Outside Activities FAQ's

About HMS

More... Share to Twitter Share to Facebook

Frequently Asked Questions about interactions with industry, outside activities and conflicts of interest and commitment and their responses are provided below. Additional questions can be directed to the Office for Academic and Research Integrity at Outside_Activities@hms.harvard.edu.

Please visit the following link to view/edit your Outside Activity Report
https://esupport.hms.harvard.edu/OAR

Frequently Asked Questions

Background/Coverage
Faculty Activities
Research
Education
Continuing Medical Education (CME)
Conflicts of Commitment
Other

Background/Coverage

Q: Who is subject to the COI Policy and its related policies?

A: The COI Policy applies to any person possessing either a full or part-time academic or fellowship appointment at the Faculty of Medicine. Full-time faculty members on sabbatical or other paid leave are considered full-time for the purpose of the policy. Faculty members on approved unpaid leave are not considered full-time for these purposes.

Q: What happens if a faculty member does not comply with the COI Policy?

A: An allegation of noncompliance with the COI Policy is initially reviewed by faculty member’s primary institution.  If an allegation comes directly to the Office of the Dean it will be referred to the primary institution to conduct the initial review.  Noncompliance may include a breach of the outside activity reporting process or engaging in activity prohibited by one of the research rules. Such instances of noncompliance include but are not limited to refusing to make the periodic required reports, responding with incomplete or inaccurate information, a failure to remedy prohibited conflicts, or a failure to comply with a prescribed oversight plan. If the initial review has merit , it is forwarded to the Standing Committee on Conflicts of Interest and Commitment for subsequent review. This committee comprises representatives from both clinical and preclinical faculty. The committee is responsible for reviewing the facts and recommendations made by the affiliate institution and for making recommendations to the Dean regarding disciplinary actions where appropriate. Sanctions for noncompliance can range from formal admonition to dismissal from the Faculty of Medicine. HMS takes any claim of noncompliance seriously, and  reviews each claim thoroughly. Faculty members are given ample opportunity to respond to claims and to comment on any recommended action. An effort is made to keep the existence and status of all such proceedings confidential.

Q: How often will faculty need to report their outside activities to HMS under the COI Policy?

A: HMS requires all faculty to complete an annual outside activities report. Faculty members should report their outside activities are in accordance with the process established by their home institution.  Please refer to your local institution’s requirements and instructions in completing this outside activities report.  Those institutions report annually to HMS and note any issues of non-compliance including failure to annually report.

HMS Quad, HSDM and VA Faculty can access the outside activities reporting system at https://esupport.hms.harvard.edu/OAR. After logging in, faculty will directly enter the Outside Activity Reporting interface.  Faculty can return to the link at any time to update reports or submit additional reports.

Q: What outside activities must faculty members disclose?

A: The annual report to HMS or the affiliate institution must  include all outside activities relevant to an individual's role as an HMS faculty member as well as any financial interests in pharmaceutical, device, biotechnology, and medical education and communication companies. These may include uncompensated activities, income, equity and royalties.

Policy in Action

In April, HMS sends an e-mail to all members of the faculty asking them to submit their annual outside activity reports before May 30. The Faculty member has received the following five W-2s and 1099s for income earned during the preceding calendar year:

From Harvard University:

Salary earnings from prior calendar year. Royalties paid to the faculty member under Harvard's institutional royalty sharing policy. The royalties represent a portion of a milestone payment paid by Biotech Company X to Harvard under its license to three University-owned patents invented by the faculty member.

From Pharma Y:

Honoraria for three speaking events discussing the latest advances in preventing cardiac disease in adult men over the age of 50.

From Law Firm Z:

Expert witness testimony during three days in July of the previous year. Faculty member was asked to discuss typical side effects of a commonly used drug for hypertension.

From Art Museum A:

Modest income earned as a member of the company's fiduciary board of directors.

From Journal B:

Income earned as editor of scientific manuscripts submitted.
 

Faculty member also holds equity in a start-up medical device company, a doll manufacturer and multiple large mutual funds.

Regardless of the amount received or held, the faculty member must report to HMS all of the following: royalty income from Harvard from license to Biotech Company X, honoraria from Pharma Y, consulting income from Law Firm Z, income from Journal B and equity in the start-up medical device company. The faculty member will not have to report the income received from Art Museum A, equity in the doll manufacturer or the mutual funds

Q: Who will review faculty outside activity reports?

A: In addition to review by the HMS Office for Academic and Research Integrity , staff, and liaisons at each affiliated institution, department chiefs and division chairs may be provided access to outside activities reported by faculty they supervise. They will be responsible for identifying and assisting HMS and the affiliated institutions in resolving any concerns raised about the disclosures.

