Ordinarily, informed consent should be obtained from research subjects according to the following rules.
Where it is infeasible to observe these rules due to such reasons as methodology or purpose of the research, nature of research subjects, or the like, exceptions to the Guidelines may be permitted only when approval of both the ethics review committee and the institute head have been secured.
Ethics review committees shall make certain that all of the following conditions are met in research proposals, whenever relaxing, waiving or deviating from the general rules for obtaining informed consent:
1- The epidemiological research involves no more than minimal risk to the subjects; 2- The relaxation, waiver or deviation will not adversely affect the interests of the subjects;
37 3- The epidemiological research could not practically be carried out without the
relaxation, waiver or deviation;
4- Whenever appropriate, any of the following measures shall be taken:
A. The population in which the subjects are included shall be informed about the details of collection and use of human biological materials and information, including collection methods;
B. Research subjects shall be provided with pertinent information after participation, as soon as practically possible (group briefings are also acceptable);
C. Where human biological materials and information are collected or used continuously for a long period of time, reasonable efforts shall be taken to make all relevant details known to the public by disseminating pertinent information including the methods of collection and use;
5- The epidemiological research is recognized as having great social importance. Regarding observational research using only existing materials, informed consent does not necessarily need to be obtained from research subjects. However, for these types of research, researchers shall publish all relevant details regarding the study to be carried out.
(Ministry of Education, Culture, Sports, Science and Technology, Ministry of Health, Labour and Welfare. Japan, 2002)
38 Glossary
Epidemiology
Epidemiology is the study of the distribution and determinants of health-related states or events in specified populations, and application of this study to control of health
problems.” （John Last, Dictionary of Epidemiology, 4th edition）
Public Health Practice
Public Health Practice is an activity to protect the public’s health through
epidemiological investigations, surveillance, programmatic evaluations, and clinical care for populations. (Perlman, 2008)
Public Health Research
Public Health Research is an activity to design and conduct of studies involving human subjects or the purpose of generating knowledge that often benefits those beyond the participating community bearing the risk of participation (Perlman, 2008)
Registry
A register is an ordered collection of records, for instance of births or of deaths. A registry is an organized system to develop, maintain and use one or more registers, for example a national registry may keep the registers of births and deaths. By
extension the institution responsible for the system is also called a registry (e.g., a cancer registry) (CIOMS, 2009).
39 REFERENCES
Agrawala, R., Johnson C. (2007). Securing electronic health records without impeding the flow of information. International journal of medical informatics, 76, 471-479.
Al-Shahi, R., Vousden, C., & Warlow, C. (2005). Bias from requiring explicit consent from all participants in observational research: prospective, population based study. BMJ, 331, 942.
AMA HIPAA Health Insurance Portability Accountability Act. HIPAA Violations and Enforcement. Retrieved June 29, 2010 from
http://www.ama-assn.org/ama/pub/physician-resources/solutions-managing-your- practice/coding-billing-insurance/hipaahealth-insurance-portability-accountability- act/hipaa-violations-enforcement.shtml
Appelbaum, P.S.(2001). Dr. Appelbaum Replies. American Journal of Phychiatry 158,1745-1746
Armstrong, D., Kline-Rogers, E., Jan,i S.M. et al. (2005). Potential impact of the HIPAA privacy rule on data collection in a registry of patients with acute coronary syndrome. Archives of Internal Medicine, 165, 1125-1129.
40 Ayanian J.Z. (1999). Using administrative data to assess health care outcomes.
European Heart Journal, 20, 1689–1691.
Barrett, G., Cassell, J.A., Peacock, I.L. et al. (2006). National survey of British public’s view on use of identifiable medical data by the National Cancer Registry. BMJ. 332, 1068-1072
Beecher, H.K. (1966). Ethics and clinical research. New England Journal of Medicine, 274, 1354-1360.
Behlen, F.M., Johnson, S.B. (1999). Multicenter Patient Records Reseach: Security Policies and Tools. Journal of the American Medical Informatics Association. 6, 435-443.
Bertholf, B.L (2001). Protecting Human Research Subjects. Annals of Clinical and Laboratory Science, 31, 119-127
Belmont Report. (1979). The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report :Ethical
Principles and Guidelines for the Protection of Human Subjects of Research. April 18, 1979. Retrieved June 29, 2010 from
41 Black, D.W., Warrack. G., and Winokur. G. (1985). The Iowa record-linkage study, III:excess mortality among patients with “functional” disorders. Archives of General Psychiatry, 42, 82-88.
Black, N. (1996). Why we need observational studies to evaluate the effectiveness of health care. BMJ, 312, 1215-1218.
Buchanan, D.R. (2008). Autonomy, paternalism, and justice: ethical priorities in public health. American Journal of Public Health, 98, 15-21.
Byerly, W.G. (2009). Working with the instutitional review board. American Journal of Health-System Pharmacy, 66, 176-184.
