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INTRODUCTION

These guidelines describe practices generally accepted by members of the Faculty of Medicine and already in effect in their laboratories. The primary intent of codifying them is to bring them to the attention of those beginning their careers in scientific research. These recommendations are not intended as rules, but rather as guidelines from which each group of investigators can formulate its own set of specific procedures to ensure the quality and integrity of its research.

1. SUPERVISION OF RESEARCH TRAINEES

Careful super-vision of new investigators by their preceptors is in the best interest of the institution, the preceptor, the trainee, and the scientific community. The complexity of scientific methods, the necessity for caution in interpreting possibly ambiguous data, and the need for advanced statistical analysis, all require an active role for the preceptor in the guidance of new investigators. This is particularly true in the not uncommon circumstance of a trainee who arrives in a research unit without substantial experience in laboratory science.

Recommendations

• 1. The responsibility for super-vision of each junior investigator should be specifically assigned to some faculty member in each research unit.

• 2. The ratio of trainees to preceptors should be small enough that close interaction is possible for scientific interchange as well as oversight of the research at all stages.

• 3. The preceptor should supervise the design of experiments and the processes of acquiring, recording, examining, interpreting, and storing data. (A preceptor who limits his/her role to the editing of manuscripts does not provide adequate supervision.)

• 4. Collegial discussions among all preceptors and trainees constituting a research unit should be held regularly, both to contribute to the scientific efforts of the members of the group and to provide informal peer review.

The preceptor should provide each new investigator (whether student, postdoctoral fellow, or junior faculty) with applicable governmental and institutional requirements for conduct of studies involving healthy volunteers or patients, animals, radioactive or other hazardous substances, and recombinant DNA.

11. DATA GATHERING, STORAGE,AND RETENTION

A common denominator in most cases of alleged scientific misconduct has been the absence of a complete set of verifiable data. The retention of accurately recorded and retrievable results is of utmost importance for the progress of scientific inquiry. A scientist must have access to his/her original results in order to respond to questions including, but not limited to, those that may arise without any implication of impropriety. Moreover, errors may be mistaken for misconduct when the primary experimental results are unavailable. In addition, when statistical analysis is required in the interpretation of data, it should be used in the design of studies as well as in the evaluation of results.

Recommendations

1. Custody of all original primary laboratory data must be retained by the unit in which they are generated. An investigator may make copies of the primary data for his/her own use.

2. Original experimental results should be recorded, when possible, in bound books with numbered pages. An index should be maintained to facilitate access to data.

3. Machine print-outs should be affixed to or referenced from the laboratory notebooks.

4. Primary data should remain in the laboratory at all times and should be preserved as long as there is any reasonable need to refer to them. The chief of each research unit must decide whether to preserve such primary data for a given number of years or for the life of the unit. In no instance, however, should primary data be destroyed while investigators, colleagues, or readers of published results may raise questions answerable only by reference to such data.

AUTHORSHIP

A gradual diffusion of responsibility for multi-authored or collaborative studies has led in recent years to the publication of papers for which no single author was prepared to take full responsibility. Two critical safeguards in the publication of accurate, scientific reports are the active participation of each co-author in verifying that part of a manuscript that falls within his/her specialty area and the designation of one author who is responsible for the validity of the entire manuscript.

Recommendations

1. Criteria for authorship of a manuscript should be determined and announced by each department or research unit. The Committee considers the only reasonable criterion to be that the co-author has made a significant intellectual or practical contribution. The concept of "honorary authorship" is deplorable.

2. The first author should assure the head of each research unit or department chairperson that he/she has reviewed all the primary data on which the report is based and provide a brief description of the role of each co-author. (In multi- institutional collaborations, the senior investigator in each institution should prepare such statements.)

3. Appended to the final draft of the manuscript should be a signed statement from each co-author indicating that he/she has reviewed and approved the manuscript to the extent possible, given individual expertise.

IV. PUBLICATION PRACTICES

The Committee has observed certain practices that make it difficult for reviewer and reader to follow a complete experimental sequence: the rapid publication of data without adequate tests of reproducibility or assessment of significance, the publication of fragments of a study, and the submission of multiple similar abstracts or manuscripts differing only slightly in content. In such circumstances, if any of the work is questioned, it is difficult to determine whether the research was done inaccurately, the methods were described imperfectly, the statistical analyses were flawed, or inappropriate conclusions were drawn. Investigators should review each proposed manuscript with these principles in mind.

Recommendations

1. The number of publications to be reviewed at the time of faculty appointment or promotion should be limited in order to encourage and reward bibliographies containing fewer but more substantive publications rather than those including many insubstantial or fragmented reports. (It has been suggested, for example, that no more than 5 papers be reviewed for appointment as Assistant Professor, no more than 7 for Associate Professor, and no more than 10 for Professor.)

2. Simultaneous submissions of multiple similar abstracts or manuscripts to journals is improper.

V. LABORATORY GUIDELINES

Because each research unit addresses different scientific problems with different methods, each unit should develop its own specific guidelines to identify practices that seem most likely to enhance the quality of research conducted by its members. Those guidelines should be provided to the new investigators upon starting work.

INTRODUCTION

These guidelines outline principles that should be followed at Harvard Medical School when conducting research. They are a supplement to the Guidelines for Investigators in Scientific Research, first issued in February 1988. Clinical research may be defined as investigations involving human subjects or the use of patient samples. The scientific practices described here are generally accepted by investigators conducting both multicenter and single-institution clinical studies and help ensure both the quality and integrity of scientific findings in clinical research. The guidelines are not intended to relieve investigators of any ethical obligations that may be imposed by individual Institutional Review Boards overseeing the rights of Study subjects in clinical research.

A major component of clinical research consists of either prospective clinical trials or retrospective studies based on medical or administrative records. Of these two types of studies, prospective trials contain fewer chances for investigator bias and for lost or incomplete data than do retrospective studies, and are to be preferred whenever they are feasible. Some phenomena, however, such as rare diseases or diseases requiring exceptionally long follow-up, can only be studied from a case series assembled from medical records. These guidelines address issues that arise in both types of studies.

The implementation of these guidelines rests within each of the affiliated institutions and the department in which the research is conducted, Whenever research is carried out by non-faculty, such as a student or fellow, the supervisor of that individual is responsible for ensuring that these guidelines are followed.

1. EXPERIMENTAL DESIGN

Successful clinical studies acknowledge the complexity of conducting scientific research with human subjects, and are based both on the principles of experimental design and on respect for the rights of study subjects. Experiments in human subjects generally have highly variable outcomes, and efficient designs that lead to unbiased conclusions are critical.

Recommendations

1. Each study, whether it be observations on one or more patients, a randomized trial, or a population based study, should have clearly articulated research objectives that can be achieved from a successful execution of the study design.

2 Whenever some aspects of a study involve clinical or scientific specialties outside the expertise of the investigator, drafts of the protocol or research plan should be circulated to specialists in those areas for review and comment.

3. Every prospective or retrospective clinical study should have a written protocol or research plan that states the goals of the study, provides a background and rationale for the study, specifies the criteria for inclusion or exclusion of cases, outlines the methods and timing of follow-up, gives a precise definition of the types of anticipated outcome measures, and gives the details of the statistical design. The study design should minimize the possibility for investigator bias in the interpretation of the results. The design specification may range from a description of anticipated measurements in an exploratory study to a precise specification of the number of cases that will be registered in a phase III randomized trial. In the case of prospective trials, the protocol should describe in detail how patients are to be treated or managed. Any substantial changes to the conduct of the study, including modifications of the sample size, eligibility criteria, or treatment regimens, should be reflected in amendments made to the protocol or research plan and approved by coinvestigators and the Institutional Review Board.

