Conflict Of Interest Disclosure Research Articles

Ethics Centers’ Conflicts of Interest and the Failure of Disclosure to Remedy this Endemic Problem

Individual and institutional conflicts of interest arise with increasing frequency and negative sequelae as universities and their principals, as well as individual faculty members, engage in research (and other activities) with support from profit/not-for-profit entities. This essay examines how institutional and individual conflicts of interest (COI) arise for ethics centers and their faculty/staff, respectively. It defines COI, endorses a reasonable person standard for determining when COI exist, and considers problems that arise when disclosure of COI is embraced as a remedy for them. It argues that transparency and disclosure are generally inadequate measures to address COI, especially those of ethics centers. It concludes by sketching other measures that may be ingredients in attempts to avoid, manage, or mitigate the COI of ethics centers and their faculty/staff.

Management of conflict of interest in Japanese Society of Hematology

Conflict of interest (COI) is a conflict between related parties, such as researchers, research institutions, academic societies, and third parties (commercial companies and patients). COI sometimes twists research and clinical practice, resulting in the profit instruction of related individuals or organizations. In medical research, high ethical standards are demanded to protect human rights, life, and safety of study participants, and COI must be properly enforced to maintain study fairness and ensure transparency. In Japan, the Japanese Association of Medical Science issued COI guideline in 2017, which formed the basis of many societies in making their common COI guidelines. The Japanese Society of Hematology issued COI management guideline in 2018 and is strictly managing COI of its members, organization, and clinical guideline committee members. As industry-academia collaboration activities become more active, the concept of COI is deepening; therefore, appropriate COI disclosure should be conducted based on recent trends to promote sound research and business activities.

Lessons from the vaginal mesh scandal: enhancing the patient-centric approach to informed consent for medical device implantation.

The vaginal mesh scandal, in which thousands of women were irreversibly maimed by polypropylene mesh, revealed multilevel failures in medical device regulation and implantation, demonstrating that patient-centric care has not yet fully transcended from policy into practice. In law, informed consent is considered by a two-stage test: reasonable treatment and patient information disclosure. The standard of reasonable treatment is determined according to what is deemed acceptable in accordance with a body of medical opinion. However, such bodies of medical opinion were vulnerable to external influence from device manufactures. Vaginal mesh manufacturers were found to have had financial links to research, royal colleges, and influential clinicians, which then influenced the basis of the evidence-based practice that often guides such bodies of medical opinion. According to the Independent Medicines and Medical Device Safety Report, patients' mesh complications were also frequently under-reported and patient-based evidence of harm disregarded. Patients were also not sufficiently informed of the material risks or reasonable alternatives to mesh, which is required of the second stage of informed consent pertaining to information disclosure. This paper makes the following recommendations: that conflict of interest disclosure be mandated, that greater value be afforded to patient-based evidence to improve evaluation of treatments, and that information disclosure for informed consent should relate to the risks, benefits, and alternatives to the surgical procedure and medical device. This will ensure that patients can evaluate whether surgeons are offering unbiased treatment options and are also informed of the potential long-term risks associated with device implantation.

Introduction Special Dermatology Plastic Surgery Issue Part 2.

Lasers in Surgery and MedicineVolume 53, Issue 1 p. 8-8 Introduction Introduction Special Dermatology Plastic Surgery Issue Part 2 Thomas Adrian M.D., FAAD, Corresponding Author Thomas Adrian M.D., FAAD Tomadrian@lasersurgery.com orcid.org/0000-0001-8061-8617 Center for Laser Surgery, 3301 New Mexico NW, Washington, District of Columbia Correspondence to: Thomas Adrian, Center for Laser Surgery, 3301 New Mexico NW, Washington, DC 20016. E-mail: Tomadrian@lasersurgery.comSearch for more papers by this author Thomas Adrian M.D., FAAD, Corresponding Author Thomas Adrian M.D., FAAD Tomadrian@lasersurgery.com orcid.org/0000-0001-8061-8617 Center for Laser Surgery, 3301 New Mexico NW, Washington, District of Columbia Correspondence to: Thomas Adrian, Center for Laser Surgery, 3301 New Mexico NW, Washington, DC 20016. E-mail: Tomadrian@lasersurgery.comSearch for more papers by this author First published: 01 February 2021 https://doi.org/10.1002/lsm.23362 Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume53, Issue1Special Issue: Dermatology / Plastic SurgeryJanuary 2021Pages 8-8 RelatedInformation

