Section One:
Section Two:
Section Three:
Section Four:
Section Five:
Section Six:
Introduction:
Section Three: Institutional Responsibility
Introduction | Major Issues for Discussion | Case Study |
Footnotes | Additional Resources | Section Assessment and Certificate
Individual researchers have the responsibility to know and follow the rules regarding the responsible conduct of research. They also have the responsibility to understand the intention behind the rules and to work as ethically as possible. Officials at a research institution have the additionally responsibility of creating an environment that encourages both compliant and ethical research.
Employees, students, and volunteers should report suspected misconduct in research to the Research Integrity Officer. The institution, then, has related responsibilities to make sure that concerns about possible misconduct are treated seriously and with sensitivity toward all involved. Institutional responsibilities include:
1). Reviewing allegations;
By the end of this section, successful readers will be able to describe some of the ways that these institutional responsibilities can be met.
Major Issues for Discussion
1). Reviewing Allegations
It is ethically encouraged for researchers to report suspected research misconduct. Reporting can be as informal as a student discussing a concern about how notations are made in lab notebooks with the lab director or as formal as a written complaint sent to the Vice President of Research. Allegations may be made anonymously. Sometimes allegations are vague and lack the kind of substantiation necessary for officials to figure out what is going on. Regardless of the source or evidence backing an allegation, the official who receives the report has the responsibility to ask critical questions: Is it possible that misconduct occurred? Is further examination warranted?
2). Protecting Whistleblowers and Respondents
Whatever one's motivations for reporting possible misconduct, it is likely that the complainant will be met with suspicion from one's colleagues. It is particularly difficult for students or post-docs who are dependent upon the lab director and his or her mentoring to bring up concerns about what they see happening in the lab. They are legitimately worried about retaliation. The Federal Office of Research Integrity (ORI) "strongly believes in the importance of protecting whistleblowers who make good faith allegations of scientific misconduct to ORI or appropriate institutional authorities." Research institutions are responsible for making sure that whistleblowers and respondents are protected. ORI encourages institutions to adopt principles consistent with the Whistleblower Bill of Rights. These principles include:
1). Whistleblowers are free to disclose lawfully whatever information supports a reasonable belief of research misconduct as it is defined by PHS policy;
It is clear from these guidelines that the person making allegations does not have to be correct about his or her concerns, but the allegations must be made in good faith. It is possible for an observation or what one has overheard to be misinterpreted. The review of the allegation is a way of determining if there is the possibility of misconduct before the institution moves into a formal inquiry stage. When an allegation is made, it is usually possible to protect the identity of the complainant (whistleblower), and possibly the identity of the respondent as well. The institution has a dual responsibility at this stage to decide if there is a matter worth pursuing and to protect the reputations of complainants and respondents. Whistleblowers usually cannot be promised confidentiality if the complaint moves to an investigation. The whistleblower may need to be called as a witness in the proceedings. It is important for institutional officers to be clear with complainants about what level of confidentiality is reasonable to expect.
Complaints involving concerns regarding federally-funded projects can be made directly to relevant funding agencies if the potential whistleblower is concerned that the institution will not be sufficiently protective, or if the potential whistleblower is concerned that the allegation will not be reviewed in a satisfactory manner by the institution. The identity of the whistleblower is protected by funding agencies. The theory behind such protection is that if the funding agency finds that there is sufficient reason to conduct an inquiry, the issue is no longer between the complainant and respondent, but between the respondent, who must answer the inquiry, and the funding agency and institution, which will conduct the formal reviews. However, the jurisdiction of the funding agency is limited to projects for which funds from that agency were requested or provided.
The National Science Foundation's Office of Inspector General (OIG) follows this guideline, "To the extent possible the identity of informants who wish to remain anonymous will be kept confidential. To the extent allowed by law, documents and files maintained by NSF during the course of an inquiry or investigation of misconduct will be treated as investigative files exempt from mandatory pubic disclosure upon request under the Freedom of Information Act." Generally, OIG will inform the research institution of the alleged misconduct without naming the informant and encourage the institution to undertake an inquiry./2
3). Conducting Inquiries and Investigations
All relevant materials that could be evidential should be sequestered at this time. Removing relevant data from the respondent protects both the evidence and the respondent. Respondents are protected from charges that data was altered during an inquiry if they do not have access to the data.
The focus of an inquiry committee is not the determination of whether misconduct occurred. Through examination of documents and interviews with witnesses, the committee determines if there is sufficient evidence to proceed to a formal investigation. If the committee finds that there is not sufficient evidence to proceed to a formal investigation, the institution has no reporting requirement and should work to protect the reputations of both the complainant and the respondent. The record should be sealed unless a new charge of misconduct is made -- that the allegation was made with malicious intent. Notification to federal funding sources is required at the beginning of the inquiry stage only if the charge involves misuse of an animal or human subject, if federal funds are at risk of being misused, or if a felony is possible. If the allegation is substantiated, however, the institution must inform the federal funding agency and move forward to the investigation stage.