CIOMS. (no date). The Council for International Organizations of Medical Sciences. About Us. Retrived June 29, 2010 from http://www.cioms.ch/about/frame_about.htm
CIOMS. (2002). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Retrieved June 29, 2010 from
http://www.cioms.ch/publications/guidelines/guidelines_nov_2002_blurb.htm
CIOMS.(2009). International Ethical Guidelines for Epidemiological Studies. Geneva, WHO Press
42 Coleman, M.P., Muir, C.S., and Menegoz, F. (1992). Confidentiality in the Cancer
Registry. British Journal of Cancer, 66, 1138-1149.
Cuttini, M., Saracci, R. (2009). Commentary: Can we facilitate the ethical approval of international observational studies? International Journal of Epidemiology, 38, 1108- 1109.
The European Union PrivacyDirectives (EU) . Retrived June 29, 2010 from http://eur- lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31995L0046:EN:NOT
Dudeck, J. (2001). Informed consent for cancer registration. Lancet Oncology, 2, 8-9.
Emanuel, E.J., Wendler, D., and Grady, C. (2008). An ethical framework for biomedical research. In Emanuel, E.J. et al. (Eds), The Oxford Textbook of Clinical Research Ethics. (pp.130). New York, NY: Oxford University Press.
Emanuel, E.J., Wendler, D., Grady, C. (2000). What makes clinical research ethical? JAMA, 283, 2701-2711.
Enfield, K.B., Truwit, J.D. (2008). The purpose, composition, and function of an IRB: balancing priorities. Respiratory Care, 53, 1330-1336.
43 Erler, C.J., Thompson, C.B. (2008). Ethics, Human rights, and clinical research. Air Medical Journal, 27, 110-143.
Gershon, A.S., Tu JV. (2008). The effect of privacy legislation on observational research. Canadian Medical Association Journal, 178,871-873
Goldman, M.P. (2001). Use of Psychiatric Records. American Journal of Phychiatry, 158, 1744-1745.
Gordis, L. (1991). Ethical and professional issues in the changing practice of epidemiology. Journal of Clinical Epidemiology, 44, Suppl 1, 9S-13S.
Goss, E., Link, M.P., Bruinooge, S.S. (2009). The Impact of the Privacy Rule on Cancer Research: Variations in Attitudes and Application of Regulatory Standards. Journal of Clinical Oncology, 27, 4014-4020.
Gruskin, S. (2002). Ethics, Human rights, and public health. American Journal of Public Health, 92, 698.
Haynes, B. (1999). Can it work? Does it work? Is it worth it? BMJ, 319, 652-653.
Hearnshaw, H. (2004). Comparison of requirements of research ethics committees in 11 European countries for a non-invasive interventional study. BMJ, 328, 140-141.
44 Hoppe, D.J. Schemitsch, E.H., Morshedet, S. et al. (2009). Hierarchy of Evidence: Where Observational Studies Fit in and Why We Need Them. Journal of Bone and Joint Surgery, American Volume, 91 Suppl 3, 2-9.
Horning, S.J. (2009). Cancer Research and Privacy: The Problem with Being Joined at the Hip. Journal of Clinical Oncology , 27, 3879-3880.
IARC. (2005). Guidelines on confidentiality for population-based cancer registration. European Journal of Cancer Prevention, 14, 309-327.
Ingelfinger, J., Drazen,J.M. (2005). Registry Research and Medical Privacy. New England Journal of Medicine, 350, 1452-1453.
Institute for Clinical Evaluative Sciences. Privacy code: protecting personal health information at ICES. Toronto: The Institute; 2005. Retrived June 29, 2010 from www.ices.on.ca/file/ACF20B.pdf<http://www.ices.on.ca/file/ACF20B.pdf>
Introna, L.D. (1997). Privacy and the computer: why we need privacy in the information society. Metaphilosophy, 28, 259-275.
Jacobsen, J., Xia, Z., Campion, M.E. et al. (1999). Potential effect of authorization bias on medical record research. Mayo Clinic Proceedings, 74, 330-338.
45 Jean Heller. New York Times Page 1. July 26, 1972
Kass, N. (2001). An Ethics Framework for Public Health. American Journal of Public Health, 91, 1776-1782.
Kendler, K.S., McGuire, M., Gruenberg, A.M. et al.(1994). An epidemiologic, clinical, and family study of simple schizophrenia in County Roscommon, Ireland. American Journal of Psychiatry, 151, 27-34.
Kho, M.E., Duffett, M., Willison, D.J. et al. (2009). Written informed consent and selection bias in observational studies using medical records: systematic review. BMJ, 338, 866.
Lerner, B.H. (2004). Sins of omission: Cancer research without informed consent. New England Journal of Medicine, 351, 628-630.
Levy, D., Splansky, G.L., Strand, N.K. et al.(2010). Consent for genetic research in the Framingham Heart Study. American Journal of Medical Genetics, 152A, 1250-1256.
Lindsaya, R. (2007). Beyond clinical trials: The importance of large databases in evaluating differences in the effectiveness of bisphosphonate therapy in
46 Lynn, M.R., Nelson, D.K. (2005). Common (Mis) Perception about IRB review of human subjects research. Nursing Science Quartery, 16, 264-270.
