A&A Case Reports: A Progress Report and an Update on Requirements for Patient Consent Nancy Nussmeier, MD,*† Lawrence J. Saidman, MD,* Steven Shafer, MD‡§
A
&A Case Reports has had a remarkably successful first year of publication. Through September 2014, >900 case reports describing fascinating clinical (and, more recently, management and education) scenarios have been submitted, and nearly 150 have been accepted for publication. In addition, notable case reports have been highlighted with editorial commentaries from experts. We have been gratified to see a vigorous response: correspondence from interested readers, communications from manufacturers addressing product flaws or other problems, and tens of thousands of “hits” on the A&A Case Reports website. However, one important issue of concern relates to an increasing number of authors unable to obtain consent for publication from either their patient(s) or the patient’s family member(s). In some instances, the patient actually refused to provide consent, yet the authors still attempted to proceed with publication! Ethical considerations mandate that we “tighten up” our criteria for considering publication of any clinical case report. Hence, we have revised our guidelines, as detailed in the following paragraphs. These guidelines will become effective January 1, 2015. Case reports about one or more patients must include a statement that the patient and/or the patient’s family reviewed the case report and gave written permission for the authors to publish the report. At least one author must have participated in the care of the patient described in the case report. In cases where neither the patient nor any family member can be contacted due to certain circumstances (e.g., patient death), and the local IRB has determined that review and written approval are unnecessary, a statement by the author explaining this circumstance may be acceptable if: 1. The reported event(s) occurred more 3 years prior to submission of the case report. In this circumstance, the year of the event(s), as well as a detailed explanation
regarding why attempts to obtain written consent were unsuccessful, should be included in the cover letter. 2. The patient(s) can be de-identified by removing obvious demographic information without compromising the scientific value of the case report. The editors reserve the right to further delete or request additional information considered essential for complete understanding of the case report. A case report becomes a research study if the authors intend to publish the outcome at the time they are providing treatment for the patient(s). In this situation, the authors should obtain IRB approval and written informed consent before treating the patient(s). If that is not possible (e.g., because the need for treatment was unanticipated), then the author should obtain patient consent(s) or IRB approval in the manner detailed above before submission of the manuscript to A&A Case Reports. Retain copies of your documentation of written informed consent from each patient and/or the IRB approval and reasons for obtaining it. The editors or reviewers for A&A Case Reports may request copies of these documents at any time. These standards will apply to both adult and minor patients. All requests for such exceptions to written consent will be reviewed by the Editorial Board of A&A Case Reports, and decisions will be made on a case-by-case basis. As editors, we are extremely encouraged regarding the Journal's progress thus far, and look forward to continued publication of the most clinically important case reports in our specialty. E RECUSE NOTE
Nancy Nussmeier is the Associate Editor-in-Chief of A&A Case Reports, Lawrence J. Saidman is the Editor-in-Chief of A&A Case Reports, and Steven Shafer is the Editor-in-Chief of Anesthesia & Analgesia.
From *A&A Case Reports, International Anesthesia Research Society, San Francisco, California; †Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard University, Boston, Massachusetts; ‡Anesthesia & Analgesia, International Anesthesia Research Society, San Francisco, California; and §Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Stanford, Calfornia. Accepted for publication September 9, 2014. The authors declare no conflicts of interest. Address correspondence to Steven L. Shafer, MD, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, 300 Pasteur Dr., MC-5640, Stanford, CA 94305. Address e-mail to [email protected]. Copyright © 2014 International Anesthesia Research Society DOI: 10.1213/XAA.0000000000000117
December 1, 2014 • Volume 3 • Number 11 cases-anesthesia-analgesia.org 141
A
&A Case Reports has had a remarkably successful first year of publication. Through September 2014, >900 case reports describing fascinating clinical (and, more recently, management and education) scenarios have been submitted, and nearly 150 have been accepted for publication. In addition, notable case reports have been highlighted with editorial commentaries from experts. We have been gratified to see a vigorous response: correspondence from interested readers, communications from manufacturers addressing product flaws or other problems, and tens of thousands of “hits” on the A&A Case Reports website. However, one important issue of concern relates to an increasing number of authors unable to obtain consent for publication from either their patient(s) or the patient’s family member(s). In some instances, the patient actually refused to provide consent, yet the authors still attempted to proceed with publication! Ethical considerations mandate that we “tighten up” our criteria for considering publication of any clinical case report. Hence, we have revised our guidelines, as detailed in the following paragraphs. These guidelines will become effective January 1, 2015. Case reports about one or more patients must include a statement that the patient and/or the patient’s family reviewed the case report and gave written permission for the authors to publish the report. At least one author must have participated in the care of the patient described in the case report. In cases where neither the patient nor any family member can be contacted due to certain circumstances (e.g., patient death), and the local IRB has determined that review and written approval are unnecessary, a statement by the author explaining this circumstance may be acceptable if: 1. The reported event(s) occurred more 3 years prior to submission of the case report. In this circumstance, the year of the event(s), as well as a detailed explanation
regarding why attempts to obtain written consent were unsuccessful, should be included in the cover letter. 2. The patient(s) can be de-identified by removing obvious demographic information without compromising the scientific value of the case report. The editors reserve the right to further delete or request additional information considered essential for complete understanding of the case report. A case report becomes a research study if the authors intend to publish the outcome at the time they are providing treatment for the patient(s). In this situation, the authors should obtain IRB approval and written informed consent before treating the patient(s). If that is not possible (e.g., because the need for treatment was unanticipated), then the author should obtain patient consent(s) or IRB approval in the manner detailed above before submission of the manuscript to A&A Case Reports. Retain copies of your documentation of written informed consent from each patient and/or the IRB approval and reasons for obtaining it. The editors or reviewers for A&A Case Reports may request copies of these documents at any time. These standards will apply to both adult and minor patients. All requests for such exceptions to written consent will be reviewed by the Editorial Board of A&A Case Reports, and decisions will be made on a case-by-case basis. As editors, we are extremely encouraged regarding the Journal's progress thus far, and look forward to continued publication of the most clinically important case reports in our specialty. E RECUSE NOTE
Nancy Nussmeier is the Associate Editor-in-Chief of A&A Case Reports, Lawrence J. Saidman is the Editor-in-Chief of A&A Case Reports, and Steven Shafer is the Editor-in-Chief of Anesthesia & Analgesia.
From *A&A Case Reports, International Anesthesia Research Society, San Francisco, California; †Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard University, Boston, Massachusetts; ‡Anesthesia & Analgesia, International Anesthesia Research Society, San Francisco, California; and §Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Stanford, Calfornia. Accepted for publication September 9, 2014. The authors declare no conflicts of interest. Address correspondence to Steven L. Shafer, MD, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, 300 Pasteur Dr., MC-5640, Stanford, CA 94305. Address e-mail to [email protected]. Copyright © 2014 International Anesthesia Research Society DOI: 10.1213/XAA.0000000000000117
December 1, 2014 • Volume 3 • Number 11 cases-anesthesia-analgesia.org 141