Dental Student Research

"Dental Student Research." Journal of the California Dental Association, 48(12), p. 645 Additional informationNotes on contributorsSo Ran KwonSo Ran Kwon, DDS, MS, PhD, MS, is a professor and director of the student research program at the Loma Linda University School of Dentistry. Conflict of Interest Disclosure: None reported.

"There are ways … drug companies will get into DTC decisions": How Australian drug and therapeutics committees address pharmaceutical industry influence.

One tool for protecting quality use of medicines in hospitals is a drug and therapeutics committee (DTC) that oversees medicines availability. Pharmaceutical industry marketing to prescribers is associated with less appropriate prescribing and increased costs. There is little data on decision-making practices of DTCs so it is unknown whether or how they might be vulnerable to pharmaceutical industry influence. This project explores DTC decision-making with a focus on how pharmaceutical industry influence on access and use of medicines is identified and managed. We used a qualitative methodology with individual interviews of 29 participants who were current or recent members of public hospital DTCs across New South Wales, Australia. Participants included medical, pharmacy and nursing staff and 1 citizen. Committees were linked to specific hospitals or regions, and some were affiliated with paediatric, neonatal, rural or mental health services. Drug committee processes for oversight of medicines in public hospitals are vulnerable to pharmaceutical industry influence at several points. Applications for formulary additions are sometimes initiated and completed by company representatives. Conflict of interest disclosures among applicants and committee members may be incomplete. In some institutions, medicines are available from pharmaceutical companies without committee review, including through free samples and industry-supported medicines access programmes. Participants noticed the presence and impact of pharmaceutical company marketing activities to local clinicians, resulting in increased prescriber demand for products. Improved DTC practices and review of hospital policies concerning pharmaceutical marketing activities might preserve the independence of evidence-based decision-making for safe, cost-effective prescribing.

Public Speaker Characteristics at Meetings of the Dermatologic and Ophthalmic Drug Advisory Committee and the Ophthalmic Devices Panel

We investigated meetings of the Dermatologic and Ophthalmic Drug Advisory Committee (DODAC) and the Ophthalmic Devices Panel (ODP) of the Food and Drug Administration (FDA) to determine whether a relationship exists between receipt of industry payments by speakers of the Open Public Hearing (OPH) portion and the nature of their recommendations regarding treatment approval. Cross-sectional study. We reviewed publicly available transcripts of all DODAC and ODP meetings from February 2009 to December 2019. For each meeting, information about each public speaker including presence of conflict of interest (COI) and whether their testimony regarding the drug or device was positive, negative, or neutral toward treatment approval was extracted in a blinded fashion using a pilot-tested Google Form. Of the 86 speakers, 66 (76.7%) included a COI disclosure statement and 41 (47.7%) disclosed a COI. Regarding classification of the speakers' testimonies, 70 (81.4%) of 86 were positive, 9 (10.5%) of 86 were negative, and 7 (8.1%) of 86 were neutral. Each one of the 41 speakers with a COI gave a positive testimony. Speakers who disclosed a COI were significantly more likely to give a positive testimony than speakers who did not (P < .001). We recommend the DODAC and ODP require full disclosure of COI information and introduce stricter policies to manage COIs, allowing the committee to fully understand the context of the public speakers' comments, including the possible influence of COI on these comments.

Sugar-Sweetened Beverages and Oral and Systemic Overall Health: A Guide for Oral Health Care Providers

Click to increase image sizeClick to decrease image size Additional informationNotes on contributorsSahar MirfarsiSahar Mirfarsi, DDS, is an assistant professor in the division of oral medicine and co-coordinator of the Advanced Oral Diagnosis Workgroup at the Western University of Health Sciences College of Dental Medicine in Pomona, Calif. Conflict of Interest Disclosure: None reported.

