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In defense of the corporate author for multicenter trials
In Defense of the Corporate Author for Multicenter Trials Curtis L. Meinert Department of Epidemiology, The Johns Hopkins University, School of Hygiene and Public Health, Baltimore, Maryland.
The ban announced by the editors of the New England Journal of Medicine (NEJM) on November 21, 1991 [1] on use of the corporate form of author attribution is ill advised and should be lifted. It creates more problems than it solves and sends the wrong message to multicenter groups, present and future. Rather than discouraging that form of attribution, we should be encouraging it to nurture climates conducive to multicenter work. That such nurturing is needed should be obvious from the fact that many of the most pressing health care and treatment questions we face today can only be answered via multicenter collaborative efforts. And rather than despair, we should be buoyed by the existence of the corporate form of attribution because of the hope the form offers for the emergence of a new social-medical ethic in which the focus is shifted from individuals to groups and where wholes are more highly valued than their individual parts. The usual form of attribution is to persons, named in the masthead of a paper. This form may be modified to include the name of the corporate research group as well in the case of multicenter trials, e.g., as in Ann A. Meyers and Henry C. Brown for the XYZ Research Group, or Ann A. Meyers and Henry C. Brown and the XYZ Research Group (both forms herein referred to as the modified conventional form). Only the corporate name of the research group appears in the masthead for works published under an unmodified, corporate form of attribution. Authors are not named in the manuscript. This form, when modified to include names of authors in a footnote to the masthead or elsewhere in the manuscript, will be referred to as the modified corporate form. The conventional form of attribution serves not only to identify authors but to establish forms of primacy. In the case of reports of original research, one expects that the people listed as authors, in addition to having written the manuscript, have a legitimate basis for the implied claim of primacy in relation to the conception, initiation, and conduct of the work being reported. That implied claim is usually legitimate in the traditional single-center model for research, but not when the work is done under the multicenter model.
Address reprint requests to: Curtis Meinert, MD, Received March 18, 1993; revised March 18, 1993. Controlled Clinical Trials 14:255-260 (1993) © Elsevier Science Publishing Co., Inc. 1993 655 Avenue of the Americas, New York, New York I0010
255 0197-2456/93/$6.00
256
c.t,. Meinert
In my view, it is those in multicenter settings using the conventional form of attribution who should be made to justify that use rather than the other way around. As a writer in the multicenter setting, my responsibility is to the group I represent. I am not free, in that setting, to present my own interpretations or conclusions, except to the extent that they conform to those of the group, even if my name appears in the masthead of the manuscript. It is illogical for editors to lean over backward in devising disclosure systems to inform readers of potential conflicts of interest, on the one hand, while confusing them, on the other, as to whether a named author is speaking as an individual or as a representative of a group. Even if we might wish to operate under the single-center model, we are inexorably forced into the multicenter model when addressing health care and treatment questions that can only be addressed via collaborative, multicenter efforts. Usually there is one person in the single-center setting who is recognized as the principal investigator because of that person's role in initiating and carrying out the work being reported. There is no such person in most multicenter settings. Typically, the initiative for a trial in those settings is the result of a multidisciplinary group effort and, in the case of many of the National Institutes of Health (NIH)-funded multicenter trials, may be due to the combined efforts of people at the NIH and investigators at various academic institutions scattered around the country or world. Hence, even the language, instilled from the single-center model, has to be changed to accommodate the complexities and sensitivities of the multicenter setting. Even the designation of "principal investigator" is best avoided in those settings to the extent that the designation implies primacy as an