Research and Reporting Methods6 October 2015

Guidelines International Network: Principles for Disclosure of Interests and Management of Conflicts in Guidelines

    Author, Article, and Disclosure Information


    Conflicts of interest (COIs) have been defined by the American Thoracic Society as “a divergence between an individual's private interests and his or her professional obligations such that an independent observer might reasonably question whether the individual's professional actions or decisions are motivated by personal gain, such as direct financial, academic advancement, clinical revenue streams, or community standing.” In the context of guideline development, the concerns are not simply about identifying and disclosing direct financial or indirect COIs. Despite this recognition, the management of COIs in guidelines is often unsatisfactory. In response to requests from its international membership and informed by existing syntheses of the evidence and policies of international organizations, the Guidelines International Network Board of Trustees developed guidance on the disclosure of interests and management of COIs. Current approaches are relatively similar throughout the guideline development community, with an increasing recognition of the importance of disclosing and managing indirect COIs. Although there are differences in detail among the approaches, the similarities allow for the formulation of 9 core principles for managing COIs. In formulating these principles, the Guidelines International Network Board of Trustees recognizes that COIs cannot be totally avoided when panel members are being chosen for certain guidelines or in certain settings; thus, the important issue is the management of COIs in a fair, judicious, transparent manner.

    In the context of guidelines, one can broadly describe conflicts of interest (COIs) as direct financial COIs that refer to financial relationships with entities that have investment in products or services directly relevant to the guideline topic and indirect COIs that relate to such issues as academic advancement, clinical revenue streams, and community standing (1, 2). Intellectual COIs, including attachment to ideas or “academic activities that create the potential for an attachment to a specific point of view” (3) belong in the latter category. These COIs may ultimately lead to indirect financial gain related to salaries or other benefits resulting from academic advancement. Although COIs are often hard to detect, evidence suggests that all types of COIs can influence guideline recommendations. For example, authors with recent publications about the management of breast disease were more likely to make recommendations for breast cancer screening than those without recent publications (4).

    Because COIs create a risk of bias in decisions or recommendations (5), systematic approaches to the disclosure of interests and COI management are necessary to minimize potential bias (6). Discussions about COIs are not only about understanding and reporting direct financial interests but also about managing COIs (7–10). Despite recognition of these issues, guideline developers' disclosure and management of COIs are often unsatisfactory (11, 12).

    Established in 2002, the Guidelines International Network (G-I-N) ( is a network of guideline developers, comprising 100 organizations and 127 persons from 48 countries. The G-I-N has published guideline development standards that emphasize the importance of disclosing and managing COIs, but these standards do not elaborate on specific COI management (9). Yet, when surveyed, the 94 participating G-I-N members indicated that managing COIs was one of the areas that needed further guidance (13).

    Writing for the G-I-N Board of Trustees (BoT), we reviewed the recent research and developments in managing direct financial and other COIs by using examples from several organizations and state the consensus-based principles of the G-I-N BoT for managing COIs. The Table describes the types of COIs. Here we reiterate that G-I-N recognizes the potential for indirect financial or other gains that may represent COIs. For simplicity, we will use the phrase “direct financial and indirect COIs.”

    Table. Types and Examples of Conflicts of Interest in Guidelines



    The G-I-N BoT, comprising 12 guideline developers from most regions of the world with backgrounds in evidence-based medicine and guideline development, used a consensus-based process to develop the principles for managing COIs. Two members of the BoT developed the idea, and 11 BoT members formed a writing group.

    We consulted published articles on managing COIs in guideline development (1, 3, 8, 13), reviewed empirical research (14, 15), and updated a targeted literature search by reviewing PubMed on 1 December 2014 to identify work on the topic that was published after our previous search in 2011 (13). In our search, we combined the terms “conflict of interest” and “guidelines or recommendations.” We also used a comprehensive review of existing policies and guideline manuals that abstracted information about COI declaration and management (16), and we reviewed the policies of organizations that board members belonged to or had worked with previously. The authors and nonauthor members of the BoT reviewed manuscript drafts to arrive at consensus-based principles for dealing with COIs in guidelines. Disagreement was resolved by in-depth discussion during board meetings and teleconferences among the authors or in-depth conversations between the first author and individual board members. Final written agreement on the principles was obtained from all board members. The G-I-N provided travel support for participants, but the study was not otherwise funded.

