Stanford Center for
Biomedical Ethics

Readings on Incidental Findings

This site is maintained by the:

Program in Neuroethics
Center for Biomedical Ethics
Stanford University
NIH/NINDS RO1 #NS045831
Advanced Neuroimaging:
Ethical, Legal, and Social Issues
J.Illes, Ph.D., Principal Investigator

and

The University of Minnesota
Consortium on Law and Values in Health, Environment, and the Life Sciences
NIH/NHGRI RO1 #HG003178
Incidental Findings in Research
S. Wolf, J.D., Principal Investigator

Appelbaum PS, Roth LH, Lidz CW, et al. (1987) False hopes and best data: consent to research and the therapeutic misconception. Hastings Center Report 17(2):20-24.

Appelbaum, PS, Lidz CW, Grisso T. (2004) Therapeutic misconception in clinical research: frequency and risk factors. IRB: A Review of Human Subjects Research 26(2): 1-8.

Bottrell MM, Alpert H, Fischbach RL, Emanuel LL. (2000) Hospital informed consent for procedure forms: facilitating quality patient-physician interaction. Archives of Survey 135(1): 26-33.

Centers for Disease Control (CDC). (1998) Consent for CDC Research: A Reference for Developing Consent Forms and Oral Scripts. Obtained August 30, 2004.

Chidiac RM, Aron DC. (1997) Incidentalomas: A disease of modern technology. Endocrinology & Metabolism Clinics of North America 26(1): 233-253.

Cho MK, Shohara R, Schissel A, Rennie D. (2000) Policies on faculty conflicts of interest at US universities. JAMA 284(17): 2203-2208.

Chung CS, Lehmann LS. (2002) Informed consent and the process of cadaver donation. Archives of Pathology & Laboratory Medicine 126(8): 964-968.

Daugherty C, Ratain MJ, Grochowski E, et al. (1995) Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 13(5):1062-1072.

Deck W, Kosatsky T. (1999) Communicating their individual results to participants in an environmental exposure study: insights from clinical ethics. Environmental Research 80(2 Pt 2): S223-S229).

Fernandez CV, Kodish E, Taweel S, Shurin S, Weijer C, Children’s Oncology Group. (2003) Disclosure of the right of research participants to receive research results: an analysis of consent forms in the Children’s Oncology Group. Cancer 97(11): 2904-2909.

Fernandez CV, Skedgel C, Weijer C. (2004) Considerations and costs of disclosing study findings to research participants. Canadian Medical Association Journal (CMAJ) 170(9): 1417-1419.

Food and Drug Administration. (2001) Protection of Human Subjects. 21(50), available at http://www.fda.gov/oc/ohrt/irbs/appendixb.htm.

Greely, HT. (2001) Human genomics research: New challenges for research ethics. Perspectives in Biology and Human Medicine 44(2):221-229.

Green L. (2004) PACS: effect on incidental findings. Radiology management 26(1): 26-29.

Havlik DM, William WL, Hazlick R. (1999) Case of the month: incidental and not-so-incidental findings. Archives of Internal Medicine 159(15): 1655-1656.

Henneman L, Timmermans DR, van der Wal G. (2004) Public experiences, knowledge and expectations about medical genetics and the use of genetic information. Community Genet 7(1):33-43.

Horng S, Emanuel EJ, Wilfond B, Rackoff J, Martz K, Grady C. (2002) Descriptions of benefits and risks in consent forms for phase 1 oncology trials. New England Journal of Medicine 347(26): 2134-2140.

Kimura BJ, Pezeshki B, Frack SA, et al. (1998) Feasibility of "limited" echo imaging: characterization of incidental findings. J Am Soc Echocardiogr 11(7):746-750.

Lerner BH. (Sept. 16, 2003) When a doctor stumbles on a family secret. New York Times, F1, F7.

Lo B, Wolf LE, Berkeley A. (2000) Conflict-of-interest policies for investigators in clinical trials. New England Journal of Medicine 343(22): 1616-1620.

Messersmith WA, Brown DF, Barry MJ. (2001) The prevalence and implications of incidental findings on ED abdominal CT scans. Am J Emerg Med 19(6):479-481.

