GPP 2022 Frequently Asked Questions

The aim of the GPP 2022 Steering Committee is to provide answers to questions on a rolling basis, so feel free to reach out. Email [email protected].

Author Reimbursement and Payments

Has anything changed about “author payments” and reimbursements from GPP2 and GPP3 to GPP 2022? The language looks very different.

We recognize that there has been a lot of discussion around the rewording in GPP 2022. However, this rewording was not a change to current best practices or the intended meaning of prior GPP iterations.

Elizabeth Wager explained that the original intention of language about “author payments” in GPP2 and GPP3 was to prevent unethical practices such as paying experts to lend their names to ghostwritten papers or providing payments far in excess of fair market value to entice experts to support work (https://www.youtube.com/watch?v=QYhWaEO-7Bk). The authors of GPP 2 and GPP 3 did not expect that contributors to publications work, such as steering committee members, would devote significant amounts of time to publication-related activities on behalf of corporate sponsors without any form of monetary compensation or that colleagues might be excluded from author bylines because their work was done while receiving monetary compensation. The GPP 2022 text was developed with reference to those remarks as well as to better encompass its larger scientific scope and the expanding role of patients.

The text of GPP 2022 relevant to the discussion reads:

Key points:

General overview:  These above-quoted statements from GPP 2022 refer to practices that are permissible without violating the ethical principles inherent to GPP, in keeping with its new expanded scientific scope and the increasing role of patients and patient advocates in publications activities. No new requirements were added regarding payments or reimbursements.

Adherence to law:  GPP principles have always indicated that laws, journal guidelines, and accepted professional ethical frameworks—as for medical specialties—must also be followed, which may affect the application of GPP 2022. Legal requirements, including corporate integrity agreements, may supersede guidance provided in GPP 2022. In some countries, it is not legally permissible for a government employee to accept any money from a corporate sponsor, including travel expenses for conference attendance, even if that employee is a presenting author. This position is consistent with GPP 2022. Companies whose standard operating procedures (SOPs) and publication policies were composed under a corporate integrity agreement may not have been permitted to make any sort of payment to authors of publications. This situation is also consistent with GPP 2022.

Compensation not required:  GPP 2022 does not require that company sponsors or other groups to offer compensation for time spent in reviewing manuscript drafts or making nominal critical comments. GPP 2022 does not prohibit sponsors from requesting that patients and investigators serve in various roles, including as steering committee members, on a volunteer basis. Nor does it require that clinical investigators receive added monetary compensation, over and above that received in the course of trial activities, for reviewing manuscript drafts and making comments.

Transparency and communication:  GPP 2022 requires that the specific terms of author requirements, review requests and an explanation of any applicable internal policies be clearly communicated to potential authors and ideally included in the author agreement. Potential byline authors must also be given a clear opportunity to opt in or out of participation. (Note: An author who opts out of fulfilling the role of a byline author may still be acknowledged or listed in an author group, investigator group, or study group.) 

Of course, any monetary compensation offered for participation in publication authoring or steering committee membership must be reasonable (ie, set at a fair market rate) and transparently disclosed as required by law or other requirement, such as journal or conference guidelines.

Authors not required to accept compensation, even if offered:  Importantly, GPP 2022 does not mandate that patients, patient advocates, government employees, or academics must accept monetary or other compensation offered in the context of publication activities, even if that compensation is nominal or at a fair market rate. There is, likewise, no requirement that because one author accepts or rejects monetary compensation that all other authors are required to abide by that decision. In other words, GPP acknowledges the basic ethical principle of autonomy and respects the rights of individuals to make these decisions.

Scope of requests may affect best practice:  A basic principle of ethics and integrity is that when profit-driven enterprises request people to perform work on their behalf, such work generally should be compensated. Therefore, in cases where investigators are invited to participate in meta-analytical work or asked to devote time and effort to designing and interpreting new data analyses, adequate attention should be paid to the usual practices within the company context. In other words, if a consultant or steering committee member would normally be compensated for performing such work, then it is not unreasonable for an academic investigator to expect to be treated equitably in that regard, subject to any institutional policies in place by their employer, if applicable.

Our academic authors are demanding payments because the text states “compensating patients or other participants in publication activities, such as patient advocates or SC members, for their time.” What should we do?