initiator and as an "owner" of the work. Neutral, more informative terminology is preferred, such as chair of the trial for the person presiding over the research group and center director for the person heading a clinic or one of the resource centers in a multicenter trial. Our thinking, as researchers and teachers, is steeped in the single-center model of research. It is the model we prefer, in part because we know it to be the one recognized by the committees that review our proposed promotions and in part because its use avoids the administrative and organizational headaches of multicenter collaborative work. That we have such a preference is obvious from our collective behavior as seen by the number of single-center, small-scale (and often underpowered), short-term trials compared to the number of large-scale, long-term, multicenter trials appearing in the published literature. We train our doctoral students within the framework of the singlecenter model, even though we know in our hearts that it is not the one they are likely to be working under when they "leave the nest." Nonetheless, we reject any thought of their dissertations being other than something they conceive of and sweat through on their own. We comfort ourselves simply with the hope that somehow they will be ready to enter a world of multidisciplinary collaborative research when they finish. As a society, we place too much emphasis on the "act" of authorship and too little on the processes making authorship possible in the first place. Certainly, in the case of the long-term multicenter trial, the final act of analysis, interpretation, and writing is one of the easier ones to complete. Yet, seemingly, it is the only one that counts for promotions committees or for the
Corporate Authorship
257
world at large. Hence, the mere fact that a person's name happens to be first among the several listed in a masthead of a manuscript means, in all probability, that the results being reported will be forever attributed to that person alone, to that person and coworkers, or to that person and that ubiquitous colleague, "et al." Contrary to the impression conveyed in the NEJM announcement, the attribution form used by most multicenter groups is not an eleventh hour decision made as the ink dries on their first manuscript. Rather the form chosen is usually the product of a good deal of discussion and debate, before any papers are written, and once established is not likely to be changed simply because of the dictates of a journal, even one with the standing of NEJM. The corporate form of attribution was used for one or more of the manuscripts published from 8 of the 11 multicenter trial groups reviewed by Meinert and Tonascia [2]. It was used for 51 of the 130 (39%) papers listed in the combined bibliography of those 11 multicenter groups. A review of publications produced from multicenter trials sponsored by the NIH over a 20year period, starting with 1970, by Hawkins and McCaffrey [3], produced 42 corporately authored manuscripts (out of the 453 reviewed). It was used for 18 of the 401 manuscripts appearing in NEJM in 1991, 14 of which were from groups reporting on multicenter trials. The irony of the ban imposed by Drs. Kassirer and Angell is that it is likely to encourage the very practice they are trying to eliminate--"gift" author designations. The desire to have one's name in the masthead of a manuscript (ideally first, but if not first then at least among the first six to ensure a listing in Index Medicus and MEDLINE) is what leads to back-room maneuvering and horse trading in relation to masthead listings. The ban imposed is justified by them, in part, by citing requirements for authorship, as contained in a set of international guidelines for manuscripts [4]. In reality, however, those guidelines are in the main written from the perspective of the single-center research model and do not address the special needs and requirements arising under the multicenter research model. The ultimate irony is that those same guidelines were themselves published under a corporate form of attribution and in the very journal now banning the form! The corporate form of attribution has drawbacks to be sure. One of them stems from the fact that the form is not recognized by the National Library of Medicine. The author field for corporately authored publications is blank in both the print (Index Medicus) and electronic media (MEDLINE)---a practice that should be changed. A second drawback stems from the inherent inequity of any form of attribution that fails to differentiate on the basis of effort contributed to a given paper. The inability to differentiate by using names in the masthead may be most disadvantageous to people in the coordinating center and other key positions in a multicenter trial who, of necessity, must play major roles in every writing effort. However, the conventional form of attribution does not address that problem and may in fact be perceived by some people as less equitable than the unmodified c o r ~ r a t e form of attribution. A system in which the only names listed are those of the "principal investigators" is the least equitable, especially when that designation is reserved for study physicians. People in coordinating centers and other nonclinical positions in the
