Bias in Research Retrospective Review Procedures

Procedures for Retrospective Review of Bias in Research

Purpose
1. Public Health Service (PHS) regulations and Department of Energy (DOE) policy require that, if the University fails to timely identify a Financial Conflict of Interest (FCOI), an Investigator fails to disclose an FCOI, or an Investigator fails to comply with a Conflict Management Plan (CMP) in relation to a federally funded project, the University must conduct a Retrospective Review of the conflicted Investigator’s activities and sponsored Research (Review) to determine if the Research was biased in the design, conduct, or reporting prior to identifying and managing the FCOI.
2. The Vice President for Research and Innovation (VPRI), at their discretion, may direct the University to use the Review process for other research that does not fall under the federal regulations.
3. Evaluation under these procedures consists of a Preliminary Assessment by the Director of Conflict Disclosures and Management (DCDM) or their designee, the Associate Vice President for Research Regulatory Support (AVP), and the Responsible Administrator, and, if deemed necessary, a Retrospective Research Review performed by a Retrospective Review Committee (RRC). These procedures set out the process for each stage and how the University will address any Bias that is found.
Applicability
1. Review not Required. Review is not required if an FCOI is timely identified and managed. An FCOI is considered to have been timely identified and managed if the CMP is implemented before the project funds are released or is established within sixty days[1] of an investigator’s timely disclosure of a related significant financial interest (SFI). Since University policy requires Investigators to report SFIs within thirty days of discovering or acquiring the interest (e.g., through purchase, marriage, inheritance), the FCOI is timely managed if a management plan is implemented within ninety days of its discovery or acquisition during on-going Research.
2. Review Required. Review must be completed within 120 days of the Preliminary Assessment Team’s determination that an FCOI was not timely disclosed, identified, or managed. An untimely FCOI could exist in any of the following circumstances:
  1. The Investigator failed to disclose an SFI that the DCDM or the University’s Conflict Review Committee (CRC) determines constitutes an FCOI;
  2. The University failed to review or manage an FCOI (e.g., it was not timely reported by a subrecipient or timely reviewed by the University); or
  3. An Investigator failed to comply with a Conflict Management Plan.
3. Reporting an Undisclosed or Unmanaged FCOI. Any member of the University community or other person who believes an Investigator has a non-disclosed FCOI shall contact the DCDM regarding their concern. The DCDM may also independently determine that an investigator failed to adequately disclose an FCOI.
4. The Office of Conflict Disclosures and Management (OCDM) shall coordinate implementing these procedures.
Time Frame Summary
1. Appendix A contains a summary of time frames and responsibilities associated with these procedures.
Definitions
1. Bad Faith: dishonesty in belief, purpose, or motive[2]
2. Bias in Research (Bias): systematic error introduced into planning, sampling, testing, or reporting by selecting or encouraging one outcome or answer over others[3]
3. Conflicted Investigator: an Investigator who has a Financial Conflict of Interest related to the subject matter of the Research under review.
4. Conflict Management Plan (CMP): a formal plan created to manage conflicts that arise from actual or apparent overlap between an Investigator’s outside relationships and/or interests and their university responsibilities.
5. Evidence: any document, tangible item, or testimony that is offered or received during a Review to prove or disprove the existence of a fact relevant to the question of Bias. Evidence could include, but is not limited to:
  1. proposals, grant applications, and related comments;
  2. relevant research data and related records;
  3. laboratory notebooks and computer files;
  4. telephone logs and memoranda of calls;
  5. correspondence; and/or
  6. manuscripts, posters, publications, and tapes of oral presentations.
6. Financial Conflict of Interest (FCOI): a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of research[4]
7. Good Faith: a state of mind consisting of honesty in belief or purpose, faithfulness to one’s duty or obligation, or absence of intent to defraud or seek unconscionable advantage.[5] This includes cooperating with the Review by impartially carrying out the duties assigned under these Procedures.
8. Institutional Responsibilities: an Investigator's professional responsibilities on behalf of the University as defined by the University’s Conflict of Interest Policy, Outside Work for Pay Policy, or an appointment letter
9. Investigator: the project director (PD), principal Investigator (PI), or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of Research.[6] This may include, for example, collaborators or consultants.
