AACP › About › Who We Are

AACP Research Misconduct Investigation Procedures

AACP Research

Introduction
This Investigation Policy is a necessary companion to the American Association of Colleges of Pharmacy Research Misconduct Policy. This Investigation Policy addresses AACP’s actions to resolve concerns arising from possible violations of its research misconduct policy.

If a conflict between the terms of this policy and any other AACP policy arise, this AACP Research Misconduct Investigation Policy shall govern in all cases involving research projects supported by internal AACP funds or resources or by external research sponsors through awards made to AACP,

Application
This Policy applies to AACP employees, volunteers, contractors or other individuals engaging in internal AACP research, i.e., research projects supported by internal AACP funds or resources or by external sponsors for the purpose of performing research through awards made to AACP.

For the purpose of these AACP Research Misconduct Investigation Procedures, Research Misconduct is as defined as in the AACP Policy on Research Misconduct:

  1. Fabrication is making up data or results and recording or reporting them.
  2. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
  3. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.
  4. Research misconduct does not include honest error or differences of opinion.

A finding of research misconduct under this policy will require that:

  1. There be a significant departure from accepted practices of the relevant research community; and
  2. The misconduct be committed intentionally, knowingly, or recklessly; and
  3. The allegation be proven by a preponderance of the evidence.

Research Misconduct Investigation Procedures

  1. Reporting Concerns: Concerns about research misconduct should be raised by sending an email to Sibu Ramamurthy, AACP Vice President of Finance/Chief Financial Officer (VPF/CFO) , at  sramamurthy@aacp.org.

    A complaint should include the following information, to the extent possible:
  • name of the individual involved in the alleged research misconduct and contact information;
  • name and contact information of the person raising the concern and how the person became aware of the alleged research misconduct;
  • names of any witnesses or others with pertinent information, and contact information, if known;
  • description of the alleged research misconduct, with the date, approximate time, location/setting/activity, and all known relevant facts and circumstances;
  • a clear statement of any facts that may indicate any ongoing concern of imminent threat to safety of any person(s) or safety or condition of property, and the sources of such facts, with contact information if known;
  • any relevant documents available to the person filing the complaint;
  • any other information that would help AACP understand the full nature of the alleged research misconduct; who was involved and who and what may be affected; who may have pertinent information and related context.

When an expression of concern regarding research misconduct has been received, disclosure of the identity of respondents and complainants is limited, to the extent possible, to those who need to know, consistent with a thorough, competent, objective and fair research misconduct proceeding, and as allowed by law. The AACP Research Misconduct Policy prohibits retaliation against those who raise concerns regarding research misconduct.

Except as may otherwise be prescribed by applicable law, confidentiality must be maintained for any records or evidence from which research subjects might be identified. Disclosure is limited to those who have a need to know to carry out a research misconduct proceeding.

However, AACP must disclose the identity of respondents and complainants to ORI pursuant to an ORI review of research misconduct proceedings.

  1. Initial Review: The AACP VPF/CFO will conduct a preliminary review of the report to determine if the allegation falls within the definition of research misconduct given in the AACP Research Misconduct Policy and is sufficiently credible and specific so that potential evidence of research misconduct may be identified. The AACP VPF/CFO may be assisted in this review by Fact-finders and Decision-makers, as identified in the AACP Research Misconduct Policy.  Fact-finders and Decision-makers assigned to address a particular research misconduct concern are required to be free of conflicts that would interfere with their performance of their responsibilities. When possible and applicable, Fact-finders for an allegation of research misconduct should not be part of the same AACP unit as the respondent.

In all cases strict confidentiality will be maintained during this review. Following this preliminary review, the AACP VPF/CFO will decide whether the report merits further consideration. Regardless of their decision, the AACP VPF/CFO will provide a report on the case to the Executive Committee of the AACP Board of Directors.

  1. Inquiry into Potential Research Misconduct: If the AACP VPF/CFO and Decision-maker(s) determine that the reported concern is a substantive allegation of research misconduct, AACP’s Fact-finders and Decision-makers will undertake an inquiry into the facts relating to the reported research misconduct concern.
    1. The purpose of an inquiry is to conduct an initial review of the evidence to determine whether to conduct an investigation. Therefore, an inquiry does not require a full review of all the evidence related to the allegation. Fact-finders will make recommendations to the Decision-makers regarding the suitability (or not) of an informal resolution (in the case where an inquiry indicates no research misconduct) or the need for an investigation into the research misconduct concern.
    2. At the time of or before beginning an inquiry, AACP will make a good faith effort to notify in writing the presumed respondent, if any. If the inquiry subsequently identifies additional respondents, AACP will notify them as well.
    3. To the extent it has not already done so at the allegation stage, AACP will, on or before the date on which the respondent is notified or the inquiry begins, whichever is earlier, promptly take all reasonable and practical steps to obtain custody of all the research records and evidence needed to conduct the research misconduct proceeding, inventory the records and evidence, and sequester them in a secure manner, except that where the research records or evidence encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments.
  2. Determination if an Inquiry is Warranted: An inquiry's purpose is to decide if an allegation warrants an investigation. An investigation is warranted if there is -
  1. A reasonable basis for concluding that the allegation falls within the definition of research misconduct under the AACP Research Misconduct Policy; and
  2. Preliminary information-gathering and preliminary fact-finding from the inquiry indicates that the allegation may have substance.