As explained above, the intention of GPP 2022 was not as a change to current best practices or the intended meaning of prior iterations of GPP. We acknowledge that this text does not preclude offering monetary compensation to publication authors, such as patients or patient advocates, for time spent reviewing drafts and making comments. However, GPP 2022 does not require such compensation.

We understand that it is awkward to have these conversations with academic authors and that the expanded scope of GPP 2022 and consequent rewording may have created some confusion.

Some recommendations:

• Create a clear policy regarding possible compensation to authors in applicable categories for your organization and for specific types of publications.
  • Some companies may decide that policies for patients and other “lay” participants should be different than those for professional stakeholders, such as clinical investigators. This is permissible under GPP 2022.
  • Policies may differentiate between activities, such as a clinical trial investigator critically reviewing a straightforward manuscript for general agreement, or projects where investigators are asked to participate in designing and interpreting new data analyses. 
  • If the company does not compensate clinical trial authors for reviewing manuscripts, this ideally should be communicated and formally documented at the investigator meeting. Ideally, a publication policy should appear in each clinical trial protocol. However, even if a full policy or publication plan is not included, a statement about possible compensation and reimbursement might be included.
    
    
• Ensure that text regarding compensation and reimbursement appears in the author agreement. A standardized author agreement template might be helpful. The payment (or nonpayment) policy also should be reviewed if a publication launch meeting is held live. In some cases, a reminder might be needed in the initial email communication that accompanies the author agreement.
  
  
• Conduct training on this question with stakeholders within your organization to ensure clarity and consistency.
  
  
• Create a clear SOP or working instruction (or section of an existing SOP or working instruction) regarding discussions about payments within the publications group. Medical writers and publication planners should have a clear path to refer such questions to a responsible party if a misunderstanding occurs. This communication should be transparent.
  
  

Our investigators are saying they will not participate in publications because we are not paying them, but other companies are. Are they allowed to do this?

All stakeholders are free to opt out of publications activities or author bylines for any reason. Keep in mind that some people may feel obligated to make an excuse for nonparticipation because they do not feel comfortable simply declining. Also keep in mind that conversations reported to you second hand may be lacking context. Not every communication requires action, and maintaining consistency and adherence to your SOPs and policies is often the best way forward.

Can we compensate patient participants and patient advocates for time spent in publications activities?

Yes. Compensation may be offered at a reasonable rate for participation in publications activities, including, but not limited to, Steering Committee membership, reviewing manuscripts and/or plain language summaries, and travel to meetings. Appendix Section G indicates that this is not a disqualification from authorship.

Is compensation for time spent on publications an automatic disqualification from authorship?  Could that constitute “payment for authorship?”

No. As explained by GPP3 authors, it is not unethical to compensate (at a reasonable rate) those who spend time on publications activities even if those activities come to qualify them as authors of a paper. Such activities might include, but are not limited to, contributions to data analysis or serving on a publication steering committee.  

The phrase “payment for authorship” does not appear in GPP 2022, and this concept should probably be redefined as “payment for guest authorship”—that is, when an expert is compensated at a highly generous rate to list their name on a paper of which they are not a qualified author.

We understand that a concern around the issue of paying investigators for authorship activities has always existed, especially for those investigators who are also prescribers, because of the potential perception that company sponsors might trade authorship for influence over prescribing habits. (See Supplement Table 3). We also recognize that regulatory guidelines and reporting requirements regarding payments to prescribers may differ based on various factors—GPP 2022 specifies that such requirements must be met. Companies must assess these requirements and related risks when developing their policies around payments to healthcare providers, both generally and for specific cases. Companies should assess such risks when executing contracts with clinical trial investigators, whether for work directly on the clinical trial, or for other services, such as authoring papers, reviewing documentation, or serving on a publication steering committee.

Authorship and Document Review

Does the recent update to International Committee of Medical Journal Editors (ICMJE) authorship criteria affect any specific advice presented in GPP 2022?

No. GPP 2022 was specifically intended to accommodate various authorship standards established by journal editors and conferences. Therefore, any changes made by ICMJE to their recommendations remain within the scope of GPP 2022 by design. 

Why do you distinguish “byline” authors in GPP 2022? This terminology is confusing for many stakeholders.