10. Preliminary Assessment: initial information gathering to determine whether there has been a failure to disclose or identify an FCOI or to comply with a CMP that may require referral to a Research Review Committee
11. Preponderance of the Evidence: The greater evidentiary weight that, while not sufficient to free the mind wholly from all reasonable doubt, is sufficient to incline a fair and impartial mind to one side of the issue rather than the other.[7]
12. Research: systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge. The term includes basic and applied research (e.g., a published article, book, or book chapter), product development (e.g., a diagnostic test or drug), and any such activity for which research funding is available through a grant, cooperative agreement, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.[8]
13. Research Record: the physical or electronic record of data or results from scholarly inquiry, including, but not limited to, research proposals, laboratory records, progress reports, abstracts, theses, oral presentations, internal reports, journal articles, books, other publications of any kind in any media, and/or any material in any media necessary to support the content of any such document, presentation, or publication.
14. Research Review Committee (RRC): a group of at least three individuals appointed by the RRC chair to conduct a Review (See also, § 7(c))
15. Responsible Administrator: the administrator who has most immediate responsibility for the Conflicted Investigator and who is not disqualified from serving as Responsible Administrator by a COI (including, but not limited to, an FCOI). If the Responsible Administrator is a dean, an associate vice president, an assistant vice president, or the VPRI, they may designate a subordinate to fulfill the role. If the Conflicted Investigator is a student, the Responsible Administrator shall be the chairperson of the department with which the student is affiliated.
16. Retaliation: an adverse action or adverse treatment against an individual involved in a Review by an individual who knew of the individual's participation in the Review
17. Retrospective Research Review (Review): evaluation of the Conflicted Investigator’s research to determine whether research was biased in design, conduct, or reporting
18. Significant Financial Interest (SFI): a financial interest of the Investigator, their spouse, or dependent children, that reasonably appears to be related to the Investigator’s Institutional Responsibilities[9]
Role of the Office of Conflict Disclosures and Management
1. The DCDM shall initiate and coordinate the Preliminary Assessment.
2. The DCDM shall advise the RRC as requested. If requested, the DCDM shall provide logistical support, recruit expert witnesses, and arrange for legal advice through the Office of the General Counsel (OGC).
3. When the FCOI involves Research supported by PHS or DOE, the DCDM shall work with OGC to assist the University in meeting all legal requirements related to FCOIs in PHS- and DOE-sponsored research.
4. The DCDM shall report regularly to the Associate Vice President for Research Regulatory Support (AVP) on the status of the Preliminary Assessment and Review.
5. The DCDM shall take all reasonable and practical steps to inform custodians of all Evidence needed to conduct the Review and request that they inventory and sequester the Evidence in a secure manner, except where the Evidence encompasses shared scientific instruments. The Responsible Administrator or RRC Chair may take custody of copies of the Evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments.
6. Upon the conclusion of the Review, the OCDM will keep Review Records secure and will only allow access on a need-to-know basis or as otherwise required by law or federal or state agency. The OCDM shall keep all Review Records for at least three years after the completion of the funded project.
7. The AVP and/or DCDM may disqualify the Responsible Administrator or any potential or sitting member of the RRC if the DCDM determines that such person has a COI or may be biased in a way that could affect the outcome of the Review.
8. The DCDM may delegate any of the duties required by these procedures to another member of the OCDM.
Preliminary Assessment
1. No later than fourteen calendar days after the discovery of facts that could require a Review, the DCDM shall conduct a Preliminary Assessment to determine whether a Researcher has failed to meet FCOI disclosure or management requirements and whether the failure was knowing and/or intentional.
2. As part of the Preliminary Assessment, the DCDM shall consult with the AVP and the Responsible Administrator (“Preliminary Assessment Team” or “Team”), to determine whether there is an undisclosed or unmanaged FCOI relating to a research project or projects or if an Investigator failed to comply with a CMP.
3. If any member of the Team believes a Review should be conducted, the Review will move forward.
4. Review Required. If the Preliminary Assessment Team agrees that Review is required the following shall occur:
  1. No later than ten days after the Team’s determination, the DCDM shall prepare a Preliminary Assessment report that explains the basis for the Team’s determination. The DCDM shall transmit copies of the Preliminary Assessment report to the Team and the RRC Chair. The report shall include the following information:
    1. The name and position of the Conflicted Investigator;
    2. The project number and title;
    3. The nature of the alleged Conflict, including the name and description of the entity with which the Investigator has the FCOI;
    4. A description of the information the DCDM reviewed that led to their conclusion;
    5. The list of individuals the DCDM contacted as part of their determination; and
    6. Explanatory support for the Team’s determination.
  2. No later than ten days after communicating the Preliminary Assessment report, the DCDM, in consultation with the AVP and other offices as necessary, shall identify an RRC Chair. The RRC Chair will be responsible for administering the Review fairly and impartially.