    Review Findings

    What Types of COIs Are Relevant to Guideline Development?

    Influential organizations, such as the Institute of Medicine (IOM), have recognized the need to declare, disclose, and manage financial and intellectual COIs in guidelines (9). The World Health Organization (WHO) asks advisors about financial COIs and queries, “Is there any other aspect of your background or present circumstances not addressed above that might be perceived as affecting your objectivity or independence?” (17). The National Institute for Health and Care Excellence has a written policy on managing COIs for all its employees; board members; and members of advisory bodies, including guideline groups (18). Its policy classifies interests as being “personal nonpecuniary” (an intellectual or academic interest), “personal pecuniary,” “nonpersonal pecuniary,” (payment to a department or organization managed by someone), and “personal family.” The latter 3 may be either specific to the topic under consideration or nonspecific, which means that there is an interest in “the manufacturer or owner of the product or service, but … unrelated to the matter under consideration” (19). Management of COIs for the U.S. Preventive Services Task Force (USPSTF) requires that members who participated in determining the direction and strength of a recommendation must have no substantial financial, intellectual, or other conflicts (20). For the management of nonfinancial (indirect) COIs, the American College of Physicians, American Thoracic Society (ATS), American College of Chest Physicians (ACCP), and other organizations review leadership or persons with close involvement in an advocacy group; persons who are chairs or members of other guideline committees; and expert witnesses or persons with personal relationships that may interfere with an unbiased publication process at the stages of authorship, peer review, editorial decision making, or publication (1, 3, 21).

    The description of COIs applies to all members of a guideline development group. Thus, health care professionals, patients, and policymakers who participate in guideline panels are all at risk for being unduly influenced by COIs related to specific recommendations.

    Health Professionals

    For many health professionals engaged in guideline development, financial COIs are the most problematic (22). However, health professionals may also be conflicted when considering procedures that they currently perform or if their practice prevents them from approaching a question with an open mind. For example, they may find it difficult to recommend new treatments and procedures that they are unfamiliar with because of the need for training or investment. Indirect COIs may also result if health professionals emphasize the importance of their own research. Health professionals are included for their expertise, but that expertise may lead to COIs (3). One solution for dealing with such COIs is to allow these persons to provide information about the topic but minimize their influence by working with them as external advisors or nonvoting panel members.


    Patients, like other guideline panel members, may have a COI if they receive support from external organizations that receive industry funding. Patients should not be bound to the view or ideology of specific organizations and must bring their own experience and expertise to the panel. This may result in a contradiction because patient representatives are asked to represent the patients' voice and act in the interest of patients, but they should avoid taking an advocacy role for an organization. Patients may also be biased about a particular intervention if they believe they have personally benefited from or been harmed by it.


    Policymakers, including health program managers, who participate in guideline development may benefit by enhancing their public profile if they recommend or agree to reimburse specific interventions. They may, however, lose professional standing for recommending or reimbursing interventions that might be costly to implement. Policymakers may also support guideline topics that are important for their constituency but not necessarily important for public health.

    Financial Amounts, Degree of Involvement, or Relevance

    Although evidence suggests that any financial benefit can influence judgments about interventions in guidelines (23), direct relevance and larger amounts are considered more important than indirect relevance and lesser amounts. However, varying income and resource structures make defining such a scale challenging. The ATS has used rating scales to define both the degree and relevance of COIs (Appendix Tables 1 and 2). Chairs, organizers, and others responsible for reviewing COIs should follow step-by-step procedures that clearly articulate the process, including what happens and who is responsible at each stage of disclosure and review; further, these procedures should provide guidance on evaluating the relevance and significance of COIs and determining the appropriate methods of resolution (1).

    Appendix Table 1. “Weight” of potential conflict of interest based on “value.”**

    Appendix Table 1.

    Appendix Table 2. Relevance to the topic.*

    Appendix Table 2.

    What Processes Do Guideline Development Groups Use to Manage COIs?

    The IOM report suggests generally excluding persons with financial COIs from guideline development panels. However, because obtaining the necessary expertise from persons without conflicts (for example, in rare conditions or specific settings) may sometimes be impossible, the IOM requires the following: chairs should have no COIs, only a small minority of panel members should have COIs, members with COIs should be precluded from voting on topics in which they have a financial interest, and members with COIs should be prohibited from drafting and deciding on specific recommendations (9). The IOM also calls for guideline development groups to involve the public in attempts to identify experts without COIs and to disclose publicly any COIs of persons selected for membership on panels. The IOM report included specific recommendations made by a WHO working group for dealing with COIs (8, 13).

