AMERICAN JOURNAL OF
Pulblic
Editorials IIOath July 1979 Volume 69, Number 7
EDITOR Alfred Yankauer, MD, MPH EDITORIAL BOARD) Michel A. Ibrahim, MD, PhD (1980), Chairperson Ruth B. Galanter, MCP (1980) George E. Hardy, Jr., MD, MPH (1981) David Hayes-Bautista, PhD (1981) C. C. Johnson, Jr., MSCE (1980) Selma J. Mushkin, PhD (1981) George M. Owen, MD (1979) Doris Roberts, PhD, MPH (1980) Pauline 0. Roberts, MD, MPH (1979) Ruth Roemer, JD (1981) Sam Shapiro (1979) Robert Sigmond (1979) Jeannette J. Simmons, MPH, DSc (1981) David H. Wegman, MD, MSOH (1979) Robert J. Weiss, MD (1980)
STAFF William H. McBeath, MD, MPH Executive DirectorlManaging Editor Allen J. Seeber Director of Publications Doyne Bailey Assistant Managing Editor Deborah Watkins Production Editor Monica Pogue Administrative Assistant Ann Profozich Classified Advertising CONTRIBUTING EDITORS William J. Curran, JD, SMHyg Public Health and the Law Barbara G. Rosenkrantz, PhD Public Health Then and Now Jean Conelley, MLS Book Corner
AJPH July, 1979, Vol. 69, No. 7
Established 1911
Controlling the Cost of Dental Health Care Insurance During the past five years there has been close to a seven fold increase in the number of Americans with dental insurance and more than a doubling of the money spent annually for dental care. This is the reason for the assertion by Bailit, Raskin, Reisine and Chiriboga in their article' published in this issue of the Journal, that methods for controlling dental care expenditures are assuming greater importance. These authors examine a wide range of factors which may increase or reduce the costs of dental care services, and they do so in an intelligent, unemotional and sophisticated fashion. Their analysis leads to the conclusion that only marginal or limited control appears promising through any one of the methods considered: prepaid group practice, pretreatment review, changes in the mix of services, and monitoring the performance of participating dentists. In their opinion, the most likely approach to success in controlling costs is through acquainting the public with the fact that many expensive dental services have small marginal effects on oral health. They acknowledge the difficulty of achieving public acceptance of the concept that to be covered by insurance, dental services should be required to demonstrate by cost-effectiveness studies that they contribute significantly to improving the health of the majority of the people. Implicit in this stimulating concept is the more imposing difficulty-that of the dental profession acknowledging and providing public guidance on the marginal, limited and questionable worth of some dental services. The concept is stimulating to me because it provides a basis for optimism and holds potential for success in dealing with the challenges in this race toward prepaid dental care for all. The need for a system of priorities or ranking in the relative effectiveness and importance of dental health services is an unequivocal requirement of any program designed to improve the dental health status of an employment group, population unit, community, state or nation. It is one of the imperatives in dental health services for two reasons: first, there is not enough dental manpower available to provide more than a fraction of the backlog of accumulated care needs and the annually recurring increment of new needs; second, even if a crash program could be designed to train the personnel required for a comprehensive services program it is unrealistic to assume that the public would be willing to quadruple their current level of expenditure on dental care services. On the other hand, the rapid and continuing increase in prepaid dental care plans-"'now better than one in four Americans''2-is indicative of the public's genuine interest and pervasive concern for dental health services. It seems ironical therefore, that virtually all congressional bills proposing national health insurance systems,3 as well as The President's Committee on National Health Insurance,4 either ignore or specifically exclude dental care. They do so at this time for the two reasons stated above. Although both statements are valid in themselves, neither one nor both justify excluding dental care from a national health insurance scheme. What they justify in unequivocal terms is the need for establishing priorities, the need for opting 647
EDITORIALS