4. In randomized clinical trials, the sequence of treatment assignments should be prepared by a statistician or other experienced investigator associated with the trial and kept confidential. In no instance should an investigator treating patients on the trial know the sequence of potential treatment assignments.

5. Clinical studies all require approval of local Institutional Review Boards. Every prospective clinical study should contain an Informed Consent form that explains in clear, non- technical terms the possible risks and benefits for subjects participating in the trial.

11. DATA MANAGEMENT AND TRIAL MONITORING

Complete and accurate data are an essential part of the record of any clinical research. Since serious problems can occur when data are missing or are not consistent with source medical records, each study should include a plan for the keeping of accurate and well documented data not subject to loss through computer failure or insecure storage.

Recommendations

1. In prospective trials, data should be abstracted from source medical records as the trial proceeds, using data collection forms designed at the outset of the study. Data collection forms should also be used in retrospective record studies.

2. The criteria for the evaluation of study subjects (including the classification of outcome and any treatment side effects) should be specified in the protocol or research plan.

3. Interim review of the data from an ongoing trial should make use of statistical methods that guard against increased false-positive or false-negative reporting rates caused by inappropriate conclusions from preliminary analyses.

4. For research involving primary data collection, the principal investigator should retain original data for as long as practically possible, but never for less than five years from the first major publication or from the completion of an unpublished study. All data should be kept in the research unit responsible for conducting the study. Copies of computer programs and the results from statistical calculations used in research involving nationally gathered survey data should also be kept by research units for a minimum of five years from publication based on these results. After notification to responsible departmental officials, principal investigators may make copies of original data or computer programs for personal use or when moving to another research unit or institution.

5. If primary data are kept on a computer file, backup files should be maintained, preferably at a second site, to prevent loss from computer failure.

SCIENTIFIC REPORTING

Writing a manuscript reporting the results of a clinical study is a complex and demanding task. Unclear or ambiguous reports reduce the value of a study and may lead to a discrediting of the research.

Recommendations

I . The statistical analysis used in reporting the results should coincide with the planned analysis used to design the study. Reasons should be given in the manuscript for any different analyses that are used.

2. All cases registered in a clinical trial or records reviewed in a retrospective study must be accounted for in any manuscript reporting the results. Any case not used in the analysis of outcome data should be identified (by case number) and the reason for exclusion noted.

. AUTHORSHIP

Clinical studies often involve investigators from several subspecialties, and it may not always be possible for a single investigator to confirm each piece of data used in the report of a trial. While each participating investigator must be actively involved in verifying the sections of a manuscript that discuss his/her specialty area, there must nevertheless be a primary author who is responsible for the validity of the entire manuscript.

Recommendations

I . Criteria for authorship of a manuscript should be determined and announced by each department or research unit. The committee considers the only reasonable criterion to be that the co-author has made a significant intellectual or practical contribution. The concept of "honorary authorship" is deplorable.

2. The first author should assure the head of the research unit or department chairperson that he/she has reviewed all primary data on which the report is based and provide a brief description of the role of each co-author. (In multi- institutional collaborations, the senior investigator in each institution should prepare such statements.)

3. Appended to the final draft of the manuscript should be a signed statement from each co-author indicating that he/she has reviewed and approved the manuscript to the extent possible, given individual expertise.

PRINCIPLES

The integrity of the teaching, research and clinical programs of the Faculty of Medicine requires that the Faculty pay careful attention to and resolve in an equitable manner allegations of misconduct of faculty appointees and fellows.

Because of variations in such factors as the kind of misconduct alleged, the seriousness of the allegations, the nature of the dispute over the facts, and the interests and involvement of other private or public institutions and agencies, the course of action that will enable the Faculty to fulfill this responsibility in the best possible manner is likely to vary from case to case. Accordingly, the procedures set forth below permit flexibility and are designed to provide a framework that should enable equitable resolution of allegations of misconduct in a wide variety of circumstances. When applying these procedures to a specific case, persons acting on behalf of the Faculty and others involved in the proceedings should keep in mind the following concerns:

The importance of the Faculty's maintaining standards consistent with the highest traditions of teaching, patient care, and research in medicine and with the lawful obligations of the Faculty.

The responsibility of the Faculty to the public and the scientific community and to the private and public institutions and agencies with which the Faculty is affiliated or has contractual or other arrangements.

The necessity of the Faculty's protecting the rights and reputations of all individuals, including the person who is alleged to have engaged in misconduct and the person who has made the allegation.

The necessity of the Faculty's resolving allegations with care and objectivity, with ample opportunity for all interested parties to be heard, and as promptly as the circurnstances permit.

PROCEDURES

1. The Office of the Dean shall have principal responsibility for assessing a proper response to allegations' of misconduct concerning faculty appointees and fellows. To enable the Office of the Dean to meet this responsibility, all allegations of misconduct, whether initially received by a Department Head or other person, shall be promptly brought to the attention of the Office of the Dean (and where appropriate, the Chief Executive Officer of an affiliated institution) unless they are clearly frivolous or otherwise lacking in substance.

2. Upon receipt of an allegation of misconduct, the Office of the Dean and, in those instances where the faculty member has a dual appointment, the Chief Executive Officer of the other institution shall determine, after such consultation as may seem appropriate, whether primary responsibility for resolving the allegation rests with the Faculty or with another institution. For example, primary responsibility for resolving an allegation of misconduct in connection with

'An allegation will ordinarily be made by a written statement describing the misconduct in sufficient detail to form the basis of an inquiry.

care of a patient would ordinarily reside in a hospital. In the case of an allegation pertaining to externally funded research, primary responsibility ordinarily rests with the institution that has administered the research grant or contract. An affiliated institution that has received support for research by a Harvard appointee may request, however, that allegations related to research by such appointees be dealt with by the Medical School. In any case, where the interests of two or more institutions are significantly implicated, it is expected that such inquiry and any investigation will proceed with the simultaneous participation of all concerned institutions, with agreement regarding which institution bears primary responsibility.

3. If primary responsibility rests with the Faculty, the Office of the Dean shall determine whether, taking into account the nature of the allegation, it is appropriate to attempt to resolve the matter through informal processes and discussions. The affected Department Head shall ordinarily have the responsibility for such efforts. Final resolution through informal means shall require the approval of the Office of the Dean. When primary responsibility rests with an affiliated institution, notice of resolution should be transmitted to the Office of the Dean.

4. If the matter is not resolved under paragraph 3, and if in the view of the Office of the Dean further proceedings are required, the Office of the Dean shall, in the absence of any specific Faculty procedure designed to cover the subject matter of the allegation, refer the allegation to the Committee on Faculty Conduct' with the request that the Committee make such factual inquiry, investigation, findings and recommendations to the Office of the Dean as seem appropriate to the circumstances. If there is a dispute over facts or for other good cause, the Office of the Dean, after consultation with the Chairperson of the Committee and other appropriate people, may first create one or more panels of inquiry of one or more individuals, who need not be members of the Committee, to inquire into the facts and submit the result of its inquiry to the Committee. In deciding upon the size and composition of the Panel, the Office of the Dean, to help insure competence and objectivity, shall take into account such factors as:

a) the subject matter of the inquiry, including the desirability of the panel's possessing competence in a specialized area or investigative skills,

b) the desirability of including on the panel persons associated with anothcr affiliated hospital or individuals who are not mernbers of the Faculty or not associated with Harvard University, and

c) the importance of selecting people who have had no prior involvement in the subject matter of the inquiry.

