Protecting Research Participants and Patients Rights in Scientific Publication
Ethical and Legal Considerations
An experiment is ethical or not at its inception; it does not become ethical post hoc—ends do not justify means. There is no ethical distinction between ends and means.
Henry K. Beecher1
Contemporary rules for protecting the rights of individuals (namely, research participants and patients) in scientific publication have their foundations in doctrines developed during the mid-20th century: the Nuremberg Code,2 the World Medical Association’s Declaration of Geneva,3 and the World Medical Association’s Declaration of Helsinki,4 as well as the 1979 US Belmont Report.5 Modern research protection of such rights is governed by national and international guidelines and requirements.4,5,6,7,8,9,10,11,12,13,14 In the United States, the primary policy governing biomedical research is the Regulations for the Protection of Human Subjects (45 CFR §46), also known as the Common Rule.6
Since its release in 1991, the Common Rule has been amended over the years and was revised substantially in 2017 (82 FR §7149),7 with these revisions taking effect in early 2019.15 The revisions to the Common Rule address substantial research developments, including the following7,16:
■An increase in the number and types of clinical trials and observational studies
■More diverse social and behavioral research that involves human participants
■Use of sophisticated analytic techniques to study human biospecimens
■Expanded use of electronic health data, other digital records, and large data sets in research
■The increased volume and availability of public and private data and biospecimens
Common Rule reforms aim to provide enhanced protections for study participants and improve efficiency for researchers, funders, research host institutions, institutional review boards (IRBs), and research participants.16,17
Researchers and authors have an ethical duty to follow the core foundational principles outlined in these doctrines (namely, autonomy, beneficence, and justice).4 They must also honor individuals’ rights to privacy when conducting and reporting research that involves human participants and patients with identifiable information. Journal editors have similar ethical duties when reviewing and making decisions about publishing studies that involve human or animal participants and when evaluating manuscripts that contain identifiable information about patients or study participants.18,19,20,21,22,23 Additional privacy doctrines and laws in the United States and many other countries protect an individual’s right to privacy.9,10,11 Legal claims for invasion of privacy (eg, nonconsensual publication of identifying details in text, photographs, video, or audio of individuals) could be brought against an author, editor, or a journal. Privacy law differs from defamation law in that truth may not be used as a defense for invasion of privacy (see 5.9, Defamation, Libel).
5.8.1 Ethical Review of Studies and Informed Consent.
To protect the safety and dignity of individuals who participate in research, academic institutions and funding agencies require any study that involves human participants be reviewed and approved by an IRB or independent ethics review committee. (Note: When referring to individuals who participate in studies, the word participant is preferred to subject [see 11.1, Correct and Preferred Usage of Common Words and Phrases]. However, a number of guidelines and regulations cited herein refer to human “subjects.”)
Final revisions to the Common Rule provide the following useful definitions regarding protection of human participants in research7:
Research: “any systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.”
Human subject: “a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”
Intervention: “includes both physical procedures by which information or biospecimens are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.”
Interaction: “includes communication or interpersonal contact between investigator and subject.”
Private information: “includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).”
Identifiable private information: “private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.”
Identifiable biospecimen: “a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.”
220.127.116.11 Institutional Review Board and Ethical Approval.
All reports of research involving human participants should include indication of ethical review and approval or exemption or exclusion based on institutional policies or regulations. For research conducted in the United States, according to the revised Common Rule, categories of research that involve human participants that may be exempt or excluded from IRB review are based on the level of risk posed to the study participants.7 A list of these categories and additional specific protections for studies including pregnant women, human fetuses, neonates, children, and prisoners are available in the Final Revisions to the Common Rule.7 In addition, the revised Common Rule indicates that the following activities, which may be reported in manuscripts submitted to medical or health journals, may be excluded or deemed outside the scope of the regulation requiring IRB review7,17: “scholarly and journalistic activities (eg, oral history, journalism, biography, literary criticism, legal research, and historical scholarship)” and “public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority” (eg, public health authority investigations of a major disaster, disease outbreak, or injuries from a consumer product). However, investigators should not make independent determinations of exemption or exclusion of IRB review because of the potential for conflicts of interest and should follow the formal policies of their respective institutions.7
An example of low-risk research that may be considered exempt from formal IRB review and informed consent requirements includes secondary research of nonidentifiable information or biospecimens from existing data sets.7 Here again, investigators should indicate if such research has been determined to be exempt from formal IRB review by their institutions and if the data are deidentified or protected by prior consent or privacy safeguards. Research that involves the use of cadaver specimens is exempt because the Common Rule defines human study participants as “living individuals.” However, other regulations may apply to research that involves cadaver specimens.6 See also 18.104.22.168, Reporting Waivers, Exclusions, and Exemptions.