  3. No later than ten days after receiving the request to serve as chair, the RRC Chair, in consultation with the DCDM and AVP, will identify and contact members of an ad hoc Retrospective Review Committee (RRC).
5. Review not Required. If the Team unanimously agrees that Review is not warranted, the DCDM shall prepare a Preliminary Assessment report that states the basis and rationale for the Team’s determination. The DCDM shall provide a copy of the Preliminary Assessment report to the Team for review and comment. Once the Preliminary Assessment is complete, the report is finalized, and no further action is necessary, the DCDM shall provide a copy of the report to the VPRI.
Retrospective Review
1. Unless prohibited by law, requested otherwise by law enforcement, or requested otherwise by the VPRI or University President, the DCDM shall contact the Conflicted Investigator at the start of the Review and attempt to answer any questions the Investigator may have about the Review process.
2. Committee Charge. Within seven days of receiving the Team’s Report, the Chair of the RRC, with assistance from the DCDM and AVP, shall draft a Charge to the RRC based on the Preliminary Assessment.
3. Retrospective Review Committee
  1. Committee Composition. The Chair of the RRC, in consultation with the DCDM and AVP, shall appoint a Retrospective Review Committee (RRC) of no fewer than three members, chosen for their expertise. While the RRC will usually be composed of University faculty, it may include persons other than University faculty if the RRC Chair determines that such individuals have relevant and useful experience or expertise. When a student is the Conflicted Investigator, at least one student shall be a member of the RRC. The RRC Chair will provide the RRC with the Preliminary Assessment Report and any supporting evidence to the RRC.
  2. Briefing. Before the Review begins, the DCDM and the AVP shall brief the RRC on these procedures, other relevant University regulations, and legal and procedural issues that the RRC is likely to encounter during the Review.
  3. Scientific or Technical Expertise. If the RRC requires special scientific or technical expertise to evaluate the Research, it shall advise the DCDM, who shall attempt to secure such assistance, if reasonable.
  4. DCDM Assistance. The RRC may request assistance from the DCDM during its deliberations and in preparing its Review Report but shall not seek the DCDM’s opinion as to whether Bias occurred.
4. Federal Requirement. To the extent that a published federal funding source regulation requires a specific procedural element(s) in the Review, the Review procedures shall include that element(s).
5. Standard for Determination. The RRC shall determine by the Preponderance of the Evidence whether Bias occurred in the conduct, design, or reporting of the sponsored research.
6. Initial Review. The RRC will first consider whether the Research is at a stage at which bias could have occurred.
  1. If a majority of the RRC concludes that Research is in the preliminary stages such that bias could not yet have occurred, the RRC will document that finding and will evaluate whether referral for other administrative or disciplinary action outside of the scope of these procedures is necessary to address an untimely disclosure or failure to comply with a CMP. The RRC will provide this finding to the AVP, DCDM, and Responsible Administrator.
  2. If a majority of the RRC determines Research is at a stage at which bias could have occurred, it will continue with the Review.
7. Evidence Review. The RRC shall examine all Evidence that it deems pertinent to the Review. At its discretion, the RRC may request or obtain additional evidence, conduct interviews, inspect laboratories, or examine laboratory specimens, materials, procedures, and methods.
8. Interviews
  1. If it deems necessary, the RRC may conduct interviews with the Conflicted Investigator and other persons, if any, who have material information regarding the Review.
  2. If the RRC conducts interviews, it must appoint an objective, non-participant note-taker for each interview to take notes on, but not transcribe, the interview.
  3. Alternatively, the RRC may record the interview if all participants agree. If it does record the interview, the recording shall be provided to the OCDM at the completion of the Review process. The recording provided to the OCDM shall be the only copy maintained at the conclusion of the Review.
9. Neither the DCDM nor the Responsible Administrator shall participate in the deliberations of the RRC or vote on whether Bias occurred.
10. The RRC must complete the Review within 120 days of the Preliminary Assessment Team’s determination.
11. Additional Conflicted Investigators. If, during any Review, the RRC identified additional Conflicted Investigators, those investigators shall be notified of the need for a Review immediately. The DCDM and the Responsible Administrator shall attempt to coordinate Reviews of the Conflicted Investigators’ Research.