The Committee, with the benefit of a report from the panel of inquiry, if one is created, and after such further investigation, deliberations and proceedings as it deems appropriate or necessary, taking into account any applicable governmental regulations, shall submit its report to the Office of the Dean. The Committee will submit conclusions and, ordinarily, comments on gravity of offense possible sanctions, and prevention of future misconduct.

The Committee on Faculty Conduct, appointed by the Dean, shall consist of nine faculty members with overlapping three-year terms.

5. The Office of the Dean, after receiving comments on the report from such other people as may seem appropriate, shall decide the matter and take such action or make such recommendations as may be required. In cases involving another institution, the Dean will confer with the Chief Executive Officer of such institution in reaching a final resolution and applying appropriate sanctions. Sanctions may range, for example, from a letter of censure, to probation and monitoring, to termination of appointment.

6. The Office of the Dean, in carrying out its responsibilities under these procedures, shall bear in mind the concerns of the Faculty as set forth in the preamble and in particular:

a) the importance of care, fairness and objectivity, and of the appearance of these attributes,

b) the necessity of informing at the appropriate time other Faculty and University officers, including the Chairperson of the Committee on Faculty Conduct, the Head of the Department(s) involved, and the General Counsel to the University, of the existence of allegations, and of consulting with these and other Faculty and University officers as resolution of allegations progresses,

c) the responsibility of informing and consulting with officers of affiliated institutions and of other private and public institutions and agencies to the extent necessary to meet in good faith the obligations of the Faculty to others, and of coordinating the Faculty's proceedings with those of affected institutions and agencies,

d) the importance of protecting the reputations of individuals and to that end ordinarily maintaining confidentiality to the extent practicable and to the extent consistent with other obligations of the Faculty during the course of and at the conclusion of proceedings,

e) the need to protect the rights of the person alleged to have engaged in misconduct, including the right to be informed with specificity at the appropriate time of the allegations and the evidence in support of the allegations, and the need to discuss with that person the procedures to be followed,

f) the need to protect the rights of individuals who, in good faith, make allegations,

g) the importance of using the' staff resources of the Faculty and the University to aid in any inquiry and of broadening the scope of any inquiry, when indicated, to make certain that the full obligations of the Faculty are met, and

h) the need to make certain that the President of the University is informed when allegations may constitute grave misconduct under the Third Statute of the University and that resolution of the matter proceeds with this fact in mind.

7. The Office of the Dean and the Committee on Faculty Conduct shall maintain records of any proceedings in which they are involved.

Adopted by the Faculty Council (Harvard University Faculty of Medicine) on December 14, 1989.

ADDENDUM

When an allegation of misconduct by a Faculty appointee or fellow pertains to research, research training, applications for support of research or research training, or related activities for which Public Health Service (PHS) funds have been provided or requested, the following additional principles and procedures shall be observed in accordance with applicable governmental requirements:

1. Where the Office of the Dean determines that there is an allegation or other evidence of possible misconduct that would be subject to the Final Rule of the PHS entitled "Responsibilities of Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science, 11 or any successor document ("PHS Rule"),'the Office of the Dean, after consultation with the Chair of the Committee and other appropriate people, shall create one or more panels of inquiry as described in the "Principles and Procedures for Dealing with Allegations of Faculty Misconduct." The panel(s) shall conduct an inquiry in accordance with the requirements of the PHS Rule and shall present a written report of the findings within sixty calendar days to the Committee on Faculty Conduct.

2. Within thirty days after receiving the report of the panel of inquiry, the Committee shall determine whether the findings of that inquiry provide sufficient basis for conducting an investigation. If deemed to be necessary, such investigation shall be conducted in accordance with the requirements of the PHS Rule and with such additional assistance from the members of the panel of inquiry as the Cominittee shall deem necessary and appropriate.

3. In the event the Committee concludes that an investigation is warranted, the Office of the Dean shah report this decision in writing to the Director, Office of Scientific Integrity of the National Institutes of Health (OSI), on or before the date the investigation begins and shall take any other actions required by the PHS Rule.

4. The Committee shall submit a report of its investigation, including any recommended sanctions, to the Office of the Dean upon its completion. Unless an extension of time has been granted by OSI in accordance with the requirements of the PHS Rule, such report shall be submitted to the Office of the Dean within ninety days of the initiation of such investigation.

5. After receiving the final report and such comments from other persons as may seem appropriate, the Office of the Dean shall decide the matter and take such action or make such recommendations as may be deemed fitting, including submission of the final report to the OSI and any other actions required by the PHS Rule. In cases involving another institution, the Dean will confer with the Chief Executive Officer of such institution in reaching a final resolution.

' "Misconduct" or "Misconduct in Science" means fabrication falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community_for proposing, conducting or reporting research. It does not include error or honest differences in interpretations or judgments of data.

The Harvard University Faculty of Medicine welcomes industrially supported research agreements which stimulate its investigators, promote technological transfer, and provide valuable support. At the same time, it recognizes the need to avoid arrangements that might compromise, or seem to compromise, its intellectual principles and purposes and the freedom of inquiry that members of the Faculty enjoy. As an institution, the University benefits from public research funds and the public's trust, and it has an obligation to develop its research discoveries with concern for the public's interest.

This statement outlines some general principles - concerning how and why research is conducted within the Faculty of Medicine with which all research agreements concluded with for-profit external sponsors (referred to, hereafter, as industrially-sponsored research agreements) should conform.

1. CONDUCT OF RESEARCH

The exchange of information and the discussion and interchange of ideas are basic elements of all University research. Agreements to perform secret research in Harvard laboratories are unacceptable.

A. The proscriptions on secrecy in industrially-sponsored research agreements must conform with those that apply to federally-sponsored research. If involvement in a research project would inhibit free and open interactions among scholars, the University should not accept it. However, it is recognized that it may be appropriate to accept confidential background information from industrial sponsors. Such disclosures should be minimized and should be made available only to those members of the research team who require access to them. Harvard and the principal investigator should assure that the confidential nature of the information is understood by those who receive it and should exert reasonable efforts (no less than the protection given Harvard's own confidential information) to maintain such information in confidence. Acceptance of confidential background information must not be permitted to affect the ability of investigators to openly publish all the results of sponsored research. Investigators may agree not to include confidential background information in publications so long as such emissions do not affect the reporting of research results and the ability of other scholars to replicate the published results.

B. It is essential that the research of students and postdoctoralfellows-in-training contribute, and be perceived to contribute, to their scholarly development. They should not ordinarily participate in inclustrially-sponsored research that involves confidential information or otherwise constrains the right to publish or communicate Freely. Exceptions consistent with the principles of Faculty of Medicine should be approved in advance by the student's Department or at a higher level, In addition, Departments,

C.degree-granting committees and/or the Division of Medical Sciences should periodically review the work of students engaged in industrially-sponsored research to see that the educational commitment of the University to its students is maintained.