One of the efficiencies included in the revision of the Common Rule is the requirement for a single IRB to review and approve studies conducted at multiple sites or centers in the United States, unless the study is governed by other US laws or conducted in other or multiple countries.7,16,17
22.214.171.124 Informed Consent.
The nature and purpose of all procedures and their possible risks must be fully explained to potential research participants in advance, including consent for secondary research on identifiable private information and biospecimens at the time of initial collection.8 Participants must fully comprehend the nature of the participation and voluntarily agree to such participation. However, informed consent documents must be posted online for advance review and be simplified to include “essential information that a reasonable person should know” with additional details in an appendix to the informed consent document.7,17 Research protocols for studies that involve human participants typically address the following minimum set of protections: risks to all participants, experimental procedures, anticipated benefits to participants (if any), consent for secondary research of private identifiable information or biospecimens, proposed consent document and process to be used, and appropriate additional safeguards if the study is to include vulnerable participants (eg, children, incapacitated adults).6,7
5.8.2 Journal Policies and Procedures.
All journals should require authors of manuscripts that report studies that involve human participants to state explicitly in the Methods section of the manuscript that an appropriate independent ethics committee or IRB approved the study protocol or project or determined that the investigation was excluded or exempt from such approval and the reasons why. The name of the ethics committee(s) or IRB(s) should be specified in the Methods section. If the study protocol was approved by several ethics committees or IRBs, as might be expected in a study conducted in more than 1 country, it is appropriate to note that review and approval were conducted by the ethics committees or IRBs of all participating centers or institutions.
Journals should also require authors to indicate in the Methods section that informed consent was obtained in a manner consistent with the Common Rule requirements (or regulations of other countries or the Declaration of Helsinki4) from all adult participants and from parents or legal guardians for minors or incapacitated adults and how such consent was obtained (ie, written or oral). Authors should also indicate whether research participants received compensation or were offered any incentive for participating in the study.
126.96.36.199 Reporting Waivers, Exclusions, and Exemptions.
Authors and investigators should not make a personal determination about whether a study is excluded or exempt from formal ethical review and approval. They should cite the exclusion or exemption policies of their institutions per the relevant provisions of the revised Common Rule7 (or additional supporting guidance) for studies conducted in the United States or similar regulations of other countries. If an IRB or ethics committee waived or exempted the requirement for informed consent, or if a study uses publicly available deidentified data, authors should explain the reason for such waiver or exemption.
188.8.131.52 Policies for Studies That Involve Animals.
Ethical approval for research that involves animals and relevant animal-handling protocols should be reviewed and approved by independent animal care and use committees as required by national regulations, such as the US National Institutes of Health Office of Laboratory Animal Welfare requirements,21 the guidelines of the International Association of Veterinary Editors,22 or the ARRIVE (Animals in Research: Reporting In Vivo Experiments) guidelines.23 Such review and approval or waiver should be adequately described in the Methods section of all manuscripts that report research that involves animals.