258
C.L. Meinert s t u d y structure will rightfully feel e v e r y bit as "principal" to the effort as the s t u d y physicians. Given the choice b e t w e e n the modified or u n m o d i f i e d corporate forms of attribution, m y vote goes to the u n m o d i f i e d f o r m - - t h e one absolutely b a n n e d by NEJM. (Since the original a n n o u n c e m e n t , Drs. Kassirer a n d Angell have softened their stand to allow the modified corporate form of attribution [5].) Operationally, there is not m u c h difference b e t w e e n the two conventional forms a n d the modified corporate form. All three forms can lead to jockeying and bickering regarding the n a m e s to be listed and their o r d e r - - b e h a v i o r s avoided with the u n m o d i f i e d corporate form of attribution. As if to a d d insult to injury, the editors place restrictions as well on the extent a n d nature of crediting* allowed contributors to the journal. (They d o not distinguish b e t w e e n credits a n d a c k n o w l e d g m e n t s in w h a t they write; their reference t h r o u g h o u t the a n n o u n c e m e n t is to " a c k n o w l e d g m e n t s , " meaning, one surmises, a c k n o w l e d g m e n t s and credits.) The listing is proscribed from exceeding one c o l u m n in length, regardless of the actual size of the g r o u p involved, and is basically limited to an u n s t r u c t u r e d list of names. It m a y not include committees or lists of their m e m b e r s h i p s . The format being i m p o s e d is neither informative nor particularly useful. Further, there is the implication in w h a t Drs. Kassirer a n d AngeU write that credits (acknowledgments) should not include those " m e r e l y carrying out their jobs, such as technicians." T h e y imply that pay is its o w n r e w a r d for "technicians" while seemingly ignoring the fact that all persons, from the top d o w n , in most long-term research activities are paid for w h a t they do, especially in this age of cost accounting. T h e y imply that there are some with a higher calling, e n g a g e d in research for the sheer joy of discovery and m o r e as an avocation than a vocation. The view that one engages in an activity taking years to complete for joy alone is at o d d s with reality. W h a t e v e r joy there m a y be in long-term trials soon gives way to the t e d i u m of slugging on d a y after day with routine patient visits and data collection. The distinction implied smacks of a kind of elitism as well. Certainly, in the case of the long-term multicenter trial, "technicians," are as i m p o r t a n t to the overall effort as are most of the persons we call principal investigators in that setting. In any case, the simple ethic of fairness a n d equity requires a system for crediting their effort. It is unlikely that one can maintain the esprit de corps and dedication n e e d e d for years of effort if the technician's only r e w a r d is seeing his or her boss's n a m e in print. Their proscription regarding the listing of committees in the NEJM ann o u n c e m e n t s h o w s a lack of appreciation of the i m p o r t a n t role of committees
*Credits in the context of manuscripts are statements of fact regarding the activities, roles, or functions of named persons, groups of persons, committees, or institutions associated with the research being reported on. Acknowledgments are expressions of thanks or of appreciation to named persons, groups, or agencies for specificservices or considerations provided or rendered in connection with the reported work. Credits and acknowledgments serve different functions and should not be confused. Credits in manuscripts from multicenter trials serve to identify the participating centers and associated staff and key committees and their memberships, and usually are placed at the end of the manuscript. Acknowledgments are simply forms of thanks and may be expressed in a footnote to the title or in a section immediately preceding or following the credits.