The investigation committee should have different membership from the inquiry committee. An investigation is conducted by an institutional committee of knowledgeable but disinterested parties. The purpose of the investigation committee is to determine whether research misconduct has taken place.
The investigation proceeds with involvement of any relevant federal funding agency and may take up to 120 days to complete. If the respondent "confesses" to misconduct or leaves the institution, the institution still has a responsibility to continue with the matter. The goal of the investigation committee is to determine if misconduct occurred, determine an appropriate response, report its findings to funding agencies, and initiate corrections or retractions for any relevant publications. The respondent's resignation does not change this institutional responsibility. Even without involvement of an external funder, research institutions have a responsibility to investigate and respond to credible evidence of research misconduct.
4). Creating and Maintaining Conflict of Interest and Conflict of Commitment Policies
The purpose of policies regarding conflicts of interest and commitment is to protect the institution from situations that might bias an individual's work or prove detrimental to the institution's mission or reputation.
Here are some of the important concepts from the University of Montana policy:
The University of Montana-Missoula actively encourages interactions with both the public and private sectors as an important component of its research, education, and public service activities. Research, educational, and public service activities supported by grants, contracts, or gifts from public and private entities and individuals provide a valuable source of funds, equipment, and topics for University of Montana-Missoula activities. Professional interactions, including consulting arrangements, between faculty and governmental entities and private businesses advance The University of Montana-Missoula's ability to provide a high-quality research and educational experience for students, and thus enhance their employment opportunities. The University of Montana-Missoula's licensing of technology, assisting in new business start-ups, and other forms of technology transfer to both public and private entities are critical to meeting society's needs.
A conflict of interest, or potential conflict of interest, occurs when there is a divergence between the faculty member's private interests and professional obligations to the University, such that an independent observer might reasonably question whether the faculty member's professional actions or decisions are determined by considerations of personal gain, financial or otherwise. A potential conflict of interest exists when a faculty member has a significant financial interest in a business that has any dealings with the University. An actual conflict of interest occurs when a faculty member has a significant financial interest in a business that could directly and materially affect, or be directly and materially affected by, the design, conduct, or use of facilities in, or reporting of, research, educational, or public service activities performed as part of the faculty member's duties at The University of Montana-Missoula.
A conflict of commitment, although this term is not used in The University of Montana policy, refers to conflicts based on the variety of roles that we all have, and the nature of relationships with colleagues or with external public or private parties. Financial interest is not required for conflicts of commitment./3
The University of Montana-Missoula assumes that potential for conflicts of interests or commitments will occur regularly in the normal conduct of activities. It is essential that any significant potential for conflicts be disclosed and reviewed by The University of Montana-Missoula prior to a faculty member entering into the situation or relationship. After disclosure, The University of Montana-Missoula can then make an informed judgment about a particular case and require appropriate oversight, limitations, or prohibitions.
The University requires disclosure of a significant financial interest when the interest in a single business, external to The University of Montana, by a faculty member or by an immediate family member exceeds $10,000 in annual income of all types in the past twelve months, and equity or ownership interest from all sources in a single entity exceeds five (5) percent ownership.
The University excludes disclosure income from royalties, seminars, lectures, or teaching engagements sponsored by public or non-profit entities, income from service on advisory committees or review panels for public or non-profit entities, and equity interest that, when aggregated for the faculty member and the faculty member's spouse and dependent children, meets both of the following tests:
All faculty members must temporarily disqualify themselves from any University of Montana-Missoula committee or review process that is considering an activity in which they have a significant financial interest. In addition, faculty members must also disclose to committee chairs and the appropriate administrator or executive officer any interest (business, financial, or family) that might cause the faculty member to compromise judgment while serving as a committee member or making advisory decisions.
Further information on The University of Montana's conflict of interest policy can be found at www.umt.edu/research/files/coi1297.txt. Conflict of interest and commitment policies can be found on most research institution Web sites. It is interesting to compare and contrast policies. Some differences between institutional policies include conditions under which disclosure is required, allowable number of days for consulting, and limitations on outside remuneration.
5). Federally Mandated Boards Relating to Research Ethics
The University of Montana's interpretation of federal and state law is that IACUC and IRB are open meetings. Investigators and interested other parties may attend to observe the committee's process and review. Research protocols involving animals or human participation are available for public examination. However, institutional interpretation, along with state law, may differ.
The institutional responsibilities for the Institutional Animal Care and Use Committee (IACUC) and the Institutional Review Board (IRB) are briefly described here. The work of those committees is more completely described in Sections V and VI, respectively.