184.108.40.206 Policies to Guide Authors to Report Ethical Protections.
Although numerous regulations and international documents require compliance with these procedures with support from groups such as the International Committee of Medical Journal Editors (ICMJE),18 World Association of Medical Editors,19 and Committee on Publication Ethics (COPE),20 authors and journals have failed to properly report information on ethical review and approval of research and participants’ informed consent.24,25,26,27 Several studies have evaluated the rate of publication of articles with and without reporting review by IRB or ethics oversight committees and participants’ informed consent. Although the quality of reporting has improved over time, the proper reporting of ethical protections in research studies remains concerning. An assessment of 1133 articles that reported studies of human participants, human tissue, or identifiable personal data that were published in 5 leading general medical journals (BMJ, The Lancet, Annals of Internal Medicine, JAMA, and the New England Journal of Medicine) in 2005 and 2006 found that 36 articles (3.2%) lacked a statement of ethical approval, 62 (5.5%) lacked disclosure of informed consent, and 15 (1.3%) lacked both.28 Other more recent evaluations of specialty medical journals found higher rates of failure to report on ethical approval and participant informed consent.29,30 Studies that evaluated the reporting of ethics protections in clinical trials found rates of failure to report ethical protections ranging from 4% to 26% of trials.31,32 A 2013 content analysis of 491 journals’ instructions for authors found that only 203 (40%) stated that participant consent to publish identifiable information was necessary, 154 (30%) required submission of participant consent forms, and 50 (10%) had specific consent forms for publication of identifiable information.33
Specific guidelines regarding documentation of formal ethical review and informed consent should be included in a journal’s instructions for authors, and editors should require authors to properly report on ethical protections for participants in all studies considered for publication.
A number of studies have identified discrepancies in the reporting of research methods in published articles in contrast with what is reported in study protocols. Protocols should include description of the ethical protections and informed consent provided to study participants. Clinical trial authors must submit study protocols to journals, along with their manuscripts; this practice is recommended for other types of studies. For example, the JAMA Network journals require submission of clinical trial protocols, including statistical analysis plans, with manuscripts, and if these manuscripts are accepted for publication, the trial protocol is published as an online supplement34 (see 2.12, Online-Only [Supplementary] Material). The revised Common Rule also indicates that investigators should post copies of the generic informed consent documents and any related appendixes used in studies on funder or institutional websites.7
220.127.116.11 Additional Regulations and Principles.
US biomedical investigators who are subject to jurisdiction of an IRB or formal ethics review committee should follow the principles described in the revised Common Rule.6,7 Investigators outside the United States should rely on their relevant national regulations11,12 or applicable regional guidelines, such as the Council of Europe’s Convention on Human Rights and Biomedicine.13 Investigators who are not subject to jurisdiction of an institutional ethical review committee or national or regional guidelines should rely on the international guidelines, such as the Council for International Organizations of Medical Science (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects11 or the Declaration of Helsinki.4 The Declaration of Helsinki requires that (1) research protocols specify that the study was reviewed by a qualified research ethics committee independent of the investigator and sponsor, (2) research participants have “freely given informed consent, preferably in writing,” and (3) reports of experimentation not in accordance with the basic principles described in the Declaration “should not be published.”4
For studies conducted in a host country by investigators from another country, regulations from the host country and the investigator’s home (sponsoring) country should be followed, and the IRB or ethics committees that reviewed and approved the study should be cited in the Methods section of the manuscript.11,14,35,36 For studies conducted in multiple countries, relevant regulations of all host countries and any home or sponsoring countries and/or the Declaration of Helsinki4 or the Universal Declaration on Bioethics and Human Rights14 should be followed. All IRB or ethics committees that reviewed and approved the study should be cited in the Methods section. In all multinational and multicultural studies, ethical requirements for protecting the interests of the research participants should be addressed. These requirements include acquiring informed consent, avoiding harm, attending to the study participants’ needs, and adhering to obligations when the study is completed.36 Each of these considerations should be addressed in the Methods section of the manuscript. See also 18.104.22.168, Reporting Waivers, Exclusions, and Exemptions.