for less than comprehensive care, and the need for excluding the services of marginal, limited or questionable benefit, as suggested by Bailit and his colleagues. A basic premise for successful action on these three needs is general acceptance of the concept that the public is interested in dental services largely for their social and mental health benefits rather than because of concerns over physical health. The impact of dental health on social and job relationships is more important than its contribution, if any, to longevity. It contributes to the qualify of life by enhancing freedom to engage in conversation, smile, dine, kiss, and to seek and retain jobs without the inhibitions of handicapping or disfiguring dental conditions, including edentulousness. These qualities are much more important than the functional ability to "eat corn off the cob." Although there appears to be universal agreement that prevention should be accorded first priority and pervade all aspects of a health program, our dental preventive performance rating is unsatisfactory. It will remain so until the incentive power of the budget process is acknowledged and implemented specifically for primary prevention programs such as water fluoridation, alternative uses of fluorides, and nutritional guidance with constraints on sweet snacks in order to prevent dental caries; and, for the long-term promotion of oral hygiene practices in order to prevent and control peridontal diseases. An example of an urgent need for attention and action is the indifferent and negative attitude toward preventive dental services by labor union officials responsible for negotiating contracts for dental care benefits. Their indifference is rationalized as an honest reflection of their constituents' interest in tangible benefits or services which they can see, feel and count, e.g., fillings, extractions and appliances. Changing the prevailing negative attitude to one of positive participation and cooperation should be a high priority action program for all organizations of health professionals. The exclusion of dental services from national health insurance plans ranges from total exclusion through varieties of limited and/or highly specific exclusions, to no exclusion whatsoever. However, there are few if any assessments of progress or success in attaining specific goals (such as the maintenance of lifetime teeth) in populations associated with varying degrees of coverage. In contrast, there is good evidence that our water fluoridation program has effected a significant decrease in the edentulous rate.S This is in accordance with expectations, and the rate should continue to decrease as more and more of the adult population benefit from a childhood history of drinking fluoridated water. It is of long-term relevance because of the likelihood that artificial dentures for the edentulous will remain high on the list of benefits of prepaid programs. I think they should remain a high priority item and that our ability to supply this benefit can be improved by an analysis of experiences in the several states which have prosthodontic committees charged with developing uniform clinical procedures and a standard technique for making full dentures of good quality and at a reasonable cost. The use of technicians and other auxiliary personnel in supplying this dental benefit should also be ex-
plored. 648
The exclusion from insurance coverage of fixed bridges to replace teeth in the posterior part of the mouth will be the greatest contributor to cost containment but this exclusion must be absolute if meaningful cost control is to be attained. On the other hand, fixed bridges to replace missing anterior teeth would be allowed. Another absolute exclusion would be major periodontal surgery. In this case the exclusion is based on the marginal or questionable value of the surgery.6'7 One of the most common exclusions in dental prepayment plans is orthodontic care, largely because of the difficulties of limiting the scope and cost of the care. Because disfiguring malocclusion can be a severe social and emotional handicap, orthodontic care should not be excluded. Its scope can and must be rigidly controlled, because some degree of malalignment of teeth is more common than perfect alignment. Among the important considerations in cost control is the fact that one-half the cases classified as malocclusion during the mixed dentition period-children aged 6 to 12 years-are self correcting.8 9 For this and scope-limiting reasons, prior approval for treatment should be given by a panel of specialists whose approval is guided by relating severity of the malocclusion to the funds budgeted for orthodontic services. Absolute exclusion of restorative care or fillings for the deciduous tooth population is justified by the pressing need for concentrating our limited