Agreements may permit industrial sponsors to examine manuscripts for potential inventions or discoveries on which patent applications should be filed. With Principal Investigator approval, sponsors may be given an advance period of thirty (30) days to review such manuscripts before they are submitted for publication so that optimal protection of intellectual property can be achieved. If necessary to permit the preparation and filing of patent applications before publication, the Principal Investigator may agree to delay submission for an additional period of up to thirty (30) days. Agreements with industry may not otherwise restrict the rights of investigators to publish their findings nor to communicate their research results fi7eely in other ways consistent with ethical and professional standards. Agreements to treat University-based research as confidential, to withhold publication, or to pen-nit sponsors to modify materials submitted for publication, are unacceptable.

D. The responsibility for the design and conduct of industrially- sponsored research programs and flexibility in directing them must remain with principal investigators. Sponsors may consult on matters of mutual concern but they may not dictate how research shall proceed.

E. Protocols for research to be funded by industry must be approved by the Department head.

F. Faculty members should be informed of the existence of industrially-sponsored agreements in their Department, and any special provisions in these agreements should be explained to them

G. General information on the subject, duration, funding sources, and budget of each industrially-sponsored research agreement should be openly available, along with information on whether there are any associated exclusive or nonexclusive patent agreements or any restrictions on open communication.

H. The support of a major portion of a faculty member's research by a single corporate sponsor is generally undesirable; whenever such support is permitted, the research should be periodically reviewed and approved by the Dean.

1. It is expected that these guidelines on free and open exchange of information will be followed in all instances that involve concepts, processes, products, and other information about natural phenomena. There may, however, be situations (for example, studies involving records of individuals or identifiable industrial organizations, or university-coordinated educational programs of an

n apprenticeship character) where exceptions to these guidelines are consistent with the University's educational, professional and scholarly principles. Such exceptions should be granted only after detailed review by the appropriate Dean with advice from appropriate Faculty Committees, and the reasons should be publicly explained.

11. MOTIVATION FOR RESEARCH (CONFLICTS OF INTEREST)

Section IL Motivation for Research (Conflicts of Interest) has been superceded by the Policy on Conflicts of Interest and Commitment (p.12).

III. QUALITY OF RESEARCH (PROJECT REVIEW)

The distinction between fundamental intellectual inquiry and commercially targeted development is not always clear and no faculty committee should attempt to define a line of demarcation. Many investigators in the faculty of Medicine are committed to studying tools and processes whose primary purpose is to benefit the health or welfare of society in areas that might have commercial value. Nevertheless, the following University principles and policies apply:

A. The primary assurance of the quality of research carried out under University auspices stems from the scholarly qualifications required of individual principal investigators.

B. Since most federally or foundation sponsored research proposals are subject to peer review, prior approval by the Dean of the scientific content of proposals to conduct such research is often perfunctory. In the absence of other review processes, the Department head should examine the suitability of an industrially-sponsored research proposal before granting Departmental approval. When proposals are large, extend over a long period, and/or entail a substantial conurritment of a Department's resources, the Department head and/or Dean may arrange for an additional and more extensive review. Continuing projects should be subject to periodic review.

C. The responsibility faculty members bear for the intellectual development of their research students and the responsibility of the Department, degree-granting committee and/or the Division of Medical Sciences to oversee graduate student research are especially important when industriallysponsored research is involved, and when conflicts of interest may appear to exist for faculty members or for the University.

IV. COMMERCIAL APPLICATIONS OF RESEARCH (PATENT LICENSING)

A. License negotiations should be governed by the University's policy on patents and copyrights, and especially the principle that any invention deriving from University-based research should be developed fully and rapidly in the public interest. In some instances, this goal may be achieved by granting non- exclusive licenses to every company that wishes to develop the research commercially. In others, exclusive licenses may be more appropriate. When they are, for example to justify the investment a pharmaceutical company must make in testing before commercial introduction of a new product, the potential exclusive licensee should satisfy Harvard that:

1. commercial products for public use will be developed as or more effectively through exclusive licenses than through non- exclusive licenses; and that

2. adequate resources can and will be committed to bringing these commercial products promptly into use.

B. The University should retain the right to "march-in" if, after a suitable period, a licensee has not developed and/or commercialized the discovery satisfactorily.

C. The prospective granting of exclusive licenses in industrially- sponsored research agreements raises a number of questions. When one does not know what the invention Will be, one cannot demonstrate in advance that an exclusive license will be needed nor that the sponsor will be able to develop it effectively. Accordingly, prospective exclusive licensees should be required to give evidence of their willingness and ability to develop and commercialize the kinds of products or processes likely to result from the research.

in cases in which the investigator or the University has a significant private financial relationship with a potential industrial sponsor of research, it should ordinarily be presumed that a prospective exclusive license would create at least the perception of a conflict-of-interest. Prospective exclusive licensing in such situations should only be contemplated after the Dean or his designee (or, for agreements not emanating from a single Faculty, a committee of Deans or their designees) has examined the private financial relationships, the suitability of the research, and the licensing terms. The Harvard Corporation should be advised of the background and conditions of any such proposed arrangement.

INTRODUCTION

An important goal of the Harvard Faculty of Medicine is to make scientific discoveries that will benefit the sick and suffering. For many years the Faculty has worked hard to achieve this goal. In 1980, the United States Congress explicitly sanctioned and facilitated this process with the passage of legislation designed to stimulate the commercialization of faculty inventions by permitting academic institutions and scientists to benefit financially if their federally- sponsored research led to commercial products. Moreover, during the past decade the rate of growth of biomedical research has outpaced federal funding, compelling universities and hospitals to develop alternative sources of revenue to support the expenses associated with their educational, research and clinical missions.

In response to these influences, biomedical research institutions have cultivated a growing variety of relationships with industry which promise to benefit the public as well as the institutions themselves, their faculty and staff, and their industrial partners. Over the last several years, these relationships have grown substantially, bringing new resources to the support of science and facilitating the translation of knowledge from the laboratory to the bedside. The Harvard Faculty of Medicine remains strongly committed to continued growth in these innovative and mutually beneficial relationships.

Together with these benefits, the growing partnership between for- profit enterprises and the University has created new possibilities for conflicts of interest. These conflicts arise from a faculty member's opportunities to benefit financially either from the outcome of his/her' research or from the legitimate activities conducted in the course of his responsibilities as a faculty member. In light of these possibilities, there is emerging public concern regarding the appropriateness of some relationships between academic medicine and industry.

Public trust in the enterprise of academic medicine and the legitimacy of its powerful role in society require a constant amenability to public scrutiny. Consequently, it is necessary at this time to ensure the continued confidence of the public in the judgment of researchers and clinicians and in the dedication of academic research institutions to the integrity of the scientific enterprise. The strength of this assurance is based on

'Masculine parts of speech are hereafter presumed to include the feminine

two assumptions underlying the explicit rules and implicit norms governing faculty behavior at the Harvard Medical School:

that the vast majority of scientists are honest and conduct their research with the highest standards and integrity, and,

that, for the vast majority of cases, self-regulating structures and processes in science are effective.

Based on these assumptions, the Faculty of Medicine believes that with clear guidelines and principles, in conjunction with appropriate mechanisms for supervision and monitoring, cooperation between industry and academic medicine is consistent with the highest traditions of the medical profession and can energize scientific creativity.