If the research involves PHS supported biomedical or behavioral research, research training or activities related to that research or research training, all special requirements under CFR Title 42 Part 93 will be met, including required disclosures to ORI regarding the instigation of an investigation into the allegation of research misconduct.

  1. Inquiry into Potential Research Misconduct:

AACP will complete its inquiry within 60 calendar days of its initiation unless circumstances clearly warrant a longer period. If the inquiry takes longer than 60 days to complete, the inquiry record must include documentation of the reasons for exceeding the 60-day period.

If the Decision-maker(s) determines that the results of the inquiry indicate that the allegation of research misconduct doesn’t fall within the definition of research misconduct in the AACP Research Misconduct Policy or that the allegation doesn’t have substance, AACP will notify the complainant and respondent of the decision not to proceed with an investigation. AACP will also notify the complainant and respondent if it decides to pursue an informal resolution of the research misconduct concern. (See the AACP Research Misconduct Policy, “RESPONDING TO ALLEGATIONS OF RESEARCH MISCONDUCT,” Section 5 “Informal Resolution.” Note that informal resolution is not an option when the inquiry finds an investigation into the allegation of research misconduct is warranted.)

  • The Decision-maker(s) will document its decision not to investigate in all cases. In cases where the allegation concerns PHS-funded research, the documentation will be sufficiently detailed to permit a later assessment by ORI of the reasons why AACP decided not to conduct an investigation. Consistent with CFR Title 42, Part 93, AACP must keep these records in a secure manner for at least 7 years after the termination of the inquiry, and upon request, provide them to ORI or other authorized HHS personnel.

If the Decision-maker(s) determines based on the inquiry that an investigation is warranted, they will create a written report of the inquiry which includes the following information:

  1. The name and position of the respondent;
  2. A description of the allegations of research misconduct;
  3. The PHS support, including, for example, grant numbers, grant applications, contracts, and publications listing PHS support, if applicable;
  4. The basis for recommending that the alleged actions warrant an investigation; and
  5. Any comments on the report by the respondent or the complainant.

If the research was PHS-funded, within 30 days of finding that an investigation is warranted, AACP must provide ORI with the written finding by the Decision-maker(s) and a copy of the inquiry report. AACP will also provide the following information to ORI on request

  1. The AACP policies and procedures under which the inquiry was conducted;
  2. The research records and evidence reviewed, transcripts or recordings of any interviews, and copies of all relevant documents; and
  3. The charges for the investigation to consider.

The Decision-maker will provide a copy of that determination and supporting facts to the respondent, along with a copy of AACP’s Research Misconduct Policy and Research Misconduct Investigation Procedures. For allegations related to PHS-funded research, AACP will also provide a link to CFR Title 42, Part 93, in compliance with which AACP policies and procedures were prepared. The respondent has an opportunity during a 14-day period that begins when the inquiry report is given to them, to again access the factual record and respond in writing, providing the Decision-maker with any relevant facts or circumstances that the responder believes should inform the investigation. AACP, in its discretion, may also provide a copy of its determination and all or portions of the inquiry report to the complainant and allow the complainant an opportunity to respond.

NOTE: In the case of PHS-funded research, at any time during a research misconduct proceeding, AACP must notify ORI and other PHS agencies, as relevant, of any special circumstances that may exist:

  1. Health or safety of the public is at risk, including an immediate need to protect human or animal subjects.
  2. HHS resources or interests are threatened.
  3. Research activities should be suspended.
  4. There is reasonable indication of possible violations of civil or criminal law.
  5. Federal action is required to protect the interests of those involved in the research misconduct proceeding.
  6. The research institution believes the research misconduct proceeding may be made public prematurely so that HHS may take appropriate steps to safeguard evidence and protect the rights of those involved.
  7. The research community or public should be informed.
  1. Investigation into Potential Research Misconduct:

When the Decision-maker has determined that an investigation is warranted, AACP will begin the investigation within 30 days after that determination is made.

As outlined in Point 5 above, AACP will notify the respondent in writing of the allegations within a reasonable amount of time after determining that an investigation is warranted, but before the investigation begins. AACP will algo give the respondent written notice of any new allegations of research misconduct within a reasonable amount of time of deciding to pursue allegations not addressed during the inquiry or in the inquiry report.

