Ethics Case Studies

Preamble

As part of their normal work duties, publication professionals are frequently required to untangle difficult ethical problems. As a service to its members, the ISMPP Ethics Committee developed the CoE to be used as a touchstone to provide guidance on the most appropriate and ethical practices and conduct. To demonstrate how the CoE might facilitate discussions and find the best solution to ethical dilemmas, the ISMPP Ethics Committee has created some hypothetical case studies to illustrate how the CoE might aid you in your professional life. The case studies are not prescriptive, as each ethical dilemma encountered is unique. The Ethics Committee does believe, however, that through a collective experience, you may find some useful commonalities to your particular issue. In all cases, you should consider the wider impact of your decisions on patients and their treatment.

NOTE: Although these cases are provided as a tool to assist you, your first step to a resolution of your ethical issue should be to consult your organization’s compliance department, if available.

To view the CoE simultaneous to the Case Studies, you may access them in another window through here:


ISMPP Code of Ethics Case Studies

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Case Study 1:
What are your responsibilities if you learn about data discrepancies between manuscripts and other source documents, such as reports?

Case Study 2: 
What are your responsibilities for accurately conveying qualifications and competencies?

Case Study 3: 
What are your responsibilities when you discover a possible premature submission?

Case Study 4: 
How do cultural differences affect authorship?

Case Study 5: 
Should medical writers ever qualify for authorship?

Case Study 6: 
Should all data, regardless of quality, be published?
Case Study 7:  
What should be done about clinical data when the sponsor has changed business focus?
Case Study 8:
What are the authorship considerations for narrative reviews by industry employees?
Case Study 9:
Should your publication team use a scientific lexicon?
Case Study 10:
Should members of a company’s upper management team be reviewers and/or approvers of scientific publications?
Case Study 11:
Adding or removing authors late in publication development

Case Study 1:

Issue: What are your responsibilities if you learn about data discrepancies between manuscripts and other source documents, such as reports?

Relevant ISMPP Code of Ethics Sections: Ethical Principles I. 1, 2, 3.

Scenario: You are assigned to an established team and are asked to complete an ongoing project. Discrepancies are evident between the data in the study reports or other source documents and the resulting manuscript(s).

Points to consider:

  • Does the degree of discrepancy in the data require an intervention?
If yes:
    • What type of intervention is appropriate?
    • Have appropriate team members been involved in making this evaluation?
    • Do these discrepancies affect the final conclusions or clinical interpretation of the study?
    • Do these data represent a completely different dataset compared with the one that should be published according to the publication plan?
    • How can you meet minimum acceptable ethical standards and maintain relationships?

If changes would be beneficial but not absolutely required:

    • Is the team open to making the suggested changes?
    • How can this situation be used to encourage better practices in future?

If no:

    • Are these differences consistent with legitimate differences of medical opinion?
    • Can discrepancies be explained as minor differences likely to occur when separate table packages are run for publications and reports?
    • Should these differences and the reasons behind them be documented?
  • Can colleagues in clinical development or medical writing provide additional information regarding the data?

  • Does this manuscript possibly represent a deviation from a publication plan mandated by a CIA?

 If yes:

    • Can the plan be updated under usual processes?
    • Is some other intervention necessary?

If no:

    • Should these differences and the reasons behind them be documented?
    • Do company procedures require that publications table packages be prepared as addenda to the study report?
  • Are there legal or intellectual property ramifications?

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Case Study 2:

Issue: What are your responsibilities for accurately conveying qualifications and competencies?

Relevant ISMPP Code of Ethics Sections: Ethical Principles I. 3, 4, 5.

Scenario: A medical communications agency has been invited to take on a publications program in a therapeutic area in which they have no expertise. However, this is a fantastic opportunity for the agency to expand its business. Further, it has been implied that there would be a significant amount of additional work in the near future should things go well.

Points to consider:

  • Should the medical communications agency advise the potential client of their lack of experience in this therapeutic area?