The IACUC is appointed by the Vice President for Research and is composed of not fewer than three members, and shall include at least one individual who has no association with the research institution and at least one doctor of veterinary medicine. Before animals can be used for research or educational purposes, the IACUC must review and approve the animal use. In addition, the IACUC reviews the care and treatment of animals in all animal study areas and facilities at least semi-annually to evaluate compliance with applicable guidelines for appropriate animal care and treatment, keeps appropriate records of reviews conducted under sub-paragraph, and files with appropriate federal agencies a certification that required reviews have been conducted along with reports regarding any violations or instances of non-compliance./4
The IRB must have at least five members. Through the composition of the committee, the IRB must have a diversity relevant to the institution, community, and projects, including race, gender, and cultural backgrounds, experiential background, and sensitivity to community attitudes. The IRB should also be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, persons with disabilities, or persons from particular minority populations, one or more individuals who represent the vulnerable category (or who are knowledgeable about and experienced in working with these populations) should be members of the IRB.
Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in non-scientific areas. Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.
Each IRB shall, except when an expedited review procedure is used, review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in non-scientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting. An IRB shall review and have authority to approve, require modifications necessary for approval, or disapprove all research activities involving human participation in research./5
Case Study
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Case Study: Expensive Lesson.
Footnotes
1/ori.dhhs.gov/html/publications/guidelines_guidelin.ASP, p. 1.
2/See Werhane, P. and Doering, J. (1997). "Conflicts of Interest and Conflicts of Commitment" in Elliott, D. and Stern, J. (eds.). Research Ethics, A Reader. Hanover, NH: University Press of New England, pp. 165-196.
3/frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=45&PART=689&SECTION=4&YEAR=1999&TYPE=TEXT.
4/grants.nih.gov/grants/olaw/references/hrea1985.htm.
5/ohsr.od.nih.gov/mpa/45cfr46.php3#subparta.
Additional Resources
Below are links that may help you understand the concept of institutional responsibility a little better:
Section Assessment and Certificate Make sure you have reviewed all of the materials within this section, before you attempt the assessment.
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2). Protecting whistleblowers and respondents;
3). Conducting inquiries and investigations;
4). Reporting findings to appropriate constituencies;
5). Creating and maintaining conflict of interest policies; and
6). Appointing and supporting the Institutional Animal Care and Use Committee and the Institutional Review Board (that oversees human subjects research).
An allegation is any written or oral statement made by one or more complainants to an institutional official that indicates possible misconduct by one or more respondents. While everyone associated with research is strongly encouraged to report suspected misconduct, any person in a supervisory or administrative role is ethically required to do so.
It is ethically encouraged for researchers to report suspected misconduct because every person associated with research has a responsibility to ensure the integrity of the research environment at the institution. It seems to follow rather easily that reporting observations of possible misconduct is part of that responsibility. However, in practice, it is very difficult for individuals to come forward with their concerns.
2). Institutions have a duty not to tolerate or engage in retaliation against good-faith whistleblowers;
3). Institutions have a duty to provide fair and objective procedures for examining and resolving complaints, disputes and allegations of research misconduct;
4). Institutions have a duty to follow procedures that are not tainted by partiality arising from personal or institutional conflict of interest or other sources of bias;
5). Institutions have a duty to elicit and evaluate fully and objectively information about concerns raised by whistleblowers;
6). Institutions have a duty to handle cases involving alleged research misconduct as expeditiously as possible without compromising responsible resolutions; and
7). At the conclusion of proceedings, institutions have a responsibility to credit promptly, in public or private as appropriate, those whose allegations are substantiated./1
The inquiry is the second stage in the process of institutional handling of allegations of research misconduct. Institutions may take up to 60 days to complete inquiries regarding federally-funded projects. This level is a fact-finding mission, conducted by a committee of knowledgeable but disinterested parties working to determine if there is evidence that misconduct may have occurred. Once an allegation enters the inquiry stage, the respondent must be notified of the charges against him or her.
Institutions have a responsibility to guard against conflicts of interest in a variety of circumstances. During the inquiry and investigation stage of an allegation of misconduct, committee members should not have conflicts of interest or commitment, nor should inquiry and investigation committee members overlap. Avoiding conflicts on such committees is part of a broader conflicts policy for the institution. Most research institutions have adopted conflict of interest policies as prescribed by National Science Foundation and the Department of Health and Human Services.
Research institutions are required, by federal law, to appoint and support the Institutional Animal Care and Use Committee (IACUC) and the Institutional Review Board (for research involving human participation) (IRB). The committees are unusual in the research institution structure in that, unlike most committees, they are not advisory in nature. Instead, they have decision-making responsibilities. Institutional officers, for example, may not approve use of animal or human subjects over the denial of use by the appropriate committee.