This policy is intended to serve as a guide for faculty members in structuring their relationships with industry and other outside ventures in view of their academic responsibilities for teaching, research and patient care. Faculty members are expected to make reasonable inquiry as to whether their relationships and activities fall within the provisions of the policy. It is not the intent of this policy to regulate or eliminate all situations of conflict of interest, but rather to enable faculty members to recognize situations that may be subject to question and ensure that such situations are properly reviewed and, if necessary, supervised or monitored. Thus, an integral part of the policy is a disclosure mechanism whereby faculty members regularly review their activities. The guidelines are intended to maintain the professional autonomy of scientists and physicians inherent in the self-regulation of science. These guidelines should be viewed as complementing and elaborating upon the Faculty of Medicine's Statement on Research Sponsored by Industry'.

The policy fulfills two other purposes as well. First, it provides faculty members with meaningful guidance for the continued development and future structuring of productive relationships with industry. Second, by virtue of its explicit nature and provision for full disclosure, the policy will provide assurance to the faculty, the University, and most importantly the public, that such relationships have been examined and will be conducted in a manner consistent with institutional and public values. It is expected that these relationships will allow the University and its affiliated Hospitals to pursue energetically new knowledge in the biomedical sciences and to insure that the transfer of such knowledge to the care of patients is rapid and cost-effective.


TYPES OF CONFLICTS

Conflicts of Commitment

With the acceptance of a full-time appointment in the Faculty of Medicine, an individual makes a commitment to the University (and Hospital, if part of a hospital-based department)'that is understood to be full-time in the most inclusive sense. Full-time members of the Faculty of Medicine are expected to devote their primary professional loyalty, time, and energy to their teaching, research, administrative responsibilities and, where applicable, patient care at the School and its affiliated Hospitals. Accordingly, they should arrange outside activities and financial interests so as not to interfere with the primacy of these commitments. The Faculty of Medicine recognizes that its members may engage in outside professional work, and to the extent these activities serve the Faculty's interests, as well as those of the participant, the Faculty of Medicine approves of such involvement. However, no more than twenty percent (20%) of a full- time faculty member's total professional effort may be directed to outside work, not to exceed the equivalent of one working day per week. Potential conflicts of commitment must be disclosed and resolved as described in the section on implementation in Appendix B.

Members of the Faculty whose appointments are less than fialltime are expected to devote professional loyalty, time, and energy to their teaching, research, patient care, and administrative activities, in accordance with their agreed-upon time commitments.

Conflicts of Interest

A Faculty Member' is considered to have a conflict of interest when he, any of his Family, or any Associated Entity possesses a Financial Interest in an activity which involves his responsibilities as a member of the Faculty of Medicine. Included in these responsibilities are all activities in which the Faculty Member is engaged in the areas of teaching, research, patient care and administration.

The following is a representative and non-inclusive list of extramural relationships subject to this policy. These examples have been divided into three groupings.

Categories Ila) and lab) consist of relationships that are generally not allowable, with certain de rninimis exceptions. Categories I(c) - 0) consist of relations that are generally allowable only after disclosure, review, and approval with oversight by the University or affiliated Hospital with advice from a standing committee of the Harvard Medical Center when requested. A second classification (Category 11) consists of instances that will ordinarily be permissible following disclosure and, where necessary, the implementation of oversight procedures designed to ensure academic standards, intellectual values, and institutional integrity. Lastly, there is a

3A similar parenthetical insert may be inferred throughout this document.

category of relationships (Category 111) that are thought to be allowable because they are (a) accepted practices and (b) generally minimal in their personal financial impact.

These classifications are not intended to serve as a rigid or comprehensive code of conduct or to define "black letter" rules with respect to conflict of interest. It is expected that the guidelines will be applied in accordance with the spirit of the mission of Harvard Medical School in education, research and patient care. Hence, an integral part of the adaptation to the guidelines will be a process of interpretation and application by a standing committee of the Faculty. By this process, it is expected that a common institutional experience in the application of these guidelines will gradually evolve. The complexity of the subject matter is such that the current guidelines and their ensuing interpretations should be formally reviewed on a periodic basis. The first review should take place approximately one year after the submission of the first disclosure form.

The impact of a Faculty Member's conflict of interest on student training (including that of post-doctoral fellows and other trainees) is of special concern to the Faculty of Medicine. Many of the specific issues related to student training have already been addressed in the Faculty of Medicine's Statement on Research Sponsored by Industry. As noted in that policy, students and trainees "should not ordinarily participate in research that involves confidential information or otherwise constrains their right to publish or communicate freely." Additionally, the Faculty is particularly concerned about the content and quality of the training experience for students whose research is sponsored by a for-profit business and whose preceptors have a personal interest in that business.

It is essential that Faculty Members demonstrate at all times their commitment to the highest intellectual and ethical standards in all aspects of research, particularly research in which opportunities for conflict may exist. As a corollary, the training experiences of students are expected to incorporate the values of objectivity in research and the importance of public trust.

Lastly, the rigorous application of the guidelines will be particularly important in the case of persons exercising significant authority. There are those in the Faculty of Medicine who have substantial influence over others by virtue of their major role in professional appointments, promotions, tenure decisions, allocation of space and determination of salary. Typically these individuals hold positions such as Chief Executive Officer (CEO or equivalent title) of an affiliated Hospital, Dean or Executive Dean of the Faculty of Medicine, or Heads of Departments. While the guidelines are applicable to all Faculty, these individuals must take particular care not to become involved in research relationships that would lead to their personal financial gain or that would adversely affect the professional or academic advancement of Junior faculty members.

4A series of operating definitions of terms appearing with initial capital letters is found in Appendix A if this policy.

CATEGORY I (a) and (b) Activities that are Generally Not Allowable. The only exceptions are conflicts that were previously approved by the Standing Committee of the Harvard Medical Center, the Dean and the CEO and allowed to continue for a finite period of time with oversight pursuant to the policy, and conflicts that arise in extraordinary circumstances such as the recruitment of a new Faculty Member, where a conflict may be allowed to continue for a finite time period with disclosure and the approval of the Standing Committee, the Dean and the CEO.

Research Activities

(a) A Faculty Member Participating in Clinical Research on a Technology owned by or contractually obligated 'to a Business in which the Faculty Member, a member of his Family, or an Associated Entity has a consulting relationship, holds a stock or similar ownership interest, or has any other Financial Interest, other than receipt of University- or Hospital- supervised Sponsored Research support or royalties under institutional royalty-sharing policies.

(b) A Faculty Member receiving University- or Hospitalsupervised Sponsored Research support (whether in dollars or in kind) for Clinical Research or research which does not involve human subjects, from a Business in which he, a member of his Family, or an Associated Entity holds a stock or similar ownership interest.

De Minimus Exception to Category I (a) and I (b) Conflicts

(a) A Faculty Member may continue to hold stock or similar ownership interest in a Business in a situation which would otherwise create an impermissible Category I (a) or I (b) conflict only if all of the following conditions are met:

1. The stock or similar ownership interest must be in a publicly held, widely traded Business.

2. The current value of the stock or similar ownership interest may not exceed $20,000 at any time.

3. There must be no relationship between acquisition of the stock or similar ownership interest and research to be conducted. Situations that satisfy this requirement include stock or similar ownership interest acquired in armslength transactions or by family gift sufficiently prior to the beginning of the research to assure the lack of a relationship and stock or similar ownership interest acquired by inheritance. In any such situation there must be complete independence between a purchase decision or other acquisition and the research.

