This section contains an extensive list of references. The authors of this module have included an annotated list of what they consider to be the most important references regarding this topic.

Introduction Case Study Q & A Annotated Case Foundation Text »Resources« Conclusion

»Resources«

Table of Contents
1: Annotated Primary References
2: Resources by Topic
3: Summary List of Resources: Privacy and Confidentiality in Research
4: Video Resources

1: Annotated Primary References

Anderlik MR, Rothstein MA. Privacy and confidentiality of genetic information: what rules for the new science? Annu Rev Genomics Hum Genet
2001;2:401-433.
-- This review article covers the ethical, legal, and policy issues associated with the generation and dissemination of genetic information. Research findings on public attitudes toward privacy and genetics and other factors relevant to policymaking are reviewed. Genetic research is used to highlight the importance of attention to the intrinsic harms associated with violations of genetic privacy. National databases, biobanks, gene brokers, pharmacogenomics, and insurer access to genetic information are discussed, highlighting the importance of attention to discrimination and other harms.

Artnak K, Benson M. Evaluating HIPAA compliance: a guide for researchers, privacy boards, and IRBs. Nurs Outlook. 2005;53:79-87.
-- The privacy components of the Health Information Portability and Accountability Act (HIPAA) have special bearing on the work of nurses, particularly those engaged in health-services research. In general, a person’s private health information may be disclosed only for treatment, payment, and business procedures related to health care service delivery. Access and/or use of the same information for research purposes necessitates another layer of review and may require a separate process of authorization. A brief historical overview of regulatory requirements regarding health information privacy and security standards for the electronic transformation of data and the protection of electronically kept medical records is discussed and related to the roles and responsibilities of researchers and organizations where research is conducted.

Bayer R, Fairchild A. Public health. Surveillance and privacy. Science. 2000;290(5498):1898-1899.
-- Although medical privacy is a fundamental value, it is not an absolute. Surveillance involving name-based reporting necessitates recognition that the protection of public health may require some limitations on privacy. This article addresses five themes that help to explain the circumstances under which surveillance is contested and those under which it is accepted without debate. One theme is the extent to which surveillance might trigger public health intervention and the way that such interventions have been viewed. A second theme is the extent to which proposals for reporting provoke resistance or alarm when they involve diseases carrying social stigma or touch those who view themselves as socially marginalized or vulnerable to social or economic injury. Third, special populations such as children can elicit special protections. Fourth, constituencies are not consistently alert to the potential imposition of a surveillance regime. Fifth, changes in expectations regarding privacy have had an impact on the acceptability of name-based reporting systems and the willingness of policymakers to consider alternatives.

Easter MM, Davis AM, et al. Confidentiality: more than a linkage file and a locked drawer. IRB. 2004;26(2):13-17.
-- Keeping confidentiality as promised by investigators is more challenging during data collection and analysis in interview studies. Too little attention is being paid to the risk of disclosure of participants’ Protected Health Information in social-science research. Often, in survey research, the main risk to participants is a breach of confidentiality. The authors provide suggestions for researchers and Institutional Review Boards (IRBs) for comprehensively examining their confidentiality procedures on a regular basis and readjusting them as research studies progress. It is important to provide education in data management and protection procedures to study staff, researchers, and IRB members.

English A, Ford CA. The HIPAA Privacy Rule and adolescents: legal questions and clinical challenges. Perspect Sex Reprod Health. 2004;36(2):80-86.
-- In the past several decades, adolescents have been given many opportunities to receive confidential health care services, particularly for concerns related to sexual activity, pregnancy, HIV and other sexually transmitted diseases (STDs), substance abuse, and mental health. Protection of confidentiality for adolescents is based on the recognition that some minors would not seek needed health care if they could not receive it confidentially. Privacy concerns can deter them from communicating openly with providers. Confidentiality protections for adolescent health care are reflected in the policies and ethical guidelines of a wide range of medical and health care professional organizations. They also are embodied in numerous state and federal laws that have great significance for the application of the HIPAA Privacy Rule to adolescents' health information.