The quality of physical activity guidelines, but not the specificity of their recommendations, has improved over time: a systematic review and critical appraisal.

While numerous guidelines for the prescription of physical activity are released each year, the quality and practicability of these guidelines is unknown. We assessed the quality of 95 guidance documents published since 2000 that included recommendations about physical activity for the promotion of general health and prevention of cardiometabolic disease. We used 3 tools: Appraisal of Guidelines for Research and Evaluation (AGREE II), the National Academy of Medicine's (NAM) Standards for Trustworthy Clinical Practice Guidelines, and the Frequency, Intensity, Time, and Type (FITT) score. Average AGREE II domain scores ranged from 38%-84%, and the portion of criteria fulfilled per NAM domain ranged from 7%-39%. The average FITT score for all recommendations was 2.48 out of 4. While guidelines improved according to both AGREE II and the NAM standards over time, their practicability as assessed by FITT score did not improve. Guidelines produced by governmental agencies or other nonprofit organizations, using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach, or fulfilling a higher number of NAM criteria tended to be of higher quality. Organizations producing physical activity guidelines can improve their quality by establishing and reporting processes for public representation, external review, and conflict of interest (COI) management. Future recommendations about physical activity should be more specific and include strategies to improve implementation. Registration no.: PROSPERO CRD42019126364. Novelty: Most physical activity recommendations are not sufficiently specific to be practically implemented. The overall quality of guidelines has improved over time, but the specificity of recommendations has not. Improved public representation, external review, and COI disclosure and management processes would improve guideline quality.

The Policies for the Disclosure of Funding and Conflict of Interest in Surgery Journals: A Cross-Sectional Survey.

Industry through its funding of research and through its relationships with study authors can influence the results of research. Most journals have policies for reporting funding and disclosing conflict of interest (COI) to mitigate the influence of industry on research. The objective of this study is to assess the policies of surgery journals for the reporting of funding and the disclosure of COI. We described the prevalence and characteristics of funding and COI policies of journals indexed under "Surgery" in the Journal Citation Reports. We extracted data from publicly available information and through simulation of manuscript submission. Of the 186 eligible journals, 171 (92%) had policies for reporting of funding. None of the policies described procedures to deal with non-reporting or underreporting of funding. Of the 186 journals, 183 (99%) had a policy for disclosure of COI. All journals with a COI policy required disclosure of financial interest, while 96 (52%) required the disclosure of non-financial interests. Only 24 (13%) policies described how non-disclosure of COI affects the editorial process, and none described procedures to verify COI disclosure. Of the policies that required disclosing COI, 94 (51%) also required reporting the source of financial COI. Most journals have policies for reporting of funding and disclosure of financial COI. However, many do not have clear policies for disclosing non-financial COI. Major limitations in the policies include the lack of processes for the verification of disclosed interests and for dealing with underreporting of funding and of COI.

How Dentists Can Avoid Bad Choices: Commentary

Click to increase image sizeClick to decrease image size Additional informationNotes on contributorsRobert D. StevensonRobert D. Stevenson, DDS, practiced general dentistry in the Inland Empire area. He is an assistant professor at the Western University College of Dental Medicine and is responsible for ethics and jurisprudence education. Dr. Stevenson also served on the CDA Judicial Council. Conflict of Interest Disclosure: None reported.

Ethics and Law: ‘Truth’ and ‘Trust’ in a 21st Century Practice

Click to increase image sizeClick to decrease image size Additional informationNotes on contributorsNick F. ForooghiNick F. Forooghi, JD, Esq., is a practicing attorney and an educator. He is the executive associate dean at Lincoln Law School in San Jose, Calif., and an assistant professor of professionalism and ethics at the University of the Pacific, Arthur A. Dugoni School of Dentistry in San Francisco. Conflict of Interest Disclosure: None reported.