Policy in Action

A HMS Quad based faculty member submits his annual financial report through the Outside Activities Reporting system. Shortly thereafter, a staff member in the Office for Academic and Research Integrity (ARI) logs into the same system and reviews the financial report. The ARI staff member notices that the faculty member has not disclosed her role on the Scientific Advisory Board at Pharma X. In light of this inconsistency, the ARI staff member contacts the faculty member to better understand his or her disclosures. The faculty member simply forgot to include her membership on Scientific Advisory Board. The error is fixed and the ARI staff member completes the review of the financial report.

Q: How will the COI Policy intersect with the policies of the many HMS-affiliated institutions?

A: A faculty member is required to be in compliance with both the COI Policy and any policy of an institution with which the faculty member is affiliated. If the COI Policy is more stringent on any particular topic, the faculty member will be expected to comply with the HMS requirements regardless of what the affiliated institution requires.

Q: Do faculty members need to separately disclose their financial interests annually to each HMS-affiliated institution with which they hold appointments?

A: HMS requires all faculty to complete an annual outside activities report. All outside activities are to be reported in accordance with the process established by a faculty member’s home institution.  Please refer to your local institution’s requirements and instructions in completing this outside activities report. HMS Quad, HSDM and VA Faculty report directly to HMS through for https://esupport.hms.harvard.edu/OAR. Faculty members should only have to report once and the administrative offices share those reports as necessary. 

Q: How do the COI Policy and its related policies intersect with federal regulations that address investigator conflicts of interest related to research?

A:HMS and its affiliated institutions have integrated the COI Policy with federal regulations and coordinate the reporting processes to minimize duplication for the investigator community. .

Q: What if there are areas of the COI Policy that cause confusion, need clarification, or become inconsistent with applicable law or affiliated institutions' policies?

A: The Standing Committee on Conflict of Interest and Commitment is charged with reviewing  policy questions and concerns and recommending resolutions to the Dean. .Conflicts of interest is a dynamic topic that is regularly informed by ongoing research, changes in the regulatory environment, and guidance from groups such as the AAMC, the IoM and others. It is important for the Faculty of Medicine, through the Standing Committee, to be aware of and continually assess changes that might affect the COI Policy and our understanding of what a conflict is and how to address it. The Standing Committee is currently undertaking a review of the COI Policy. Although the review is ongoing, in November 2015, the Standing proposed recommended changes to the Research Support Rule (The "I(b)" Rule). Please refer to the COI Policy for the most up to date policy language.

top

Faculty Activities

Q: Can faculty members earn consulting income or honoraria from a for-profit company?

A: Yes. Faculty members are encouraged to collaborate with industry on a variety of endeavors. Under the COI Policy, a faculty member may continue to earn income from any for-profit company for services provided, except for the following:

A faculty member may not earn income in excess of $10,000 per year from a company that owns (or exclusively licenses or markets) a device, drug or other technology studied under a clinical research protocol in which the faculty member participates.

A faculty member may generally earn less than $10,000 per year from a company that owns (or exclusively licenses/markets) a device, drug or other technology studied under a clinical research protocol in which the faculty member participates. However, this is not the case if the relevant institutional review board or COI review committee concludes, following formal review, that the faculty member's personal financial interests pose an unacceptable conflict of interest under the circumstances presented.

A faculty member may not participate in an industry-sponsored speakers’ bureau or accept a speaking engagement sponsored by a for-profit company if the company denies or otherwise limits the faculty member's intellectual independence over the educational content of his or her presentation.

Q: Can faculty members hold equity or rights to equity in a for-profit company?

A: Yes. Faculty members can continue to hold equity in most companies. A faculty member's equity may be restricted only under the following circumstances:

A faculty member typically may not hold any equity in a privately held company or equity valued at 1%  or more in a publicly-traded company that sponsors the faculty member's research.* Sponsorship may be through cash funding or in kind. Material Transfer Agreements (MTAs) must be institutionally reviewed to determine whether the provision of materials constitutes "sponsorship" under the circumstances set forth in the relevant MTA.

A faculty member may not hold any equity in a privately held company, or equity valued at $30,000 or more in a publicly traded company that owns (or exclusively licenses or markets) a drug, device or other technology studied under a clinical research protocol in which the faculty member participates.

A faculty member may not hold equity in a company if there is a direct relationship between the acquisition of the equity and clinical research being conducted by the faculty member or basic research sponsored by the particular company. Equity must be acquired in an arms-length transaction under circumstances that ensure complete independence either between the purchase decision or other acquisition and relevant research.