4. A Faculty Member who is a successfal applicant for Public Health Service and/or National Science Foundation funding in a situation which would otherwise create an impeni-iissible Category 1(a) conflict can continue to hold stock or similar ownership interest in a publicly held, widely traded Business if the value of the ownership interest, when aggregated with that of spouse and dependent children, does not exceed $10,000 and the ownership interest was acquired in a manner unrelated to the research.

' By license or exercise ofan option to license.

5. While meeting the above criteria excepts a Faculty Member from what would otherwise be an impermissible Category I (a) or I (b) conflict, it does not except a Faculty Member from other conflict categories such as Category I (h) which imposes an obligation to disclose a Financial Interest in the research in any publication or presentation.
(b) A Faculty Member may consult for a Business in a situation which would otherwise create an impermissible Category I (a) conflict only if all of the following conditions are met:

1. The amount of money received by the Faculty Member for consulting relationships or honoraria from a given Business should not exceed $10,000 a year. Consulting relationships include contractual relationships with a Business ( or from an agent or other representative of such Business), service on advisory boards and any other relationship whereby the Faculty Member receives, or has the right or expectation to receive, income from a Business in exchange for services. Honoraria include commissioned papers and occasional lectures (no more than four lectures a year) for which money is received, either directly or indirectly, from a given Business (or from an agent or other representative of such Business).

2. While meeting the de minimis criteria above exempts a Faculty Member from what would otherwise be a Category I (a) conflict, it does not exempt the Faculty Member from other possible conflict categories such as Category I (h) which imposes an obligation to disclose a Financial Interest in the research in any publication or presentation.

CATEGORY I (c) - 0) Activities that May be Allowable Only after Disclosure, Review, and Approval by the University or Affiliated Hospital with Advice from the Standing Committee of the Harvard Medical Center When Requested:

Research Activities

(c) A Faculty Member conducting research externally that woul ordinarily be conducted within the University or Hospitals.

Committee Participation

(d) A Faculty Member participating in the consideration by a committee of the FDA, other governmental agency, or private insuror of Clinical Research on a Technology which is owned by or contractually obligated to a Business in which that Faculty Member, a member of his Family, or an Associated Entity has a Financial Interest.

External Activities

(e) A full-time Faculty Member assuming an Executive Position in a for-profit Business engaged in commercial or researc
activities of a biomedical nature.

(f) A Faculty Member making clinical referrals to a Business 'in which such Faculty Member, a member of his Family, or an Associated Entity has a Financial Interest.

' The definition qf'Business' excludes the University, arty affiliated Hospital, any Private Medical Practice or any entity controlled by, controlling, or under common control with the University or affiliated Hospital.

(g) A Faculty Member possessing a Financial Interest in a Business which competes with the services provided by the University or any Hospital with which the Faculty Member is affiliated.

Public Disclosure

(h) A Faculty Member publishing or formally presenting research results, or providing expert commentary on a subject, without simultaneously disclosing any Financial Interest in a Business which owns or has a contractual relationship to the Technology being reported or discussed or which sponsors the research being reported or discussed.

Administrative Responsibilities

(i) A Faculty Member taking administrative action within the University or any affiliated Hospital which is beneficial to a Business in which he has a Financial Interest.

Applicants for Public Health Service and/or National Science Foundation Non-Clinical Research Funding

0) Under federal regulations'a Faculty Member who is an applicant for Public Health Service and/or National Science Foundation funding for non-Clinical Research has a potential conflict under the federal regulations, if the Faculty member, spouse and/or dependent children have a "significant financial interest", which could directly and significantly affect the design, conduct or reporting of the federally funded research. A Faculty Member who is an applicant for Public Health Service and/or National Science Foundation funding for Clinical Research is covered by Category I(a) above.

"Significant Financial Interest" for Category 16) Conflict

For the purposes of a Category 10) conflict, as defined above, a "significant financial interest" consists of "anything of monetary value" from the Business, including salary, consulting fees, honoraria, equity interests and intellectual property rights, with the exception of salaries, royalties and remuneration from University or an affiliated Hospital, honoraria for presentations sponsored by public or non- profit entities or income from service on advisory or review panels for public or non-profit entities. Also excepted for the purposes of a Category 10) conflict are salary, royalties or other payments that, when aggregated for the Faculty Member, spouse and/or dependent children, are not expected to exceed $10,000 over the subsequent twelve months and equity interests, that, when similarly aggregated, do not exceed $10,000 in value or 5% ownership interest in the business.

Resolution of Category 10) Conflict

A Category 10) conflict as defined above must be resolved by management, reduction or elimination, prior to the expenditure of funds from the Public Health Service and/or National Science Foundation. Possible resolution of Category 10) conflicts may include, but is not limited to, public disclosure of the significant financial interest, monitoring of research by independent reviewers, modification of research plans, disqualification from participation in Public Health Service and/or National Science Foundation funded research, divestiture of the significant financial interest, and severance of relationships that create the Category 10) conflict.

' Public Health Service Final Rule 42 CFR Part 50 and 45 CFR Part 94; National Science Foundation Rule 59 FR 3308 and 60 FR 35820.

CATEGORY II Activities that are Ordinarily Allowable Following Disclosure and, Where Necessary, the Implementation of Oversight Procedures:

Research Activities

(a) A Faculty Member Participating in Clinical Research on a Technology developed by that Faculty Member or a member of his Family, unless the activity falls under the guidelines of Category 1.

(b) A Faculty Member assigning students, post-doctoral fellows or other trainees to projects sponsored by a for-profit Business in which the Faculty Member, a member of his Family, or an Associated Entity has a Financial Interest, unless the activity falls under the guidelines of Category 1.

Board Memberships

(c) A Faculty Member serving on the Board of Directors or Scientific Advisory Board of a Business from which that Faculty Member or a member of his Family receives University- or Hospital-supervised Sponsored Research support or with which the University has a substantial contractual relationship known to the Faculty Member, unless the activity falls under the guidelines of Category 1.

External Activities

(d) A Faculty Member assuming an Executive Position in a not- for-profit Business engaged in commercial or research activities of a biomedical nature.

CATEGORY III Activities that are Routinely Allowable:

(a) A Faculty Member receiving royalties for published scholarly work and other writings.

(b) A Faculty Member receiving royalties under institutional royalty-sharing policies.
Appendix A - OPERATING DEFINITIONS

(a) An "Associated Entity" of a Faculty Member means any trust, organization or enterprise other than the University or any affiliated Hospital over which the Faculty Member, alone or together with his Family, exercises a controlling interest.

(b) "Business" means any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company, joint stock company, receivership, business or real estate trust, or any other legal entity organized for profit or charitable purposes, but excluding the University, any affiliated Hospital, any Private Medical Practice, or any other entity controlled by, controlling, or under common control with the University or an affiliated Hospital.

(c) "Clinical Research" means any research or procedure involving human subjects in vivo or the use of human samples for the development and evaluation of patient therapies such as diagnostic tests, drug therapies, or medical devices. It includes early clinical studies, evaluative research, epidemiological studies and clinical trials. It does not include a Faculty Member's participation in the design of a clinical study for which he is subsequently neither a participant nor an author.