If yes:

    • Will it jeopardize this new business opportunity?
    • Will it jeopardize existing business and/or future opportunities with this client?

If no:

    • Will this tarnish the agency’s name and reputation if it is discovered that their expertise has been misrepresented?
    • Will it potentially compromise existing work with this client?
    • Will it jeopardize future opportunities with this client and/or other companies?
  • Would ethical standards be violated by not revealing or being transparent about the agency’s lack of qualifications?
  • Should the agency refer this potential client to another medical communications agency that is known to have expertise in this therapeutic area?

If yes:

    • Will the potential client respond well and commend the agency for being truthful, and for assisting their immediate needs by recommending a competitor?
    • Will this enhance the agency’s reputation and increase their chances of future work, or will this jeopardize existing and future opportunities with this long-standing client?

Or:

    • Should the agency consult with an external expert in the therapeutic area before making any decisions regarding what information to provide to this potential client?
  • What are the responsibilities of the pharmaceutical company, or those individuals responsible, when choosing an agency for new business as it relates to therapeutic area expertise?
  • What are the potential risks assumed by a pharmaceutical company, and/or individuals within the company who are responsible for selecting the agency, when hiring an agency without experience in the therapeutic area of interest?
  • How might the lack of experience in a given therapeutic area affect the agency’s ability to effectively work with authors who have expertise in this area?
  • Could the agency’s lack of experience compromise existing relationships with experts/authors in the area?

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Case Study 3:

Issue: What are your responsibilities when you discover a possible premature submission?

Relevant ISMPP Code of Ethics Sections: Ethical Principles I. 1, 2, 3.

Scenario: An academic author forwards the acceptance email and manuscript version for a rapid online publication by a prominent medical journal. You believe that the manuscript in question is still under internal medical and legal review by the Sponsor, and the legal reviewer determined that intellectual property issues had to be resolved prior to journal submission.

The content of the accepted manuscript, and the author list, differ substantially from that of the version under medical and legal review.

Points to consider:

  • Is this the same manuscript/dataset/study (as opposed to a closely related one)?

If yes:

    • Did the academic author prematurely submit secondary or exploratory data?
    • Are the data from an old version of a study report or preliminary data package rather than the final data?

If no:

    • Is this manuscript on the publication plan? Should it be on the plan?
    • Does it require medical accuracy review or full development review?
    • Can it be added without creating another ethical question?
  • Do the authors on the current list meet appropriate authorship criteria? Is the author list complete? Are the listed coauthors aware of the submission and version submitted?

If no:

    • Can review and necessary updates be made in the timeframe permitted?
  • What are the intellectual property and liability issues in this situation? Can the existing manuscript be reviewed?
  • If a corporate integrity agreement is in place, is this submission in violation of the accepted publication plan?
  • Were internal policies and status clearly communicated? By whom? Was an authorship contract issued?
  • What steps can be taken to prevent this situation in future?
  • What steps should be taken (if any) to inform the journal of patent-related issues (if they still exist) which may delay publication?

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Case Study 4:

Issue: How do cultural differences affect authorship?

Relevant ISMPP Code of Ethics Sections: Ethical Principles I.1; II.A.1; II.B. 4 & 5; II.C. 3 & 4.

Scenario: You have been working with investigator authors on a manuscript to report the results of a company-sponsored multinational clinical trial on an investigational drug. The manuscript is close to completion and will soon be ready to submit to the chosen journal. Upon review, you notice that there is a new author listed in this draft. After checking, you discover that this author is not an investigator and lists his affiliation as the same institution as the lead author, one that is located in a country in the emerging markets. After consulting with the publication team, you approach the lead author about the inclusion of this new author and are informed that he was critical to the successful execution of the study.