* It is presumed that Faculty (and the members of their Family) who have an Equity Financial Interest in a Business may not receive Sponsored Research support from that Business for Research. Faculty holding a presumptively prohibited financial interests may request an exception from the Standing Committee or its designee which will be reviewed on a case-by-case basis.

Q: Can a faculty member still be a founder of a company?

A: Yes. Faculty members are encouraged to form companies to advance scientific objectives and to commercialize research products. There are no direct limits on a faculty member's capacity to be a founder of a company, except as may be imposed on the income and equity holdings of a founder who simultaneously conducts clinical research on a company's technology of the company or who receives sponsored-research support from the company.

Harvard's Office of Technology Development (and its counterpart offices at the affiliated institutions) is an important resource to faculty members in forming new companies based upon specific core technologies, or upon platform technologies licensed from Harvard or an affiliated institution.

Q: Can faculty members serve on the scientific advisory board of a biomedical company?

A: Yes. Faculty members are encouraged to continue to participate as members of a company's scientific advisory boards (SABs). HMS is dedicated to lending its voice and expertise to industry efforts to bring new therapies to the public. SABs provide a critical avenue for achieving this objective.

Again, there are no direct limits on a faculty member's capacity to be a member of a company's SAB, except as may be imposed on the income and equity holdings of a SAB member who simultaneously conducts clinical research on a technology of the company or receives sponsored-research support from the company.

Q: Can faculty members serve on a company's the fiduciary board of directors?

A: It depends. Participation on the fiduciary board of a for-profit company engaged in commercial or research activities of a biomedical nature will, effective January 1, 2011, be subject to periodic review by HMS (and its affiliated institutions, as applicable) in order to evaluate whether the arrangement gives rise to a conflict of interest requiring management and/or elimination. As an individual's authority within HMS (and/or the individual's affiliated institution, as applicable) increases, the scrutiny applied by HMS (and the affiliated institution) will similarly increase in view of the individual's scope of authority. Assessment of these relationships will occur in connection with the HMS annual disclosure process.

Q: Will exceptions be granted to the research prohibitions under any circumstance?

A: Exceptions will generally not be granted. However, an exception may be granted under the following very limited circumstances:

Limited Exception to the Clinical Research Rule and the Research Support Rule for Some Dual-career Families: The revised policy will allow limited exceptions following a formal petition to and review by the Standing Committee on Conflicts of Interest. These exceptions are as follows:

If a faculty member is subject to the rule solely by reason of the activities/financial interests of his or her spouse or domestic partner;
The standing committee concludes that strict application of the rule under the circumstances unduly inhibits scientific progress; and
The potential conflict can be effectively managed pursuant to a formal management plan.

*Please contact the Office for Academic and Research Integrity or the office responsible for conflicts of interest at your home institution in order to complete and submit a petition to request an exception.

 

Request Exception to the Research Support Rule  to Receive Sponsored Research Support:  The COI Policy allows a faculty member with a financial interest in a business to request an exception to the Research Support Rule in order to receive Sponsored Research Support from that business even if otherwise presumptively not permitted under the COI Policy. Exceptions will be granted after thorough review and under limited circumstances.

Limited Exception to Research Support Rule  for Certain SBIR/STTR Subawards: The COI Policy allows limited exceptions to the Research Support Rule for grants and subgrants received under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs if the potential conflict of the faculty recipient can be effectively addressed with an institutional management plan. This exception was effective as of January 1, 2011.

Q: In applying the research restrictions, do the same caps apply to annual consulting income and publicly traded equity?

A: No. In applying the Clinical Research Rule, a faculty member is permitted up to $10,000 per year of income from a business while conducting clinical research on that business’s technology subject to review and management by the COI Committee and IRB at the faculty member’s primary institution.   A faculty member is permitted a maximum of $30,000 equity in a publicly traded company while conducting clinical research on that company’s technology as well as up to 1% if the faculty member wishes to receive sponsored research support from a publicly traded company.

Post-market royalties earned by a faculty member through an institutional royalty-sharing program will continue to be excluded from the calculation of a faculty member's annual company income unless the relevant post-market royalties relate to a drug, device or other technology that is the subject of a phase IV clinical study in which the faculty member participates. Post-market royalties do not include a faculty member's share in equity, licensing fees, milestones payments and other payments received by the institution as part of the licensing or other agreement. Such payments will continue to be included in the calculation of a faculty member's annual company income for the purpose of applying the Category I(a) clinical research restriction.

Q: Will an investigator be prohibited from participating in clinical research that poses a very low risk to human participants—such as survey studies, medical record reviews or studies that use discarded tissues—if he or she has a personal financial interest in the company that either owns or has rights to the technology being studied?