22.214.171.124 Reports of Unethical Studies.
Despite prior publications of unethical research, such practices cannot be tolerated. In a 1966 pioneering article on ethics and clinical research, Beecher1 identified 50 unethical studies involving human participants that were published in medical journals. Beecher concluded that “an experiment should be ethical at its inception and is not made ethical by publication”1 and that “failure to obtain publication would discourage unethical experimentation.”1 Editors should seek more information from authors of a report of an experimental investigation that involves humans or animals that lacks information about formal ethical review or appropriately obtained informed consent from human participants. Authors may have neglected to report this information because of inadvertent omission or a misunderstanding. For example, an author may not report this information because ethical review was deemed excluded or exempt by a regulatory authority or considered unnecessary (such as in a retrospective audit of publicly available data) or an informed consent requirement was formally waived by an IRB (eg, in public health surveillance). See examples of exclusions and exemptions indicated in the revised Common Rule in 5.8.1, Ethical Review of Studies and Informed Consent. In such cases, this rationale for an exclusion, exemption, or waiver should be reported in the Methods section of research reports. If a manuscript contains a secondary analysis and the information about IRB or ethical approval and/or informed consent was reported in the primary publication, this information should be included in all subsequent reports and secondary analyses.
All manuscripts, including those that report studies in which IRB or ethical approval, informed consent requirements, or both were deemed unnecessary, exempt, or previously reported, must include details about how the ethical requirements were met or why these requirements were considered unnecessary or exempt. Investigators and authors should not make personal determinations on the appropriateness of ethical review and informed consent. See 5.8.1, Ethical Review of Studies and Informed Consent.
Even when a study has been approved by an ethical oversight committee or IRB, the ethics of the reported research may be questioned by reviewers and editors. In such cases, editors are obliged to ask the authors to clarify the situation and respond to any concerns. Unless the authors can provide satisfactory responses and reassurance, editors may reject the manuscript in question for publication.
If an author refuses to address concerns about such ethical requirements, the editor may consider notifying the author’s institutional or funding authority (see 5.7.2, Confidentiality in Allegations of Scientific Misconduct, and 5.4, Scientific Misconduct).
Publication of an investigation that raises ethical dilemmas may be warranted if such publication would encourage professional and public debate and reform. Such publication should be accompanied by an editorial or an editor’s note that describes the ethical issues and concerns. Research that violates established ethical principles should not be published.
5.8.3 Patients’ Rights to Privacy and Anonymity and Consent for Identifiable Publication.
Privacy is a state or condition of limited access to matters of a personal nature, including but not limited to personal information about individuals, their bodies, their decisions, and their familial and intimate relations, as well as their right to control such access.37 When individuals grant others some form of access to themselves (eg, during a patient-clinician or participant-investigator encounter), they (patients and study participants) may allow limited intrusions in private matters but are not waiving all such rights. Thus, a loss of privacy depends on the kinds or amount of access, who has access, through what means, and pertaining to which aspect of a person’s identity.37 Some privacy is surrendered when individuals grant others access to their personal information, bodies, or biospecimens (eg, during encounters between patient and clinician or research participant and investigator).37 During these encounters, confidentiality, a subset of privacy, should be maintained, and identifiable information should not be shared with others or made public without consent.
Authors and editors should ensure protection of patients’ and research participants’ rights to privacy, anonymity, and confidentiality in publication, including (1) withholding or deleting patients’ and study participants’ identifiable information from case reports and detailed descriptions in reports of studies unless they have provided permission for publication and (2) not including or removing identifiable information from text descriptions, demographic data listed in tables or displayed in figures, laboratory reports, genetic pedigrees, other data displays, photographs and other digital images, video, and audio unless the patients or research participants have provided permission for publication.18,38,39,40 Photographs with black bars or other objects placed over the eyes of patients or partially obscuring part of a face should not be used in publication in print, online, video, or other multimedia. Patients can identify themselves (or be identified by others) from identifying features, dermatologic presentations, scars, and even clothing worn at the time a photograph was taken or video was recorded.41,42,43 Authors must use care when submitting manuscripts that have any detailed descriptions of patients or study participants in text, tables, figures and clinical images, audio, or videos.
Case descriptions and case reports serve as important contributions to the medical literature and make up a substantial portion of some journal content, especially in some specialties. Traditionally, such reports have included specific details about patients. However, as Pitkin and Scott44 have noted, “The degree of detail and specificity is sometimes sufficient to permit identification, and at the same time, it is often much greater than necessary for any message the author means to convey.” Only those details essential for understanding and interpreting a specific case report or case series should be provided. In most instances, the description can be more general than specific to ensure anonymity, without substantive loss of meaning. Although the degree of specificity needed will depend on the context of what is being reported, specific ages, race/ethnicity, and other sociodemographic details should be presented only if clinically or scientifically relevant and important.