Eysenbach G, Till J. Ethical issues in qualitative research on internet communities. BMJ. 2001;323(7321):1103-1105.
-- Internet communities (such as mailing lists, chat rooms, newsgroups, or discussion boards on Web sites) are rich sources of qualitative data for health researchers. Qualitative analysis of Internet postings may help to systematize and codify needs, values, and preferences of consumers and professionals relevant to health and health care. The main problem with using Internet communities for research is that researchers may have difficulty separating spaces regarded as private from spaces regarded as public. This article recommends that researchers and Institutional Review Boards (IRBs) should carefully consider these points when developing and reviewing research protocols, and provides examples to show how complex such considerations may be.

Hirtz DG, Fitzsimmons LG. Regulatory and ethical issues in the conduct of clinical research involving children. Curr Opin Pediatr. 2002;14(6):669-675.
-- Children are a uniquely vulnerable population, yet there is an overwhelming need to test the safety and efficacy of therapies and preventions in the pediatric population. Results from studies in adults do not provide sufficient or accurate information. Recently, the need for research involving children has been recognized and action has been taken at the federal level to address both the need for pediatric research and the protection of the welfare and rights of children as research subjects. Other ethical and legal issues, such as privacy and confidentiality of information, are addressed.

Hyman SE. The needs for database research and for privacy collide. Am J Psychiatry. 2000;157(11):1723-1724.
-- Large medical databases are a critical resource for research that has an important impact on public health, but use of these databases raises important issues with respect to patient confidentiality. Population-based medical databases are an additional arena for the balancing of public health goals and individual protections. The author recommends that organizations (e.g., provider organizations, practitioners, pharmacies) that collect patient data provide clear information in plain language on the possible uses of such data, including clinical care, research, and commercial purposes. IRBs, or other appropriate peer review groups, should ensure that proposed research on medical databases is of high quality and therefore warrants any risk to subjects. IRBs must ensure that consent issues are considered in an appropriate manner and that patient confidentiality is protected effectively.

Lowrance WW. The promise of human genetic databases. BMJ. 2001 Apr 28;322:1009-1010.
-- The author provides a list of ethical requirements for genetic databases and recommends getting broad public support for pursuing genetic research by emphasizing the common good and collective benefit of genetic databases.

Lowrance WW. Learning from experience: privacy and secondary use of data in health care research. J Biolaw Bus. 2003;6(4):30-60.
-- In this fast-moving age of data banking, data are a currency, and often a commodity. Electronic health records are being developed everywhere. Increasingly, data collected for various primary purposes are being re-used for research. With personal mobility, contracting of services, and telemedicine, health care data are crossing national borders, and therefore, so are genetic information, biological materials, and reimbursement data. There is much public and legal concern about the implications. This article addresses the question: Under what conditions may data not collected specifically for research, such as primary medical data, be re-used for health research without compromising the privacy of the subjects?

Margolin G, Chien D, Duman S, Fauchier A, Gordis E, Oliver P, et al. Ethical issues in couple and family research. J Fam Psychol. 2005;19(1):157-167.
-- Federal regulations, ethical standards, and state laws governing ethics do not adequately address important issues in couple and family research. Including multiple family members, particularly dependent minors, in research requires the special application of fundamental ethical issues such as confidentiality, privacy, and informed consent. The sensitive, commingled nature of couple and family information necessitates clear policies about data ownership and disclosure. Researchers need to have respect for the family as a unit and to evaluate benefits versus harms for the family as well as for individuals. This article highlights areas of potential concern and ambiguity related to abuse reporting and Certificates of Confidentiality, and also addresses ethical issues with observational data, intervention studies, longitudinal designs, and computer-assisted research.

Marshall PA, Rotimi, C. Ethical challenges in community-based research [Symposium] Am J Med Sci. 2001;332(5):259-263.
-- Population-based studies have unique ethical challenges due to the community context, the relationship between the investigator and the community, and the methods used. Strategies for respecting populations in community-based studies are presented. Informed consent, protecting privacy and maintaining confidentiality and relationships between investigators and participants are more complex and significant beyond the individual research participant. Ethically responsible population studies must consider community needs and priorities, and researchers should work collaboratively with community representatives. Community representatives should participate in the research development, implementation, interpretations, and study objectives, and be provided with regular and timely feedback of results.

