- Email: [email protected]
On the Subject of Human Subjects
ON THE SUBJECT OF HUMAN SUBJECTS
To the Editor: Two issues arise with regard to the use of institutional review boards (IRBs) for scientific research and the responsibilities that editors have in relation to notifying their readers about the ethical issues involved in the research published under their aegis.1 The first is that all research performed in any institution that receives federal funds require submission to the IRB after due consideration by a human subject compliance officer (who may make the determination that a proposal is exempt or subject to expedited review). Thus, it has long been the assumption that, upon submission of a manuscript from such an institution, such procedure has been followed. Journal editors may query an author on this should an overt statement not be found in the manuscript proper, and we typically add such a short statement to the methods section of the paper. However, the onus for ensuring that appropriate procedures have been followed falls on author and institutions, not on editors, although it is certainly within our purview to ask should we feel that this is not the case. The International Committee of Medical Journal Editors2 states that, bWhen reporting experiments on human subjects, authors should indicate whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000 (5). If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach, and demonstrate that the institutional review body explicitly approved the doubtful aspects of the study.Q It is important to note that this comment does not require that all research be submitted to the IRB, only a statement that the work is in accord with such standards; it should also be noted that the uniform requirements refer here to work that must, by necessity, be evaluated by an IRB (ie, institutionally affiliated work). A second point concerns research coming from private practice. In the absence of an institutional affiliation and any federal funding, any research derived in the private practice setting is not subject to review by an IRB; neither is it legally required. This does not take the burden of human subject protection off investigators or authors but does suggest that we carefully examine how we are to treat such submissions. In such cases, it would be appropriate to ask to see the consent form used by the investigator and assess it to see if it follows appropriate guidelines with regard to construction. Should it not, we should immediately return the paper. 730
What is the private researcher to do? There are certainly for-profit IRBs that one can submit research to, and these are generally quite expensive, running upward of $1500 or higher to do the review. Although institutional affiliation is one possible answer, this may not work for all those in private practice who wish in some fashion to collect and analyze data. We editors should not categorically reject their work as a result, but we should very carefully exercise our oversight responsibilities. Dana J. Lawrence, DC Associate Professor Palmer Center for Chiropractic Research Davenport, IA 52803 Editor Emeritus 0161-4754/$30.00
DOI of original article 10.1016/j.jmpt.2005.01.012 Copyright D 2005 National University of Health Sciences doi:10.1016/j.jmpt.2005.09.005
REFERENCES 1. Johnson C. On the subject of human subjects. J Manipulative Physiol Ther 2005;28:79 - 80. 2. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. http://www.ICMJE.org, accessed March 21, 2005.
RESPONSE TO LETTER TO THE EDITOR BY LAWRENCE In Response: 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.1 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 1996.2 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.3
To the Editor: Two issues arise with regard to the use of institutional review boards (IRBs) for scientific research and the responsibilities that editors have in relation to notifying their readers about the ethical issues involved in the research published under their aegis.1 The first is that all research performed in any institution that receives federal funds require submission to the IRB after due consideration by a human subject compliance officer (who may make the determination that a proposal is exempt or subject to expedited review). Thus, it has long been the assumption that, upon submission of a manuscript from such an institution, such procedure has been followed. Journal editors may query an author on this should an overt statement not be found in the manuscript proper, and we typically add such a short statement to the methods section of the paper. However, the onus for ensuring that appropriate procedures have been followed falls on author and institutions, not on editors, although it is certainly within our purview to ask should we feel that this is not the case. The International Committee of Medical Journal Editors2 states that, bWhen reporting experiments on human subjects, authors should indicate whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000 (5). If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach, and demonstrate that the institutional review body explicitly approved the doubtful aspects of the study.Q It is important to note that this comment does not require that all research be submitted to the IRB, only a statement that the work is in accord with such standards; it should also be noted that the uniform requirements refer here to work that must, by necessity, be evaluated by an IRB (ie, institutionally affiliated work). A second point concerns research coming from private practice. In the absence of an institutional affiliation and any federal funding, any research derived in the private practice setting is not subject to review by an IRB; neither is it legally required. This does not take the burden of human subject protection off investigators or authors but does suggest that we carefully examine how we are to treat such submissions. In such cases, it would be appropriate to ask to see the consent form used by the investigator and assess it to see if it follows appropriate guidelines with regard to construction. Should it not, we should immediately return the paper. 730
What is the private researcher to do? There are certainly for-profit IRBs that one can submit research to, and these are generally quite expensive, running upward of $1500 or higher to do the review. Although institutional affiliation is one possible answer, this may not work for all those in private practice who wish in some fashion to collect and analyze data. We editors should not categorically reject their work as a result, but we should very carefully exercise our oversight responsibilities. Dana J. Lawrence, DC Associate Professor Palmer Center for Chiropractic Research Davenport, IA 52803 Editor Emeritus 0161-4754/$30.00
DOI of original article 10.1016/j.jmpt.2005.01.012 Copyright D 2005 National University of Health Sciences doi:10.1016/j.jmpt.2005.09.005
REFERENCES 1. Johnson C. On the subject of human subjects. J Manipulative Physiol Ther 2005;28:79 - 80. 2. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. http://www.ICMJE.org, accessed March 21, 2005.
RESPONSE TO LETTER TO THE EDITOR BY LAWRENCE In Response: 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.1 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 1996.2 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.3