professional services on the first priority task of conserving the permanent teeth. The initial professional reaction to this exclusion is likely to be highly emotional and negative even though its official implementation will effect relatively minor changes in the current status of care for deciduous teeth. This is true because less than one-half of our child population receives conservative dental care before the age of 15 years, and surveys repeatedly reveal that only a small proportion of those who do go to the dentist get fillings in their deciduous teeth. Closely allied to the goal of lifetime permanent teeth is the strategy of effectively treating those attacked by dental caries. Our Hagerstown studies,'0 which were among the earliest to be concerned with the epidemiologic characteristics of the disease, served as the basis for evolving and proposing the incremental care approach, i.e., provide care when the disease first occurs in the permanent teeth for children (which is usually age 6 years or first graders) and periodically thereafter by increments as the children advance by chronological age or by grade in school. Subsequent extension of our knowledge, however, on such factors as the impact of dental caries by tooth type, relative importance adolescents place on "front'" versus ""back" teeth, cost of replacing lost anterior teeth with fixed bridgework, and the positive change in the attitude of teenagers toward dental care justifies a concentration of initial care on children of junior and senior high school age, and working back by age or grade to first graders. The foregoing examples of opinions on priority decisions, on absolute exclusions, on limiting services by requiring prior approval, and on judgments on services of marginal value, are indicative of the challenging tasks which must be performed in opting for less than comprehensive dental care AJPH July, 1979, Vol. 69, No. 7
EDITORIALS
and controlling costs in a prepaid program or in a national health insurance program. These tasks are of sufficient importance to be examined by committees appointed by the American Dental Association. They will become less formidable but not less challenging when it is recognized that absolute exclusions are a requirement for administrative success by minimizing the needs for prior review and approval. The tasks become less arduous but not less important when it is recognized that we have a continuing professional obligation to enlighten our patients and the public on the results of that examination. If we address them forthrightly, the optimism and high potential for success referred to in my introductory comments will be justified. The nature of dental diseases and disorders and the current status of prevention, control, and treatment procedures make it easier to impose priorities, exclusions, and budgetary constraints on the dental content of a health program than on the program's medical content. If we are to avoid a professional leaderless drift to a program concerned largely with replacement rather than with the conservation of lifetime teeth, then the need for establishing and implementing a program based on priorities becomes urgent as well as timely.
JOHN W. KNUTSON, DDS, DrPH
Address reprint requests to Dr. John W. Knutson, Professor Emeritus, Schools of Dentistry and Public Health, University of California at Los Angeles, The Center for Health Sciences, Los Angeles, CA 90024.
REFERENCES 1. Bailit HL, Raskin M, Reisine S, and Chiriboga D: Controlling the cost of dental care. Am J Public Health 69:699-703, 1979. 2. ADA News. American Dental Association News, February 19, 1979, p. 1. 3. Schoen MH: Dental care in a socialized health system. Jour of Public Health Dentistry. Accepted for publication, 1979. 4. Dummit CO: Dentistry and national health insurance. Texas Dental Journal, %:12-16, 1978. 5. Percentage of Denture Wearers Over 30 Drops. ADA News, American Dental Association, Aug. 8, 1977, p. 8. 6. Waerhaug J: Review of Cohen: Role of periodontal surgery. Jour of Dent Res, 50:219-224, 1971. 7. Ramfjord SP, Knowles JW, Nissle RR, et al: Longitudinal study of periodontal therapy. Jour of Periodontology, 44:66-77, 1973. 8. Moore GR: Orthodontic program of the Michigan state department of health with a new classification of occlusion for survey purposes. Am J Orthodont, 34:355-361, 1948. 9. Knutson, JW: Status of orthodontics as a health service. J Amer Dent Assn, 70:1204-1210, 1965. 10. Klein H, Palmer CE and Knutson JW: Studies on dental caries. I. dental status and dental needs of elementary school children. Public Health Reports, 53:751-765, 1938.