High impact nutrition and dietetics journals\u2019 use of publication procedures to increase research transparency

BackgroundThe rigor and integrity of the published research in nutrition studies has come into serious question in recent years. Concerns focus on the use of flexible data analysis practices and selective reporting and the failure of peer review journals to identify and correct these practices. In response, it has been proposed that journals employ editorial procedures designed to improve the transparency of published research.ObjectiveThe present study examines the adoption of editorial procedures designed to improve the reporting of empirical studies in the field of nutrition and dietetics research.DesignThe instructions for authors of 43 journals included in Quartiles 1 and 2 of the Clarivate Analytics’ 2018 Journal Citation Report category Nutrition and Dietetics were reviewed. For journals that published original research, conflict of interest disclosure, recommendation of reporting guidelines, registration of clinical trials, registration of other types of studies, encouraging data sharing, and use of the Registered Reports were assessed. For journals that only published reviews, all of the procedures except clinical trial registration were assessed.ResultsThirty-three journals published original research and 10 published only reviews. Conflict of interest disclosure was required by all 33 original research journals. Use of guidelines, trial registration and encouragement of data sharing were mentioned by 30, 27 and 25 journals, respectively. Registration of other studies was required by eight and none offered Registered Reports as a publication option at the time of the review. All 10 review journals required conflict of interest disclosure, four recommended data sharing and three the use of guidelines. None mentioned the other two procedures.ConclusionsWhile nutrition journals have adopted a number of procedures designed to improve the reporting of research findings, their limited effects likely result from the mechanisms through which they influence analytic flexibility and selective reporting and the extent to which they are properly implemented and enforced by journals.

Transparency in surgical randomized clinical trials: cross-sectional observational study.

BackgroundRCTs provide the scientific basis upon which treatment decisions are made. To facilitate critical review, it is important that methods and results are reported transparently. The aim of this study was to explore transparency in surgical RCTs with respect to trial registration, disclosure of funding sources, declarations of investigator conflicts and data‐sharing.MethodsThis was a cross‐sectional review of published surgical RCTs. Ten high‐impact journals were searched systematically for RCTs published in years 2009, 2012, 2015 and 2018. Four domains of transparency were explored: trial registration, disclosure of funding, disclosure of investigator conflicts, and a statement relating to data‐sharing.ResultsOf 611 RCTs, 475 were eligible for analysis. Some 397 RCTs (83.6 per cent) were registered on a trial database, of which 190 (47·9 per cent) had been registered prospectively. Prospective registration increased over time (26 per cent in 2009, 33·0 per cent in 2012, 54 per cent in 2015, and 72·7 per cent in 2018). Funding disclosure was present in 55·0, 65·0, 69·4 and 75·4 per cent of manuscripts respectively. Conflict of interest disclosure was present in 49·5, 89·1, 94·6 and 98·3 per cent of manuscripts across the same time periods. Data‐sharing statements were present in only 15 RCTs (3·2 per cent), 11 of which were published in 2018.ConclusionTrial registration, disclosure of funding and disclosure of investigator conflicts in surgical RCTs have improved markedly over the past 10 years. Disclosure of data‐sharing plans is exceptionally low. This may contribute to research waste and represents a target for improvement.

Oral Health Literacy: Hope for Better Understanding

"Oral Health Literacy: Hope for Better Understanding." Journal of the California Dental Association, 48(8), pp. 371–372 Additional informationNotes on contributorsLindsey A. RobinsonLindsey A. Robinson, DDS, is a board-certified pediatric dentist and has maintained a dental practice in Grass Valley, Calif., since 1996. She received her certificate in pediatric dentistry from the University of Florida and dental degree from the University of Southern California. Dr. Robinson is a past president of the California Society of Pediatric Dentistry and the California Dental Association (CDA) and served as chair of the CDA Foundation. She was a member of the American Dental Association Council on Access, Prevention and Interprofessional Relations (now called CAAP) for six years, and during her tenure served as chair for two years. Dr. Robinson has served on the National Academies of Sciences, Engineering and Medicine Roundtable on Health Literacy as an oral health representative since 2013. Conflict of Interest Disclosure: None reported.