Neale A, Schwartz K. A primer of the HIPAA Privacy Rule for practice-based researchers. J Am Board Fam Pract. 2004;17(6):461-465.
-- Concerns about the privacy of personal health information have grown with the increased use of electronic medical records and with the patient-centered philosophy that physician-patient relationships should rest on principles of respect, autonomy, and confidentiality. Practicing clinicians are aware that the HIPAA Privacy Rule sets rigorous standards for the protection of personal health information. This article addresses some common questions about the research use of Protected Health Information and presents definitions and interpretations of selected Privacy Rule terms.

Offit K, Groeger E, Turner S, Wadsworth BA, Weiser MA. The “duty to warn” a patient’s family members about hereditary disease risks. JAMA. 2004;292(12):1469-1473.
-- The failure to warn relatives of inherited health risks has resulted in malpractice lawsuits in the US, although the potential legal liability of a “duty to warn” family members of their inherited health risk is still unclear. While a physician’s “duty to warn” is in conflict with his or her obligation to respect the privacy of patients, the authors believe that health care professionals “have a responsibility to encourage but not coerce the sharing of genetic information in families.”

Robertson JA. Privacy issues in second stage genomics. Jurimetrics. 1999;40:59-76.
-- Research that identifies genes that are useful in the prevention and treatment of disease will require access to biologic samples and medical records protected by the traditional concepts of privacy and confidentiality. Resolving conflicts between privacy and genomic research will require articulating the ethical rules that should govern such practices and then implementing those rules in national, regional, or local health systems.

Rogers B. Research with protected populations—vulnerable participants. AAOHN J. 2005;53(4):156-157.
-- Workers, as study participants, are a vulnerable population; additional considerations need to be taken regarding their protection in research. Issues related to invasion of privacy and coercion to participate in research studies must be carefully weighed and closely monitored. Worker autonomy must be fostered with respect to assuring that informed consent is given, meaning that the information transferred is understood. Research will add to the body of knowledge and advance nursing practice, but one must always remember that risks and benefits must be balanced to achieve appropriate end results.

Rothstein M. Genetic privacy and confidentiality: why they are so hard to protect. J Law Med Ethics. 1998;26(3):198-204,178.
-- The author notes that widespread concerns have been raised about protecting genetic privacy and confidentiality in insurance and employment. He argues that effective protections are difficult because procedural safeguards, such as limits on disclosure by health care providers, although necessary, bring up important issues, such as the right of access to health care, equality of opportunity, and allocation of resources. No single procedural law can resolve the complex issues involved in genetic privacy and confidentiality.

Rubin R. Whose medical history is it, anyway? USA Today, Health. 2001 April 8. Available from: http://www.usatoday.com/news/health/2001-04-08-privacy.htm
-- Richard Curtin triggered a national controversy when he made an official complaint that researchers at Virginia Commonwealth University overstepped their bounds in sending his daughter a questionnaire that asked not only about her medical history but about her parents and her twin brother. Genetic information raises important questions about privacy, because genetic information from one person reveals sensitive information about other people besides the one that researchers are talking to. If information could harm those individuals, those individuals need to grant permission for researchers to obtain and use the information. Researchers are anxious about the results of this complaint. Their concerns for obstacles to their research may be warranted.

2: Resources by Topic

Privacy and Confidentiality in Research

Case P. Confidence matters: the rise and fall of informational autonomy in medical law. Med Law Rev. 2003;11(2): 208-236.

Kulynych J, Korn D. The effect of the new Federal Medical-Privacy Rule on research. N Engl J Med. 2002;346(3):201-204.

Reily P. Been there; done that (we've been there; they've done that). IRB.
2001;23(1)8-9.

Siegler M. Sounding Boards. Confidentiality in medicine - a decrepit concept. N Engl J Med. 1982;1518-21.

Singer N, Couper M. The impact of privacy and confidentiality concerns on survey participation. Public Opin Q. 1993;57:465-482.