Institutional Review Boards and Consumer Surveys The Public Health Brief by Stolurow and Moeller in this issue of the Journal reports on a survey of dental x-ray use in Boston that found the percentages of x-ray utilization "'substantially in excess of those reported by other investigators in which the respondents were aware that their policies with respect to the use of x-rays were being evaluated."' This simple telephone survey of 40 dental practices in Boston by researchers was based on the deception of the subject being interviewed about the purpose of the telephone inquiry and the concealment of the interviewer's intention to compile and disseminate the results of the survey to the public, which may evoke controversy in some circles. The Journal, through its editorial review process, raised the question of possible institutional review for this research protocol which had been conceived originally as a student project. The issue of review-when it is appropriate and what its proper scope should be-reflects a growing concern for public health research, whether that be a simple survey or large project. The issue is how much freedom will investigators be allowed in seeking the truth about health and health-related concerns. Federally-mandated Institutional Review Boards (IRBs), now required by law of institutions sponsoring research under grant or contract with the Department of Health, Education, and Welfare, must review "research, development and related activities in which human subjects are involved" in order to determine whether those subjects are placed at risk within the meaning of applicable federal regulations.2 The threshold "at risk/not at risk" determination is central to the review process for many research protocols AJPH July, 1979, Vol. 69. No. 7
because it determines whether additional protective constraints will be imposed, most notably the requirement of documented, legally effective informed consent "in accordance with the provisions" of the regulations.3 For many simple protocols, this is a life-or-death decision. Requiring written informed consent of telephone respondents would have constituted regulatory overkill. Assuming this telephone survey were DHEW funded (or that internal institutional policies required review regardless of funding source), IRB review would have been indicated. But what would the proper review conclude? Does the survey place responding dentists or receptionists "at risk" within the meaning of the regulations? Clearly, it does not. The regulations define a "subject at risk" as "'any individual who may be exposed to the possibility of injury, including physical, psychological, or social injury, as a consequence of participation as a subject in any research, development, or related activity which departs from the application of those established and accepted methods necessary to meet his needs, or which increases the ordinary risks of daily life, including the recognized risks inherent in a chosen occupation orfield of service." The key words in the definition are the ones italicized. They focus on the nature of the risks which require safeguards. The risk of being deceived by someone seeking information about a health care provider's practices or procedures as well as any risk from subsequent disclosure are well within the range of risks common to the health care profession. All professionals are subject to inquiries about their practices and methods. The survey which simply parallels common 649
Pulblic
Editorials IIOath July 1979 Volume 69, Number 7
EDITOR Alfred Yankauer, MD, MPH EDITORIAL BOARD) Michel A. Ibrahim, MD, PhD (1980), Chairperson Ruth B. Galanter, MCP (1980) George E. Hardy, Jr., MD, MPH (1981) David Hayes-Bautista, PhD (1981) C. C. Johnson, Jr., MSCE (1980) Selma J. Mushkin, PhD (1981) George M. Owen, MD (1979) Doris Roberts, PhD, MPH (1980) Pauline 0. Roberts, MD, MPH (1979) Ruth Roemer, JD (1981) Sam Shapiro (1979) Robert Sigmond (1979) Jeannette J. Simmons, MPH, DSc (1981) David H. Wegman, MD, MSOH (1979) Robert J. Weiss, MD (1980)
STAFF William H. McBeath, MD, MPH Executive DirectorlManaging Editor Allen J. Seeber Director of Publications Doyne Bailey Assistant Managing Editor Deborah Watkins Production Editor Monica Pogue Administrative Assistant Ann Profozich Classified Advertising CONTRIBUTING EDITORS William J. Curran, JD, SMHyg Public Health and the Law Barbara G. Rosenkrantz, PhD Public Health Then and Now Jean Conelley, MLS Book Corner
AJPH July, 1979, Vol. 69, No. 7
Established 1911
Controlling the Cost of Dental Health Care Insurance During the past five years there has been close to a seven fold increase in the number of Americans with dental insurance and more than a doubling of the money spent annually for dental care. This is the reason for the assertion by Bailit, Raskin, Reisine and Chiriboga in their article' published in this issue of the Journal, that methods for controlling dental care expenditures are assuming greater importance. These authors examine a wide range of factors which may increase or reduce the costs of dental care services, and they do so in an intelligent, unemotional and sophisticated fashion. Their analysis leads to the conclusion that only marginal or limited control appears promising through any one of the methods considered: prepaid group practice, pretreatment review, changes in the mix of services, and