Response to Letter to the Editor by Lawrence

Abstract

Dr. Lawrence's letter raises interesting issues as they apply to institutional review boards (IRBs), protection of patient privacy, and author responsibilities. According to the Code of Federal Regulations, all research conducted at institutions that receive federal funds are required to be reviewed for human subjects protection and protection of patient privacy by a privacy officer and/or IRB before they are to be conducted.1US Department of Health and Human Service. Code of Federal Regulations. Title 45 Public Welfare, Part 46: Protection of human subjects. Washington, DC: US Department of Health and Human Services; 2001. Available from: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.Google Scholar Some research designs do not require a full IRB review and may receive expedited review or exemption, depending on the judgment of the IRB chair and/or privacy officer. Authors may wish to visit the National Institutes of Health website for additional resources (http://www.nih.gov/sigs/bioethics). Human experimental research arising from private practice must conform to international policies related to the protection of human subjects and, in the United States, must also be compliant with the Health Insurance Portability and Accounting Act of 1996.2Health Insurance Portability and Accountability Act of 1996. Pub. L. 104-191, 110 Stat. 1936 (1996).Google Scholar The Journal of Manipulative and Physiological Therapeutics instructions for authors provide guidance for authors on these matters and are described in the editorial pertaining to the protection of patient/subject privacy in the September 2005 issue.3Green BN Ensuring the privacy of protected health information in research.J Manipulative Physiol Ther. 2005; 28: 461-462Abstract Full Text Full Text PDF Scopus (3) Google Scholar As stated earlier, matters of appropriate patient protection are complex and go far beyond obtaining patient consent.4Johnson C On the subject of human subjects.J Manipulative Physiol Ther. 2005; 28: 79-80Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar Independent practitioner-scientists may not possess the resources necessary to ensure that their experimental research conforms to various laws and policies; however, their obligation to abide by ethical standards remains. Authors are expected to ensure that ethical standards are followed and that patients' health and personal information are protected whether or not there is an enforceable legal requirement pertaining to their individual situation. Authors are expected to include these information in the manuscript; this is not the responsibility of editors. The “Recommendations on Publication Ethics Policies for Medical Journals” from the World Association of Medical Editors (http://www.wame.org) states:“Documented review and approval from a formally constituted review board (Institutional Review Board or Ethics committee) should be required for all studies involving people, medical records, and human tissues.”The Declaration of Helsinki5World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. 2004 Sept 10 [cited 2005 Jun 15]. Available from: http://www.wma.net/e/policy/pdf/17c.pdf.Google Scholar also provides guidance:“…protocol should be submitted for consideration, comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence. This independent committee should be in conformity with the laws and regulations of the country in which the research experiment is performed.” Therefore, regardless of whether a researcher is private or is affiliated with a company or an institution, he or she should obtain ethical approval for human experimental projects. It is recommended that private researchers who are unaffiliated with a research institution use an ethical review board prior to beginning a research project. It is agreed that the onus of responsibility to ensure appropriate safeguards is on authors and that the journal editorial office cannot, and should not, serve as a surrogate IRB or privacy office. Descriptions of procedures and protocols should be included in submitted manuscripts as described in the Journal of Manipulative and Physiological Therapeutics instructions for authors. It is each author's responsibility to perform research according to ethical standards and to state the human subject and privacy protection processes that were used so that what occurred is clear to the readership.