    The Agency for Healthcare Research and Quality manages COIs for the USPSTF and, on review of members' COIs, makes recommendations in 4 categories: no action (no relevant COIs), information disclosure to USPSTF only (member may participate as a topic lead and may discuss and vote on the topic), recusal from participation as lead of the topic workgroup (member may discuss and vote but not lead the topic), and recusal from all participation (member will leave the meeting room for all discussion and voting) (20).

    Work by the ATS and a committee advising on guideline development at the American College of Chest Physicians considered in the IOM report defined indirect financial and intellectual COIs and provided suggestions for management strategies (1, 3). Practical application of COI management principles supports the conclusion that disclosure is insufficient and approaches that are consistent with recusal and managed participation of conflicted experts are a possible solution (1, 3, 14, 24).

    Thus, major organizations have recognized the importance of disclosing and managing both direct financial and nonfinancial interests, as the Table defines. Organizations agree that all interests should be made public, including monetary amounts for direct financial and indirect COIs. Further, organizations agree that persons with a leading role in a guideline panel (for example, chairs and persons summarizing the evidence) should be free of relevant COIs.

    However, the inclusion of guideline development group members with COIs in other roles than chair can be necessary and unavoidable, such as when dealing with rare conditions, in settings or jurisdictions with a small pool of potential guideline panel members, or when the most informed persons are those who have led the research and development of an area of focus. Pluralism of stakeholders is a desirable feature of guideline panels and may reduce the risk of bias resulting from COIs and lead to balanced final decisions (25).

    What Does the G-I-N Recommend? G-I-N Principles

    The G-I-N BoT agreed on and suggests applying 9 principles for disclosing interests and managing COIs.

    Principle 1: Guideline developers should make all possible efforts to not include members with direct financial or relevant indirect COIs.

    Although the G-I-N recognizes the need for exceptions when this is not practical, such issues should not diminish the importance of this principle. In situations in which panel members have COIs, conflicted members should represent a minority on a guideline panel and the guideline developer should be transparent about the reasons for including conflicted members and the management of COIs.

    Principle 2: The definition of COI and its management applies to all members of a guideline development group, regardless of the discipline or stakeholders they represent, and this should be determined before a panel is constituted.

    Principle 3: A guideline development group should use standardized forms for disclosure of interests.

    Principle 4: A guideline development group should disclose interests publicly, including all direct financial and indirect COIs, and these should be easily accessible for users of the guideline.

    As part of this disclosure, the guideline development group should disclose all specific monetary values because COIs may arise at different levels in different settings. Reporting of actual or approximate amounts, if known, increases transparency. Registries of disclosures could be used (6).

    Principle 5: All members of a guideline development group should declare and update any changes in interests at each meeting of the group and at regular intervals (for example, annually for standing guideline development groups).

    Principle 6: Chairs of guideline development groups should have no direct financial or relevant indirect COIs. When direct or indirect COIs of a chair are unavoidable, a co-chair with no COIs who leads the guideline panel should be appointed.

    A relevant COI exists if it influences the direction or strength of a recommendation. An example of a co-chair without such conflicts is a methodologist who has no interest related to the direction or strength of the recommendation.

    Principle 7: Experts with relevant COIs and specific knowledge or expertise may be permitted to participate in discussion of individual topics, but there should be an appropriate balance of opinion among those sought to provide input.

    In some settings, persons who fulfill this role may be considered expert advisers who are neither voting nor nonvoting members of the guideline development group.

    Principle 8: No member of the guideline development group deciding about the direction or strength of a recommendation should have a direct financial COI.

    These members should not participate in this phase of guideline development. They should be physically absent from the discussion about the direction and strength of the recommendation.

    Principle 9: An oversight committee should be responsible for developing and implementing rules related to COIs.

    The oversight committee should address issues of dispute and advise the chair of the guideline development group on determining who is a voting or nonvoting member and who should be designated as an expert adviser.

    How Can Guideline Developers Implement the G-I-N Principles?