Patients have occasionally recognized descriptions of themselves in medical articles without accompanying photographs and even after “superfluous social details” have been removed.39 To protect a patient’s right to privacy, nonessential identifying data (eg, sex, age, race/ethnicity, occupation, and location of treatment) generally should be removed from a manuscript, unless clinically or epidemiologically relevant or important. However, omitting certain details may be problematic.39,40 For example, omitting a patient’s occupation from a case report might seem reasonable at first, but such information may be needed later during an occupational exposure assessment or an epidemiologic investigation. More important, authors and editors should not alter or falsify details in case descriptions to secure anonymity because doing so may introduce false or inaccurate data into the medical literature.27 For example, changing the city in which the patient lived may seem innocuous, until another investigator subsequently cites the case report and the erroneous city in an epidemiologic analysis of locations of disease outbreaks. Changing specific demographic data, such as sex, could be considered falsification.
Several cases have occurred in which patients who had not consented to publication of their personal details in medical journals were recognized by themselves or others in specific articles or subsequent news coverage.39,45 In several recent cases, retractions have been published with parts or entire articles removed from public availability.46,47,48 The ICMJE and a number of medical journals have important rules for protecting patients’ rights to privacy by adding a specific requirement for consent for publication from any potentially identifiable patient.18,40,41,42,43
Therefore, when detailed case descriptions or identifiable data, identifiable photographs, videos of faces or identifiable body parts, or patient audio that might permit any patient to be identified are included in a manuscript or online supplement to the manuscript, authors should obtain written permission from the identifiable patients (or legally authorized representatives) to publish the information and share a copy of the permission with the journal. Such consent should include an opportunity for the patient to read the manuscript before publication or waive the right to do so. Nonspecific institutional consent forms that do not include a provision for a patient to review the information to be published or waive that right are not acceptable. Although institutions often obtain consent from patients to use such information obtained in a medical encounter or research for “educational purposes or publication,” such consent does not always cover publication in journals or via the internet. Some institutional consent forms permit a revocation of the consent at a later date without qualification. Accordingly, generic institutional consent forms may not be acceptable for publication of identifiable information in a journal. An example of the patient permission for publication form used by the JAMA Network journals appears in Box 5.8-1. The JAMA Network journals have versions of this form translated into multiple languages, which are available on request.
Box 5.8-1. The JAMA Network Journals’ Permission for Publication of Identifying Material in the JAMA Network Journals
I give my permission for the following material to appear in the print, online, and licensed versions of the JAMA Network journals and for the JAMA Network journals to grant permission to third parties to reproduce this material.
Title or subject of article or photograph, video, or audio:__________________
I understand that my name will not be published but that complete anonymity cannot be guaranteed.
Please check the appropriate box below after reading each statement.
□ I have read the manuscript or a general description of what the manuscript contains and reviewed all photographs, illustrations, video, or audio files in which I am included that will be published.
□ I have been offered the opportunity to read the manuscript and to see all photographs, illustrations, video, or audio files in which I am included, but I waive my right to do so.
If you are granting permission for another person, what is your relationship to that person?__________________________________________________________
The ICMJE recommends that patient permission forms “be archived with the journal, the authors, or both, as dictated by local regulations or laws.”18 The JAMA Network journals store patient permission forms in a secure location that is accessible to only a few staff members. According to the ICMJE, some journals may choose to require authors to archive the consent form and then provide the journal with “a written statement that attests that they have received and archived written patient consent.”18
For manuscripts accepted for publication, journals should indicate that such consent for publication from identifiable patients or study participants has been obtained, either in the Methods section, if appropriate, or in the Acknowledgment section at the end of the article as follows:
Methods: This investigation was approved by the medical center’s institutional review board. The 12 patients in this case series provided written informed consent for the investigation. In addition, each patient was given an opportunity to review the manuscript and consented to its publication.