A: Not always. The definition of "clinical research" for the purpose of applying the Clinical Research Rule excludes certain defined types of "nominal risk" clinical research. A faculty member should consult with institutional officials to determine whether his or her proposed research meets the requirements of the "nominal risk" exclusion. Such nominal risk research, however, remains subject to local COI Committee and  IRB review to evaluate whether the investigator's financial interests pose an unacceptable risk to the study. Additional restrictions or prohibitions may be imposed by either in view of such concerns.

Q: When does an investigator end his or her participation in clinical research for purpose of applying the Clinical Research Rule?

A: All investigators that are subject to the Clinical Research Rule remain subject to the Rule until the latter of twelve months following the last day that a human-subject participant completes the clinical trial, the date of the first publication of data derived from the clinical research study, or a decision is made not to publish the data derived from the study. All investigators participate in the clinical research for the entire duration of the study and may not elect to “end” the participation for purposes of eluding the application of the rule.

Q: How are payments from third-party entities, including medical education and communication companies (MECCs) that receive funding from industry, treated in applying the Clinical Research Rule?

A: If a faculty member knows that the source of a third-party or MECC payment is from a particular business, the faculty member must treat the third-party payment as being from that particular business and apply the I(a) restriction accordingly. However, the following exceptions apply:

If the payment is from a ACCME-accredited provider of continuing medical education (CME);
If the payment is for an ACCME-accredited event; or
The third-party payer applied ACCME Standards for Commercial Support in implementing the particular CME event.

All such payments, however, must be reported to HMS annually. Faculty members have a responsibility to track an industry source of a third-party payment for a non-accredited event if such information is readily available to the faculty member. Such income should be included in calculating one's annual compensation from a particular company for the purpose of applying the research restrictions. The Standing Committee may issue additional guidance regarding the treatment of payments related to industry sponsored ACCME accredited events in the future. Check back for additional information.

Q: Will material transfer agreements with a company continue to be considered sponsored research under the Research Support Rule?

A: Sometimes. "Sponsored research" for the purpose of applying the Research Support  Rule includes any proposal that accepts key project resources (cash, equipment, personnel, materials) from a company. Material transfer agreements may be subject to institutional review prior to the determination that the agreement and the materials provided in the context of the aims of the project constitute "sponsorship" for the purpose of applying the rule. Faculty Members may elect to petition for an exception to the Rule. The application is available here and can be submitted to outside_activities@hms.harvard.edu or directly to the affiliate institution.

Q: Will faculty members be prohibited from earning more than $10,000 in consulting income or honoraria if they do not participate in clinical research on the company's technology, or research sponsored by the company?

A: No. There is no absolute prohibition keeping faculty members from having financial interests in a business provided that the faculty member is not conducting research on the business's technology and is not sponsored by the business itself. There is a misconception that all faculty members are limited to receiving no more than $10,000 in consulting income or honoraria per year if they generally conduct research. However, this only applies to payments from those companies whose products might be affected by the research conducted by the faculty member.

Q: Can faculty members still participate in industry-funded speakers bureaus?

A: No. A faculty member cannot participate in an industry-sponsored speakers bureau, be knowingly listed as a member of a company's speakers bureau, or otherwise accept a speaking engagement sponsored by a for-profit company if the company denies or otherwise limits the faculty member's intellectual independence over the educational content of his or her presentation.

Q: Can faculty members still participate in an industry-funded speaking event?

A: Yes, provided that he or she independently develops and retains intellectual independence over the educational content of his or her presentation. The Standing Committee may issue additional guidance regarding the treatment of industry-funded speaking events in the future. Check back for additional information.

Q: What is the HMS policy on ghostwriting?

A: Ghostwriting is a term referring to the practice of listing individuals as authors on a manuscript that other undisclosed individuals have actually written. In biomedicine, the term includes the practice of some pharmaceutical and medical device companies to draft peer-reviewed publications secretly, and then list academic researchers as the authors to lend credibility to article's findings. It may also include adding a particularly prominent academic researcher in the field to a list of actual authors, a so-called "honorary author", even though the researcher does not merit authorship under applicable authorship guidelines. Participation of faculty members in such activities is deplorable and has been rebuked in various Harvard Medical School policies for many years.

The current HMS Authorship Guidelines, Guidelines for Investigators in Scientific Research, and Guidelines for Investigators in Clinical Research have long prohibited the practice of guest authorship. The COI policy reinforces this position by clarifying that a faculty member is prohibited from presenting him or herself as an author on a publication if he or she has not satisfied HMS authorship guidelines or the guidelines of the International Committee of Medical Journal Editors.

Q: Can faculty members continue to hire medical writers to assist students in putting together the results of their research for peer-reviewed publication?