Morin K. (1998) The standard of disclosure in human subject experimentation. Journal of Legal Medicine 19(2): 157-221.

National Institutes of Health. (2005) Frequently Asked Questions From Applicants. OER Human Subjects Web Site, available at http://grants2.nih.gov/grants/policy/hs/gaqs_aps_hsp.htm#4_q15

National Institutes of Health. (2004) Clinical research and the HIPAA privacy rule. Available at http://privacyruleandresearch.nih.gov/clin_research.asp

Parker LS, Majeske RA. (1995) Incidental findings: patients’ knowledge, rights, and preferences. Journal of Clinical Ethics 6(2): 176-179.

Reilly PR, Boshar MF, Holtzman SH. (1997) Ethical issues in genetic research: disclosure and informed consent. Nature Genetic 15(1): 16-20.

Richardson HS, Belsky L. (2004) The ancillary-care responsibilities of medical researchers: an ethical framework for thinking about the clinical care that researchers owe their subjects. The Hastings Center Report 34(1): 25.

Roberts LW, Hammond KA, Warner TD, et al. (2004) Influence of ethical safeguards on research participation: comparison of perspectives of people with schizophrenia and psychiatrists. Am J Psychiatry 161(12):2309-2311.

Roof K, Gregorio DI, Kulko J, et al. (1999) Incidental findings in a federally-sponsored cancer screening program. J Community Health 24(4):305-312.

Schulte PA, Hunter D, Rothman N. (1997) Ethical and social issues in the use of biomarkers in epidemiological research. IARC scientific publications 142: 313-318.

Shah AN, Sugarman J. (2003) Protecting research subjects under the waiver of informed consent for emergency research: experiences with efforts to inform the community. Annals of Emergency Medicine 41(1): 72-78.

Sharp HM, Orr RD (2004) When “minimal risk” research yields clinically significant data, maybe the risks aren’t so minimal. American Journal of Bioethics 4(2): W32-W36.

Silverman H, Hull SC, Sugarman J. (2001) Variability among institutional review boards’ decisions within the context of a multicenter trial. Critical care medicine 29(2): 235-241.

Sugarman J, McCrory DC, Hubal RC. (1998) Getting meaningful informed consent from older adults: a structured literature review of empirical research. The Hastings Center Report 29(1): S1-S42.

U.S. Food and Drug Administration. (1998) Frequently Asked Questions. Institutional Review Boards and Clinical Investigators – 1998 Update. Available at http://www.fda.gov/oc/ohrt/irbs/faqs.html#informed%20Consent%20Process

U.S. Food and Drug Administration. (1998) A guide to informed consent. Institutional Review Boards and Clinical Investigators – 1998 Update. Available at http://www.fda.gov/oc/ohrt/irbs/informedconsent.html

Veatch RM, Moreno JD. (1991) Consensus in panels and committees: conceptual and ethical issues. Journal of Medical Philosophy 16: 371-373.

Wachbroit R. (1998) The question not asked: The challenge of pleiotropic genetic tests. Kennedy Institute of Ethics Journal 8(2):131-144.

Wagner SC, Morrison WB, Carrino JA, et al. (2002) Picture archiving and communication system: effect on reporting of incidental findings. Radiology 225(2):500-505.

Weinfurt KP, Sulmasy DP, Schulman KA, et al. (2003) Patient expectations of benefit from phase I clinical trials: linguistic considerations in diagnosing a therapeutic misconception. Theor Med Bioeth 24(4):329-344.


Neuroimaging

Awad IA, Spetzler RF, Hodak JA, Awad CA, Carey R. (1986) Incidental Subcortical Lesions Identified on Magnetic Resonance Imaging in the Elderly. I. Correlation with Age and Cerebrovascular Risk Factors. Stroke 17(6):1084-1090.

Barnes B, Cawley CM, Barrow DL. (2002) Intracerebral Hemorrhage Secondary to Vascular Lesions. Neurosurgery Clinics of North America. 13:289-297.

Blomgren K, Robinson S, Lonnqvist T, Saxen H, Pitkaranta A. Clinical significance of incidental magnetic resonance image abnormalities in mastoid cavity and middle ear in children. International journal of pediatric otorhinolaryngology 67(7): 757-760.

