- Email: [email protected]
Response to Letter to the Editor by Lawrence
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
Journal of Manipulative and Physiological Therapeutics Volume 28, Number 9
As stated earlier, matters of appropriate patient protection are complex and go far beyond obtaining patient consent.4 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 bRecommendations on Publication Ethics Policies for Medical JournalsQ from the World Association of Medical Editors (http://www.wame.org) states: bDocumented 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.Q The Declaration of Helsinki5 also provides guidance: b. . .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.Q 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.
Claire D. Johnson, DC, MSEd Editor 0161-4754/$30.00
Copyright D 2005 National University of Health Sciences doi:10.1016/j.jmpt.2005.09.003
Letters to the Editor
REFERENCES 1. US 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. 2. Health Insurance Portability and Accountability Act of 1996. Pub. L. 104-191, 110 Stat. 1936 (1996).
3. Green BN. Ensuring the privacy of protected health information in research. J Manipulative Physiol Ther 2005;28:461 - 2. 4. Johnson C. On the subject of human subjects. J Manipulative Physiol Ther 2005;28:79 - 80. 5. World 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.
MEASUREMENT OF LUMBAR SPINE LOADS AND MOTIONS DURING ROTATIONAL MOBILIZATION
To the Editor: The authors Tsung et al are to be congratulated for their recent 3-dimensional evaluation of lumbar spine mobilization procedures (JMPT 2005;28:238 - 44). Quantitative biomechanical estimates are important to their relative risks and means by which performance can be enhanced. On review of the analytic methods, the authors appear to have used an assumption likely to introduce significant error in their estimates of the loads and acting through the target slice of the torso at L4/S1. The equation (Fig. 1) yields the formulation for a load transformation between two reference frames that remain parallel, that is, the reference frame defining the components of force and moment recorded at the force plate being parallel and having the same sense of direction as that used to define the loads at the lumbar spine. However, the initial orientation components are offset, in the worst cases, by approximately 308 (Fig. 2) with additional displacement as much as 28 (Fig. 4) in the same plane. The orientation differences violate the underlying assumption for Fig. 1, introducing significant error. The exact nature (overestimate or underestimate) and extent of error for each component depends on which of the several different admissible formulations for the instantaneous rotation matrix were used and are a function of the Eulerian angles that separate the two systems. For flexion orientation alone, the difference in estimate would be on the order of the sine of 308, equating to a 50% error and for the least case, a function of the cosine of 308 yielding a 15% error. In reality, for each instant in time, the error is a complicated combination of the multiples of sine and cosine for any two of the 3 Eulerian angles. A more accurate formulation of Fig. 1 would incorporate a coordinate transformation into the moment arm submatrix (lower left 3 3), accounting for their distinct representation in each of the two coordinate systems. Defining the direction cosines for the orientation of the force plate with respect to the L5/S1 segment as
731
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
Journal of Manipulative and Physiological Therapeutics Volume 28, Number 9
As stated earlier, matters of appropriate patient protection are complex and go far beyond obtaining patient consent.4 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 bRecommendations on Publication Ethics Policies for Medical JournalsQ from the World Association of Medical Editors (http://www.wame.org) states: bDocumented 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.Q The Declaration of Helsinki5 also provides guidance: b. . .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.Q 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.
Claire D. Johnson, DC, MSEd Editor 0161-4754/$30.00
Copyright D 2005 National University of Health Sciences doi:10.1016/j.jmpt.2005.09.003
Letters to the Editor
REFERENCES 1. US 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. 2. Health Insurance Portability and Accountability Act of 1996. Pub. L. 104-191, 110 Stat. 1936 (1996).
3. Green BN. Ensuring the privacy of protected health information in research. J Manipulative Physiol Ther 2005;28:461 - 2. 4. Johnson C. On the subject of human subjects. J Manipulative Physiol Ther 2005;28:79 - 80. 5. World 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.
MEASUREMENT OF LUMBAR SPINE LOADS AND MOTIONS DURING ROTATIONAL MOBILIZATION
To the Editor: The authors Tsung et al are to be congratulated for their recent 3-dimensional evaluation of lumbar spine mobilization procedures (JMPT 2005;28:238 - 44). Quantitative biomechanical estimates are important to their relative risks and means by which performance can be enhanced. On review of the analytic methods, the authors appear to have used an assumption likely to introduce significant error in their estimates of the loads and acting through the target slice of the torso at L4/S1. The equation (Fig. 1) yields the formulation for a load transformation between two reference frames that remain parallel, that is, the reference frame defining the components of force and moment recorded at the force plate being parallel and having the same sense of direction as that used to define the loads at the lumbar spine. However, the initial orientation components are offset, in the worst cases, by approximately 308 (Fig. 2) with additional displacement as much as 28 (Fig. 4) in the same plane. The orientation differences violate the underlying assumption for Fig. 1, introducing significant error. The exact nature (overestimate or underestimate) and extent of error for each component depends on which of the several different admissible formulations for the instantaneous rotation matrix were used and are a function of the Eulerian angles that separate the two systems. For flexion orientation alone, the difference in estimate would be on the order of the sine of 308, equating to a 50% error and for the least case, a function of the cosine of 308 yielding a 15% error. In reality, for each instant in time, the error is a complicated combination of the multiples of sine and cosine for any two of the 3 Eulerian angles. A more accurate formulation of Fig. 1 would incorporate a coordinate transformation into the moment arm submatrix (lower left 3 3), accounting for their distinct representation in each of the two coordinate systems. Defining the direction cosines for the orientation of the force plate with respect to the L5/S1 segment as
731