    The guiding principles for defining, disclosing, and managing COIs should be similar across jurisdictions, regions, and countries; however, the details of implementation may vary. Therefore, we are proposing principles rather than standards. The use of forms (such as the Declaration of Interests for WHO Experts) and rules based on these principles will permit a fairer and more transparent guideline development process, which will help prevent concerns and criticism of bias after the guideline is published (Principle 3). These forms should specify a period in the past for which interests should be declared, and participants should provide consent that future COIs should be avoided. Transparency not only involves full disclosure of COIs but also a clear description of the process used to identify and manage them for each recommendation because COIs may differ from each recommendation in a guideline.

    Recognizing the inherent direct and indirect COIs of health care providers and patients, one may ask why they should be included in a guideline development group. Content and patient experts are essential for defining key health care questions because they often have unique insight into the clinical, public health, or policy problems. They can explain what is relevant to practice and persons with the condition; interpret how directly the evidence applies to the actual question by describing professional and patient preferences, safety, equity, and effectiveness; consider if resources are spent appropriately; and balance the considered options fairly. Avoiding bias may be achieved by careful and astute chairing of the guideline development group that reinforces management of COIs, ideally by a guideline methodologist who has in-depth understanding of research question formulation, evidence synthesis, evidence to recommendation processes, and guideline panel leadership. Further, oversight committees, which should also be responsible for handling disputes about COIs, may classify panel members as either “voting” or “nonvoting.” This classification will identify persons who can actively participate in defining a recommendation and those who may participate in discussion but not decision making about recommendations; further, formal voting should rarely be necessary if appropriate consensus-finding approaches are used and a guideline panel is well-chaired. Organizations could also consider involving persons with declared substantial conflicts as informants or expert advisors but not official guideline development group members (Principle 7). A clear description of members' and expert advisors' COIs and their involvement (for example, voting or nonvoting) in each recommendation should be included in the final guideline documents. In addition, the process for the development of recommendations and management of COIs should be clearly articulated before the establishment of the group (6). Having clear rules in place will be particularly important for guideline developers who are not part of a national quality assurance program that supervises or oversees guideline production, dissemination, and implementation.

    The degree to which COIs affect the risk of bias will be influenced by how other steps in guideline development are handled. For example, the use of systematic methods to synthesize and assess evidence, formal processes to reach consensus, or the involvement of methodologists without COIs will probably reduce the effect of COIs. In addition to the G-I-N standards for guideline development, a partnership between G-I-N and McMaster University provides a comprehensive checklist for the guideline development process (16, 26). Thus, managing COIs will be of greater importance when such standards or processes for guideline development are not closely followed or are not overseen by quality assurance programs (Principle 9).


    The G-I-N BoT provides guidance for its members and other organizations on disclosing and managing COIs. The G-I-N BoT emphasizes that because COIs cannot usually be eliminated completely, the challenge lies in judicious management. The G-I-N BoT looks forward to seeing further research that evaluates the proposed principles.

    Appendix: G-I-N BoT and Contributions

    All persons named in the byline were authors and members of the G-I-N BoT at one point during the preparation of the manuscript. Membership on the BoT changed in August 2013 and August 2014, and the following persons were additional members of the board who approved this manuscript as nonauthor contributors: Richard Rosenfeld, MD (United States); Susan Huckson, PhD (Australia); Duncan Service, PhD (Scotland); and Joan Vlayen, PhD (Belgium).

    Drs. Schünemann and Qaseem (immediate past G-I-N BoT chair) had the idea for this manuscript. Dr. Schünemann drafted the initial manuscript and was responsible for writing all other versions of the manuscript. Drs. Komulainen, Macbeth, Phillips, van der Wees, and Qaseem; and Ms. Al-Ansary and Ms. Kersten provided detailed feedback on early drafts of the manuscript, provided examples, and critically reviewed the manuscript. Drs. Forland, Kopp, and Robbins critically revised drafts and provided feedback, and all other G-I-N BoT members commented on or approved an early version of the manuscript and the final version.