Corporate Authorship
259
in the design and conduct of multicenter trials. It is ironic that journal editors, those of NEJM included, require assurance that a trial have IRB review and approval as a condition for publication, yet they are seemingly indifferent to the processes in a trial intended to ensure its proper and ethical conduct. The steering committee and treatment effects monitoring committee or data and safety monitoring committee are paramount in providing such assurance. Should we not, as readers of a manuscript, know whether or not those committees existed and something about their membership? And should not their work be acknowledged? The credit (acknowledgment) proscription is rationalized in part by concerns regarding space. As an editor, I have sympathy for this concern, but not for the solution [placing the full credit list on deposit at the National Auxiliary Publications Service (NAPS) when it exceeds the allowable length]. It is a solution that is de facto hostile to large multicenter trials. The policy forces investigators into difficult and potentially divisive stands when it means choosing between their authorship attribution and crediting principles or the joumal to which they submit. Their compromise of providing reprints, at the contributors request, that carry the full credit list is not of much help. Though we might deny it, each of us takes pride in seeing our name in print (except on the crime pages of newspapers). Having one's name on file at NAPS or appearing only in reprints is not the same as having it in an indexed journal on the shelves of libraries around the world. The confusion between credits (acknowledgments) and authorship attribution in the multicenter setting is not unique to editors of NEJM. Others seem to have the same problem. The recent announcement from the Archives of Ophthalmology is a case in point [6]. There, as well, the preferred form of attribution is the unmodified conventional form and although the corporate form of attribution is not banned, it is not warmly embraced, as evidenced by the certifications required from groups submitting under that form of attribution. Only the persons listed in the masthead of a manuscript, under the conventional form of attribution, are required to submit letters attesting to the authenticity and veracity of the results being reported and to either attest to being free of financial conflicts of interest or to disclose such conflicts when not free of them. All members of the research groups are required to submit such letters of certification and disclosure with either of the two corporate forms of attribution and with the modified conventional form of the type, Ann A. Meyers and Henry C. Brown and the XYZ Research Group. The policy of the Archives is prejudicial to multicenter groups having the sense of duty and responsibility to credit all members of a research group. In addition, it is punitive because of the administrative burden imposed by the policy. Obtaining signed letters of disclosure and veracity assurances from as many as 200 members of a research group is not a trivial task. The purpose served by such extensive certification remains obscure. Its primary value appears to be in the protection it provides the journal if questions are ever raised regarding a manuscript published from a multicenter group. It is unreasonable to regard all members of a group as having the same ability to attest to the veracity of results presented in a manuscript and it is just as unreasonable to assume that conflicts of interest have the same meaning and potential for impact regardless of where they exist in a multicenter
260
C.L. Meinert structure. Surely, my concerns in regard to conflicts of interest, as a reader of a paper, focus on those people in a group who have the potential for influencing the data collected or actions taken. The focus is not without regard to the function or position a person has in a structure. The policy does not produce a viable disclosure system. The requirement for disclosure can be limited either by simply converting from the corporate to the conventional form of attribution or, if the modified conventional form of attribution is used, by changing a single word in the masthead listing (letters of disclosure are required of every member of the research group if the attribution reads Ann A. Meyers and Henry C. Brown and the XYZ Research Group, but only from Meyers and Brown if the attribution reads Ann A. Meyers and Henry C. Brown for the XYZ Research Group). If a broader system of disclosure is to be implemented, pertaining to all members of a research group, then that system should be implemented for all research groups submitting to the journal, regardless of the form of attribution used. Part of the need for named authors, as expressed by Drs. Kassirer and Angell, arises from their desire to make certain readers can "contact those who are accountable for the study." However, in reality, it is the leaders of a multicenter trial who are accountable, whether or not named as authors in a masthead. Readers know who to contact, given adequate information in the credits. The reason stated by the editors of NEJM for named authors, namely, the need for assurance regarding the authenticity and veracity of the results submitted, is also the need stated by the editor of Archives of Ophthalmology. Such assurance is important, but there are other ways to satisfy that need short of the procedures implemented by Archives of Ophthalmology or the attribution ban imposed by NEJM. The most obvious one in the case of NEJM is for the editors to simply require that authors be identified to them, even when not listed in the manuscript, and to require the usual letters of assurance and disclosure from them. My hope is that groups choosing the corporate form of attribution will stay the course, even if that means foregoing submission to journals with de facto policies hostile to multicenter collaborative trials. We need less emphasis on the trappings of authorship for trials and more on the work of trials if the multicenter trial is to survive alive and well into and through the 21st century.