monitoring the performance of participating dentists. In their opinion, the most likely approach to success in controlling costs is through acquainting the public with the fact that many expensive dental services have small marginal effects on oral health. They acknowledge the difficulty of achieving public acceptance of the concept that to be covered by insurance, dental services should be required to demonstrate by cost-effectiveness studies that they contribute significantly to improving the health of the majority of the people. Implicit in this stimulating concept is the more imposing difficulty-that of the dental profession acknowledging and providing public guidance on the marginal, limited and questionable worth of some dental services. The concept is stimulating to me because it provides a basis for optimism and holds potential for success in dealing with the challenges in this race toward prepaid dental care for all. The need for a system of priorities or ranking in the relative effectiveness and importance of dental health services is an unequivocal requirement of any program designed to improve the dental health status of an employment group, population unit, community, state or nation. It is one of the imperatives in dental health services for two reasons: first, there is not enough dental manpower available to provide more than a fraction of the backlog of accumulated care needs and the annually recurring increment of new needs; second, even if a crash program could be designed to train the personnel required for a comprehensive services program it is unrealistic to assume that the public would be willing to quadruple their current level of expenditure on dental care services. On the other hand, the rapid and continuing increase in prepaid dental care plans-"'now better than one in four Americans''2-is indicative of the public's genuine interest and pervasive concern for dental health services. It seems ironical therefore, that virtually all congressional bills proposing national health insurance systems,3 as well as The President's Committee on National Health Insurance,4 either ignore or specifically exclude dental care. They do so at this time for the two reasons stated above. Although both statements are valid in themselves, neither one nor both justify excluding dental care from a national health insurance scheme. What they justify in unequivocal terms is the need for establishing priorities, the need for opting 647
EDITORIALS
for less than comprehensive care, and the need for excluding the services of marginal, limited or questionable benefit, as suggested by Bailit and his colleagues. A basic premise for successful action on these three needs is general acceptance of the concept that the public is interested in dental services largely for their social and mental health benefits rather than because of concerns over physical health. The impact of dental health on social and job relationships is more important than its contribution, if any, to longevity. It contributes to the qualify of life by enhancing freedom to engage in conversation, smile, dine, kiss, and to seek and retain jobs without the inhibitions of handicapping or disfiguring dental conditions, including edentulousness. These qualities are much more important than the functional ability to "eat corn off the cob." Although there appears to be universal agreement that prevention should be accorded first priority and pervade all aspects of a health program, our dental preventive performance rating is unsatisfactory. It will remain so until the incentive power of the budget process is acknowledged and implemented specifically for primary prevention programs such as water fluoridation, alternative uses of fluorides, and nutritional guidance with constraints on sweet snacks in order to prevent dental caries; and, for the long-term promotion of oral hygiene practices in order to prevent and control peridontal diseases. An example of an urgent need for attention and action is the indifferent and negative attitude toward preventive dental services by labor union officials responsible for negotiating contracts for dental care benefits. Their indifference is rationalized as an honest reflection of their constituents' interest in tangible benefits or services which they can see, feel and count, e.g., fillings, extractions and appliances. Changing the prevailing negative attitude to one of positive participation and cooperation should be a high priority action program for all organizations of health professionals. The exclusion of dental services from national health insurance plans ranges from total exclusion through varieties of limited and/or highly specific exclusions, to no exclusion whatsoever. However, there are few if any assessments of progress or success in attaining specific goals (such as the maintenance of lifetime teeth) in populations associated with varying degrees of coverage. In contrast, there is good evidence that our water fluoridation program has effected a significant decrease in the edentulous rate.S This is in accordance with expectations, and the rate should continue to decrease as more and more of the adult population benefit from a childhood history of drinking fluoridated water. It is of long-term relevance because of the likelihood that artificial dentures for the edentulous will remain high on the list of benefits of prepaid programs. I think they should remain a high priority item and that our ability to supply this benefit can be improved by an analysis of experiences in the several states which have prosthodontic committees charged with developing uniform clinical procedures and a standard technique for making full dentures of good quality and at a reasonable cost. The use of technicians and other auxiliary personnel in supplying this dental benefit should also be ex-