  1. Fact-Finding The Fact-finders will investigate the research misconduct allegation. In performing the investigation, the Fact-finders will:
    1. Custody of the records.  To the extent they have not already done so at the initial report or inquiry stages, take all reasonable and practical steps to obtain custody of all the research records and evidence needed to conduct the research misconduct proceeding, inventory the records and evidence, and sequester them in a secure manner. When the research records or evidence encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments. Whenever possible, the institution must take custody of the records 
      1. Before or at the time the institution notifies the respondent; and
      2. Whenever additional items become known or relevant to the investigation.
    2. Documentation.  Use diligent efforts to ensure that the investigation is thorough and sufficiently documented and includes examination of all research records and evidence relevant to reaching a decision on the merits of the allegations.
    3. Ensuring a fair investigation.  Take reasonable steps to ensure an impartial and unbiased investigation to the maximum extent practicable, including participation of persons with appropriate scientific expertise who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the inquiry or investigation.
    4. Interviews.  Interview each respondent, complainant, and any other available person who has been reasonably identified as having information regarding any relevant aspects of the investigation, including witnesses identified by the respondent, and record or transcribe each interview, provide the recording or transcript to the interviewee for correction, and include the recording or transcript in the record of the investigation.
    5. Pursue leads.  Pursue diligently all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of additional instances of possible research misconduct, and continue the investigation to completion.

Upon completion of the fact-finding portion of the investigation, the Fact-finders will provide to the Decision-maker the documented facts, together with any supporting documents and notes (including but not limited to interview transcripts or recordings.)

  1. Decision-making: The Decision-maker(s) will review the documented facts and supporting materials; and, if needed in the Decision-maker’s view, require any supplementary fact-finding to be undertaken by the Fact-finder.

The Decision-maker(s) will make a preliminary determination on whether or not research misconduct occurred, based on a preponderance of the evidence standard (see “Definitions” section), and prepare a draft investigation report. This draft investigation report will include:

  1. Allegations.  Describe the nature of the allegations of research misconduct.
  2. PHS support (if applicable.)  Describe and document the PHS support, including, for example, any grant numbers, grant applications, contracts, and publications listing PHS support.
  3. Institutional charge.  Describe the specific allegations of research misconduct for consideration in the investigation.
  4. Policies and procedures.  AACP’s policies and procedures under which the investigation was conducted (e.g., AACP Research Misconduct Policy, AACP Research Misconduct Investigation Proceedings, AACP Code of Conduct.)
  5. Research records and evidence.  Identify and summarize the research records and evidence reviewed, and identify any evidence taken into custody but not reviewed.
  6. Statement of findings.  For each separate allegation of research misconduct identified during the investigation, provide a finding as to whether research misconduct did or did not occur, and if so
  • Identify whether the research misconduct was falsification, fabrication, or plagiarism, and if it was intentional, knowing, or in reckless disregard;
  • Summarize the facts and the analysis which support the conclusion and consider the merits of any reasonable explanation by the respondent;
  • Identify the specific PHS support (if applicable);
  • Identify whether any publications need correction or retraction;
  • Identify the person(s) responsible for the misconduct; and
  • List any current support or known applications or proposals for support that the respondent has pending with non-PHS Federal agencies.
  1. Notification of Respondent: AACP will give the respondent a copy of the draft investigation report and, concurrently, a copy of, or supervised access to, the evidence on which the report is based. The comments of the respondent on the draft report, if any, must be submitted within 30 days of the date on which the respondent received the draft investigation report.

In its discretion, AACP may also provide the complainant a copy of the draft investigation report or relevant portions of that report. The comments of the complainant, if any, must be submitted within 30 days of the date on which the complainant received the draft investigation report or relevant portions of it.

The Decision-maker(s) will review any comments received from the respondent and complainant and make a final determination of whether research misconduct occurred.

  1. Final Report: The Decision-maker will prepare a final investigation report, which will capture the information from the draft investigation report and include and consider any comments made by the respondent and complainant on the draft investigation report.

In the case of research misconduct proceedings related to PHS-funded research, AACP will maintain and provide to ORI upon request all relevant research records and records of the institution's research misconduct proceeding, including results of all interviews and the transcripts or recordings of such interviews.

AACP will complete its investigation within 120 days of beginning it, including conducting the investigation, preparing the report of findings, providing the draft report to the respondent and, in AACP’s discretion the complainant, for comment, and sending the final report to ORI (in the case of allegations related to PHS-funded research.) In cases of research misconduct allegations involving research supported by PHS, if AACP is unable to complete the investigation in 120 days, AACP must ask ORI for an extension in writing.