REFERENCES
1. Kassirer JP, Angen M: On authorship and acknowledgments. N Engl J Med 325:15101512, 1991 2. Meinert CL, Tonascia S: Clinical Trials: Design, Conduct, and Analysis. Oxford University Press, New York, 1986 3. Hawkins BS, McCaffrey L: Publication practices in NIH-sponsored multicenter clinical trials (abstract). Controlled Clin Trials 12:634, 1991 4. International Committee of Medical Journal Editors: Uniform requirements for manuscripts submitted to biomedical journals. N Engl J Med 324:424-428, 1991 5. Kassirer JP, Angell M: The editors reply. N Engl J Med 326:1085, 1992 6. Goldberg MF: Changes in the archives. Arch Ophthalmol 111:39-40, 1993
The ban announced by the editors of the New England Journal of Medicine (NEJM) on November 21, 1991 [1] on use of the corporate form of author attribution is ill advised and should be lifted. It creates more problems than it solves and sends the wrong message to multicenter groups, present and future. Rather than discouraging that form of attribution, we should be encouraging it to nurture climates conducive to multicenter work. That such nurturing is needed should be obvious from the fact that many of the most pressing health care and treatment questions we face today can only be answered via multicenter collaborative efforts. And rather than despair, we should be buoyed by the existence of the corporate form of attribution because of the hope the form offers for the emergence of a new social-medical ethic in which the focus is shifted from individuals to groups and where wholes are more highly valued than their individual parts. The usual form of attribution is to persons, named in the masthead of a paper. This form may be modified to include the name of the corporate research group as well in the case of multicenter trials, e.g., as in Ann A. Meyers and Henry C. Brown for the XYZ Research Group, or Ann A. Meyers and Henry C. Brown and the XYZ Research Group (both forms herein referred to as the modified conventional form). Only the corporate name of the research group appears in the masthead for works published under an unmodified, corporate form of attribution. Authors are not named in the manuscript. This form, when modified to include names of authors in a footnote to the masthead or elsewhere in the manuscript, will be referred to as the modified corporate form. The conventional form of attribution serves not only to identify authors but to establish forms of primacy. In the case of reports of original research, one expects that the people listed as authors, in addition to having written the manuscript, have a legitimate basis for the implied claim of primacy in relation to the conception, initiation, and conduct of the work being reported. That implied claim is usually legitimate in the traditional single-center model for research, but not when the work is done under the multicenter model.
Address reprint requests to: Curtis Meinert, MD, Received March 18, 1993; revised March 18, 1993. Controlled Clinical Trials 14:255-260 (1993) © Elsevier Science Publishing Co., Inc. 1993 655 Avenue of the Americas, New York, New York I0010
255 0197-2456/93/$6.00
256
c.t,. Meinert
In my view, it is those in multicenter settings using the conventional form of attribution who should be made to justify that use rather than the other way around. As a writer in the multicenter setting, my responsibility is to the group I represent. I am not free, in that setting, to present my own interpretations or conclusions, except to the extent that they conform to those of the group, even if my name appears in the masthead of the manuscript. It is illogical for editors to lean over backward in devising disclosure systems to inform readers of potential conflicts of interest, on the one hand, while confusing them, on the other, as to whether a named author is speaking as an individual or as a representative of a group. Even if we might wish to operate under the single-center model, we are inexorably forced into the multicenter model when addressing health care and treatment questions that can only be addressed via collaborative, multicenter efforts. Usually there is one person in the single-center setting who is recognized as the principal investigator because of that person's role in initiating and carrying out the work being reported. There is no such person in most multicenter settings. Typically, the initiative for a trial in those settings is the result of a multidisciplinary group effort and, in the case of many of the National Institutes of Health (NIH)-funded multicenter trials, may be due to the combined efforts of people at the NIH and investigators at various academic institutions scattered around the country or world. Hence, even the language, instilled from the single-center model, has to be changed to accommodate the complexities and sensitivities of the multicenter setting. Even the designation of "principal investigator" is best avoided in those settings to the extent that the designation implies primacy as an initiator and as an "owner" of the work. Neutral, more informative terminology is preferred, such as chair of the trial for the person presiding over the research group and center director for the person heading a clinic or one of the resource centers in a multicenter trial. Our thinking, as