Slaughter PM, Varney C, Leman K, McGill P. Safeguarding privacy: the ICES experience. Healthc Q.2005;8(1):29-30.

Belmont Report

National Institutes of Health. [Web site on the Internet].The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. April 18, 1979. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. [cited 2006 March 19]. Available from: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html.

Code of Federal Regulations Title 45 Part 46: The Common Rule

Department of Health and Human Services [Web site on the Internet]. Code of Federal Regulations. Title 45 Part 46. Protection of human subjects. [Revised 2005 June 23, effective 2005 June 23; cited 2006 March 20]. Available from: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.

Food and Drug Administration Regulation: 21 CFR Part 50 and 56

U.S. Food and Drug Administration [Web site on the Internet]. Information Sheet Guidances. Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors. [cited 2006 March 20]. Available from: http://www.fda.gov/oc/ohrt/irbs.

Certificates of Confidentiality (COC)

National Institutes of Health [Web site on the Internet]. Office of Extramural Research: Certificates of Confidentiality Kiosk. 2005 Dec 2 [updated 2006 Feb 28; cited 2006 March 20]. Available from: http://grants2.nih.gov/grants/policy/coc/.

HIPAA and Research

AMA. Helping Doctors Helping Patients [Web site on the Internet]. HIPAA Violations and Enforcement. [updated 2005 Nov 1; cited 2005 Nov 16]. Available from: http://www.ama-assn.org/ama/pub/category/11805.html.

Annas G. Medical privacy and medical research--judging the new federal regulations. N Engl J Med. 2002;346(3):216-220.

English A, Ford CA. The HIPAA Privacy Rule and adolescents: legal questions and clinical challenges. Perspect Sex Reprod Health. 2004;36(2):80-86.

HIPAA Substance Abuse and Mental Health Services Administration [Web site on the Internet]. HIPAA: What it Means for Mental Health and Substance Abuse Services; [updated 2004 Feb 24; cited 2006 March 20]. Available from: http://www.hipaa.samhsa.gov/hipaa.html.

HIPAAdvisory [Website on the Internet]. OCR Guidence Explaining the Significant Aspects of the Privacy Rule; 2002 Dec 4 [updated 2003 April 3; cited 2006 March 20]. Available from: http://www.hipaadvisory.com/regs/finalprivacymod/guidance.htm.

HIPAAdvisory [Web site on the Internet]. Frequently Asked Questions About the HIPAA Privacy Rule; 2002 Oct 2. [cited 2006 March 20]. Available from: http://www.hipaadvisory.com/action/faqs/faqs1001.doc.

Inconsistent interpretation of HIPAA creates research recruitment barrier. IRB Advisor; 2005 Apr;5(4), p. 37-48.

Kaiser, J. Patient records: privacy rule creates bottleneck for U.S. biomedical researchers. Science. 2004 July 9;305(5681):168-169.

Kulynych J, Korn D. The effect of the new federal medical-privacy rule on research. N Engl J Med. 2002;346(3):201-204.

Kulynych J, Korn D. The new HIPAA medical privacy rule: help or hindrance for clinical research? Circulation. 2003;108:912-914.

Morbidity and Mortality Weekly Report [Web site on the Internet]. HIPAA Privacy Rule and Public Health: Guidance from CDC and the U.S. Department of Health and Human Services; 2003 April 11. [cited 2006 March 20]. Available from: http://www.cdc.gov/mmwr/preview/mmwrhtml/m2e411a1.htm.

National Human Genome Research Institute [Web site on the Internet]. Washington, D.C.: Protecting Human Research Subjects: Office for Protection from Research Risks, 1993 Institutional Review Board Guidebook. [Last reviewed March 2006; cited 2006 March 20]. Available from: http://www.genome.gov/10001752.

National Institutes of Health [Web site on the Internet]. How Do Other Privacy Protections Interact with the Privacy Rule? [updated 2004 Aug 4; cited 2006 March 20]. Available from: http://privacyruleandresearch.nih.gov/pr_05.asp.