12. Extension. If the Review cannot be completed in 120 days from the Preliminary Assessment determination, the RRC Chair shall notify the DCDM, AVP, and Responsible Administrator; explain why the extension is necessary; provide a progress report of the RRC's activities to date; and provide an estimated Review completion date. If the DCDM and AVP, in consultation with the OGC as necessary, agree that the request is reasonable and the request would put the completion of the entire Review process outside of 120 days, the DCDM shall contact the research sponsor and request the extension. If the extension would not put the completion of the Review process outside of 120 days, the DCDM, at their discretion, may grant the extension request.
Bias Finding and Report
1. To conclude that Bias occurred, a majority of the members of the RRC must evaluate the degree to which Bias prevented proper study design, conduct, or reporting. By way of example, not limitation, Bias may be demonstrated by the following[10]:
  1. Flawed study design;
  2. Selection bias;
  3. Channeling bias;
  4. Interviewer bias;
  5. Chronology bias;
  6. Recall bias;
  7. Transfer bias;
  8. Misclassification of exposure or outcome;
  9. Performance bias;
  10. Citation bias; or
  11. Confounding.
2. Written Report. Within fourteen days of the conclusion of its Review, the RRC shall prepare a written report, which shall include:
  1. The name and position of the Conflicted Investigator;
  2. The PD or PI contact;
  3. The application or grant number and project title;
  4. The name of the entity with which the Investigator has an FCOI;
  5. A detailed methodology of the retrospective review, including the process and documents that were reviewed;
  6. An analysis of any explanation offered by the Conflicted Investigator and the Evidence in support thereof;
  7. An analysis pursuant to the standards set forth in Section 8(a) above;
  8. Findings and conclusions; and
  9. Hyperlinked references to any University policies or procedures it relied upon to reach its conclusion.
3. The RRC Chair must provide a copy of the Review report to the Team, the Conflicted Investigator, and the VPRI.
4. Dissent. Any member of the RRC who does not agree with the determination of the majority of the RRC may file a dissent to the Review report, which shall be appended to the Report.
Resolution and Outcome
1. Notifying Investigator. Promptly after completion of the Review, the DCDM shall notify the Conflicted Investigator of the Review outcome and provide them with a copy of the Review report, including those portions of the Review report that address the Conflicted Investigator’s role and testimony, if any, in the
2. Notifying Sponsoring Entity. If Bias is found, the DCDM, in consultation with AVP, VPRI, and OGC, will communicate findings to the sponsoring entity after the time for appeal has lapsed.
3. Bias Mitigation. If the RRC finds Bias, the DCDM, after consultation with the AVP and OGC, shall work with the necessary individuals to attempt to mitigate the effects of the bias by correcting and/or seeking retraction of any part of the Research Record materially affected by the Bias. The DCDM shall then produce a written report summarizing the mitigation actions and proving any additional related information the sponsor requires. The Conflicted Investigator shall not interfere with the DCDM’s efforts in these
4. Federal Sponsor. If Bias is found involving federally funded Research, the DCDM shall submit the Review report and mitigation report to the federal source, and provide such other information, if any, as the funding source may request.
5. Non-Federal Sponsor. If Bias is found involving non-federally funded Research, the DCDM shall notify the funding source of the outcome of the Review promptly after its completion, provide the sponsor with the Review report, and provide such other information, if any, as the sponsor may request.
6. Referral to Research Integrity Officer
  1. The DCDM shall refer any Bias finding to the University’s Research Integrity Officer for further review pursuant to the University’s Research Misconduct Policy and Procedures.
  2. If no Bias is found, the RRC may refer other activities identified in the Review to the University’s Research Integrity Officer.
7. Reputation Protection. If no bias is found, the University shall work diligently to protect the position and reputation of each individual who has, in Good Faith, participated in or cooperated with a Review under these Procedures. These efforts shall be: (1) reasonable and practical under the circumstances; (2) proportionate to the risk to the individual’s position and reputation; and (3) consistent with applicable sponsor expectations.
Appeal
1. Time Frame. The Conflicted Investigator may appeal an RRC’s finding of Bias to the VPRI within fourteen days of the RRC providing the finding to the Investigator. The appeal must be in writing and must set forth the reasons the Conflicted Investigator believes the Bias finding is incorrect.