A: HMS recognizes that third-party medical writers can provide a valuable service to researchers in compiling data from primary research into publication format. Using such services is allowable, provided that the manuscript only lists those authors who merit authorship under the HMS Authorship Guidelines, and that the use of any third-party medical writer or editor is fully disclosed to journals in connection with the manuscript submission process.

top

Research

Q: Will the revised COI policy retain the research prohibitions set forth under Category I of the current policy?

A: Category I of the HMS COI policy has always contained two important research restrictions:

Clinical Research Restriction (Current I(a) Rule): A faculty member cannot design, conduct, report upon the results of, or otherwise participate in clinical research on a drug, device or other technology of a company if the faculty member accepts more than $20,000 per year in consulting or other income from that company, holds any equity in the company if the company is privately held, or equity valued at $30,000 or more if the company is publicly traded (provided the equity is acquired through an arms-length transaction and is not related to or contingent upon the proposed research).  The clinical research rule is currently under revision.  Please send an email to Outside_Activities@hms.harvard.edu with questions.

Sponsored Research Restriction (Current I(b) Rule): A faculty member cannot accept sponsored research support (for either clinical or basic research) from a company if he or she holds equity or rights to equity in the company sponsor. If the company is privately held, the prohibition is absolute. If the company is publicly traded, the faculty member may hold equity valued at up to $30,000, but all such equity must be acquired through arms-length transactions not related to or contingent upon the proposed research.

The Category I(a) and Category I(b) rules will be retained, with several significant changes. For category I(a), these changes include:

Lowering the annual income cap from $20,000 to $10,000 per year and requiring IRB or COI committee review of all income below the maximum cap. This change was effective as of April 1, 2011. Pre-existing contract obligations will be reviewed on a case-by-case basis all outstanding commitments were completed by December 31, 2011.
 
Modifying the definition of clinical research to exclude certain defined types of nominal risk research. This change was effective as of January 1, 2011.
 
Imposing a six-month washout period on any consulting arrangement or other paid engagement prior to commencement of participation. This change was effective as of July 1, 2011.
 
Clarifying certain terms, including the duration of a faculty member's participation and what it means to conduct research "on a technology" as opposed to "with a technology." Implementation of these clarifications were made effective on July 1, 2011.

Q: Will exceptions be granted to the research prohibitions under any circumstance?

A: A rule-based approach to these restrictions will continue and exceptions will generally not be granted to either the Category I(a) or Category I(b) rule, except under the following very limited circumstances:

Limited Exception to Categories I(a) and I(b) for Some Dual-career Families: The revised policy will allow limited exceptions to Categories I(a) and I(b) following a formal petition to and review by the Standing Committee on Conflicts of Interest. These exceptions are as follows:

If a faculty member is subject to the rule solely by reason of the activities/financial interests of his or her spouse or domestic partner;
The standing committee concludes that strict application of the rule under the circumstances unduly inhibits scientific progress; and
The potential conflict can be effectively managed pursuant to a formal management plan.
The Standing Committee on Conflicts of Interest and Commitment is currently accepting petitions. Please complete this petition to request an exception.

Limited Exception to Category I(b) for Certain SBIR/STTR Subawards: The revised policy will allow limited exceptions to Category I(b) for grants and subgrants received under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs if the potential conflict of the faculty recipient can be effectively addressed with an institutional management plan. This exception was effective as of January 1, 2011.

Q: In applying the research restrictions, will the same caps apply to annual consulting income and publicly traded equity?

A: No. In applying the clinical research restriction of Category I(a), the income maximum has been lowered from $20,000 to $10,000 per year. Local IRB and/or COI committee review will be required for any earned income less than $10,000 per year. The public equity maximum will remain the same (less than $30,000). The income maximum reduction was effective as of April 1, 2011.

Post-market royalties earned by a faculty member through an institutional royalty-sharing program will continue to be excluded from the calculation of a faculty member's annual company income unless the relevant post-market royalties relate to a drug, device or other technology that is the subject of a phase IV clinical study in which the faculty member participates. Post-market royalties do not include a faculty member's share in equity, licensing fees, milestones payments and other payments received by the institution as part of the licensing or other agreement. Such payments will continue to be included in the calculation of a faculty member's annual company income for the purpose of applying the Category I(a) clinical research restriction.

Q: Will an investigator be prohibited from participating in clinical research that poses a very low risk to human participants—such as survey studies, medical record reviews or studies that use discarded tissues—if he or she has a personal financial interest in the company that either owns or has rights to the technology being studied?