(d) "Executive Position" refers to any position which includes responsibilities for a material segment of the operation or management of a Business.

(e) "Faculty Member" means any person possessing either a fullor part-time academic or fellowship appointment in the Faculty of Medicine.

(f) The "Family" of a Faculty Member includes his spouse, minor children, and other persons living in the same household.

(g) A "Financial Interest" is an interest in a Business consisting of (1) any stock, stock option or similar ownership interest in such Business, but excluding any interest arising solely by reason of investment in such Business by a mutual, pension, or other institutional investment fund over which the Faculty Member does not exercise control; or (2) receipt of, or the right or expectation to receive, any income from such Business (or from an agent or other representative of such Business), whether in the form of a fee (e.g., consulting), salary, allowance, forbearance, forgiveness, interest in real or personal property, dividend, royalty derived from the licensing of Technology, rent, capital gain, real or personal property, or any other form of compensation, or any combination thereof.

(h) "Participate" means to be part of the described activity in any capacity, including but not limited to serving as the principal investigator, co -investigator, research collaborator or provider of direct patient care. The term is not intended to apply to individuals who provide primarily technical support or who are purely advisory, with no direct access to the data (e.g., control over its collection or analysis) or, in the case of clinical research, to the trial participants, unless they are in a position to influence the study's results or have privileged information as to the outcome.

(i) "Private Medical Practice" means the professional services rendered by a physician, including departmental practice plans, and the procedures integral to those services.

6) "Sponsored Research" ' means research, training and instructional projects involving funds, materials, or other compensation from outside sources under agreements which contain any of the following:

1. The agreement binds the University or Hospital to a line of scholarly or scientific inquiry specified to a substantial level of detail. Such specificity may be indicated by a plan, by the stipulation of requirements for orderly testing or validation of particular approaches, or by the designation of performance targets.

2. A line-item budget is involved. A line-item budget details expenses by activity, function or project period. The designation of overhead (or indirect costs) qualifies a budget as "line item".

3. Financial reports are required.

4. The award is subject to external audit.

5. Unexpended funds must be returned to the sponsor at the conclusion of the project.

6. The agreement provides for the disposition of either tangible or intangible properties which may result from the activity. Tangible properties include equipment, records, technical reports, theses or dissertations. Intangible properties include rights in data, copyrights or inventions.

(k) "Technology" means any compound, drug, device, diagnostic, medical or surgical procedure intended for use in health care or health care delivery.

' Adaptedfrom the Harvard University Principal Investigator's Handbook, 1988.


Appendix B - IMPLEMENTATION

STANDING COMMITTEE ON CONFLICTS OF INTEREST AND COMMITMENT

The Dean of the Faculty of Medicine will appoint a standing committee of the Harvard Medical Center. This Standing Committee on Conflicts of Interest and Commitment will be comprised of representatives from both the clinical and preclinical faculty and will be responsible for reviewing cases which are brought to its attention by the Office of the Dean. It will review such cases and will make recommendations for conflict resolution to the Dean. The Committee will develop procedures for implementing the disclosure and approval process, the establishment of oversight protocols, and the handling of cases involving non-compliance and breach, and the designing of appropriate subsequent disciplinary actions.

The Standing Committee is responsible for reviewing the implementation of the policy on a regular basis and providing oversight to assure that the policy is applied consistently to the Faculty including both those based in the quadrangle and those based in the affiliated Hospitals. The Standing Committee is responsible for reviewing cases which may be referred to it where the application of the policy to an individual is unclear. Finally, the Standing Committee will continue to review both the policies of other institutions and any government requirements in this area and to recommend changes to the policy when appropriate.

The Office of the Dean is responsible for overseeing the implementation of the policy by all affiliated institutions, including the process and mechanism for disclosure. This Office will review all breaches of the disclosure process, including (a) failures to comply with such process, whether by virtue of a Faculty Member's refusal to respond or by his responding with incomplete or knowingly inaccurate information, (b) failures to remedy conflicts, and (c) failures to comply with a prescribed oversight plan.

Such cases will be forwarded to the Standing Committee for review. Based on its review, the Committee will make recommendations to the Dean for further action. In all cases, Faculty Members will be provided the explicit opportunity to respond in person and in writing to the issues raised in the course of such review. Any such written response will be appended to the Committee's report for review by the Dean and, in the case of hospital-based Faculty Members, the hospital CEO. The Committee will also be available to advise affiliated institutions on the application of the guidelines to specific cases as disclosed by their Faculty.

DISCLOSURE PROCESS AND IMPLEMENTATION

The Office of the Dean has the ultimate responsibility for confirming compliance by all Faculty Members with the policies of the Faculty of Medicine. Such responsibility extends not only to quadrangle-based Faculty but also to Faculty based in the affiliated hospitals.

Many Faculty will wish to resolve existing conflicts of interest

under the new policy prior to submitting their disclosure forms. To make this opportunity available, the deadline for disclosure form submission will be no less than three months after the effective date of the policy.

Submission of Disclosure Forms

1. Each hospital is independently responsible for the dissernination, collection and review of the disclosure forms for members of the Faculty of Medicine based in its institutions'. In the case of quadrangle-based preclinical faculty, these responsibilities will be fulfilled by the Office of the Dean.

2. All members of the Faculty of Medicine, both full- and part-time, are required to complete and submit a disclosure form on an annual basis. Updated forms must be submitted throughout the year if changes arise which the Faculty Member believes may either: (a) give rise to a conflict of interest or (b) eliminate a conflict previously disclosed.

3. Individuals holding fellowship positions are not required to complete and submit a disclosure form unless they believe that they are involved in or may be involved in a situation which gives rise to a conflict of interest. The Office of the Dean is responsible for sending individuals who hold fellowship positions appropriate notification of their obligations under the policy.

4. Disclosure forms should be returned to the designated office at the hospital (for clinical faculty) or the Medical School (for quadrangle-based faculty), with a copy to the department head for review'. Basic science faculty in hospitals must return disclosure forms to their hospital and to their quadrangle department head. In such cases, the review responsibilities will be handled by the quadranglebased department head.

In consultation with the Office of the Dean, each hospital will establish its own mechanism for collection and review of the forms to ensure compliance with the disclosure process. This mechanism will include written reminders for Faculty Menibers to return disclosure forms, as well as statements encouraging Faculty Members to seek assistance in the event of questions or special circumstances. Offices providing such assistance will be designated in each of the hospitals as well as in the quadrangle. Regardless of the mechanism selected, disclosure forms which implicate any conflict category should be reviewed regularly by the department head.

The disclosure forms will be considered strictly confidential, and it will be the responsibility of the designated offices in the quadrangle and hospitals to ensure that the information disclosed in the forms is available only to the individuals duly charged with the responsibility for review. Similarly, offices of department heads, the Dean and the President will be required to establish means for the preservation of confidentiality.

'The hospitals have delegated the responsibilityfor dissemination of the disclosurejorms to the Medical School.

'Most hospitals have elected to return the disclosurejorms initially to the Medical School for subsequent delivery to the hospital.


