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:


ISMMP 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 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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