A: Not always. The definition of "clinical research" for the purpose of applying the Category I(a) rule has been modified to exclude certain defined types of "nominal risk" clinical research. The modification was effective as of January 1, 2011. A faculty member should consult with institutional officials to determine whether his or her proposed research meets the requirements of the "nominal risk" exclusion. Such nominal risk research, however, remains subject to local IRB review to evaluate whether the investigator's financial interests pose an unacceptable risk to the study. Additional restrictions or prohibitions may be imposed by the IRB in view of such concerns.

Q: What is the six-month washout period for the clinical research restriction?

A: In applying the clinical research restriction of Category I(a), HMS will now require faculty members to have terminated or completed his or her consulting contract or service engagement at least six months prior to commencing participation in clinical research on a drug, device or other technology belonging to the relevant company. The six-month washout period for clinical research was effective as of July 1, 2011.

Q: When does an investigator end his or her participation in clinical research for purpose of applying the Category I(a) rule?

A: All investigators that participate in a clinical research protocol are subject to the Category I(a) prohibition until twelve months following the last day that a human-subject participant completes the clinical trial the date of the first publication of data derived from the clinical research study, or a decision is made not to publish the data derived from the study, whichever occurs later. All investigators participate in the protocol for the entire duration of the study. For purposes of applying the Category I(a) rule, "participation" was defined (as outlined above) as of July 1, 2011.

Q: How are payments from third-party entities, including medical education and communication companies (MECCs) that receive funding from industry, treated in applying the Category I(a) rule?

A: If a faculty member knows that the source of a third-party or MECC payment is from a particular business, the faculty member must treat the third-party payment as being from that particular business and apply the I(a) restriction accordingly. However, the following exceptions apply:

If the payment is from a ACCME-accredited provider of continuing medical education (CME);
If the payment is for an ACCME-accredited event; or
The third-party payer applied ACCME Standards for Commercial Support in implementing the particular CME event.
All such payments, however, must be reported to HMS annually. Faculty members have a responsibility to track an industry source of a third-party payment for a non-accredited event if such information is readily available to the faculty member. Such income should be included in calculating one's annual compensation from a particular company for the purpose of applying the research restrictions. The Standing Committee may issue additional guidance regarding the treatment of payments related to industry sponsored ACCME accredited events in the future. Check back for additional information.

Q: Will material transfer agreements with a company continue to be considered sponsored research under the Category I(b) rule?

A: Sometimes. "Sponsored research" for the purpose of applying the Category I(b) rule includes any proposal that accepts key project resources (cash, equipment, personnel, materials) from a company. Material transfer agreements may be subject to institutional review prior to the determination that the agreement and the materials provided in the context of the aims of the project constitute "sponsorship" for the purpose of applying the rule.

Q: Will faculty members be prohibited from earning more than $10,000 in consulting income or honoraria if they do not participate in clinical research on the company's technology, or research sponsored by the company?

A: No. There is no absolute prohibition keeping faculty members from having financial interests in a business provided that the faculty member is not conducting research on the business's technology and is not sponsored by the business itself. There is a misconception that all faculty members are limited to receiving no more than $10,000 in consulting income or honoraria per year if they generally conduct research. However, this only applies to payments from those companies whose products might be affected by the research conducted by the faculty member.

top

Education

Q: Can faculty members still participate in industry-funded speakers bureaus?

A: No. A faculty member cannot participate in an industry-sponsored speakers bureau, be knowingly listed as a member of a company's speakers bureau, or otherwise accept a speaking engagement sponsored by a for-profit company if the company denies or otherwise limits the faculty member's intellectual independence over the educational content of his or her presentation. This was effective as of July 1, 2011.

Q: Can faculty members still participate in an industry-funded speaking event?

A: Yes, provided that he or she independently develops and retains intellectual independence over the educational content of his or her presentation. The Standing Committee may issue additional guidance regarding the treatment of industry-funded speaking events in the future. Check back for additional information.

Q: What is the HMS policy on ghostwriting?

A: Ghostwriting is a term referring to the practice of listing individuals as authors on a manuscript that other undisclosed individuals have actually written. In biomedicine, the term includes the practice of some pharmaceutical and medical device companies to draft peer-reviewed publications secretly, and then list academic researchers as the authors to lend credibility to article's findings. It may also include adding a particularly prominent academic researcher in the field to a list of actual authors, a so-called "honorary author", even though the researcher does not merit authorship under applicable authorship guidelines. Participation of faculty members in such activities is deplorable and has been rebuked in various Harvard Medical School policies for many years.