Central Brain Tumor Registry of the United States. (2004-2005) Primary Brain Tumor in the United States Statistical Report from 1997-2001.

Check E. (2005) Brain Scan Ethics Come Under Spotlight. Nature 433(7023): 185

Eskandary H, Sabba M, Khajehpour F, Eskandari M. (2005) Incidental findings in brain computed tomography scans of 3000 head trauma patients. Surgical neurology 63(6): 550-553.

Farah MJ. (2002) Emerging ethical issues in neuroscience. Nature neuroscience 5(11): 1123-1129.

Fardon DF. (2005) From advances imaging…When incidental findings masquerade as spinal pathology. Spine Journal: Official Journal of the North American Spine Society 5(2): 223-224.

Grossman RI, Bernat JL. (2004) Incidental research imaging findings: Pandora’s costly box. Neurology 62(6): 849-850.

Illes, J., Kirschen, M.P., Edwards, E., Stanford, L.R., Bandettini, P., Michael, D.B., Ford, P.J., Glover, G.H., Kulynych, J., Macklin, R., Wolf, S.M., and the Working Group on Incidental Findings. (2006) Incidental findings in brain imaging research. Science, 311 (5762):783-784. http://www.sciencemag.org/cgi/content/full/311/5762/783?ijkey=dzAtfMjtfdrvU&keytype=ref&siteid=sci

Illes J. (2004) Neuroethics: toward broader discussion. The Hastings Center Report 34(6): 4-5.

Illes J. (2004) Medical imaging: a hub for the new field of neuroethics. Academic Radiology 11(7): 721-723.

Illes J, Kirschen MP, Karetsky K, et al. (2004) Discovery and disclosure of incidental findings in neuroimaging research. JMRI 20:743-747.

Illes J, Rosen AC, Huang L, et al. (2004) Ethical consideration of incidental findings on adult brain MRI in research. Neurology 62:888-890.

Illes J. (2003) Neuroethics in a new era of neuroimaging. American Journal of Neuroradiology 24(9): 1739-1741.

Illes J, Desmond JE, Huang LF, Raffin TA, Atlas SW. (2002) Ethical and practical considerations in managing incidental findings in functional magnetic resonance imaging. Brain & Cognition 50(3): 358-365.

Illes J, Kirschen M. (2003) New prospects and ethical challenges for neuroimaging within and outside the health care system (comment). American Journal of Neuroradiology 24(10): 1932-1934.

Illes J, Kirschen MP, Gabrieli JD. (2003) From neuroimaging to neuroethics. Nature neuroscience 6(3): 205.

Illes J, Raffin TA. (2002) Neuroethics: an emerging new discipline in the study of brain and cognition. Brain & Cognition 50(3): 341-344.

Katzman GL, Dagher AP, Patronas NJ. (1999) Incidental findings on brain magnetic resonance imaging from 1000 asymptomatic volunteers. JAMA 282(1): 36-39.

Kim BS, Illes J, Kaplan RT, et al. (2002) Incidental findings on pediatric MR images of the brain. AJNR 23:1674-1677.

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

Leonetti JP, Shownkeen H, Marzo SJ. (2001) Incidental petrous apex findings on magnetic resonance imaging. Ear, Nose & Throat Journal 80(4): 200-202.

Lim WK, Ram B, Fasulakis S, Kane KJ. (2003) Incidental magnetic resonance image sinus abnormalities in asymptomatic Australian children. Journal of Laryngology & Otology 117(12): 969-972.

Lubman DI, et al. (2002) Incidental Radiological Findings on Brain Magnetic Resonance Imaging in First-Eppisode Psychosis and Chronic Schizophrenia. Acta Psychiatrica Scandinavica 106:331-336.

Luutu I (2001). Empty sella syndrome: incidental findings at computerised tomography. African Health Sciences 1(1): 26-27.

Mamourian A. (2004) Incidental Findings on Research Functional MR Images: Should We Look? AJNR April 25, 2004.

Mirza S, Malik TH, Ahmed A, Willatt DJ, Hughes DG. (2000) Incidental findings on magnetic resonance imaging screening for cerebellopontine angle tumours. Journal of Laryngology & Otology 114(10): 750-754.