Points to consider:

  • ICMJE criteria for authorship:
    • Were all authors made aware of ICMJE criteria for authorship? Do they understand the criteria and implications thereof?
    • Does the target journal adhere to ICMJE requirements?
    • Does ICMJE criteria reflect Western values? If so, is it fair to impose these values on all cultures?
  • Have the coauthors been informed about the addition of the new author and are they in agreement to include the new author?
  • Are there different cultural practices in other countries regarding authorship requirements for medical publications?
    • Are you aware of the accepted practices in the country where the new and lead authors live?
    • Might this new author be a ‘guest’ or ‘honorary’ author, eg, is he the lead author’s mentor, or is he the head of department in which the clinical research was done?
  • How do you accommodate differences in cultural values?
    • What are the consequences of not accommodating the newly added author?
    • How will it affect your relationships with the lead author, other authors, sponsor, publication team and other stakeholders?
  • How could this situation have been prevented?
    • How might you work with sponsors and authors in future to avoid this happening again?
    • How might you, in conjunction with the clinical trial sponsor and the investigators, determine authorship requirements for future publications activities?
  • How and when should these authorship requirements and responsibilities be communicated to potential authors of future publications?

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Case Study 5:

Issue: Should medical writers ever qualify for authorship?

Relevant ISMPP Code of Ethics Sections:  Ethical Principles I.1-5; II.A. 1, 7, 9, 10, 15, 16; II.B.5.

Scenario: A professional medical writer paid by a pharmaceutical company is working with external authors to develop a review article. The medical writer performs the research required to identify requisite materials for the review article. During submission, the medical writer is required to provide details of his/her contributions to the work. Shortly thereafter, the journal sends notification that the submission cannot be processed because, according to their specifications, the medical writer qualifies as an author but has not been listed as one. Unless this is corrected within a specified time, the manuscript will be considered to have been withdrawn.

Points to consider:

  • Is the journal correct – is the medical writer an author?
    • Does the medical writer meet the ICMJE criteria?
    • If yes, why was the medical writer not listed as an author?
    • If no, why does the journal see it otherwise?
  • Are the ICMJE criteria sufficient for authorship?
    • Are any opinions stated in the manuscript those of the medical writer? Yes/No; why?
    • Is the medical writer qualified to defend their opinions stated in the manuscript? Yes/No; why?
    • Are there other criteria that need to be considered for authorship?
  • GPP3 guidelines and recommendations regarding medical writers
    • Exception if a medical writer contributes substantially to a review article
  • If the medical writer is to be included as an author, what are the ramifications?
    • How will this action affect relationships with the currently listed authors?
    • Do all current authors agree with the journal’s requirement?
  • If the medical writer is not to be included as an author, what are the ramifications?
    • How will the decision be explained to the journal?
    • What is the recourse if the journal does not accept the explanation?
  • What can be done to avoid this conundrum?
    • What actions can be taken to proactively ensure that there is no conflict?
  • Does the medical writer’s company have a policy?
  • Do other stakeholders have a policy?

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Case Study 6:

Issue: Should all data, regardless of quality, be published?

Relevant ISMPP Code of Ethics Sections: Ethical Principles I.3; IIA.1, 2, 3, 6, 7.

Scenario: An early review of the data from a Phase 3 study conducted outside of the United States indicates statistically significant adverse events and failure to meet primary endpoints for a drug that is already marketed in the United States. The local investigators cite issues with the integrity of the drug and suggest only posting the final findings on the relevant trials database in accordance with the company's policies and in compliance with the law. They further suggest repeating the study with product whose integrity is not in question. There is disagreement among the investigators regarding both the validity and medical importance of the adverse event data, as well as the urgency with which they need to be disseminated. What should be done in this case with regard to posting and publishing these data?

Points to consider:

  • Should potential issues with the drug product integrity used in this study factor in the decision to post and/or publish these data?
    • Should this issue be investigated and mentioned in any potential posting or publication?
  • Does publishing these data help practicing clinicians and patients or do they just muddy the waters?
  • In deciding about publication and urgency, how much weight should be given to the fact that these potentially negative/neutral data are not final?
  • What should be done about publishing data from trials that do not meet desired endpoints?
  • How would you respond to those who claim that only posting data rather than submitting it for publication in a journal undermines the integrity and value of the body of medical literature that is available to practitioners?
  • The legal requirements for posting differ based by country and approval status. To which legal requirements would you adhere?
    • What is your justification for your choice?
    • How would you address questions from other jurisdictions?

