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Safeguarding Human Subjects—The Role of Scientific Journals
EDITORIAL J Oral Maxillofac Surg 72:2095-2097, 2014
Safeguarding Human Subjects—The Role of Scientific Journals The American Association of Oral and Maxillofacial Surgeons (AAOMS) is currently recruiting member oral-maxillofacial surgeons to become participants in a practice-based research (PBR) project. The project involves collecting data relating to the care of patients with impacted third molars, with doctors using the routine protocols they already follow in their own office. All participating doctors must take specified training in the protection of human subjects. The training is online and requires about 40 to 120 minutes of time. The AAOMS-PBR plan was discussed during the most recent editorial board meeting of the Journal last spring. The requirement of human subject protection training was a key part of that discussion since it is anticipated that results of the project will likely be submitted to the Journal for publication. Since the Journal requires all published research results involving human subjects to have been approved by an institutional review board (IRB),* it was clear that the AAOMS-PBR project needed approval and participant training. During the discussion I shared my quandary related to PBR. The Journal has received submissions from private practice oral-maxillofacial surgeons. These projects almost always involve retrospective reviews of patient records. In all cases the practitioner was not aware that the Journal required IRB approval of the project, even though the project was a retrospective review of the surgeon’s own patients. We also get this reaction from many international authors. We reworded our Author Instructions on this topic awhile back to lessen the chance of this confusion. Nonetheless, I found it difficult to explain to the private practitioners why IRB involvement was needed at all in their project. This was because I was having trouble rectifying it myself. When one thinks about it, a retrospective chart review occurring after care is completed seems to pose little or no risks to patients. *IRBs are committees within institutions charged with reviewing research proposals that involve human subjects. Their responsibility, in brief, is to insure that 1) human subjects are protected from unnecessary risks, 2) any risks involved are properly balanced against the value to society of the research, 3) human subjects give informed consent and participate voluntarily, and 4) the planned research is scientifically sound. IRBs exist in most universities, major hospitals, and in many corporations that conduct research on humans. There are also freestanding IRBs who contract to do reviews.
The potential risks relate to the possibility that sensitive patient health information could be disclosed to people with no need or right to see it. However, at least in the United States, Health Insurance Portability and Accountability Act (HIPAA) regulations prohibit such disclosures even in private practices, including if the data are to be used as part of a research project. For a private practitioner conducting her/his own project, getting IRB approval is not an easy task. Many IRBs charge thousands of dollars for their services with the expectation that those funding the research project will pay the fee. Next, the surgeon will need to go through many hours of IRB online training to earn the privilege of having the project reviewed. Fortunately for our readers, the private practice surgeons involved were willing to bear the cost and spend the time to get an IRB to look at their research. What concerns me is that in all cases, the IRB determined that the project was exempt from full or even the need for expedited review. In fact, almost all projects, including those from universities and hospitals involving retrospective reviews of patient records, receive exemption from the IRB (the only reason to say ‘‘almost all’’ is since some authors, particularly non-US ones, do not specify whether their project was reviewed or exempted). This leads me to the question: Why does our Journal require IRB involvement if a project is limited to retrospective patient record reviews? A little background is necessary here to better understand the question at hand. The topic is reasonably complicated, so I’ll try to distill it down to some key factors leading to current practice in human subject protection. Prior to World War II there was little in the way of guidance to doctors related to protecting patients involved in research projects. However, the horrific research conducted by Nazi doctors on Jewish prisoners brought international attention to the subject. It is instructive to know that some evidence used by the doctors to defend themselves during the Nuremberg trials was that some of their project protocols were no different than research that had been going on many years prior to the war on non-Jewish patients. Of course, this did not justify the pre-war research any more than it justified the types of human research conducted on prisoners during the war. But it does point out that standards for safeguarding human subjects were not in place.
