate whether Dr. Sakata suffered any measurable economic harm as a result of the retaliatory reassignment during the period from approximately August 13, 2024 to the present. Such harm could include, for example, loss of grant-funded supplemental compensation, loss of authorship or publication opportunities, or other quantifiable professional or financial detriment. If measurable harm is identified, TMRI should consider appropriate compensation, which may include back-pay or other monetary remediation.
B. Trevor Hollins
Trevor Hollins was the victim of falsified safety-incident reports IR-2024-031 and IR-2024-038, which contained fabricated narratives attributing equipment malfunctions to operator error by Hollins. These false attributions had the potential to cause serious professional harm to Hollins and may have already affected his performance evaluations and standing within the laboratory.
We recommend the following remediation steps:
(i) Correction of Safety-Incident Reports. Safety-incident reports IR-2024-031 and IR-2024-038 should be formally corrected to remove the false attributions of equipment malfunctions to operator error by Hollins. The corrected reports should reflect the actual findings — namely, that the equipment malfunctions were not caused by operator error and that the original narratives were falsified by Dr. Ellender.
(ii) Written Acknowledgment. TMRI should issue a formal written acknowledgment to Hollins, signed by an appropriate senior official (e.g., Grace Okenwa or Dr. Philip Astbury), stating that the incident reports were falsified and that Hollins bears no responsibility for the cited equipment failures. This acknowledgment should be placed in Hollins's personnel file alongside the corrected reports.
(iii) Performance-Consequence Review. TMRI should review Hollins's performance evaluations, disciplinary records, and employment history to determine whether any negative consequences flowed from the falsified incident reports — for example, written warnings, unfavorable performance ratings, or denial of advancement opportunities. Any such consequences should be reversed or otherwise remediated.
C. Dr. Priya Chandrasekaran
Dr. Chandrasekaran was the subject of a retaliatory negative performance review authored by Dr. Ellender. In addition, witness testimony established that Dr. Chandrasekaran experienced unfavorable scheduling and was denied approval to attend at least one professional conference, in apparent connection with her having raised workplace concerns.
We recommend the following remediation steps:
(i) Correction of Performance Review. The retaliatory negative performance review authored by Dr. Ellender should be formally identified as such and superseded. The superseded review should be removed from any active section of Dr. Chandrasekaran's personnel file and replaced with a notation indicating that it was determined to have been retaliatory and is not reflective of TMRI's assessment of Dr. Chandrasekaran's performance. TMRI should arrange for a new, fair performance review to be conducted by an appropriate supervisor who was not involved in the retaliatory conduct.
(ii) Personnel File Correction. Dr. Chandrasekaran's personnel file should be updated to reflect that the negative performance review has been superseded and that the unfavorable scheduling and conference-attendance denial were part of the retaliatory pattern identified in the investigation.
(iii) Scheduling and Conference-Attendance Review. Going forward, TMRI should ensure that Dr. Chandrasekaran receives equitable treatment in scheduling and professional-development opportunities under the new supervisory structure that will be established following Dr. Ellender's termination.
(iv) Back-Pay and Other Remediation. TMRI should consider whether back-pay, retroactive conference-attendance approval (including reimbursement of any registration fees or other costs), or other remediation is appropriate in light of the harm Dr. Chandrasekaran experienced. The specific nature and extent of remediation should be determined based on a review of the relevant records and a discussion with Dr. Chandrasekaran.
D. Miguel Ferreira
Miguel Ferreira filed a grievance regarding his experience in raising safety concerns about conditions in Lab B-4 to the EHS office. While the investigation did not identify a specific discrete adverse employment action taken against Ferreira in the manner identified for Dr. Sakata, Hollins, or Dr. Chandrasekaran, Ferreira's willingness to report safety concerns was an important contribution to the identification of the PPE-protocol bypass and other safety deficiencies.
We recommend the following remediation steps:
(i) Written Confirmation of Non-Retaliation. TMRI should issue a written confirmation to Ferreira that he will not face any adverse employment action for having raised safety concerns to the EHS office or for filing his grievance.
(ii) Written Acknowledgment of Contribution. TMRI should issue a written communication to Ferreira acknowledging that his complaints were substantiated by the investigation and expressing TMRI's appreciation for his contribution to workplace safety. This communication should be placed in Ferreira's personnel file as a positive notation.
E. Sandra Nix
Sandra Nix filed a grievance and also provided testimony during the investigation that was instrumental in identifying the lab-notebook alteration related to the September 14, 2023 biohazard-containment breach in Lab B-2.
We recommend the following remediation steps:
(i) Written Confirmation of Non-Retaliation. TMRI should issue a written confirmation to Nix that she will not face any adverse employment action for filing her grievance or for providing testimony during the investigation.
(ii) Written Acknowledgment. TMRI should acknowledge Nix's role in identifying the lab-notebook alteration, which was a critical finding in the investigation. This acknowledgment should recognize her integrity in coming forward and should be placed in her personnel file.
F. General Remediation
Beyond the individual measures described above, we recommend the following general remediation steps applicable to all five complainants:
(i) Individual Meetings. Grace Okenwa should schedule individual meetings with each of the five complainants to communicate the outcome of the investigation and the specific remediation steps applicable to that individual. These meetings should be conducted in a private, confidential setting, and should convey TMRI's commitment to addressing the substantiated misconduct and preventing recurrence.
(ii) Written Summaries. Each complainant should receive a written summary of the remediation measures applicable to them. The written summary should be tailored to each individual and should describe the specific actions TMRI is taking (e.g., restoration to grant role, correction of incident reports, correction of performance review) without disclosing the full scope of the investigation findings or the details of corrective actions taken with respect to other individuals.
(iii) Reminder of Anti-Retaliation Protections. Each complainant should be reminded, both verbally during the individual meeting and in the written summary, of their ongoing protections against retaliation under TMRI Anti-Retaliation Policy HR-2021-009 and M.G.L. c. 149, § 185. TMRI should make clear that any future adverse action experienced by a complainant that they believe may be retaliatory should be reported immediately to the EHS office, Human Resources, or the General Counsel's office.
IX. EPLI Notice Obligations
A. Policy Details
TMRI maintains an Employment Practices Liability Insurance ("EPLI") policy with Meridian Indemnity Group. The key terms of the policy are summarized below:
B. Notice Requirements
EPLI policies, including the Meridian policy, typically require the insured to provide timely written notice of any "claim" as defined in the policy, as well as notice of any circumstances that may reasonably be expected to give rise to a claim. The failure to provide timely notice can, under Massachusetts law and the terms of most EPLI policies, result in a denial of coverage or a reservation of rights by the carrier.
Given the nature and scope of the matters at issue — including five formal employee grievances, a comprehensive investigation substantiating multiple categories of misconduct, and the planned termination for cause of a senior employee — we believe that the notice threshold has been triggered and that TMRI should provide written notice of circumstances to Meridian as soon as practicable.
We recommend that Elena Graff, in coordination with TMRI's insurance broker, Crestline Brokerage Partners, Inc., prepare and submit a written notice of circumstances to Meridian Indemnity Group at its principal office (600 Asylum Avenue, Hartford, CT 06105). The notice should include the following information:
(i) A description of the five formal grievances, including the dates filed and the names of the complainants;
(ii) A summary of the investigation conducted by outside counsel, including the general scope of the investigation (without attaching or disclosing privileged materials);