National Institute of Neurological Disorders and Stroke (2005) Detection and Disclosure of Incidental Findings in Neuroimaging Research.

Nelson CA, Luciana M. (2001) Handbook of developmental cognitive neuroscience. MIT Press, Cambridge, MA.

Racine E, Bar-Ilan O, Illes J. (2005) fMRI in the public eye. Nature Reviews Neuro-science 6(2): 159-164.

Ramsey RG. (2005) Evaluation of incidental findings on MRI of the central nervous system: part II. Journal of Insurance Medicine (Seattle) 37(2): 158-165.

Ramsey RG. (2004) Evaluation of incidental findings on MRI of the central nervous system: part I. Journal of Insurance Medicine (Seattle) 36(2): 167-173.


Genetics/Genomics

American Society for Human Genetics. (1996) Statement on informed consent for genetic research. American Journal of Human Genetic 59: 471.

Andrews LB. (1991) Legal aspects of genetic information. Yale Journal of Biology and Medicine 64: 29-40.

Beskow LM, Botkin JR, Daly M, Juengst ET, Lehmann LS, Merz JF, Pentz R, Press NA., Ross LF, Sugarman J, Susswein LR, Terry SF, Austin MA, Burke W. (2004) Ethical issues in identifying and recruiting participants for familial genetic research. American Journal of Medical Genetic Part A 130(4): 424-431.

Beskow LM, Burke W, Merz JF, Barr PA, Terry S, Penchaszadeh VB, Gostin LO, Gwinn M, Khoury MJ. Informed consent for population-based research involving genetics. JAMA 286(18): 2315-2321.

Clayton EW. (2005) Informed consent and biobanks. Medicine & Ethics 33(1): 15-21.

Clayton EW, Steinberg KK, Khoury MJ, Thomson E, Andrews L, Kahn MJ, Kopelman LM, Weiss JO. (1995) Informed consent for genetic research on stored tissue samples. JAMA 274(22): 1786-1792.

Fitzpatrick JL, Hahn C, Costa T, Huggins MJ. (1999) The duty to recontact: attitudes of genetics service providers. American Journal of Human Genetics 64(3): 852.

Fuller BP, Kahn MJ, Barr PA, Biesecker L, Crowley E, Garber J, Mansoura MK, Murphy P, Murray J, Phillips J, Rothenberg K, Rothstein M, Stopfer J, Swergold G,Weber B, Collins FK, Hudson KL. (1999) Privacy in genetics research. Science 285(5432): 1369-1361.

Furman RL. Genetic test results and the duty to disclose: can medical researchers control liability? 23 Seattle University Law Review 391 (1999).

Hoeyer K, Olofsson BO, Mjorndal T, Lynoe N. (2004) Informed consent and biobanks: a population-based study of attitudes towards tissue donation for genetic research. Scandanavian Journal of Public Health 32(3): 224-229.

Institute of Medicine (IOM) Committee on Assessing Genetic Risks. (1994) Assessing genetic risks: implications for health and social policy. National Academy Press, Washington, DC.

King HC, Sinha AA. (2001) Gene expression profile analysis by DNA microarays: promise and pitfalls. JAMA 286(18): 2280-2288.

Kulynych J, Korn D. (2002) Use and Disclosure of Health Information in Genetic Research: Weighing the impact of the New Federal medical Privacy Rule. AmericanJournal of Law and Medicine 28: 309.

Laidlaw S, Raffell L, Daar J. (2002) Genetic testing and human subjects in research. 24 Whittier Law Review 440.

Lucassen A, Parker M. (2001) Revealing false paternity: some ethical considerations. Lancet 357(9261): 1033-1035.

Macintyre S, Sooman A. (1991) Non-paternity and prenatal genetic screening. Lancet 338(8771): 869-871.

MacKay CR. (1984) Ethical issues in research design and conduct: developing a test to detect carriers of Huntington’s Disease, pp.1-5.

Murphy D. (2002) Gene expression studies using microarrays: principles, problems, and prospects. Advances in Physiology Education 26(1-4): 256-270.

Office for Protection from Research Risks. (1993) 1993 Institutional Review Board Guidebook. Available at www.genome.gov/10001752

Ross LF. (1996) Disclosing misattributed paternity. Bioethics 10(2): 114-130.