2095
2096 Out of the trials came the Nuremberg Code of 1947 that delineated 10 specific factors that doctors follow to protect the well-being of those involved in human experimentation. The American public became even more aware of the problem of inhumane experimenting with human subjects when the Tuskegee Syphilis study came to light in 1970s. In this case the US government conducted what today would be considered criminally inappropriate and unethical research. The World Medical Association became involved in setting standards for human subject research and in 1964 issued the Declaration of Helsinki (DoH).1 In this document researchers are given very specific guidelines of the means to be used when deciding if a research project is appropriate and, if so, how human subjects are to be protected. It has gone through several revisions and reaffirmations, the latest being in 2013. The DoH only exists as an international guideline and is unenforceable. However, prompted by widespread exposure of the Tuskegee study, the United States enacted the National Research Act in 1974 that applied legal standards to the conduct of research in the United States. This statute set the stage for the establishment of IRBs in the United States. In short, the act requires human studies include informed consent, an assessment of risks to subjects versus benefits to society, and a requirement that subject selection be fair. Most universities and other organizations that conduct human research have an IRB in place. IRBs have basically 3 avenues to follow when asked to look at a research proposal. First, if it is determined that the project poses more than a minimal degree of risk to subjects, full review is required involving the entire board. This can take several months and requires the researcher to testify before the board. The IRB can refuse to allow the research to proceed or demand modifications in the planned protocol to better protect human subjects and/or improve the chances that data generated will be worth the risks. Second, if the chair of the IRB determines the risks to subjects are minimal, the chair can approve an expedited review in which the chair or designee looks over the project and, if satisfied all is in order, approves the project (or a modification of a previously approved project). Finally, if the project is determined by the chair of the IRB to pose no risks to human subjects, the chair can exempt the study from further review. Therefore, when an IRB has exempted a project from full or expedited review, it has been decided that the involved subjects will be at no risk. This brings us back to the question of why do we require researchers to seek an IRB opinion if in cases of retrospective chart reviews the IRB always exempts the project? To me this seems like a paper chase that provides value to no one.
EDITORIAL
In a real sense, retrospective chart reviews done for research purposes closely resemble hospital quality assurance (QA) chart reviews. The data such QA reviews generate offer the opportunity to detect undesired or less than optimal outcomes, or help support practices that produce good outcomes. For research investigations involving patient care, similar societal benefits are also available. Whether the research project was done appropriately from a scientific basis, proper conclusions were reached from the results, or the conclusions have any value to society is determined by our editors and peer reviewers. Furthermore, as long as the data have been laundered of all patient identifiers as required under HIPAA regulations, there seems to be no need for IRB involvement at all, even to request an exemption. Granted, individuals tied to institutions will likely be required to involve the institution’s IRB, even for retrospective chart reviews. However, why should our Journal have a kneejerk reaction and demand IRB involvement for investigations that have no other mandate for IRB oversight, such as those done in private offices? I sat down with the IRB chair at my own institution to ask how she handles research involving retrospective chart reviews. She said they will always be exempted from full or expedited review as long as the research protocol insures that the investigator is separated from patient identifiers. She suggested that the best way to do this was for someone other than the researcher to do the data mining. In a surgical practice, she explained, this could be done by a nurse or an assistant who gathers the data and frees it of any patient identifiers before providing it to the researcher. This, to me, seems to be a straightforward means of complying with HIPAA regulations, as well as satisfying both the spirit and specific language of human subject protection guidelines. I continue to see value in all individuals conducting human subject research to read the DoH. The document helps sensitize the reader to the issues surrounding human subject experimentation. It only takes a few minutes, and the document clearly outlines proper safeguards to use when involving humans in research. Scientific journals play a major role in insuring that research it publishes has been done in a scientifically sound manner, draws appropriate conclusions based on the results, is relevant and valuable to the scientific community, and, when involving human subjects, has been done in a manner that safeguards their wellbeing. Investigators face many obstacles in their quest to expand our understanding of health and disease; these include sufficient funding, access to space and equipment, sufficient numbers of research subjects, conducting the study to generate data, and getting the results published. Unnecessarily requiring an approval from an IRB can, for some investigators, be
2097
EDITORIAL
