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
EDITORIALS
consumer study practices presents no "departure" or increase in "ordinary risk.'5 It is important that surveys like this and similar projects, which do not involve the dangers to subjects that institutional review was designed to mitigate or avoid, not be fettered by regulatory safeguards. Comprehensive research regulation is a new field and one that poses significant threats to innovative research and perhaps even to the subjects of that research if the suggestion in a recent editorial in Science is correct, that the informed consent procedure itself may be a source of iatrogenic harm.6 The requirement of ethical peer review in the form of IRBs to protect human subjects of biomedical and behavioral research was a much-needed response to some obvious abuses, particularly in medical research, including the notorious Tuskegee Syphilis Study, research on prison inmates, and drug research without proper Food and Drug Administration supervision such as some contraception and abortion (menstrual regulation) studies using Depo-Provera and diethylstilbestrol (DES). The protection provided by IRBs should, however, be for real and substantial harms defined in advance and reflective of the scientific consensus in a given department, school, or institution. Without guidelines to-
gether with much good will and common sense on the part of IRB members, the conduct of public health and other types of nontherapeutic research could turn out to be the real victim.
L. LYNN HOGUE, PHD, JD Address reprint requests to L. Lynn Hogue, PhD, JD, Assistant Professor of Law, School of Law, University of Arkansas at Little Rock, 400 West Markham St., Little Rock, AR, 72201.
REFERENCES 1. Stolurow KAC and Moeller DW: Dental x-ray use in Boston. Am J Public Health 69:709-710, 1979. 2. 45 Code of Federal Regulations, Part 46 "Protection of Human
Subjects.'" 3. 45 CFR §46.103(c); see also §46.109 (informed consent document shall exclude any exculpatory clauses). 4. 45 CFR §46.103(b). 5. A more extensive discussion of the application of IRB regulations to public health research protocols can be found in L. Lynn Hogue, "Institutional Review Boards and Public Health Research: An Analysis," University of Arkansas at Little Rock (UALR) Law Journal 1:428-454, 1978. 6. Loftus EF and Fries JF: Informed Consent May be Hazardous to Health, Science 204:11 (Apr. 6) 1979.
Announcing Minority Research Associate Program in Gerontology In response to the mandate of the 1978 Amendments to the Older Americans Acts, the Administration on Aging is initiating a Minority Research Associate Program. The program's objective is to attract minority social scientists into the field of gerontology by supporting their training, education, and research at gerontology institutes, centers, or programs of study. Limited funds are available to public or nonprofit agencies, organizations, or institutions which compete successfully to carry out the objective of the program. Closing date for application is September 20, 1979. Funded projects may start between January 1 and June 30, 1980, for a two-year project period. Interested applicants may write to the following address for detailed program guidelines:
Minority Research Associate Program Office of Education and Training Administration on Aging 330 Independence Avenue, SW Washington, DC 20201 202/472-3050 Minority social scientists who are interested in participating in this program should write to the same address for information. Direct grants to individuals cannot, however, be made under this program. Therefore, interested minority social scientists should also contact potential host institutions whose record in the field of gerontology qualify them for the Minority Research Associate Program.
650
AJPH July, 1979, Vol. 69, No. 7
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
EDITORIALS
consumer study practices presents no "departure" or increase in "ordinary risk.'5 It is important that surveys like this and similar projects, which do not involve the dangers to subjects that institutional review was designed to mitigate or avoid, not be fettered by regulatory safeguards. Comprehensive research regulation is a new field and one that poses significant threats to innovative research and perhaps even to the subjects of that research if the suggestion in a recent editorial in Science is correct, that the informed consent procedure itself may be a source of iatrogenic harm.6 The requirement of ethical peer review in the form of IRBs to protect human subjects of biomedical and behavioral research was a much-needed response to some obvious abuses, particularly in medical research, including the notorious Tuskegee Syphilis Study, research on prison inmates, and drug research without proper Food and Drug Administration supervision such as some contraception and abortion (menstrual regulation) studies using Depo-Provera and diethylstilbestrol (DES). The protection provided by IRBs should, however, be for real and substantial harms defined in advance and reflective of the scientific consensus in a given department, school, or institution. Without guidelines to-
gether with much good will and common sense on the part of IRB members, the conduct of public health and other types of nontherapeutic research could turn out to be the real victim.
L. LYNN HOGUE, PHD, JD Address reprint requests to L. Lynn Hogue, PhD, JD, Assistant Professor of Law, School of Law, University of Arkansas at Little Rock, 400 West Markham St., Little Rock, AR, 72201.
REFERENCES 1. Stolurow KAC and Moeller DW: Dental x-ray use in Boston. Am J Public Health 69:709-710, 1979. 2. 45 Code of Federal Regulations, Part 46 "Protection of Human
Subjects.'" 3. 45 CFR §46.103(c); see also §46.109 (informed consent document shall exclude any exculpatory clauses). 4. 45 CFR §46.103(b). 5. A more extensive discussion of the application of IRB regulations to public health research protocols can be found in L. Lynn Hogue, "Institutional Review Boards and Public Health Research: An Analysis," University of Arkansas at Little Rock (UALR) Law Journal 1:428-454, 1978. 6. Loftus EF and Fries JF: Informed Consent May be Hazardous to Health, Science 204:11 (Apr. 6) 1979.
Announcing Minority Research Associate Program in Gerontology In response to the mandate of the 1978 Amendments to the Older Americans Acts, the Administration on Aging is initiating a Minority Research Associate Program. The program's objective is to attract minority social scientists into the field of gerontology by supporting their training, education, and research at gerontology institutes, centers, or programs of study. Limited funds are available to public or nonprofit agencies, organizations, or institutions which compete successfully to carry out the objective of the program. Closing date for application is September 20, 1979. Funded projects may start between January 1 and June 30, 1980, for a two-year project period. Interested applicants may write to the following address for detailed program guidelines:
Minority Research Associate Program Office of Education and Training Administration on Aging 330 Independence Avenue, SW Washington, DC 20201 202/472-3050 Minority social scientists who are interested in participating in this program should write to the same address for information. Direct grants to individuals cannot, however, be made under this program. Therefore, interested minority social scientists should also contact potential host institutions whose record in the field of gerontology qualify them for the Minority Research Associate Program.
650
AJPH July, 1979, Vol. 69, No. 7