    Sign In to Submit A Comment
    Bruce Davidson, MD, MPH20 November 2015
    The Annals’ new Guidelines International Network (GIN) interest group statement (1) discards the Institute of Medicine conclusions and attempts to equate “members with direct financial” COIs and members with “relevant indirect COIs”, writing they should not be included in guideline development, but can be if “managed”.
    Where this is practiced, an expert medical scientist in an area would be perceived similarly conflicted to a physician or PhD-holder taking tens of thousands of dollars from a company. The latter have influenced guidelines a long time. The Chair of GIN neglects to disclose he is an institutional colleague of plenty of guidelines writers with direct financial conflicts, whom he and co-authors may now cover with their GIN article by lumping together cash gains with the scholarly production of medical scientists. Does Dr Schunemann believe that this benefit for his very own university colleagues with cumulative earnings in the hundreds of thousands is not a personal conflict of interest for him?
    Inherent to science are skepticism about one’s own results, modesty regarding their meaning, and openness to other viewpoints. Expert guideline panelists who love research, those who seek institutional promotion and fame, those who take money from outside companies—either consistently display these qualities, or they don’t and should be removed as panelists. The GIN committee’s equating the scholarly work of clinical medicine with taking money from outside commercial entities is a cynical undermining of honest medical scientists at every institution. It has no ethical or professional legitimacy.

    Sincerely yours,
    Bruce L Davidson MD, MPH, FACP

    1. 1. Schunemann HJ, Al-Ansary LA, Forland F, Kersten S, Komulainen J, Kopp IB et al. Guidelines International Network: Principles for disclosure of interests and management of conflicts in guidelines. Ann Intern Med 2015;163:548-553.
    William R. Phillips, MD, MPH7 January 2016
    American Academy of Family Physicians Pioneered Full Disclosure in Clinical Guidelines
    With the publication of principles for disclosing and managing conflicts of interests in clinical guidelines, the Guidelines International Network (1) has done a service to the developers and users of clinical practice guidelines and to the patients they serve. The pioneering work in this area was done by the American Academy of Family Physicians, which published in 1994 the first international call for explicit declaration of conflicts of interest in the development of clinical practice guidelines (2).

    William R. Phillips, MD, MPH

    1. Schünemann HJ, Al-Ansary LA, Forland F, Kersten S, Komulainen J, Kopp IB, et al. Guidelines International Network: Principles for Disclosure of Interests and Management of Conflicts in Guidelines. Ann Intern Med. 2015;163:548-553. doi:10.7326/M14-1885

    2. Phillips WR. Clinical policies: making conflicts of interest explicit. JAMA. 1994;272(19):1479. [PMID: 7966829] doi:10.1001/jama.1994.03520190021010.

    Alexander Nast, MD21 December 2015
    No interest - no motivation.
    Guidelines international network: principles for disclosure of interests and management of conflicts in guidelines
    I read with great interest the publication on “GINs principles for disclosure of interests and the management of conflicts”. Applying the principles to the currently broad spectrum of different guidelines systems is a challenge. As a main requirement, Schuenemann et al are asking for a limitation of member with indirect conflict of interests (COIs) and for an exclusion of members with direct COIs. The definition of indirect is very broad, including “gaining clinical income from the recommendation” would apply to almost anybody working in that field in case of any frequent disease or widely used intervention.
    Excluding or limiting the number of such panel members leaves us with the question of who is supposed to write guidelines in the future? From where do we get these ideal guideline panel members without any indirect or direct COI, who are willing to extract study results into long GRADE tables, to travel and to sit through extensive consensus conferences?
    If an ideal guidelines group consists of more than fifty percent non specialists in the field without any interest in the guidelines topic, how are we going to motivate them to work on the guidelines?
    If we are envisaging a system where a neurosurgeon is heading a dermatological guideline group, 60% of the guidelines team consist of health economists, master in public health, health scientists and doctors from other specialties, someone will have to pay them for spending their time with “pimples, pustules and scaling”; where they would usually show no interest in. Since support from pharmaceutical company is critical, public funding or funding from health insurance comes into play. However, are these institutions free from COIs? And what do we do in countries such as Germany, where no such money can be obtained easily from the government or health insurance companies? And even if government agencies did provide financial support, is it really the right path for the future to hand over control to government run guidelines agencies, where we could assume that cost cutting is likely to be the primary interest.
    In an ideal world, with abundant independent funding, given to an independent group with a good mixture of experts in the field (who always will have some interests / conflicts of interest in their topic) and “neutral” members employed for their work may work, unfortunately, up to now I am not aware of any country where such ideal conditions exist.
    Keeping this in mind, I consider the GIN principles a valuable stimulus, but we should be careful to expect worldwide immediate adaption of these principles and should be particularly careful in judging guidelines developed from groups not following the principle as “conflicted” or not “trustworthy”.
    Holger Schünemann, on behalf of authors of the original article16 December 2015
    Principles for Disclosure of Interests and Management of Conflicts in Guidelines: desirable and undesirable action and consequences
    To the editor,