We used “byline” authors to define the listing of authors that appears on the paper where the authors are listed to distinguish those authors from members of an author group who may be listed in a footnote or supplement.

Why should medical writers not perform the final data check unless they are named coauthors of a publication?

GPP 2022 uses the ICMJE authorship criteria as a default. Named authors are responsible and accountable for data integrity and therefore should perform the final data check. This recommendation does not prevent a medical writer from supervising or performing a QC process prior to the final data check.

Why was the author limit of 10 deleted from GPP 2022?

ICMJE indicates that the number of authors should not be limited. Journal editors and authors are the correct decision-makers in terms of the number of qualified authors following the appropriate guidelines.

Is it acceptable to acknowledge in-house reviewers whose suggestions were used to improve a publication?

Yes. It is always advisable to acknowledge the contributions of reviewers to any publication, even if those contributions are only editorial.

Artificial Intelligence (AI)

What is the GPP position on the use of AI?

GPP 2022 mandates compliance with regulations, guidelines, and journal and conference policies for all aspects of the publication of company-sponsored research. Therefore, publication stakeholders should follow the applicable regulations, guidelines, and policies, as set forth by government agencies and editorial groups. The use of AI does not alter policies regarding authorship, data integrity, or research ethics.

Data Transparency

Can you clarify GPP requirements for data sharing for various kinds of studies?

Policies on data sharing are usually made by journal editors, conferences, regulatory groups, and/or medicines agencies. GPP 2022 indicates that any applicable regulations should be followed. Thus, for all types of data, authors follow any data sharing policies established at journals and conferences, as consistent with also protecting patient confidentiality.

Can you clarify the scope of GPP 2022 in terms of nonclinical studies?

GPP 2022 specifically mentions nonclinical studies. However, we do recognize that the volume of nonclinical research might be prohibitive to publish on a study-by-study basis and that regulatory frameworks may not mandate the registration of nonclinical studies. The relevance of such studies to the biomedical evidence base, especially for projects that have not yet entered the clinic, may also be unclear. These factors contributed to the observation in GPP 2022 that not every study merits a standalone publication. We also note that similar barriers might be present for publishing basic research.

In the case of nonclinical and basic research, it might be useful for sponsors to form specialized steering committees to consider how and when best to publish such studies. As noted in GPP 2022, we do encourage transparency for all studies of marketed products, which would include publishing.

New Name

Why did you change the GPP terminology?

The original intention of GPP was to align with other sorts of good practice, such as good clinical practice (GCP).  These do not carry version numbers.  Feedback at the 2022 Annual Meeting of ISMPP aligned with this idea.

We envision “GPP 2022” as an interim or transitional usage. It is our hope that the profession will use GPP (2022) at the first instance of use and refer to the current version of GPP thereafter.

This should benefit future users by limiting needed adjustments to SOPs and policies.

Plain Language Summaries (PLS) and Enhanced Content

Why does GPP 2022 more strongly recommend PLS for papers following the CONSORT (Consolidated Standards of Reporting Trials) format?

GPP 2022 encourages PLS for all studies; however, in some cases, it may be more useful to create a standalone PLS from several scientific studies.

In the case of clinical trials, it may be more important that various groups have access to a PLS for each study. GPP 2022 mentioned CONSORT in this context specifically because this format is used for publications of clinical trial data. This recommendation does not preclude writing an additional standalone PLS of several clinical studies.

Where can authors and publications professionals learn more about which types of enhanced content, PLS, and infographics are acceptable at specific journals and conferences?

GPP 2022 defers to the guidelines established by journal editors and professional societies. Consistent with ICMJE recommendations, these groups are responsible for setting their own policies.

Will plain language summaries (PLSs) always dramatically increase publications costs?

No. As noted in Supplement Section A, a PLS may appear in a variety of formats from short-form, text-based abstracts to longer form, video, infographics, or other types of graphical summaries. Deciding which type or format of PLS to use should include factors such as budget and journal options. A brief plain language abstract is sufficient for many, if not most, publications and should not generate excessive additional costs.

Why is there not a PLS for GPP 2022?