Methods: This study did not require institutional review board approval based on guidelines from the National Human Research Protections Advisory Committee because it was based on government-issued, deidentified, public use data.
Acknowledgment: We are grateful to the 2 patients who provided permission after reviewing the manuscript to publish this.
Acknowledgment: We thank the father of the child in Figure 2 for granting permission for publication of this photograph.
Some editors and authors have commented that obtaining consent from identifiable patients is too burdensome.49,50,51,52 Asking those who so argue to consider that the identifiable person could be themselves or a close relative might help convey the rationale for this requirement. Others have argued that the process of obtaining such consent may be offending to the patient or the patient’s family members.49 However, subsequent discovery of unauthorized publication of a patient’s information that results in identification or unwanted publicity could be even more disturbing40,46,47,48,53 and may also violate national privacy laws, such as the US Health Insurance Portability and Accountability Act (HIPAA)9,10 or the privacy laws of other countries.11,12,13 Moreover, publication of unauthorized identifiable patient information could result in legal claims related to invasion of privacy, allegations of professional misconduct, or criminal penalties.9,10,48,53
Whether a manuscript contains identifiable patient information can be determined on a case-by-case basis. In some cases, potentially identifiable data can be removed from the manuscript. However, if such details are required, authors and editors should assess the risk of identifiability after considering the type and amount of detail that is needed, circumstances surrounding the clinical situation or investigation, and, if applicable, relevant identifiable information contained in previously published reports that involve the same patient(s) or news reports that have resulted in publicity.43 (Note: Previous publication or news coverage does not eliminate a patient’s right to privacy in a subsequent publication in a scientific journal and does not negate the need for patient permission.) After a manuscript has been submitted, if the editors determine that the information could result in recognition—even if only by the patient—they should ask the author to delete identifiable details and material. This can be done with most manuscripts. However, if deidentification is not possible, editors should ask the author to obtain consent from the patient, including offering the patient the opportunity to read the manuscript or review the video or audio. If the patient cannot be located or refuses to consent to publication and deidentification is not possible, the manuscript should not be published.
Authors should not create composite patients from their clinical experience and present these as actual cases, even in narrative essays. If a fictionalized or hypothetical case is presented as an example or for educational purposes, this should be indicated to readers with words such as “case scenario” or “hypothetical case” or by providing a prominent disclaimer in the article (see 5.8.5, Patients’ Rights in Narrative Essays and News Reports in Biomedical Journals).
5.8.4 Rights in Published Reports of Genetic Studies.
The rules for ethical approval of studies and for obtaining informed consent also apply to genetic studies of family pedigrees and population-based samples. However, obtaining written consent for publication of identifiable information from all members of a large pedigree (many of whom may be deceased or unaware of the collection of family data) may be difficult or impossible. Proposals for obtaining some form of group consent and for avoiding the publication of information about identifiable family members who will not give their permission have been considered.54 All such studies must be reviewed by an independent ethics review committee or IRB, and if the individual members of the family or population-based sample are considered to be human subjects and identifiable, consent for publication may be required; otherwise, a waiver may be granted55,56 (see 5.8.1, Ethical Review of Studies and Informed Consent). The Methods section of all reports of genetic studies should include statements about ethics committee or IRB review and approval or waiver and information about informed consent procedures or waivers and should include consent for publication of identifiable information if not covered by other acceptable informed consent documentation.
As with reports of other types of studies, nonessential identifying information should be removed from reports of genetic studies. However, data should not be altered or scrambled in an attempt to protect the identities of individuals or family members, although relevant information may be masked.54 For example, in pedigree charts, diamonds or another sex-neutral symbol can be used instead of squares and circles if the sex of family members is not essential to the report (eg, if the disease is known not to be sex linked), or sections of pedigrees may be excluded from pedigree charts or not described in detail if appropriate consent could not be obtained as long as such omissions are noted (see 4.2.2, Diagrams, and 14.6.6, Pedigrees).