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Case Study 7:

Issue: What should be done about clinical data when the sponsor has changed its business focus?

Relevant ISMPP Code of Ethics Sections: Ethical Principles I.3; IIA. 1, 2, 3, 6, 8.

Scenario: As part of a reorganization, a pharmaceutical company has decided to limit the number of therapeutic areas of focus for its research. Consequently, a program for a drug in development has been terminated immediately and all resources (personnel and funds) have been reassigned to other areas and products. You are aware that there are still some unpublished data from trials already completed, including the primary data from one study and secondary data from another.

Points to consider:

  • What are your ethical obligations?
    • Is there a necessity/ethical obligation to publish all of the unpublished data, including secondary endpoints?
    • If the data are not published, how will it affect your relationship with the investigators/authors to stop any ongoing publications?
    • What actions can you take proactively to ensure legal and ethical obligations are met
  • How would you avoid this situation in the future?
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Case Study 8:

Issue: What are the authorship considerations for narrative reviews by industry employees?

 

Relevant ISMPP Code of Ethics Sections: Ethical Principles II.A. 1, 4 & 6; II.B. 2, 8, 9 & 11; II.C. 2 & 5

 

Scenario: After learning about a physician’s questions related to appropriate use of their company’s therapy, a Medical Affairs team is interested in publishing a narrative review of the relevant data/literature. The senior director would like himself and another medical team member to author the paper. You have been asked to advise them on whether this is acceptable.

 

Points to consider:

Is there a clear unmet scientific need for the publication?

  • Is there a sound scientific clinical rationale for the publication? What will it add that does not already exist in the literature? 
  • How can this rationale be assessed and documented? Does your company have any policies on this that you should review? 
  • What is the likelihood of acceptance, recognizing that many journals do not accept unsolicited industry-sponsored reviews? Would a presubmission inquiry be helpful to assess a potential target journal’s interest in the topic?


What is the risk of a perception of bias?

  • Will the article include a balanced review of the literature, or would addressing the known questions from the physician result in a biased/selective report of the available data/literature? 
  • Can you ensure a careful non-biased methodology for the selection of references? Will the review focus on the company’s therapy only, or multiple therapies? Could the topic lend itself to a more rigorous, systematic review? 
  • Is it possible to include external authors who are experts on the topic, to offer a wider perspective?


Can ICMJE authorship criteria be fulfilled? 

  • Are the scientific director and medical team member genuine experts on this topic? Have they authored publications for the company previously?
  • Will they both contribute fully as authors of this publication and meet all authorship criteria? 
  • Will authors write the publication themselves or seek support from a medical writing partner? 
  • Does your company have a formal position about internal authors that should be considered? 
  • How should the contributions of the authors be monitored and recorded? 
  • Should any other internal reviewers be involved, to help ensure transparency?


How can you ensure full transparency in the final publication? 

  • Do the company authors understand the need for their affiliation and potential conflicts of interest to be included? Will the funding be clearly declared?
  • Will medical writing support (if used) be clearly acknowledged?


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Case Study 9:

Issue: Should your publication team use a scientific lexicon?

Relevant ISMPP Code of Ethics Sections: Ethical Principles II.A. 1, 4 & 6; II.B. 6 & 11

Scenario: A Medical Affairs team has developed a Scientific Communications Platform, which includes a lexicon of terms and phrases meant to serve as a common vocabulary for describing and differentiating the product. The publications team, including their medical communications agency, is being asked to use this scientific lexicon in publications development to ensure that points are communicated consistently and clearly.

Points to consider:

What aspects of the lexicon are pertinent to publications?