just another reason to not conduct research at all. I applaud those in private practice, as well as others under no mandate to do scholarly work, who take the time, trouble, and expense to do so anyway. I strive to find ways to encourage this in our specialty, as does AAOMS leadership. Requiring IRB involvement for retrospective studies should not be a deterrent. I strongly support the need for all prospective studies involving humans to receive IRB review. The Journal’s editorial office reviews the methods section of all submissions involving human subjects to determine if IRB involvement was indicated and/or occurred. As of now I have not decided whether the Journal will cease requiring IRB involvement in studies that are limited to retrospective chart reviews and data analysis. I am hoping this editorial will stimulate those with concerns about this idea to share with me their
thoughts of why the Journal must continue to require an IRB to be involved in all studies considered for publication. JAMES R. HUPP, DMD, MD, JD Editor-in-Chief
Reference 1. World Medical Association: WMA Declaration of Helsinki— Ethical principles for medical research involving human subjects. Available at: http://www.wma.net/en/30publications/10policies/ b3/index.html
Ó 2014 Published by Elsevier Inc on behalf of the American Association of Oral and Maxillofacial Surgeons http://dx.doi.org/10.1016/j.joms.2014.08.027
Safeguarding Human Subjects—The Role of Scientific Journals The American Association of Oral and Maxillofacial Surgeons (AAOMS) is currently recruiting member oral-maxillofacial surgeons to become participants in a practice-based research (PBR) project. The project involves collecting data relating to the care of patients with impacted third molars, with doctors using the routine protocols they already follow in their own office. All participating doctors must take specified training in the protection of human subjects. The training is online and requires about 40 to 120 minutes of time. The AAOMS-PBR plan was discussed during the most recent editorial board meeting of the Journal last spring. The requirement of human subject protection training was a key part of that discussion since it is anticipated that results of the project will likely be submitted to the Journal for publication. Since the Journal requires all published research results involving human subjects to have been approved by an institutional review board (IRB),* it was clear that the AAOMS-PBR project needed approval and participant training. During the discussion I shared my quandary related to PBR. The Journal has received submissions from private practice oral-maxillofacial surgeons. These projects almost always involve retrospective reviews of patient records. In all cases the practitioner was not aware that the Journal required IRB approval of the project, even though the project was a retrospective review of the surgeon’s own patients. We also get this reaction from many international authors. We reworded our Author Instructions on this topic awhile back to lessen the chance of this confusion. Nonetheless, I found it difficult to explain to the private practitioners why IRB involvement was needed at all in their project. This was because I was having trouble rectifying it myself. When one thinks about it, a retrospective chart review occurring after care is completed seems to pose little or no risks to patients. *IRBs are committees within institutions charged with reviewing research proposals that involve human subjects. Their responsibility, in brief, is to insure that 1) human subjects are protected from unnecessary risks, 2) any risks involved are properly balanced against the value to society of the research, 3) human subjects give informed consent and participate voluntarily, and 4) the planned research is scientifically sound. IRBs exist in most universities, major hospitals, and in many corporations that conduct research on humans. There are also freestanding IRBs who contract to do reviews.
The potential risks relate to the possibility that sensitive patient health information could be disclosed to people with no need or right to see it. However, at least in the United States, Health Insurance Portability and Accountability Act (HIPAA) regulations prohibit such disclosures even in private practices, including if the data are to be used as part of a research project. For a private practitioner conducting her/his own project, getting IRB approval is not an easy task. Many IRBs charge thousands of dollars for their services with the expectation that those funding the research project will pay the fee. Next, the surgeon will need to go through many hours of IRB online training to earn the privilege of having the project reviewed. Fortunately for our readers, the private practice surgeons involved were willing to bear the cost and spend the time to get an IRB to look at their research. What concerns me is that in all cases, the IRB determined that the project was exempt from full or even the need for expedited review. In fact, almost all projects, including those from universities and hospitals involving retrospective reviews of patient records, receive exemption from the IRB (the only reason to say ‘‘almost all’’ is since some authors, particularly non-US ones, do not specify whether their project was reviewed or exempted). This leads me to the question: Why does our Journal require IRB involvement if a project is limited to retrospective patient record reviews? A little background is necessary here to better understand the question at hand. The topic is reasonably complicated, so I’ll try to distill it down to some key factors leading to current practice in human subject protection. Prior to World War II there was little in the way of guidance to doctors related to protecting patients involved in research projects. However, the horrific research conducted by Nazi doctors on Jewish prisoners brought international attention to the subject. It is instructive to know that some evidence used by the doctors to defend themselves during the Nuremberg trials was that some of their project protocols were no different than research that had been going on many years prior to the war on non-Jewish patients. Of course, this did not justify the pre-war research any more than it justified the types of human research conducted on prisoners during the war. But it does point out that standards for safeguarding human subjects were not in place.