researchers and teachers, is steeped in the single-center model of research. It is the model we prefer, in part because we know it to be the one recognized by the committees that review our proposed promotions and in part because its use avoids the administrative and organizational headaches of multicenter collaborative work. That we have such a preference is obvious from our collective behavior as seen by the number of single-center, small-scale (and often underpowered), short-term trials compared to the number of large-scale, long-term, multicenter trials appearing in the published literature. We train our doctoral students within the framework of the singlecenter model, even though we know in our hearts that it is not the one they are likely to be working under when they "leave the nest." Nonetheless, we reject any thought of their dissertations being other than something they conceive of and sweat through on their own. We comfort ourselves simply with the hope that somehow they will be ready to enter a world of multidisciplinary collaborative research when they finish. As a society, we place too much emphasis on the "act" of authorship and too little on the processes making authorship possible in the first place. Certainly, in the case of the long-term multicenter trial, the final act of analysis, interpretation, and writing is one of the easier ones to complete. Yet, seemingly, it is the only one that counts for promotions committees or for the
Corporate Authorship
257
world at large. Hence, the mere fact that a person's name happens to be first among the several listed in a masthead of a manuscript means, in all probability, that the results being reported will be forever attributed to that person alone, to that person and coworkers, or to that person and that ubiquitous colleague, "et al." Contrary to the impression conveyed in the NEJM announcement, the attribution form used by most multicenter groups is not an eleventh hour decision made as the ink dries on their first manuscript. Rather the form chosen is usually the product of a good deal of discussion and debate, before any papers are written, and once established is not likely to be changed simply because of the dictates of a journal, even one with the standing of NEJM. The corporate form of attribution was used for one or more of the manuscripts published from 8 of the 11 multicenter trial groups reviewed by Meinert and Tonascia [2]. It was used for 51 of the 130 (39%) papers listed in the combined bibliography of those 11 multicenter groups. A review of publications produced from multicenter trials sponsored by the NIH over a 20year period, starting with 1970, by Hawkins and McCaffrey [3], produced 42 corporately authored manuscripts (out of the 453 reviewed). It was used for 18 of the 401 manuscripts appearing in NEJM in 1991, 14 of which were from groups reporting on multicenter trials. The irony of the ban imposed by Drs. Kassirer and Angell is that it is likely to encourage the very practice they are trying to eliminate--"gift" author designations. The desire to have one's name in the masthead of a manuscript (ideally first, but if not first then at least among the first six to ensure a listing in Index Medicus and MEDLINE) is what leads to back-room maneuvering and horse trading in relation to masthead listings. The ban imposed is justified by them, in part, by citing requirements for authorship, as contained in a set of international guidelines for manuscripts [4]. In reality, however, those guidelines are in the main written from the perspective of the single-center research model and do not address the special needs and requirements arising under the multicenter research model. The ultimate irony is that those same guidelines were themselves published under a corporate form of attribution and in the very journal now banning the form! The corporate form of attribution has drawbacks to be sure. One of them stems from the fact that the form is not recognized by the National Library of Medicine. The author field for corporately authored publications is blank in both the print (Index Medicus) and electronic media (MEDLINE)---a practice that should be changed. A second drawback stems from the inherent inequity of any form of attribution that fails to differentiate on the basis of effort contributed to a given paper. The inability to differentiate by using names in the masthead may be most disadvantageous to people in the coordinating center and other key positions in a multicenter trial who, of necessity, must play major roles in every writing effort. However, the conventional form of attribution does not address that problem and may in fact be perceived by some people as less equitable than the unmodified c o r ~ r a t e form of attribution. A system in which the only names listed are those of the "principal investigators" is the least equitable, especially when that designation is reserved for study physicians. People in coordinating centers and other nonclinical positions in the
258