  • Does the product have a complex mechanism of action that requires clear explanation?
  • Are there nuances with respect to points such as study methodology or different patient populations that may not be well understood?
  • Does the lexicon contain supporting references that may be useful to medical writers?
  • Are there recommendations for lay language that can be used in plain language summaries?
  • How is the lexicon maintained?
  • Are there parts that may become out of date?


Could using the lexicon present any concerns about promotional considerations factoring into publications?

  • Does the Scientific Communications Platform of which the lexicon is a part align with “brand strategy” or contain language that can be viewed as marketing terminology?
  • Were commercial colleagues involved in development of the lexicon?
  • Is the lexicon focused on ensuring medical accuracy about the product?
  • Does it concern itself with product differentiation versus competitors?
  • Were external experts (i.e., potential authors) consulted in developing the lexicon?
  • Would using the lexicon jeopardize authors’ autonomy over their content?


How rigidly is the publications team being asked to follow the lexicon?

  • Does the lexicon have categories such as “preferred,” “acceptable,” and “avoid” which indicate that use is optional rather than mandated?
  • Is the rationale for concepts in the lexicon clear such that meaning can be retained if the wording is altered?
  • Since the agency is meant to work under the direction of the authors, are there aspects of the lexicon that could conflict with author preferences? How will disagreements around wording be addressed between internal and external authors?
  • Is the team clear that authors will have final say over the publication content?


Does using the lexicon raise any concerns about plagiarism?

  • Are there specific phrases or sentences in the lexicon that are likely to be caught by journals using plagiarism-checking software if the same wording is repeated across publications?
  • Is the broader publications team aware of the issue of self-plagiarism where authors should avoid recycling their own previous work?


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Case Study 10:

Issue: Should members of a company’s upper management team be reviewers and/or approvers of scientific publications?

Relevant ISMPP Code of Ethics Sections: Ethical Principles II.B. 2, 3, 9, 10 & 11; II.C. 3 & 5

Scenario: The top executives (CEO, CCO, and CFO) of a biopharma company insist on reviewing and approving all scientific publications before release for submission. During the start-up phase of the company, R&D scientists along with members of the company’s upper management often developed and reviewed scientific publications together. Now that the company is growing and building Medical Affairs functions, the Scientific Publications Lead is seeking to develop a formal Scientific Publication SOP that will refocus the review process per publication guidelines. However, the publications team, including their internal medical writers and external medical communications agency, is being asked to continue involving upper management in the publication review process to ensure they agree with all content being produced.

Points to consider:

Would allowing commercial colleagues to review publications jeopardize authors’ autonomy over scientific content?

  • During which timeframe of the publication development process can commercial colleagues share ideas?

Should commercial colleagues be involved in data review sessions, contribute to strategy of any publication and/or publication plan, or be excluded from all publication-related activities?

If an author was to start working on a publication as a Medical Affairs employee and then get promoted to a leadership position in Commercial, how much input can this person provide?

  • Would input from the CEO, CCO, and/or CFO (or executive- and/or VP-level roles, including VP of Medical Affairs, in larger companies) interfere with the integrity of the publications?
  • Since the writer/agency is meant to work under the direction of the authors, how would they handle the conflict(s) of interest between internal upper management and author preferences?
  • What would you do if comments from the company’s upper management reviewer were not accepted by the authors?

How can the team ensure that scientific publications are free of commercial influence?

  • How would the Scientific Publications and Medical Communications Departments justify the inclusion or exclusion of the C-Suite or the Board of Directors in the publication review process?
  • Which key functions of a company should review and approve publications for release?

Would it be acceptable to limit reviewers to key functional experts from the statistics, intellectual property, legal, regulatory, asset strategy/integrated evidence, therapeutic lead, and/or real-world evidence?

Would it be possible to provide guidance outlining the extent of review expected at each stage? More detailed comments may be acceptable on early drafts versus a simple approval on an almost-final draft.