National Institutes of Health [Web site on the Internet]. Information for Researchers: Clinical Research and the HIPAA Privacy Rule; 2004 Feb 5 [updated 2004 June 22; cited 2005 Oct 11]. Available from: http://privacyruleandresearch.nih.gov/clin_research.asp.

National Institutes of Health [Web site on the Internet]. Information for Researchers: Health Services Research and the HIPAA Privacy Rule; posted 2005 May 20. [cited 2006 March 20]. Available from: http://privacyruleandresearch.nih.gov/healthservicesprivacy.asp.

National Institutes of Health [Web site on the Internet]. Information for Researchers: How Can Covered Entities Use and Disclose Protected Health Information for Research and Comply with the Privacy Rule?; [updated 2004 Aug 4; cited 2006 March 20]. Available from: http://privacyruleandresearch.nih.gov/pr_08.asp.

National Institutes of Health [Web site on the Internet]. Information for Researchers: Overview; [updated 2004 Aug 4; cited 2006 March 20]. Available from: http://privacyruleandresearch.nih.gov/.

National Institutes of Health [Web site on the Internet]. Information for Researchers: Privacy Boards and the HIPAA Privacy Rule; 2003 Sept 25 [updated 2004 July 12; cited 2006 March 20]. Available from: http://privacyruleandresearch.nih.gov/privacy_boards_hipaa_privacy_rule.asp.

National Institutes of Health [Web site on the Internet]. Information for Researchers: Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule; 2003 April 14 [updated 2004 July 13; cited 2006 March 20]. Available from: http://privacyruleandresearch.nih.gov/pr_02.asp.

National Institutes of Health [Web site on the Internet]. NIH Primer: Research and Privacy. Department of Health and Human Services Health Privacy Rule; 2000 Jan 4 [updated 2000 March 14; cited 2006 March 20]. Available from: http://www.meduohio.edu/research/nih_privacy_primer.pdf.

Neale A, Schwartz K. A primer of the HIPAA Privacy Rule for practice-based researchers. J Am Board Fam Pract. 2004;17(6):461-465.
United States Department of Health and Human Services [Web site on the Internet]. Centers for Medicare and Medicaid Services; Are You a Covered Entity? [updated 2005 Dec 14; cited 2006 March 20]. Available from: http://www.cms.hhs.gov/HIPAAGenInfo/06_AreYouaCoveredEntity.asp#TopOfPage.
United States Department of Health and Human Services [Web site on the Internet]. HIPAA Administrative Simplification: Enforcement; Final Rule; 2006 Feb 16. [cited 2006 March 20]. Available from: http://www.hhs.gov/ocr/hipaa/FinalEnforcementRule06.pdf.

United States Department of Health and Human Services [Web site on the Internet]. Medical Privacy – National Standards to Protect the Privacy of Personal Health Information (via DH&HS Office of Civil Rights (OCR)). [updated 2003 Dec 31; cited 2006 March 20]. Available from: http://www.hhs.gov/ocr/hipaa/privacy.html.

United States Department of Health and Human Services [Web site on the Internet]. Summary of the HIPAA Privacy Rule (via DH&HS Office of Civil Rights (OCR)); [updated 2003 May; cited 2006 March 20]. Available from: http://www.hhs.gov/ocr/privacysummary.pdf.

HIV/AIDS Information

Muthuswamy V. Ethical issues in HIV/AIDS research. Indian J Med Res. 2005 April;121:601-610.

Decedents’ Information

DeVita MA, Wicclair M, et al. Research involving the newly dead: an institutional response. Crit Care Med. 2003;31(5 Suppl): S385-390.

IRB
Committee on the Role of Institutional Review Boards in Health Services Research Data Privacy Protection DOHCS. Institutional Review Boards and Health Services Research Data Privacy: A Workshop Summary [monograph on the Internet].

Washington DC: National Academies Press; 2002 [cited 2006 March 20]. Available from: http://www.nap.edu/catalog/9890.html.

National Institutes of Health [Web site on the Internet]. Information for Researchers: Institutional Review Boards and the HIPAA Privacy Rule; 2003 Aug 15 [updated 2004 July 8; cited 2006 March 20]. Available from: http://privacyruleandresearch.nih.gov/irbandprivacyrule.asp.