C.L. Meinert s t u d y structure will rightfully feel e v e r y bit as "principal" to the effort as the s t u d y physicians. Given the choice b e t w e e n the modified or u n m o d i f i e d corporate forms of attribution, m y vote goes to the u n m o d i f i e d f o r m - - t h e one absolutely b a n n e d by NEJM. (Since the original a n n o u n c e m e n t , Drs. Kassirer a n d Angell have softened their stand to allow the modified corporate form of attribution [5].) Operationally, there is not m u c h difference b e t w e e n the two conventional forms a n d the modified corporate form. All three forms can lead to jockeying and bickering regarding the n a m e s to be listed and their o r d e r - - b e h a v i o r s avoided with the u n m o d i f i e d corporate form of attribution. As if to a d d insult to injury, the editors place restrictions as well on the extent a n d nature of crediting* allowed contributors to the journal. (They d o not distinguish b e t w e e n credits a n d a c k n o w l e d g m e n t s in w h a t they write; their reference t h r o u g h o u t the a n n o u n c e m e n t is to " a c k n o w l e d g m e n t s , " meaning, one surmises, a c k n o w l e d g m e n t s and credits.) The listing is proscribed from exceeding one c o l u m n in length, regardless of the actual size of the g r o u p involved, and is basically limited to an u n s t r u c t u r e d list of names. It m a y not include committees or lists of their m e m b e r s h i p s . The format being i m p o s e d is neither informative nor particularly useful. Further, there is the implication in w h a t Drs. Kassirer a n d AngeU write that credits (acknowledgments) should not include those " m e r e l y carrying out their jobs, such as technicians." T h e y imply that pay is its o w n r e w a r d for "technicians" while seemingly ignoring the fact that all persons, from the top d o w n , in most long-term research activities are paid for w h a t they do, especially in this age of cost accounting. T h e y imply that there are some with a higher calling, e n g a g e d in research for the sheer joy of discovery and m o r e as an avocation than a vocation. The view that one engages in an activity taking years to complete for joy alone is at o d d s with reality. W h a t e v e r joy there m a y be in long-term trials soon gives way to the t e d i u m of slugging on d a y after day with routine patient visits and data collection. The distinction implied smacks of a kind of elitism as well. Certainly, in the case of the long-term multicenter trial, "technicians," are as i m p o r t a n t to the overall effort as are most of the persons we call principal investigators in that setting. In any case, the simple ethic of fairness a n d equity requires a system for crediting their effort. It is unlikely that one can maintain the esprit de corps and dedication n e e d e d for years of effort if the technician's only r e w a r d is seeing his or her boss's n a m e in print. Their proscription regarding the listing of committees in the NEJM ann o u n c e m e n t s h o w s a lack of appreciation of the i m p o r t a n t role of committees
*Credits in the context of manuscripts are statements of fact regarding the activities, roles, or functions of named persons, groups of persons, committees, or institutions associated with the research being reported on. Acknowledgments are expressions of thanks or of appreciation to named persons, groups, or agencies for specificservices or considerations provided or rendered in connection with the reported work. Credits and acknowledgments serve different functions and should not be confused. Credits in manuscripts from multicenter trials serve to identify the participating centers and associated staff and key committees and their memberships, and usually are placed at the end of the manuscript. Acknowledgments are simply forms of thanks and may be expressed in a footnote to the title or in a section immediately preceding or following the credits.
Corporate Authorship
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in the design and conduct of multicenter trials. It is ironic that journal editors, those of NEJM included, require assurance that a trial have IRB review and approval as a condition for publication, yet they are seemingly indifferent to the processes in a trial intended to ensure its proper and ethical conduct. The steering committee and treatment effects monitoring committee or data and safety monitoring committee are paramount in providing such assurance. Should we not, as readers of a manuscript, know whether or not those committees existed and something about their membership? And should not their work be acknowledged? The credit (acknowledgment) proscription is rationalized in part by concerns regarding space. As an editor, I have sympathy for this concern, but not for the solution [placing the full credit list on deposit at the National Auxiliary Publications Service (NAPS) when it exceeds the allowable length]. It is a solution that is de facto hostile to large multicenter trials. The policy forces investigators into difficult and potentially divisive stands when it means choosing between their authorship attribution and crediting principles or the joumal to which they submit. Their compromise of providing reprints, at the contributors request, that carry the full credit list is not of much help. Though we might deny it, each of us takes pride in seeing our name in print (except on the crime pages of newspapers). Having one's name on file at NAPS or appearing only in reprints is not the same as having it in