The current HMS Authorship Guidelines, Guidelines for Investigators in Scientific Research, and Guidelines for Investigators in Clinical Research have long prohibited the practice of guest authorship. The revised HMS COI policy will reinforce this position by clarifying that a faculty member is prohibited from presenting him or herself as an author on a publication if he or she has not satisfied HMS authorship guidelines or the guidelines of the International Committee of Medical Journal Editors.

Q: Can faculty members continue to hire medical writers to assist students in putting together the results of their research for peer-reviewed publication?

A: HMS recognizes that third-party medical writers can provide a valuable service to researchers in compiling data from primary research into publication format. Using such services is allowable, provided that the manuscript only lists those authors who merit authorship under the HMS Authorship Guidelines, and that the use of any third-party medical writer or editor is fully disclosed to journals in connection with the manuscript submission process.

top

 

Continuing Medical Education (CME)

 

For more information on CME specific to HMS, visit the HMS Department of Continuing Education. For information specific to HSDM CME, visit the HSDM Office of Dental Education.

Q: Can faculty members continue to accept industry financial support for CME programs accredited by the HMS/HSDM CME program?

A: Yes, provided that the funding for the course or program is in conjunction with one or more other industry sponsors. Industry sponsors should fund the course or program in a relatively equitable way, with no one sponsor accounting for more than 50 percent of a particular course budget. The "relatively equitable" standard shall require that no one industry sponsor account for more than 70% of the industry-sponsored portion of an overall CME course's budget. Industry-sponsored in-kind support is included for purposes of the calculation of a program's industry support. If a HMS CME program incorporates industry-sponsored in-kind support, multiple industry supporters must be sought and support among industry sponsors (based upon the fair market value of in-kind support) must meet the "relatively equitable" requirements. Sponsorship of CME by a single healthcare corporation (pharmaceutical, medical/dental device or supply, or other biomedical company) is strictly prohibited.

HMS has established a Dean's Fund for Continuing Medical Education which is accepting unrestricted grants from industry in support of strategic CME objectives of the HMS/HSDM departments of continuing medical education.

Q: Can CME programs continue to include commercial exhibitors?

A: Yes; however, there are strict rules regarding the location of and programming at such exhibits. No co-promotion of HMS/HSDM content and industry content will be allowed. One should seek additional guidance from the HMS/HSDM Department of Continuing Medical Education regarding the other specific restrictions for exhibits.

Q: Can industrial sponsors and exhibitors still offer satellite symposia?

A: No. An industry-sponsored educational program/course must occur in a distinct location, as approved in advance by the HMS/HSDM CME Review Committee, as well as distinct time from a CME program approved for credit through HMS/HSDM.

Q: Are there restrictions on non-accredited educational events supported by an industry?

A: Yes. Faculty members should, at a minimum, abide by the ACCME Standards for Commercial Support when participating in non-accredited educational events. The policy also strongly encourages faculty members with a leadership role over any continuing medical education (accredited through another institution or non-accredited) to conduct the program in compliance with the HMS/HSDM rules for CME to the maximum extent possible. These rules include the restrictions over industry funding, required separation and required public disclosures.

Q: Are there any guidelines for speaker disclosures at a HMS/HSDM accredited CME event?

A: Yes. All speakers are required to disclose at both the beginning and the end of one's presentation (i) the nature of all relevant personal financial interests (e.g. honoraria, consulting income, equity); and (ii) a general description of how an interest is related to one's presentation.

Q: Are there any restrictions on biomedical company marketing personnel access to the HMS campus or to students while on the HMS campus?

A: Yes. Marketing and sales representatives from pharmaceutical, medical/dental device and supply companies have been prohibited from interacting with students on the HMS/HSDM campus. All industry representatives, including biomedical company representatives, must wear an identifying badge while on campus. Biomedical personnel have access to campus by invitation only from a member of the HMS/HSDM faculty or designated staff.

top

Conflicts of Commitment

Q: Can a faculty member still spend a portion of his or her professional time on activities unrelated to work for Harvard Medical School or its affiliated institutions?

A: Yes, as long as the activities are approved by the chair or chief of the department or division. Faculty members 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." However, provided that a faculty member is able to fully meet his or her institutional responsibilities and the chair of the department or chief of the division approves, then the policy does allow faculty members to spend up to 20 percent of their professional time on activities outside of their responsibilities to HMS and the affiliated hospitals. This is generally interpreted to mean that a faculty member may spend one day a week on outside activities, provided that the activities are consistent with the other requirements of the COI Policy and the policies of the faculty member's affiliated hospital.

For purposes of the COI Policy only, traditional scholarly ventures shall be subject to review and approval by chiefs and/or designated supervisors, but may be excluded from the 20 percent limitation. These scholarly ventures include academic communications or publications and professional or advisory service for other universities, non-profits or governmental entities.