2. Written Challenge. A Conflicted Investigator who wishes to file such a challenge must submit the challenge in writing to the VPRI, with notification to the AVP, DCDM and Responsible Administrator. The challenge must include supporting rationale and any available evidence.
3. VPRI Review. Within fourteen days of receiving the appeal, the VPRI must respond in writing either affirming or reversing the RRC’s finding. A rationale must accompany the decision. The VPRI may delegate this duty to a University employee who does not have a COI and who was not previously involved in the Review.
  1. The VPRI may extend this deadline for good cause by notice to the Conflicted Investigator, AVP, the DCDM, and the Responsible Administrator.
  2. In response to an appeal, the VPRI or the VPRI's designee may request further information about the Research Review in writing from the DCDM.
  3. The VPRI's decision on appeal shall be based on the Review Record, as clarified or supplemented by the DCDM upon the VPRI’s request, and the Conflicted Investigator's appeal.
4. VPRI Determination. The VPRI may overrule the RRC’s finding only if the VPRI finds procedural error in the Review process, factual error, or that the Reviewers were biased or had a COI.
  1. If the VPRI overrules the RRC's determination, the VPRI shall issue a written decision to the AVP, DCDM, Responsible Administrator, and RRC chair overruling the RRC for stated cause and instructing the RRC Chair to impanel a second RRC.
  2. If a second RRC is impaneled, it shall begin a new Review within five business days[11] of the VPRI’s decision. The second RRC's determination shall be binding. The second review shall follow the same timeframes as set forth in Sections 7 and 8, above.
  3. If a second RRC is empaneled, the DCDM shall promptly notify the funding agency and provide an approximate timeframe for completion of the second review.
5. During appellate proceedings no referral for sanction or disciplinary action will be made. However, if necessary to meet a statutory, regulatory, or agency deadline, the DCDM shall notify the funding agency that a Review has been completed, but an appeal is pending. If the RRC’s finding is overturned on appeal, the DCDM will promptly notify the funding agency of that action and next steps (if any).
6. New Evidence. If the Conflicted Investigator or any participant in the Preliminary Assessment or Review learns of previously unavailable, relevant Evidence during an appeal, they shall inform the DCDM. Within five business days of receiving the new Evidence, the DCDM shall inform the VPRI and the Conflicted Investigator.
  1. Within five business days of being informed of the new Evidence, the VPRI must review the Evidence to determine whether it could materially affect the finding of Bias. If the VPRI finds that the new Evidence could materially affect the finding, they shall remand the finding to the RRC that made the original finding for it to consider the new Evidence.
  2. If the Review is remanded, the DCDM will notify the funding agency of such fact within one business day of the determination.
  3. The RRC shall notify the VPRI, AVP, DCDM, and Responsible Administrator within ten business days whether it finds the new Evidence material to its finding and wishes to reopen the matter.
New Evidence after Final Appeal
1. If after a final, non-appealable decision that Bias has occurred, the Conflicted Investigator or any participant in the Preliminary Assessment or Review learns of previously unavailable Evidence, the person who discovered the Evidence shall send it to the DCDM with an explanation of its origin and importance. Within ten business days of receiving the new Evidence, the DCDM shall submit it to the AVP, Responsible Administrator, and the RRC Chair who conducted the Review.
2. Within ten business days of receiving the Evidence, the RRC Chair shall provide the new Evidence to the RRC to consider whether new Evidence impacts its finding. The RRC must evaluate and decide the potential impact within fourteen business days of receiving the new Evidence. The RRC Chair shall notify the AVP, Responsible Administrator, and DCDM of the RRC’s determination within one business day of that determination.
3. Within five business days of receiving the RRC’s decision, the AVP and DCDM shall submit the new Evidence and the RRC’s finding to the VPRI for review. Based on the new Evidence and the information from the RRC, the VPRI may reverse or affirm the previous finding of Bias or remand the matter to the RRC to conduct a new Review.
4. Within ten business days of receiving the notice from the AVP and DCDM, the VPRI shall issue a decision of whether to affirm, reverse, or remand a finding based on the new Evidence. The VPRI’s decision shall be in writing and contain a rationale for the determination. The VPRI may extend this period for good cause by notice to the Conflicted Investigator, the VPRI, and the DCDM.
5. Within five business days of receiving the VPRI’s decision, and if the VPRI’s decision is to reverse or remand, the DCDM shall inform the sponsor of the development.