plored. 648
The exclusion from insurance coverage of fixed bridges to replace teeth in the posterior part of the mouth will be the greatest contributor to cost containment but this exclusion must be absolute if meaningful cost control is to be attained. On the other hand, fixed bridges to replace missing anterior teeth would be allowed. Another absolute exclusion would be major periodontal surgery. In this case the exclusion is based on the marginal or questionable value of the surgery.6'7 One of the most common exclusions in dental prepayment plans is orthodontic care, largely because of the difficulties of limiting the scope and cost of the care. Because disfiguring malocclusion can be a severe social and emotional handicap, orthodontic care should not be excluded. Its scope can and must be rigidly controlled, because some degree of malalignment of teeth is more common than perfect alignment. Among the important considerations in cost control is the fact that one-half the cases classified as malocclusion during the mixed dentition period-children aged 6 to 12 years-are self correcting.8 9 For this and scope-limiting reasons, prior approval for treatment should be given by a panel of specialists whose approval is guided by relating severity of the malocclusion to the funds budgeted for orthodontic services. Absolute exclusion of restorative care or fillings for the deciduous tooth population is justified by the pressing need for concentrating our limited professional services on the first priority task of conserving the permanent teeth. The initial professional reaction to this exclusion is likely to be highly emotional and negative even though its official implementation will effect relatively minor changes in the current status of care for deciduous teeth. This is true because less than one-half of our child population receives conservative dental care before the age of 15 years, and surveys repeatedly reveal that only a small proportion of those who do go to the dentist get fillings in their deciduous teeth. Closely allied to the goal of lifetime permanent teeth is the strategy of effectively treating those attacked by dental caries. Our Hagerstown studies,'0 which were among the earliest to be concerned with the epidemiologic characteristics of the disease, served as the basis for evolving and proposing the incremental care approach, i.e., provide care when the disease first occurs in the permanent teeth for children (which is usually age 6 years or first graders) and periodically thereafter by increments as the children advance by chronological age or by grade in school. Subsequent extension of our knowledge, however, on such factors as the impact of dental caries by tooth type, relative importance adolescents place on "front'" versus ""back" teeth, cost of replacing lost anterior teeth with fixed bridgework, and the positive change in the attitude of teenagers toward dental care justifies a concentration of initial care on children of junior and senior high school age, and working back by age or grade to first graders. The foregoing examples of opinions on priority decisions, on absolute exclusions, on limiting services by requiring prior approval, and on judgments on services of marginal value, are indicative of the challenging tasks which must be performed in opting for less than comprehensive dental care AJPH July, 1979, Vol. 69, No. 7
EDITORIALS
and controlling costs in a prepaid program or in a national health insurance program. These tasks are of sufficient importance to be examined by committees appointed by the American Dental Association. They will become less formidable but not less challenging when it is recognized that absolute exclusions are a requirement for administrative success by minimizing the needs for prior review and approval. The tasks become less arduous but not less important when it is recognized that we have a continuing professional obligation to enlighten our patients and the public on the results of that examination. If we address them forthrightly, the optimism and high potential for success referred to in my introductory comments will be justified. The nature of dental diseases and disorders and the current status of prevention, control, and treatment procedures make it easier to impose priorities, exclusions, and budgetary constraints on the dental content of a health program than on the program's medical content. If we are to avoid a professional leaderless drift to a program concerned largely with replacement rather than with the conservation of lifetime teeth, then the need for establishing and implementing a program based on priorities becomes urgent as well as timely.
JOHN W. KNUTSON, DDS, DrPH
Address reprint requests to Dr. John W. Knutson, Professor Emeritus, Schools of Dentistry and Public Health, University of California at Los Angeles, The Center for Health Sciences, Los Angeles, CA 90024.