Q: Is there a process that faculty members must follow in seeking approval for the compensated outside activities in which they participate?

A: A faculty member should be in an ongoing discussion with his or her department head regarding all outside commitments. The department head must approve of a faculty member's outside commitments and may decide that certain outside activities pose a conflict of commitment or are otherwise inconsistent with the faculty member's role at HMS or an affiliated institution. In this situation, HMS may be contacted for additional formal review of the proposed arrangement by the Standing Committee on Conflicts of Interest.

In addition, HMS and some of the affiliated institutions require prior institutional review of any outside consulting engagement entered by a faculty member. You should check with your affiliated institution regarding your obligations. Faculty based on the HMS Quadrangle should have their personal consulting agreements reviewed by the director of research compliance in the Office for Academic and Research Integrity prior to execution. HMS/HSDM model consulting agreements may be found at http://www.hms.harvard.edu/orc/consultingagreement.html.  Consulting agreements may be submitted for review by email at consulting@hms.harvard. edu.

Q: What types of personal gifts are prohibited from a pharmaceutical or medical device company?

A: All faculty members are  prohibited from receiving personal gifts from a company. A personal gift includes anything of any value that is received by the individual for which the recipient has not paid fair market value. This may include (but is not limited to) entertainment or recreation items such as tickets to a theatre or sporting event, cash payments, or tangible items such as t-shirts, pads, pens, mugs or gift cards.

Q: Can a faculty's laboratory continue to receive samples from biotechnology companies of reagents, laboratory kits and other research supplies?

A: It depends. Donations to the institution in the form of data, equipment, reagents or other laboratory materials for use in the scope of one's institutional and academic work are not considered personal gifts, provided that the donations have been made in compliance with local institutional process for such donations. However, each of our affiliated institutions may have policies governing the receipt of such institutional gifts, and faculty should check with their home affiliated institution to be sure the institutional gift is allowable.

Q: Can a faculty's laboratory continue to have monthly pizza lunches sponsored by a reagent supply company?

A: No. The acceptance of any meal from a pharmaceutical, medical device or biotechnology manufacturing/supply company is prohibited unless the meal is provided in connection with a bona fide consulting or services arrangement, or in connection with an industry-funded educational event or conference that otherwise meets the requirements of HMS policy with respect to industry funding of such events.

Q: Can industry sponsor the travel costs of a student in my laboratory who wishes to attend a national meeting?

A: No, unless the student is a speaker or panelist at the meeting, or if the meeting is a part of a "users group" training session required in connection with the purchase of a technical device by the institution. Attendance at such meetings should be included as a part of the written contract for purchase.

top

Other

Q: What types of personal gifts are prohibited from a pharmaceutical or medical device company?

A: Clinical faculty members are currently prohibited from receiving personal gifts from a company. A personal gift includes anything of any value that is received by the individual for which the recipient has not paid fair market value. This may include (but is not limited to) entertainment or recreation items such as tickets to a theatre or sporting event, cash payments, or tangible items such as t-shirts, pads, pens, mugs or gift cards. Effective July 1, 2011, the gift prohibition has been extended to non-clinical faculty to the same extent it applies to clinical faculty under state law.

Q: Can a faculty's laboratory continue to receive samples from biotechnology companies of reagents, laboratory kits and other research supplies?

A: It depends. Donations to the institution in the form of data, equipment, reagents or other laboratory materials for use in the scope of one's institutional and academic work are not considered personal gifts, provided that the donations have been made in compliance with local institutional process for such donations. However, each of our affiliated institutions may have policies governing the receipt of such institutional gifts, and faculty should check with their home affiliated institution to be sure the institutional gift is allowable.

Q: Can a faculty's laboratory continue to have monthly pizza lunches sponsored by a reagent supply company?

A: No. The acceptance of any meal from a pharmaceutical, medical device or biotechnology manufacturing/supply company is prohibited unless the meal is provided in connection with a bona fide consulting or services arrangement, or in connection with an industry-funded educational event or conference that otherwise meets the requirements of HMS policy with respect to industry funding of such events. This prohibition currently applies to clinical faculty, and was extended to non-clinical faculty, to the same extent as it applies to clinical faculty under state law (effective July 1, 2011).

Q: Can industry sponsor the travel costs of a student in my laboratory who wishes to attend a national meeting?

A: No, unless the student is a speaker or panelist at the meeting, or if the meeting is a part of a "users group" training session required in connection with the purchase of a technical device by the institution. Attendance at such meetings should be included as a part of the written contract for purchase. The prohibition against travel supported by industry applies to all faculty and trainees as of July 1, 2011, to the same extent as it applies to clinicians under state law.

top