    We thank Drs. Humphrey and Mac Lellan for their comment on the Guideline International Network (GIN) Principles for Conflict of Interest Declaration and Management (1). The authors request that for panel members with indirect conflicts of interest the balance must be in retaining them in guideline development but in ensuring that there is transparency in terms of the nature of the indirect conflicts of interest. They also state that ideally the strength of the scientific evidence should inform the recommendations and balance any strong views. We agree with these demands and have laid those out in the article as published.

    We emphasize that transparent processes and evaluating the certainty in (or strength or quality of) the evidence are key issues in developing trustworthy recommendations (2). However, in addition to weighing the certainty of the scientific evidence other factors that determine the strength and direction of a recommendation should be considered transparently which inevitably require additional judgments such as use of resources, values and preferences and equity considerations (3, 4). We also agree that key leaders should not be excluded from the process as long as the potential interests or conflicts of interest can be managed. However, in many situations there is a large pool of potential contributors to choose from and those with the least potential for conflicts rather than those with clear and declared interests should be chosen in guideline panels.

    Dr. Leas and Umscheidt comment on the disclosure of non-financial conflicts of interest. They comment on the level of personal details that should be revealed in clinical practice guidelines. We feel that the disclosure of private medical information might not be relevant or kept on file if it leads to inappropriate consequences such as discrimination. Moreover, a solution to addressing the issue of intellectual conflicts and non-direct financial conflicts of interest may be to describe that certain views or personal traits were present without necessarily disclosing them. Furthermore, we agree that additional guidance regarding disclosure of non-financial conflicts of interest would be helpful. In our article on the principles of declaration and management of conflicts of interest, we do describe several of those potential strategies. Again we thank both author teams for the interest they have expressed in our work.

    *Original authors who confirmed agreement with this response letter in a timely fashion: Forland F, Kersten S, Komulainen J, Kopp IB, MacBeth F, Phillips SM, Robbins C, Qaseem A.

    1. Schunemann HJ, Al-Ansary LA, Forland F, Kersten S, Komulainen J, Kopp IB, et al. Guidelines International Network: Principles for Disclosure of Interests and Management of Conflicts in Guidelines. Ann Intern Med. 2015;163(7):548-53.
    2. Schunemann HJ, Wiercioch W, Etxeandia I, Falavigna M, Santesso N, Mustafa R, et al. Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise. CMAJ. 2014;186(3):E123-42.
    3. World Health Organization. The use of delamanid in the treatment of multidrug-resistant tuberculosis Interim policy guidance Accessed 8 Dec 2014.; 2014.
    4. World Health Organization. The use of bedaquiline in the treatment of multidrug-resistant tuberculosis. Interim policy guidance . Accessed 8 Dec 2014.; 2013.

    Disclosures: The author is a member of the Guideline International Network (GIN) Board of Trustees. No financial interests or relationships exists that is relevant to this response letter.

    Brian F. Leas, Craig A. Umscheid2 November 2015
    Guidelines international network: principles for disclosure of interests and management of conflicts in guidelines
    We commend the Guidelines International Network (G-I-N) for highlighting the challenges associated with disclosure and management of conflicts of interest (COIs) during guideline development.1 We especially applaud G-I-N for drawing attention to nonfinancial indirect COIs, including personal ideologies or characteristics, that may influence an individual’s perspective and potentially warrant disclosure. But there is a related dilemma that guideline panels, as well as authors and journal editors, should consider when addressing nonfinancial indirect COIs: balancing the need for transparency with respect for privacy. We encountered this challenge recently when performing a systematic review2 examining the association between Jewish ritual circumcision with direct oral suction and neonatal herpes simplex virus infection. We decided to volunteer private details about ourselves and our families that we believed would be important to readers:
    “B. F. L. is an adherent of Orthodox Judaism, and is not affiliated with the religious sects that commonly practice direct oral suction during circumcision… B. F. L. and his sons underwent ritual Jewish circumcision, without direct oral suction. C. A. U. is a non-practicing Roman Catholic whose wife affiliates with secular Judaism. C. A. U. and his son were circumcised by pediatricians in the hospital setting.”
    Revealing such personal details is certainly uncommon. In our situation, we disclosed this information to be transparent about our perspectives given the controversial nature of the practice and related cultural and religious significance. However, in the six published studies included in our review, none of the 36 original authors disclosed their circumcision status or religious affiliation, or that of their families. Similarly, recent guidance from the American Academy of Pediatrics’ Task Force on Circumcision included no such disclosures.3 Our disclosure was sufficiently novel that it attracted media attention.4
    Disclosure of private medical information, or personal characteristics such as faith, race, sexual orientation, or political preferences, is not mandated by guideline panels or journal editorial policies. Moreover, guideline end-users and the scientific community at large do not usually expect this type of transparency. However, rigorous scientific methods and diligent guideline panels cannot realistically eliminate the impact of personal traits or experiences, nor should they necessarily strive to do so. Although G-I-N has taken an important step towards addressing nonfinancial indirect COIs, adequate guidance regarding disclosure of these COIs remains lacking. We encourage the scientific, publishing, and bioethics communities to foster further discussion of how to expand consideration of nonfinancial indirect COIs while respecting individual privacy.