Malin, B.A., Sweeney, L. (2005). A secure protocol to distribute unlinkable health data. AMIA Annual Symposium Proceedings, 485-489.
Matsuda, T., Marugame, T., Ajiki, W, Sobue, T. (2010). Do the Japanese feel more suspicious about cancer registration that the British? Cancer Epdeimiology, 34, 122-130.
Metcalfe, C., Martin, R.M., Noble, S. et al. (2008). Low risk research using routinely collected identifiable health information without informed consent: encounters with the Patient Information Advisory Group. BMJ, 34, 37-40.
Miller, F.G. (2008). Research on medical records without informed consent. Journal of Law, Medicine, and Ethics, 36, 560-566.
Ministry of Education, Culture, Sports, Science and Technology, Ministry of Health, Labour and Welfare. Ethical Guidelines for Epidemiological Research. 2002. Retrieced June 29,2010 from http://www.niph.go.jp/wadai/ekigakurinri/ethical-gl/guidelines.htm
Myers, J., Frieden, T.R., Bherwani, K.M. et al. (2008). Privacy and public health at risk: public health confidentiality in the digital age. American Journal of Public Health, 98, 6793-801.
47 Ness, R.B. (2005). A year is a terrible thing to waste: early experience with HIPAA. Annals of Epidemiology, 15, 85-86.
Nosowsky, R., Giordano, T.J. (2007). The HIPAA Privacy Rule: Implications for Clinical Research. Annual Reviews of Medicine, 57, 575-590.
Nuremberg Code.(1949). "Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10", Vol. 2, pp. 181-182. Washington, D.C.: U.S. Government Printing Office.
Parkin, D.M. (2006). The evolution of the population-based cancer registry. Nature Reviews Cancer, 6, 603-612.
Perlman, D. (2008). Public health practice vs research: Implications for preparedness and disaster research review by state health department IRBs. Disaster Medicine and Public Health Preparedness. 2, 185-191.
Simon, G.E., Unutzer, J., Young, B.E. et al. (2000). Large medical databases,
population-based research, and patient confidentiality. American Journal of Psychiatry, 157, 1731-1737.
48 Suda, M. (2007). Expectation for cancer control measures progress. Mainichi
Newspaper, October 19, 2007
Tannen, R. L, Weiner, M. G, Xie, D. (2009). Use of primary care electronic medical record database in drug efficacy research on cardiovascular outcomes: comparison of database and randomised controlled trial findings. BMJ, 338, b81-b81
Trauth, J.M., Musa, .D, Siminof,f L. et al. (2000). Public attitudes regarding willingness to participate in medical research studies. Journal of Health Policy, 12, 23-43.
Tu, J.V., Willison, D.J., Silver, F.L, et al. (2004). Impracticability of Informed Consent in the Registry of the Canadian Stroke Network. New England Journal of Medicine, 350, 1414-21.
Turnock, B.J. (2009). Core Functions and Public Health Practice. In Public Health. What it is and how it works. Fourth edition. (pp.222). Massachusetts.:Jones and Barlett
Publishers.
U.S. Department of Health and Human Services.(no date). National Institute of Health. Regulations and Ethical Guidelines. The Belmont Report. Ethical principles and
guidelines for the protection of human subjects of research. Retrieved June 29, 2010 from http://ohsr.od.nih.gov/guidelines/belmont.html
49 U.S. Department of Health and Human Services. (2003). Standards for Privacy of
Individually Identifiable Health Information. Retrieved June 29, 2010 from
http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/introdution.html
U.S. Department of Health and Human Services. (2007). National Institute of Health. HIPAA Privacy Rule. Retrieved June 29, 2010 from
http://privacyruleandresearch.nih.gov/
US DHHS. (2008). Office for Human Research Protections (OHRP):OHRP 45 CFR part 46 Frequently Asked Questions (FAQs). Retrieved June 29, 2010 from
http://www.dhhs.gov/ohrp/45CFRpt46faq.html
U.S. Department of Health and Human Services. (2009). Code of Federal Regulations. Title 45 public welfare Part 46 protection of human subjects. Revised January 15, 2009. Retrived from http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
U.S. Department of health and Human Services. Food and Drug Administration (2009). CFR-Code of Federal Regulations Title 21. Part 50 Protection of Human Subjects. Retrieved June 29, 2010 from
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=50.
U.S. Department of Health and Human Services. Food and Drug Administration (2009). CFR-Code of Federal Regulations Title 21. Part 56 Institutional Review Board.
50 Retrieved June 29, 2010 from
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=56
Wartenberg, D., Thompson, W.D. (2010). Privacy versus public health: the impact of current confidentiality rules. American Journal of Public Health, 100, 407-412.
Whitley, E.A. (2009). Informational privacy, consent and the "control" of personal data. Information Security Technical Report, 14, 154-159.
Willison, D.C., Emerson, C., Szala-Meneok, K.V et al. (2008). Access to medical records for research purposes: varying perceptions across research ethics boards. Journal of Medical Ethics, 34, 308-314.
World Medical Association. (1964). The Declaration of Helsinki. Retrieved June 29, 2010 form http://www.wma.net/en/30publications/10policies/b3/index.html