National Institutes of Health [Web site on the Internet] Office of Human Subjects Research. Regulations and Ethical Guidelines. [cited 2006 March 20]. Available from: http://ohsr.od.nih.gov/index.html.

Genetic Privacy

Anderlik M, Rothstein M. Privacy and confidentiality of genetic information: what rules for the new science? Annu Rev Genomics Hum Genet. 2001;2:401-433.

Bianchi F, Rosati S, et al. 'Secrets and lies'--the difficulties of communicating within families with inherited cancer syndromes. Clin. Genet. 2004;66(5):476-477.

Edwards J, Young S, et al. Developing genetic privacy legislation: the South Carolina experience. Genet Test. 1998;2(1):37-41.

Everett, M. The social life of genes: privacy, property and the new genetics. Soc Sci Med. 2003;56(1): 53-65.

Hadley D, Jenkins J, et al. Genetic counseling and testing in families with
hereditary nonpolyposis colorectal cancer. Arch Intern Med. 2003;163(5):573-582.

Lin Z, Owen AB, Altman RB. Genomic research and human subject privacy. Science. 2004 July 9;305(5681):183.

Miller P. Genetic discrimination in the workplace. J Law Med Ethics. 1998;26(3):189-197,178. Review.

National Conference of State Legislatures [Web site on the Internet]. Genetics and Health Insurance. State Anti-Discrimination Laws; 2005 June. [cited 2006 March 20]. Available from: http://www.ncsl.org/programs/health/genetics/ndishlth.htm.

National Conference of State Legislatures [Web site on the Internet]. State Genetic Privacy Laws; c. 2006. [cited 2006 March 20]. Available from: http://www.ncsl.org/programs/health/genetics/prt.htm.

National Human Genome Research Institute [Web site on the Internet]. Genetic Discrimination; 2005 Dec. [cited 2006 March 20]. Available from: http://www.genome.gov/10002077.

Offit K, Groeger E, Turner S, Wadsworth BA, Weiser MA. The “duty to warn” a patient’s family members about hereditary disease risks. JAMA. 2004;292(12):1469-1473.

Pedigree Research

Worrall BB, Chen DT, et al. Ethical and methodological issues in pedigree stroke research. Stroke. 2001;32(6):1242-1249.

Pharmacogenomics/Pharmacoepidemiology

Corrigan OP. Pharmacogenetics, ethical issues: Review of the Nuffield Council on bioethics report. J Med Ethics. 2005;31:44-148.

Leufkens HG. Privacy issues in pharmacoepidemiology: the importance of weighing costs and benefits. Pharmacoepidemiol Drug Saf. 2001;10(7):659-662.

Robertson JA. Privacy issues in second stage genomics. Jurimetrics. 1999;40:59-76.

Social Sciences and Behavioral Research (SSBR)

Labott SM, Johnson TP. Psychological and social risks of behavioral
research. IRB. 2004;26(3):11-15.

Maloney DM. Institutional review boards and social science research. Hum Res Rep. 2003;18(7):1-2.

Panel on Institutional Review Boards, Surveys, and Social Science Research, The National Academies. 2002. Committee on National Statistics (CNSTAT). Letter Report: Protecting Participants in Behavioral and Social Science Research. [cited 2006 March 20]. Available from: http://darwin.nap.edu/books/NI000413/html/3.html.

Richards HM, Schwartz LJ. Ethics of qualitative research: Are there special issues for health services research? Fam Pract. 2002;19(2):135-139.

Third Party Research

Department of Health and Human Services. Office for Human Research Protections. National Human Research Protections Advisory Committee (NHRPAC). Clarification of the Status of Third Parties When Referenced by Human Subjects in Research. January 28-29, 2002 [document on the Web]. [cited 2006 March 21]. Available from: http://www.hhs.gov/ohrp/nhrpac/documents/third.pdf.

Matthews J. Father's complaint shuts down research: US agencies act on privacy concerns. Washington Post. 2000 Jan 12;Sect. B07.