    1. Schunemann HJ, Al-Ansary L, Forland F, et al. Guidelines international network: principles for disclosure of interests and management of conflicts in guidelines. Ann Intern Med. 2015; 163:548-553.
    2. Leas BF and Umscheid CA. Neonatal herpes simplex virus type 1 infection and Jewish ritual circumcision with oral suction: a systematic review. J Pediatric Infect Dis Soc. 2015; 4(2):126-131.
    3. American Academy of Pediatrics Task Force on Circumcision. Technical report: male circumcision. Pediatrics. 2012;130(3):e756-e785.
    4. Burling S. Research examines infection and a method of circumcision. Philadelphia Inquirer. July 31, 2014.

    Disclosures: The authors’ employer is an institutional member of Guidelines International Network (GIN), and the authors serve on the host committee (BFL, CAU) and scientific committee (CAU) for GIN’s 2016 annual conference.”

    Humphreys H, Mac Lellan K2 November 2015
    Balancing conflicts of interest
    TO THE EDITOR: We read with interest the study by Schünemann and colleagues (1), given our role in Ireland in the prioritisation and quality assurance of guidelines for national endorsement (2). Direct financial conflicts of interest (COIs) are easy to understand given that those involved benefit financially, and may conflict with a national or professional recommendation. Funding for research should be included as an indirect financial COI, whether from commercial, national or charitable sources, as this has the capacity to enhance professional careers and may predispose a guideline developer to the products or perspectives of the funder.

    Addressing indirect COIs can be challenging, especially where there is a limited number of guideline developers. The National Clinical Effectiveness Committee (NCEC) in Ireland has a major role in patient safety under the remits of guideline prioritisation, endorsement, quality assurance, and audit (2). While international studies and data are used in guideline development and international peer review is mandatory, we are dependent on a small pool of practitioners. Many of those involved would have indirect COIs, e.g. being acknowledged experts and providing professional leadership. Nonetheless, they bring to guideline development considerable expertise, wisdom and importantly may also have implementation and operational accountability responsibilities.

    Those who financially benefit directly such as through having stock options, and those with a strong vested interest, e.g. being clearly identified as having disproportionately strong views, should be excluded. However, for those with indirect COIs, the balance may be in retaining them in guideline development but in ensuring that there is transparency in terms of the nature of the indirect COIs. Ideally, the strength of the scientific evidence should inform the recommendations and balance any strong views. Unfortunately, the quality of evidence may sometimes not be sufficient to achieve that and it is therefore essential that all involved should transparently declare all potential COIs to ensure that the process is not compromised.

    The ultimate aim is to promote high quality clinical practice informed and directed by the evidence. The underlying processes should be ethical, transparent and appropriate. Such processes must also be proportionate, such that those who have important contributions to make and who may by virtue of clinical leadership or operational responsibilities be key to implementation, are not excluded from the process.

    1. Schünemann HJ, Al-Ansary LA, Forland F, Kersten S, Komulainen J, Kopp IB, et al. Guidelines International Network: Principles for disclosure of interests and management of conflicts in Guidelines. Ann Intern Med 2015; 163: 548-553.
    2. National Clinical Effectiveness Committee.