Improving Oral Health Literacy in California: A Perspective

Click to increase image sizeClick to decrease image size Additional informationNotes on contributorsJayanth KumarJayanth Kumar, DDS, MPH, is the California state dental director. He is a board-certified specialist in dental public health and a former director and president of the American Board of Dental Public Health. Conflict of Interest Disclosure: None reported.

National Academies of Sciences, Engineering and Medicine: Dentistry’s Valuable Investment in the Health Literacy Roundtable

Click to increase image sizeClick to decrease image size Additional informationNotes on contributorsLindsey A. RobinsonLindsey A. Robinson, DDS, has served on the National Academies of Sciences, Engineering and Medicine Roundtable on Health Literacy as an oral health representative since 2013. Conflict of Interest Disclosure: None reported.

Evaluation of Financial Conflicts of Interest Among Physician-Authors of American College of Rheumatology Clinical Practice Guidelines.

Clinical practice guidelines (CPGs) underpin patient care, and ideally authors of these guidelines would be free from outside influence. However, it has been shown many times that authors of professional society CPGs receive large sums of money from industry drug companies, creating financial conflicts of interest. This study investigated industry payments catalogued in the Open Payments Database (OPD) that have been received by authors of the American College of Rheumatology (ACR) CPGs. Guidelines on the ACR web site that were published during or after August 2014 were used to retrieve the list of authors. All general, research, associated research, and ownership payments reported on the OPD between the date of publication of the CPG and 12 months prior were extracted in a parallel and blinded manner by 2 investigators. Of the 89 US-based physician-authors from the 5 ACR CPGs identified within the study timeframe, 56 (62.9%) had received at least 1 payment according to OPD records. These 56 authors had received a median of $522 (interquartile range $119-2,500), which, combined, was a total of $9,728,751. Nineteen authors had received at least 1 industry payment relevant to the CPG recommendations, for a median amount of $748 and a total of $1,961,362 in relevant payments. Of the total relevant payments received, a significant proportion was undisclosed (for ACR CPGs during or after August 2014, undisclosed payments were $699,561, or 35.7% of the total). Fewer than one-half of the US-based physician-authors of ACR CPGs during or after August 2014 had received guideline-relevant industry payments. Nonetheless, a substantial proportion of the money received was not disclosed. Conflict of interest disclosure is a bare minimum requirement, and more permanent solutions may include divestiture or inclusion of more nonconflicted authors.

Reporting of conflicts of interest by authors of primary studies on health policy and systems research: a cross-sectional survey

ObjectivesThe objective of this study was to assess the frequency and types of conflict of interest (COI) disclosed by authors of primary studies of health policy and systems research (HPSR).DesignWe...

Corrigendum: Omission of conflict of interest disclosures.

In the article titled ‘The psychosocial burden of alopecia areata and androgenetica’ published in the February 2020 issue of the JEADV,1 the conflict of interest disclosures were omitted. The Conflict of Interest Disclosures statement should have been as follows: ‘AYF is joint copyright owner of the DLQI. Cardiff University and AYF receive royalties. AYF is a member of a Novartis advisory board. FS acted as a consultant for AbbVie, Eli Lilly and Janssen. GT has served as consultant and speaker for Abbvie, Novartis, Celgene, Janssen and Léo-Pharma. JS has served as a consultant and advisor for AbbVie, Celgene, Dignity Sciences, Leo Pharma, Novartis, Pierre-Fabre, Menlo Therapeutics, Sienna Pharmaceuticals and Sandoz. JS has been an investigator for AbbVie, Actelion, Amgen, GSK, Janssen, Merck, Novartis, Regereron, Takeda and Trevi. JS was a speaker for AbbVie, Actavis, Astellas, Janssen, Leo Pharma, Novartis, SunFarm, Sandoz and Eli Lilly. No other disclosures were reported’. The article has been corrected online to include these disclosures.