an indexed journal on the shelves of libraries around the world. The confusion between credits (acknowledgments) and authorship attribution in the multicenter setting is not unique to editors of NEJM. Others seem to have the same problem. The recent announcement from the Archives of Ophthalmology is a case in point [6]. There, as well, the preferred form of attribution is the unmodified conventional form and although the corporate form of attribution is not banned, it is not warmly embraced, as evidenced by the certifications required from groups submitting under that form of attribution. Only the persons listed in the masthead of a manuscript, under the conventional form of attribution, are required to submit letters attesting to the authenticity and veracity of the results being reported and to either attest to being free of financial conflicts of interest or to disclose such conflicts when not free of them. All members of the research groups are required to submit such letters of certification and disclosure with either of the two corporate forms of attribution and with the modified conventional form of the type, Ann A. Meyers and Henry C. Brown and the XYZ Research Group. The policy of the Archives is prejudicial to multicenter groups having the sense of duty and responsibility to credit all members of a research group. In addition, it is punitive because of the administrative burden imposed by the policy. Obtaining signed letters of disclosure and veracity assurances from as many as 200 members of a research group is not a trivial task. The purpose served by such extensive certification remains obscure. Its primary value appears to be in the protection it provides the journal if questions are ever raised regarding a manuscript published from a multicenter group. It is unreasonable to regard all members of a group as having the same ability to attest to the veracity of results presented in a manuscript and it is just as unreasonable to assume that conflicts of interest have the same meaning and potential for impact regardless of where they exist in a multicenter
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C.L. Meinert structure. Surely, my concerns in regard to conflicts of interest, as a reader of a paper, focus on those people in a group who have the potential for influencing the data collected or actions taken. The focus is not without regard to the function or position a person has in a structure. The policy does not produce a viable disclosure system. The requirement for disclosure can be limited either by simply converting from the corporate to the conventional form of attribution or, if the modified conventional form of attribution is used, by changing a single word in the masthead listing (letters of disclosure are required of every member of the research group if the attribution reads Ann A. Meyers and Henry C. Brown and the XYZ Research Group, but only from Meyers and Brown if the attribution reads Ann A. Meyers and Henry C. Brown for the XYZ Research Group). If a broader system of disclosure is to be implemented, pertaining to all members of a research group, then that system should be implemented for all research groups submitting to the journal, regardless of the form of attribution used. Part of the need for named authors, as expressed by Drs. Kassirer and Angell, arises from their desire to make certain readers can "contact those who are accountable for the study." However, in reality, it is the leaders of a multicenter trial who are accountable, whether or not named as authors in a masthead. Readers know who to contact, given adequate information in the credits. The reason stated by the editors of NEJM for named authors, namely, the need for assurance regarding the authenticity and veracity of the results submitted, is also the need stated by the editor of Archives of Ophthalmology. Such assurance is important, but there are other ways to satisfy that need short of the procedures implemented by Archives of Ophthalmology or the attribution ban imposed by NEJM. The most obvious one in the case of NEJM is for the editors to simply require that authors be identified to them, even when not listed in the manuscript, and to require the usual letters of assurance and disclosure from them. My hope is that groups choosing the corporate form of attribution will stay the course, even if that means foregoing submission to journals with de facto policies hostile to multicenter collaborative trials. We need less emphasis on the trappings of authorship for trials and more on the work of trials if the multicenter trial is to survive alive and well into and through the 21st century.
REFERENCES
1. Kassirer JP, Angen M: On authorship and acknowledgments. N Engl J Med 325:15101512, 1991 2. Meinert CL, Tonascia S: Clinical Trials: Design, Conduct, and Analysis. Oxford University Press, New York, 1986 3. Hawkins BS, McCaffrey L: Publication practices in NIH-sponsored multicenter clinical trials (abstract). Controlled Clin Trials 12:634, 1991 4. International Committee of Medical Journal Editors: Uniform requirements for manuscripts submitted to biomedical journals. N Engl J Med 324:424-428, 1991 5. Kassirer JP, Angell M: The editors reply. N Engl J Med 326:1085, 1992 6. Goldberg MF: Changes in the archives. Arch Ophthalmol 111:39-40, 1993