5. In the case of Faculty Members who hold the positions of CEO (or equivalent title) of an affiliated hospital, Dean or Executive Dean of the Faculty of Medicine, or heads of departments, the annual, as well as interim, disclosure and review processes will proceed as follows:

chairs of the preclinical departments will report directly to the Dean of the Faculty of Medicine;

· chairs of the clinical departments will report directly to the hospital CEO, with copies to the Dean;

· the Dean and Executive Deans of the Faculty of Medicine will report to the University President;

hospital CEOs (or individuals with equivalent title) will report to the Executive Committee of the Board of Trustees of the hospital, with copies to the Dean.

Review of Disclosure Forms

Following the disclosure period, on a date specified by the Standing Committee the CEO of each affiliated hospital and the department head of each Pre-clinical department will submit a report to the Office of the Dean and include the following information:

1. The number and percent of disclosure forms received from the Faculty in his hospital or department and the names of Faculty who have not submitted their forms.

2. The names of Faculty Members involved in Category I activities, recommendations as to whether these activities should be allowed and the rationales for these decisions. All such recommendations will be subject to approval by the Dean, who may refer such matters to the Standing Committee of the Harvard Medical Center.

3. The names of Faculty disclosing Category 11 activities.

The CEOs and prechnical department heads are expected to notify the Office of the Dean immediately of any cases that require review by the Standing Committee, no matter when the cases occur.

Establishment of Oversight Protocols

The hospital CEO (in the case of hospital-based Faculty) and the Standing Committee (in the case of quadrangle-bascd Faculty) are responsible for designing appropriate oversiglit mechanisms They are expected to seek advice from individuals outside as well as within their institutions in preparing such mechanisms The associated rationale and details must be presented to the Office of the Dean for review and approval.

Implementation Process under Public Health Service and National Science Foundation Regulations

1. Disclosure required by the Public Health Service and National Science Foundation regulations should be made on appropriate forms at the time of grant application submission to the appropriate offices in the quadrangle and affiliated institutions.

2. Resolution of impermissible Category I(a) conflicts (Clinical Research) identified in the federal application disclosure process should be made by the appropriate quadrangle or affiliated hospital officials. Notice of such resolution should be forwarded to the Office of Research Issues in the Office of the Dean. The Standing Committee will review these and other resolutions as appropriate.

3. Decisions as to the appropriate resolutions of Category 10) conflicts (non-clinical research) identified in the federal application process should be made by the appropriate quadrangle or affiliated Hospital officials. Notice of such resolutions should be forwarded to the Office of Research Issues of the Office of the Dean. The Standing Committee will not as a matter of course review such resolution decisions, but reserves the right to do so.

4. In the case of Public Health Service funding applicants, appropriate quadrangle and affiliated Hospital officials are responsible for notifying the Public Health Service, prior to the institution's expenditure of any funds under the award, of the existence, but not the nature, of a conflict and that the conflict will be managed, reduced or eliminated, at least on an interim basis, within 60 days after it is identified. Such officials are also responsible for informing the Public Health Service that corrective action has been or will be taken when an applicant Faculty Member does not comply with the policy.

5. In the case of National Science Foundation funding applicants, appropriate quadrangle and affiliated hospital officials are responsible for certifying to the National Science Foundation that all identified conflicts have been satisfactorily managed, reduced or eliminated prior to the institution's expenditure of any funds under the award.

COMPLIANCE RESPONSEBILITY

The Faculty of Medicine expects its members to comply fully and promptly with the policy, including the requirements of disclosure. However, in view of the novelty of detailed financial disclosure in the academic setting, the complexity of the guidelines, and the oversight arrangements that will be required in certain cases under Categories I and 11, it is anticipated that instances of technical non- compliance will occur. It will be the responsibility of the Standing Committee to make recommendations to the Office of the Dean for resolution of such cases.

Instances of deliberate breach of policy, including failure to file or knowingly Ciiing an incornplete, erroneous, or misleading disclosure forin, violations of the guidelines or failure to comply with prescribed monitoring procedures, will be adjudicated in accordance with applicable disciplinary policies and procedures of the Faculty of Medicine and of the affiliated hospitals. Possible sanctions will include the following:

1. Formal admonition;

2. The inclusion in the Faculty Member's file of a letter from the Office of the Dean indicating that the individual's good standing as a member of the Faculty has been called into question;

3. Ineligibility of the Faculty Member for grant applications, Institutional Review Board (IRB) approval, or supervision of graduate students;

4. Non-renewal of appointment;

5. Dismissal from the Faculty of Medicine.

Appendix C - EXISTING RELATIONSHIPS'

APPROACHES TO EXISTING RELATIONSHIPS FOR ACTIVITIES DEEMED UNALLOWABLE

This Faculty of Medicine Policy on Conflicts of Interest and Commitment takes a broader view of conflict and contains far more stringent guidelines than did the earlier Faculty of Medicine policy of 1983. As a result, it is expected that certain existing Faculty relationships will have to be modified. The following section sets forth transitional rules according to which some of these conflicts are to be resolved. They apply to activities which the Standing Committee and the Dean have deemed unallowable.

RESEARCH ACTIVITIES

Financial Interests

Category I (a):

In order for a Faculty Member to continue his research in situations covered by Category I (a) which are not approved by the Dean, he will be required to divest 2 himself of relevant equity holdings subject to the guidelines.

Publicly traded companies: Within three months following final disposition by the Dean, the faculty member must divest at least 75% of relevant stock holdings; 100% of the stock must be divested by the end of the sixth month following such final disposition.

Privately held companies: The Faculty Member's holdings will be valued by an independent appraiser as of the date of the final disposition by the Dean. The Faculty Member will be required to divest himself of his interest at the earliest reasonable time in the judgment of the Dean. In the event his return from such sale exceeds the value of the Faculty Member's holdings as determined by appraisal, such gain may not be received personally by the Faculty Member but shall be given to one or more of the following: (a) the company, (b) Harvard Medical School, (c) the Hospital, or (d) a public charitable organization of the Faculty Member's choice.

In addition, for Category I activities, the Faculty Member may not receive income subject to this guideline after final disposition by the Dean.

Category I (b):

In order for a Faculty Member to continue his research in circumstances subject to Category I (b) which are not approved by the Dean while retaining his equity holdings, he will be required within eighteen months following the effective date of the final disposition by the Dean to obtain research support from an entity unrelated to that in which he holds equity.

Discontinuation of Research Activities

If a Category I activity is not approved by the Dean, in lieu of divestment of a Financial Interest, a Faculty Member may retain such interest and instead discontinue the research activity in question. In such circumstance he may continue to participate in the research for a period not to exceed six months following notification by the Dean that he is no longer allowed to participate in both areas. Under such circumstances, the implementation of appropriate monitoring procedures may be warranted during such period.

COMMITTEE PARTICIPATION

Upon agreement to serve on an FDA or other review committee, a Faculty Member must disclose any relevant Financial Interests to the committee's chairperson. The Faculty Member must not participate in committee consideration of Clinical Research on a Technology subject to the guidelines.

EXTERNAL ACTIVITIES

Executive Position in an Outside Business

Unless approved by the Dean, a full-time Faculty Member must resign from a position subject to the guideline within a period deterinined by the Office of the Dean to be reasonable under the circumstances. In no case shall such period exceed six months from the date of the final disposition by the Dean. In making such determinations efforts will be made to minimize the disruption such change might create for the parties involve.

Financial Interest in a Business whic