5.8.5 Patients’ Rights in Narrative Essays and News Reports in Biomedical Journals.
Descriptions and photographs of individuals are often included in narrative essays and news stories in medical and health journals. However, if these descriptions or photographs identify patients or anyone in an actual patient-clinician encounter, the authors should be asked to deidentify those patients. Such deidentification should not include altering data or facts or presenting composites of multiple patients as a single case. Identifying details may be omitted but may not be altered or falsified. If patients cannot be deidentified, their written consent for publication must be obtained (Box 5.8-1). Fictionalized cases and reports generally should not be presented except in rare cases and unless this is made clear to readers (eg, a hypothetical case to explain a clinical scenario or a fictional essay in which it is made clear to the readers that it is fictional). In news stories, third-party photographs should not be used if they include identifiable patients, unless consent for publication has been obtained. Appropriately credited stock or staged photographs that depict patients or simulate a patient-clinician encounter are acceptable if made transparent to the reader.
5.8.6 Patients’ Rights in Social Media.
Content published in journal-related social networking sites, blogs, and online discussion groups is subject to the same norms, standards, and regulations as is all other published and posted content. Thus, the principles described in 5.8.2 (Patients’ Rights to Privacy and Anonymity and Consent for Identifiable Publication) apply, and permission for publication is required from all identifiable patients and research participants in all posts about them in social networking sites, blogs, and online discussion groups.
Principal Author: Annette Flanagin, RN, MA
I thank the following for review and helpful comments: Howard Bauchner, MD, JAMA and JAMA Network; Lawrence O. Gostin, JD, O’Neill Institute for National and Global Health Law, Georgetown University Law Center, Washington, DC; Timothy Gray, PhD, JAMA Network; James G. Hodge Jr, JD, LLM, Sandra Day O’Connor College of Law, Arizona State University, Phoenix; and Iris Y. Lo, JAMA Network.
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2.The Nuremberg Code. JAMA. 1996;276(20):1691. doi:10.1001/jama.1996.03540200077043
3.World Medical Association. Declaration of Geneva. Updated October 14, 2017. Accessed January 14, 2019. https://www.wma.net/policies-post/wma-declaration-of-geneva/
4.World Medical Association. WMA Declaration of Helsinki: ethical principles for medical research involving human subjects. 64th WMA General Assembly, Fortaleza, Brazil. October 2013. Accessed January 14, 2019. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
5.National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: ethical principles and guidelines for the protection of human subjects of research. April 18, 1979. Accessed January 14, 2019. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
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8.US Department of Health and Human Services, Office for Human Research Protections. Regulatory changes in ANPRM: comparison of existing rules with some of the changes being considered. Accessed December 27, 2018. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/regulatory-changes-in-anprm/index.html
9.US Department of Health and Human Services. Health information privacy: summary of the HIPAA privacy rule. Accessed December 27, 2018. http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/index.html
10.Office for Civil Rights. Standards for privacy of individually identifiable health information. 45 CFR §160 and 164. Revised April 3, 2003. Accessed December 27, 2018. http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/introdution.html
11.Council for International Organizations of Medical Science. International Ethical Guidelines for Biomedical Research Involving Human Subjects. 4th ed. 2016. Accessed December 27, 2018. https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf
12.Office for Human Research Protections, US Department of Health and Human Services. International compilation of human subject research standards. Content last reviewed on March 3, 2016. Accessed December 27, 2018. https://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html
13.Council of Europe. Additional protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical Research, Strasbourg, France. Adopted January 25, 2005; entered into force September 1, 2007. Accessed December 27, 2018. https://www.coe.int/en/web/conventions/full-list/-/conventions/treaty/195
14.United Nations Educational, Scientific and Cultural Organization (UNESCO). Universal Declaration on Bioethics and Human Rights. Paris, France: UNESCO; October 19, 2005. Accessed December 27, 2018. http://portal.unesco.org/en/ev.php-URL_ID=31058&URL_DO=DO_TOPIC&URL_SECTION=201.html
15.Baumann J. HHS research oversight rule set for one-year-delay. Bloomberg News. October 10, 2017. Accessed December 27, 2018. https://www.bna.com/hhs-research-oversight-n73014470727/
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