Rubin R. Whose medical history is it, anyway? Genetic information sought for studies becomes newest privacy maelstrom. USA Today. 2001 April 8. Available from: http://www.usatoday.com/news/health/2001-04-08-privacy.htm.

Vulnerable Populations

Fischbach R. The Tuskegee legacy. Harvard Medical Alumni Bulletin. 1993;25-28.

Hirtz DG, Fitzsimmons LG. Regulatory and ethical issues in the conduct of clinical research involving children. Curr Opin Pediatr. 2002;14(6):669-675.

Lutz, KF. Maintaining client safety and scientific integrity in research with battered women. Image J Nurs Sch. 1999;31(1):89-93.

Marshall M, Menikoff J, et al. Perinatal substance abuse and human subjects research: are privacy protections adequate? Ment Retard Dev Disabil Res Rev. 2003;9(1):54-59.

National Human Genome Research Institute [Web site on the Internet]. Washington, D.C.: Protecting Human Research Subjects: Office for Protection from Research Risks, 1993 Institutional Review Board Guidebook; [updated 2005 Sept; cited 2006 March 20]. Available from: http://www.genome.gov/10001752.

Rogers B. Research with protected populations--vulnerable participants. AAOHN J. 2005;53(4):156-157.

Couple and Family Research

Margolin G, Chien D, Duman S, Fauchier A, Gordis E, Oliver P, et al. Ethical issues in couple and family research. J Fam Psychol. 2005;19(1):157-167.

Neuroscience research

Greely HT. Neuroethics: The Neuroscience Revolution, Ethics, and the Law.
Remarks for the Regan Lecture on April 20, 2004. Santa Clara University: Markkula Center for Applied Ethics [Web site on the Internet]. [cited 2006 March 20]. Available from: http://www.scu.edu/ethics/publications/submitted/greely
/neuroscience_ethics_law.html

Kulynych, J. Legal and ethical issues in neuroimaging research: human subjects protection, medical privacy, and the public communication of research results. Brain Cogn. 2002;50(3): 345-357.

Community Based Research

Marshall PA, Rotimi C. Ethical challenges in community-based research. [Symposium] Am J Med Sci. 2001;332(5):259-263.

High-Profile Research

Morreim EH. High-profile research & the media: The case of the AbioCor artificial heart. Hastings Cent Rep. 2004 Jan-Feb; 34(1):11-24.

International Research & Privacy

Bernstein SW, et al. Transfer of clinical research data from the European Union to the United States.Medical Research Law & Policy. 2004 Apr 7;3(7):271-276.

Fogarty International Center [Web site on the Internet]. International Research Bioethics Initiatives; [updated 2002 Feb; cited 2006 March 20]. Available from: http://www.fic.nih.gov/programs/training_grants/bioethics/index.htm.

The World Medical Association [Web site on the Internet]. World Medical Association Declaration of Helsinki. [updated 2004 Sept 10; cited 2006 March 20]. Available from: http://www.wma.net/e/policy/b3.htm.

Tissue & Data Repositories

Caulfield T. Upshur REG, Daar A. DNA databanks and consent: A suggested policy option involving an authorization model. BMC Med Ethics 2003;4:1. [published 3 January 2003;cited 2006 March 8;] Available from: http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=140033&blobtype=pdf.
[This article is available from: http://www.biomedcentral.com/1472-6939/4/1
© 2003 Caulfield et al; licensee BioMed Central Ltd. This is an Open Access article.

de Montgolfier SG, Moutel G, et al. Ethical reflections on pharmacogenetics and DNA banking in a cohort of HIV-infected patients. Pharmacogenetics. 2002;12(9):667-675.

Hyman SE. The needs for database research and for privacy collide. Am J Psychiatry. 2000;157(11):1723-1724.

Ingelfinger JR, Drazen JM. Registry research and medical privacy. N Engl J Med. 2004 April 1;350(14):306-307.

Jeffers B. Human biological materials in research: Ethical issues and the role of stewardship in minimizing research risks. ANS Adv Nurs Sci. 2001;24(2):32-46.