The abstract and GPP 2022 itself were written using plain language suitable for their intended audience of publication participants, students, and journal editors. We also included standalone figures and tables for key elements of GPP that could be extracted and shared with authors, contributors, reviewers, and other professionals.

Why do there appear to be conflicting PLS recommendations?

Appendix Section A of GPP 2022 recommends a PLS for each publication of clinical data that follows the CONSORT guidance, in keeping with the recent ISMPP publication on PLSs.  This recommendation is intended to have more force than the suggestion on Supplement Section H that ideally each journal article should have a PLS, keeping in mind that a PLS can take many forms and that a standalone PLS can be prepared to explain multiple publications and studies.

Practical Implementation

Does a specific GPP 2022-recommended policy and procedure manual exist?

No. GPP 2022 was designed as a useful guide. However, some major companies do disclose their publications policies publicly and may also provide a strong model for others seeking to design appropriate and GPP-compliant policies.

Is there a GPP 2022 position on the use of specific software to manage publications? One reason for this question is that certain systems are cumbersome (or at times impossible) for academic authors to use, which can limit inclusivity.

Using specific products or programs to track publications and gather and archive author comments can be consistent with GPP 2022. However, the use of a program or product is not required. In the case where an author cannot access the system in use by a specific sponsor, some other accommodation should be worked out within the authoring group.

What kinds of publication strategy should be considered before designing a research study?

Researchers should have a plan for writing the various necessary documents associated with designing, conducting, and reporting a research study. Publications should be considered in this context. At the start of an overall clinical development program, for instance, researchers might consider which journals and conferences might be appropriate for sharing data from studies, which investigators might be interested in serving on a steering committee, and whether there is a need for any additional advising groups, such as a patient steering committee.

Preprints / "Premature Publication"

Does GPP 2022 permit the use of preprint servers to share clinical data about ongoing public health emergencies in response to guidelines released by health authorities or the WHO?

Yes. Relevant guidelines should always be followed, which would include the use of preprints to protect public health. If there is a guideline or regulation that requires the use of preprints for certain types of data, authors and companies should comply. This should not be understood as universal encouragement for using preprints.

Does GPP 2022 prohibit all use of preprint servers?

No. GPP 2022 indicates that—because of the danger of having unclearly inconsistent or duplicate datasets accessible to the public—routine use of preprint servers for clinical data is not recommended for the results of clinical studies. This means that the use of preprint servers should be carefully considered and consistent with authentic scientific or public health need.

Why is “premature publication” no longer mentioned in GPP 2022?

Premature publication is difficult to define, which creates confusion. The original GPP refers to press releases and does not define other problematic practices. As mentioned in GPP 2022, embargo policies of journals and conferences should be followed. GPP 2022 also specifically comments on the use of preprint servers.

Social Media

Can the authors comment further on the use of social media?

Social media is still an emerging area of communication in some parts of the world and regulations governing its use vary considerably. GPP 2022 is intended to be compliant with local and international regulations and guidelines. For this reason, GPP 2022 recommends that publications professionals and authors consult with experts who are familiar with the applicable regulatory frameworks for such communications.

Steering Committees

How many steering committees should be formed?

As explained in Supplement Section D, the function of a publication steering committee is to consider the best way to publish data that will appear across multiple publications in situations where outside advice will benefit the authors and other contributors of those publications.  Therefore, a publication steering committee should be formed for every study or group of studies for which a need of such outside advice is anticipated.  A steering committee may not be needed for each study or program, even if multiple publications are planned. In those cases, the publication working group can perform the functions that would have been performed by the steering committee.

However, it may be prudent to form a publication steering committee for every major product or program (or logical groupings of products and programs) in case questions arise.

GPP 2022 Supplement Section D also mentions patient steering committees, which may be formed in situations where it is anticipated that advice might be needed from such a body.

How should RWE/HEOR/PRO colleagues be included in publication working groups or steering committees?

As explained in Supplement Sections D and F, the purpose of each publication working group or steering committee is to oversee a specific publication or group of publications.  Therefore, appropriate RWE, HEOR, and/or PRO colleagues should be included in all publication working groups and steering committees that oversee the publication of data that would benefit from such expertise.  In cases where RWE, HEOR, and/or PRO expertise is not needed, then it is not necessary to name representatives to a steering committee or publication working group.