REFERENCES 1. Bailit HL, Raskin M, Reisine S, and Chiriboga D: Controlling the cost of dental care. Am J Public Health 69:699-703, 1979. 2. ADA News. American Dental Association News, February 19, 1979, p. 1. 3. Schoen MH: Dental care in a socialized health system. Jour of Public Health Dentistry. Accepted for publication, 1979. 4. Dummit CO: Dentistry and national health insurance. Texas Dental Journal, %:12-16, 1978. 5. Percentage of Denture Wearers Over 30 Drops. ADA News, American Dental Association, Aug. 8, 1977, p. 8. 6. Waerhaug J: Review of Cohen: Role of periodontal surgery. Jour of Dent Res, 50:219-224, 1971. 7. Ramfjord SP, Knowles JW, Nissle RR, et al: Longitudinal study of periodontal therapy. Jour of Periodontology, 44:66-77, 1973. 8. Moore GR: Orthodontic program of the Michigan state department of health with a new classification of occlusion for survey purposes. Am J Orthodont, 34:355-361, 1948. 9. Knutson, JW: Status of orthodontics as a health service. J Amer Dent Assn, 70:1204-1210, 1965. 10. Klein H, Palmer CE and Knutson JW: Studies on dental caries. I. dental status and dental needs of elementary school children. Public Health Reports, 53:751-765, 1938.
Institutional Review Boards and Consumer Surveys The Public Health Brief by Stolurow and Moeller in this issue of the Journal reports on a survey of dental x-ray use in Boston that found the percentages of x-ray utilization "'substantially in excess of those reported by other investigators in which the respondents were aware that their policies with respect to the use of x-rays were being evaluated."' This simple telephone survey of 40 dental practices in Boston by researchers was based on the deception of the subject being interviewed about the purpose of the telephone inquiry and the concealment of the interviewer's intention to compile and disseminate the results of the survey to the public, which may evoke controversy in some circles. The Journal, through its editorial review process, raised the question of possible institutional review for this research protocol which had been conceived originally as a student project. The issue of review-when it is appropriate and what its proper scope should be-reflects a growing concern for public health research, whether that be a simple survey or large project. The issue is how much freedom will investigators be allowed in seeking the truth about health and health-related concerns. Federally-mandated Institutional Review Boards (IRBs), now required by law of institutions sponsoring research under grant or contract with the Department of Health, Education, and Welfare, must review "research, development and related activities in which human subjects are involved" in order to determine whether those subjects are placed at risk within the meaning of applicable federal regulations.2 The threshold "at risk/not at risk" determination is central to the review process for many research protocols AJPH July, 1979, Vol. 69. No. 7
because it determines whether additional protective constraints will be imposed, most notably the requirement of documented, legally effective informed consent "in accordance with the provisions" of the regulations.3 For many simple protocols, this is a life-or-death decision. Requiring written informed consent of telephone respondents would have constituted regulatory overkill. Assuming this telephone survey were DHEW funded (or that internal institutional policies required review regardless of funding source), IRB review would have been indicated. But what would the proper review conclude? Does the survey place responding dentists or receptionists "at risk" within the meaning of the regulations? Clearly, it does not. The regulations define a "subject at risk" as "'any individual who may be exposed to the possibility of injury, including physical, psychological, or social injury, as a consequence of participation as a subject in any research, development, or related activity which departs from the application of those established and accepted methods necessary to meet his needs, or which increases the ordinary risks of daily life, including the recognized risks inherent in a chosen occupation orfield of service." The key words in the definition are the ones italicized. They focus on the nature of the risks which require safeguards. The risk of being deceived by someone seeking information about a health care provider's practices or procedures as well as any risk from subsequent disclosure are well within the range of risks common to the health care profession. All professionals are subject to inquiries about their practices and methods. The survey which simply parallels common 649