National Institutes of Health [Web site on the Internet]. Information for Researchers: Research Repositories, Databases and the HIPAA Privacy Rule; 2004 Jan 12 [updated 2004 July 2; cited 2006 March 20]. Available from: http://privacyruleandresearch.nih.gov/research_repositories.asp.

Internet

Eysenbach G, Till J. Ethical issues in qualitative research on internet communities. BMJ. 2001;323(7321):1103-1105.

Eysenbach G, Wyatt J. Using the internet for surveys and health research. J Med Internet Res. 2002;4(2):E13.

Haigh C, Jones NA. An overview of the ethics of cyber-space research and the implication for nurse educators. Nurse Educ Today. 2005;25(1):3-8.

Secondary Research

Barnes M, Heffernan KG. The ‘future uses’ dilemma: secondary uses of data and materials by researchers and commercial research sponsors. Med Res Law & Policy. 2004 June 2;2(11):401-454.

Kluge EH. Informed consent to the secondary use of EHRs: informatic rights and their limitations. Medinfo. 2004;11(Pt 1): 635-638.

Lowrance WW. Learning from experience: privacy and the secondary use of data in health research. J Biolaw Bus. 2003;6(4):30-60.

Melton LJ. The threat to medical-records research. N Engl J Med. 1997;337(20):1466-1470.

Pommerening K, Reng M. Secondary use of the EHR via pseudonymisation. Stud Health Technol Inform. 2004;103:441-446.

Minors’ Rights to Keep Certain Categories of Protected Health Information (PHI) Confidential

Hirtz DG, Fitzsimmons LG. Regulatory and ethical issues in the conduct of clinical research involving children. Curr Opin Pediatr. 2002;14(6):669-675.

Public Health/Surveillance

Bayer R, Fairchild A. Public health: surveillance and privacy. Science. 2000;290(5498):1898-1899.

Fairchild A, Bayer R. Public health. Ethics and the conduct of public health surveillance. Science. 2004;303(5658):631-632.

Fairchild A, Bayer R. Public health. Ethics and the conduct of public health
surveillance. Science. 2004;304(5671): author reply 681-684.

Recruitment

Bernstein S. Recruiting candidates for clinical trials: what can be done under HIPAA? Monitor. 2003 Spring:17-22.

3: Summary List of Resources: Privacy and Confidentiality in Research

Anderlik M, Rothstein M. Privacy and confidentiality of genetic information: what rules for the new science? Annu Rev Genomics Hum Genet. 2001;2:401-433.

Annas G. Medical privacy and medical research--judging the new federal regulations. N Engl J Med. 2002;346(3):216-220.

Artnak K, Benson M. Evaluating HIPAA compliance: a guide for researchers, privacy boards, and IRBs. Nurs Outlook. 2005;53:79-87.

Barnes M, Heffernan KG. The ‘future uses’ dilemma: secondary uses of data and materials by researchers and commercial research sponsors. Med Res Law & Policy. 2004 June 2;2(11):401-454.

Bernstein SW, et al. Transfer of clinical research data from the European Union to the United States.Medical Research Law & Policy. 2004 Apr 7;3(7):271-276.

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4: Video Resources

Butts

Participant's Right to Privacy
HIPAA: Privacy Power
HIPAA
Authorization, etc
Preparatory to research

Cohen

Privacy vs. Confidentiality
IP Addresses
Limited Data Set
Data Protection
Data Security and Protection
Security of Emails
Internet Research
Internet Recruitment

Fischbach

Consider the Participant
Certificates of Confidentiality (CoC)
Legal Limits of CoC
How Apply for a CoC
Third Party Research
The Richard Curtin Case
Identifying a Vulnerable Population
Vulnerable Populations
Breaches of Confidentiality: Always Consider the Participant

Klitzman

IRB’s, Informed Consent and Protections
Genetic Information
Risk of Stigmatization
Social Science Research

Payne

Balance Privacy/Confidentiality and Research Goals
Zip Codes
Safe Harbor
Investigator Training
Data Protection Plan
Anonymized versus Anonymous Data
Linking Databases
Managing Research Data on the Internet
Breaches of Confidentiality
The Challenges

Continue to the next section: → Conclusion