2095
2096 Out of the trials came the Nuremberg Code of 1947 that delineated 10 specific factors that doctors follow to protect the well-being of those involved in human experimentation. The American public became even more aware of the problem of inhumane experimenting with human subjects when the Tuskegee Syphilis study came to light in 1970s. In this case the US government conducted what today would be considered criminally inappropriate and unethical research. The World Medical Association became involved in setting standards for human subject research and in 1964 issued the Declaration of Helsinki (DoH).1 In this document researchers are given very specific guidelines of the means to be used when deciding if a research project is appropriate and, if so, how human subjects are to be protected. It has gone through several revisions and reaffirmations, the latest being in 2013. The DoH only exists as an international guideline and is unenforceable. However, prompted by widespread exposure of the Tuskegee study, the United States enacted the National Research Act in 1974 that applied legal standards to the conduct of research in the United States. This statute set the stage for the establishment of IRBs in the United States. In short, the act requires human studies include informed consent, an assessment of risks to subjects versus benefits to society, and a requirement that subject selection be fair. Most universities and other organizations that conduct human research have an IRB in place. IRBs have basically 3 avenues to follow when asked to look at a research proposal. First, if it is determined that the project poses more than a minimal degree of risk to subjects, full review is required involving the entire board. This can take several months and requires the researcher to testify before the board. The IRB can refuse to allow the research to proceed or demand modifications in the planned protocol to better protect human subjects and/or improve the chances that data generated will be worth the risks. Second, if the chair of the IRB determines the risks to subjects are minimal, the chair can approve an expedited review in which the chair or designee looks over the project and, if satisfied all is in order, approves the project (or a modification of a previously approved project). Finally, if the project is determined by the chair of the IRB to pose no risks to human subjects, the chair can exempt the study from further review. Therefore, when an IRB has exempted a project from full or expedited review, it has been decided that the involved subjects will be at no risk. This brings us back to the question of why do we require researchers to seek an IRB opinion if in cases of retrospective chart reviews the IRB always exempts the project? To me this seems like a paper chase that provides value to no one.
EDITORIAL
In a real sense, retrospective chart reviews done for research purposes closely resemble hospital quality assurance (QA) chart reviews. The data such QA reviews generate offer the opportunity to detect undesired or less than optimal outcomes, or help support practices that produce good outcomes. For research investigations involving patient care, similar societal benefits are also available. Whether the research project was done appropriately from a scientific basis, proper conclusions were reached from the results, or the conclusions have any value to society is determined by our editors and peer reviewers. Furthermore, as long as the data have been laundered of all patient identifiers as required under HIPAA regulations, there seems to be no need for IRB involvement at all, even to request an exemption. Granted, individuals tied to institutions will likely be required to involve the institution’s IRB, even for retrospective chart reviews. However, why should our Journal have a kneejerk reaction and demand IRB involvement for investigations that have no other mandate for IRB oversight, such as those done in private offices? I sat down with the IRB chair at my own institution to ask how she handles research involving retrospective chart reviews. She said they will always be exempted from full or expedited review as long as the research protocol insures that the investigator is separated from patient identifiers. She suggested that the best way to do this was for someone other than the researcher to do the data mining. In a surgical practice, she explained, this could be done by a nurse or an assistant who gathers the data and frees it of any patient identifiers before providing it to the researcher. This, to me, seems to be a straightforward means of complying with HIPAA regulations, as well as satisfying both the spirit and specific language of human subject protection guidelines. I continue to see value in all individuals conducting human subject research to read the DoH. The document helps sensitize the reader to the issues surrounding human subject experimentation. It only takes a few minutes, and the document clearly outlines proper safeguards to use when involving humans in research. Scientific journals play a major role in insuring that research it publishes has been done in a scientifically sound manner, draws appropriate conclusions based on the results, is relevant and valuable to the scientific community, and, when involving human subjects, has been done in a manner that safeguards their wellbeing. Investigators face many obstacles in their quest to expand our understanding of health and disease; these include sufficient funding, access to space and equipment, sufficient numbers of research subjects, conducting the study to generate data, and getting the results published. Unnecessarily requiring an approval from an IRB can, for some investigators, be
2097
EDITORIAL
just another reason to not conduct research at all. I applaud those in private practice, as well as others under no mandate to do scholarly work, who take the time, trouble, and expense to do so anyway. I strive to find ways to encourage this in our specialty, as does AAOMS leadership. Requiring IRB involvement for retrospective studies should not be a deterrent. I strongly support the need for all prospective studies involving humans to receive IRB review. The Journal’s editorial office reviews the methods section of all submissions involving human subjects to determine if IRB involvement was indicated and/or occurred. As of now I have not decided whether the Journal will cease requiring IRB involvement in studies that are limited to retrospective chart reviews and data analysis. I am hoping this editorial will stimulate those with concerns about this idea to share with me their
thoughts of why the Journal must continue to require an IRB to be involved in all studies considered for publication. JAMES R. HUPP, DMD, MD, JD Editor-in-Chief
Reference 1. World Medical Association: WMA Declaration of Helsinki— Ethical principles for medical research involving human subjects. Available at: http://www.wma.net/en/30publications/10policies/ b3/index.html
Ó 2014 Published by Elsevier Inc on behalf of the American Association of Oral and Maxillofacial Surgeons http://dx.doi.org/10.1016/j.joms.2014.08.027