  • Does the company have defined guidance for the type of review that can be done by company reviewers and/or approvers (e.g., comments on medical accuracy, completeness, and lack of bias only)?
  • Would implementing a publication management platform provide logistical support and support a workflow that is compliant with company SOP?
  • Given that publication guidelines discourage involvement of commercial colleagues on the publication steering committee and participate in development of scientific publication plan, should other upper management team members, such as CMO or CSO, be permitted to join the publication steering committee?


How can the Publications Lead educate upper management about industry best practices for scientific publications?

  • How would using words like “Good Publication Practices,” “compliance,” “standards,” “SOP,” “GPP3,” “ICMJE” resonate with upper management?
  • Which arguments would be useful for persuading upper management?

Would it be helpful to explain how reputation of company may be affected if the public becomes aware of commercial influence on scientific content?

Would it be a deterrent if they understand conflict of interest disclosures may be required?

  • Are there examples of commercial input that jeopardized the integrity and/or submission of a publication?
  • What are the consequences of potential commercial bias?
  • Is the company aware of any situations in which external authors might avoid collaborating with the company due to concerns of commercial bias?


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Case Study 11:

Issue: Adding or removing authors late in publication development

Relevant ISMPP Code of Ethics Sections: Ethical Principles I.A. 3 & 4; II.A.1; II.C.4

Scenario (adding an author): During publication development, the first author asks to include as an author a colleague of theirs who has provided significant input into the running of the study. The publication is at near final draft stage. The publications team must make a recommendation on this request.

Points to consider:

What is the reason the author proposes their colleague as a co-author, and does the proposed co-author meet ICMJE criteria?

  • Was there a reason that this individual was not originally included in the author list?
  • Has the new author contributed to the paper in some way (eg. discussions with other authors captured in email/text)?
  • Or are they expected to contribute in a substantive way?
  • Would it be more appropriate to add them under acknowledgements as a contributor?

What is the effect on the wider author group, study sponsor, and publication?

  • Would all authors agree with this addition to the author list/acknowledgments?
  • Does this addition pave the way for other authors to suggest their colleagues?
  • Does the inclusion of more than one author from the same institution breach any policies of the sponsor?
  • Some companies specify one author per institution: the person legally responsible or taking public responsibility for the study at that site
  • Is there enough time for the new author to provide substantial contribution to the development of the publication?

Does the nature of the publication content make a difference?

  • Is there an incentive for an author to contribute in order to appear on the byline of a high-profile clinical paper?
  • For HEOR/health modelling papers, has the project progressed such that contributors from the analysis company have performed work that now makes them eligible to serve as an author?
  • Has the direction of the publication evolved, or new analyses and interpretation been required, in a way that has introduced different contributors who warrant authorship?


Scenario (removing an author): During publication development, an author employed by the study sponsor resigns from their employment. The publication is at near final draft. The publications team must consider whether the author should remain on the author byline.

Points to consider:

Author perspective

  • Does the author want to rescind their authorship?
  • Would removing an author against their wishes violate established principles designed to protect authors who change employers?
    • Per GPP3 guidance, change of affiliation alone is not a valid reason to remove an author from a publication if they meet authorship criteria
  • Will the author be able to remain engaged and devote the needed time to future reviews and responding to journal comments?
  • Are there other planned publications where the departing employee has met ICMJE criterion 1 for authorship and is there an opportunity to ask to be included on the publications?


Study sponsor perspective

  • What are the study sponsor’s guidelines regarding ongoing authorship where the individual has left employment? Are there recommendations for how to state a former employee’s author affiliation?
  • Is the author entering new employment with a competing company? Is there a direct competition (eg. same therapy area, same mode of action) that would indicate a conflict of interest for this author and justify their exclusion as an author?
  • Was the author from a particular function where their replacement will be contributing to the publication and will need to be acknowledged?
  • Would the author need to see novel data while no longer employed by the study sponsor?
  • Would the author need to sign a non-disclosure agreement to remain an author while not employed by the study sponsor?
  • What other steps, if any, would need to be taken to prevent unauthorized access to confidential data (eg. prohibiting author to use new employers email system for correspondence)? How great is the risk if the data are intended to be published?

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