  1. Consequences: Consequences for a finding of research misconduct are outlined in the AACP Research Misconduct Policy.
  2. Appeals: Appeal of a final determination of research misconduct is available to the respondent only if the appeal standards and appeal conditions given in Section 9 “Appeals” of the AACP Research Misconduct Policy are met. An appeal must be filed by a respondent within 30 days after that party receives notice of the final determination and any consequences imposed by the Decision-maker.
  • An appeal will be decided by the “Appeal Authority,” who are individual(s) appointed by the AACP Authorized Signing Official for this role, either for one particular appeal or for appeals generally. The Appeal Authority may be an individual (who may be a volunteer or employee of AACP or an external consultant retained by AACP) or an ad hoc or standing committee of such individuals. The Appeal Authority assigned to address a particular conduct concern are required to be free of conflicts that would interfere with their performance of their responsibilities.
  • The Appeal Authority will endeavor to decide an appeal within 60 days of receiving complete submissions filed before the appeal submission deadline, initiating the appeal. However, the Appeal Authority may extend the time on its own initiative for good cause and will notify the respondent in writing of any extension. The Appeal Authority will decide the appeal based on the submissions. Upon deciding the appeal, the Appeal Authority shall notify the respondent of the determination of the appeal. The determination of the appeal is final.
    • Any appeal of a misconduct finding related to PHS-funded research that could result in a reversal or modification of the findings of research misconduct in the investigation report filed with ORI must be completed within 120 days of the report filing. If AACP is unable to complete any appeals within 120 days, AACP must ask ORI for an extension in writing and provide an explanation for the request.
  1. Notification to ORI: For allegations related to PHS-funded research, AACP will provide notice to ORI of institutional findings and actions. Notice to ORI will include:
  1. Investigation Report.  Include a copy of the report, all attachments, and any appeals.
  2. Final institutional action.  State whether AACP found research misconduct, and if so, who committed the misconduct.
  3. Findings.  State whether AACP accepts the investigation's findings.
  4. Institutional administrative actions.  Describe any pending or completed administrative actions against the respondent.

At any point in a research misconduct proceeding related to PHS-funded research, AACP must notify ORI in advance if AACP plans to close a case at the inquiry, investigation, or appeal stage on the basis that the respondent has admitted guilt, a settlement with the respondent has been reached, or for any other reason, except the closing of a case at the inquiry stage on the basis that an investigation is not warranted or a finding of no misconduct at the investigation stage, which must be reported to ORI.

Definitions
An allegation means a disclosure of possible research misconduct through any means of communication. The disclosure may be by written or oral statement or other communication to an AACP official or a research sponsor.

A complainant means a person who in good faith makes an allegation of research misconduct.

Evidence means any document, tangible item, or testimony offered or obtained during a research misconduct proceeding that tends to prove or disprove the existence of an alleged fact.

Inquiry means preliminary information-gathering and preliminary fact-finding

Investigation means the formal development of a factual record and the examination of that record leading to a decision not to make a finding of research misconduct or to a recommendation for a finding of research misconduct which may include a recommendation for other appropriate actions, including administrative actions.

Preponderance of the evidence means proof by information that, compared with that opposing it, leads to the conclusion that the fact at issue is more probably true than not.

Research means a systematic experiment, study, evaluation, demonstration or survey designed to develop or contribute to general knowledge (basic research) or specific knowledge (applied research) relating broadly to public health by establishing, discovering, developing, elucidating or confirming information about, or the underlying mechanism relating to, biological causes, functions or effects, diseases, treatments, or related matters to be studied.

Research misconduct proceeding means any actions related to alleged research misconduct taken under this policy, including but not limited to, allegation assessments, inquiries, investigations, ORI oversight reviews, hearings, and administrative appeals.

Research record means the record of data or results that embody the facts resulting from scientific inquiry, including but not limited to, research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports, journal articles, and any documents and materials provided to an AACP official or representative of a research sponsor by a respondent in the course of the research misconduct proceeding.

Respondent means the person against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding.

Retaliation for the purpose of this part means an adverse action taken against a complainant, witness, or committee member by AACP or an AACP staff member in response to -

  1. A good faith allegation of research misconduct; or
  2. Good faith cooperation with a research misconduct proceeding.

These procedures were prepared to comply with PHS regulation Title 42 CFR Part 93, PHS Policies on Research Misconduct. Definitions given above have been adapted from the PHS regulation.

Copyright Notice
© American Association for the Advancement of Science for the benefit of and sponsored by the Societies Consortium on Sexual Harassment In STEMM (https://societiesconsortium.com/); original created by EducationCounsel LLC and used by AACP under member license. AACP made changes to the copyrighted work as permitted by the member license.

 

Back to Top