6. If a new review is required, it shall follow the procedures set forth above.
Bad Faith
1. If the DCDM concludes that the person alleging failure to disclose a COI acted in Bad Faith in making the Allegation, or that any participant acted in Bad Faith during the Preliminary Assessment, the DCDM shall refer the matter for administrative review and appropriate action as set forth in this section.
2. If a majority of the members of the RRC concludes that any member or Review participant acted in Bad Faith during any part of the Review, the RRC shall refer the matter for administrative review and appropriate action as set forth in Section 9(f), above.
3. If the VPRI receives a report that an RRC member or the DCDM did not act in Good Faith in carrying out any of their duties under these procedures, the VPRI, or their delegate, will investigate the report, with advice from OGC, and in cooperation with the DCDM, if the report is not against or about the
4. If the VPRI concludes that the individual against or about whom the complaint is made did not act in Good Faith in carrying out any of their duties under these procedures, and that the failure to act had a material adverse impact on any Review, the VPRI shall:
  1. Take such action as may be necessary to preserve the integrity of the Review, including but not limited to, replacing the affected individual, abrogating the affected Review and any subsequent Reviews in which the same allegation was reviewed, and initiating new Reviews to substitute for those abrogated; and
  2. Refer the matter to the appropriate administrator for review and such action, if any, as the administrator may deem appropriate, including potential disciplinary action.
5. If there is a finding of Bad Faith, the DCDM shall promptly report that finding to the federal agency or sponsoring entity.
Retaliation
Any allegations of retaliation against any Preliminary Assessment or Review participant should follow the University’s Non-Retaliation Policy.
Additional Procedures and Guidelines
1. The University's Indemnification Policy shall govern the indemnification of Preliminary Assessment and Review participants.
2. Confidentiality
  1. Unless required by law or policy and consistent with a fair and thorough review of the Research in question, Reviews conducted under these procedures will only be disclosed to those who have a need to know.
  2. The DCDM should be informed immediately of any breach of confidentiality. The DCDM will investigate the breach of confidentiality and refer the matter to the appropriate administrator for review and such further action, if any, as the administrator may deem appropriate.
3. Location of Research. The University may review research under these Procedures regardless of where or when the Conflicted Investigator’s Research occurred.
4. Events Requiring Immediate Action.
  1. Notwithstanding any other provision of these procedures, appropriate University administrators may take any actions they deem necessary or appropriate to safeguard University personnel, other Review participants, public health or safety, experimental subjects, sponsors' funds or equipment, Evidence, or the integrity of the research environment.
  2. Any individual who is aware of issues identified in Section (i), above, must immediately report them to the DCDM who, after consultation with the AVP and OGC, shall immediately notify the VPRI, the Provost, and, if appropriate, the pertinent government official or Research sponsor.
Provisions for Changing these Procedures
1. Any member of the University community may recommend changes to these Procedures by writing to the OCDM, which shall be the primary governance venue for these Procedures. The OCDM shall forward any such recommendations of which it approves to the AVP, VPRI, and OGC.
2. The DCDM shall, after consultation with the AVP, VPRI, and OGC, modify these Procedures to incorporate relevant requirements of new laws, regulations, executive orders, and other governmental requirements as necessary.

[1] Unless otherwise indicated, these procedures refer to calendar days.
[2] Black’s Law Dictionary 166 (10th ed. 2014) (hereinafter Black’s).
[3] Dictionary.com, https://www.merriam-webster.com/dictionary/bias (last visited Dec. 7, 2022)
[4] 42 C.F.R. § 50.603
[5] Black’s at 808
[6] 42 C.F.R. § 50.603
[7] Black’s at 1373.
[8] 42 C.F.R. § 50.603
[9] 42 C.F.R. § 50.603
[10] Christopher J. Pannucci, M.D., M.S., Edwin G. Wilkins, M.D., M.S., Identifying and Avoiding Bias in Research, 126 J. Plastic & Reconstructive Surgery, 619-625, (August 2010) Fig. 1; available at https://journals.lww.com/plasreconsurg/Fulltext/2010/08000/Identifying_and_Avoiding_Bias_in_Research.34.aspx.
[11] Business Days refers to University Business Days. See https://hr.msu.edu/time-off-leave/holiday-schedule.html.

Bias in Research Retrospective Review Procedures

Procedures for Retrospective Review of Bias in Research

Guidelines