CT Colon

Advisory Committee on Human Radiation Experiments. (1995) Final Report of the Advisory Committee on Human Radiation Experiments. U.S. Government Printing Office, Washington, D.C.

Cai Q, Baumgarten DA, Affronti JP, Waring JP. (2003) Incidental findings of thickening luminal gastrointestinal organs on computed tomography: an absolute indication for endoscopy. American Journal of Gastroenterology 98(8): 1734-1737.

Cotton PB, Durkalski VL, Pineau BC, Palesch YY, Mauldin PD, Hoffman B, Vining DJ, Small WC, Affronti J, Rex D, Kopecky KK, Ackerman S, Burdick JS, Brewington C, Turner, MA, Zfass A, Wright AR, Iyer RB, Lynch P, Sivak MV, Butler H. (2004) Computed tomographic colonography (virtual colonoscopy): a multicenter comparison with standard colonoscopy for detection of colorectal neoplasia. JAMA 291(14): 1713-1719.

Dachman AH, Zalias ME. (2004) Quality and consistency in CT colonography and research reporting. Radiology 230(2): 319-323.

Edwards JT, Wood CJ, Mendelson RM, Forbes GM. (2001) Extracolonic findings at virtual colonoscopy: implications for screening programs. American Journal of Gastroenterology. 96(10): 3009-3012.

Gallo TM, Galatola G, Fracchia M, Defazio G, De Bei F, Pera A, Regge D. (2003) Computed tomography colonography in routine clinical practice . European journal of gastroenterology & hepatology 15(12): 1323-1331.

Ginnerup Pedersen B, Rosenkilde M, Christiansen TE, Laurberg S. (2003) Extracolonic findings at computed tomography colonography are a challenge. Gut 52(12): 1744-1747.

Gluecker Tm, Johnson CS, Wilson LA, Maccarty RL, Welch TJ, Vanness DJ, Ahlquist DA. (2003) Extracolonic findings at CT colonography: evaluation of prevalence and cost in a screening population. Gastroenterology 124(4): 911-916.

Green D. (2005) Incidental findings computed tomography of the thorax. Seminars in Ultrasound, CT & MR 26(1): 14-19.

Green DE, Woodward PJ. (2005) The management of indeterminate incidental findings detected at abdominal CT. Seminars in Ultrasound, CT & MR 26(1): 2-13.

Hara AK. (2005) Extracolonic findings at CT colonography. Seminars in Ultrasound, CT & MR 26(1): 24-27.

Hara AK, Johnson CD, MacCarty RL, Welch TJ. (2000) Incidental extracolonic findings at CT colonography. Radiology 215(2): 353-357.

Hellstrom M, Svensson MH, Lasson A. (2004) Extracolonic and incidental findings on CT colonography (virtual colonoscopy). American Journal of Roentgenology 182(3): 631-638.

Johnson CD, Harmsen WS, Wilson LA, Maccarty RL, Welch TJ, Ilstrup DM, Ahlquist DA. (2003) Prospective blinded evaluation of computed tomographic colonography for screen detection of colorectal polyps. Gastroenterology 125(2): 311-319.

Messersmith WA Brown DF, Barry MJ. (2001) The prevalence and implications of incidental findings on ED abdominal CT scans. American Journal of Emergency Medicine. 19(6): 479-481.

Morrin MM, Kruskal JB, Farrell RJ, Goldberg SN, McGee JB, Raptopoulos V. (1999) Endoluminal CT colonography after an incomplete endoscopic colonoscopy. American Journal of Roentgenology 172(4): 913-918.

Osman MM, Cohade C, Fishman EK, Wahl RL. (2005) Clinically significant incidental findings on the unenhanced CT portion of PET/CT studies: Frequency in 250 patients. Journal of Nuclear Medicine 46(8): 1352-1355.

Pickhardt PJ, Choi JR, Hwang I, Butler JA, Puckett ML, Hildebrandt HA, Wong RK, Nugent PA, Mysliwiec PA, Schindler WR. (2003) Computed tomographic virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults. New England Journal of Medicine 349(23): 2191-2200.

Rajapaksa RC, Macari M, Bini EJ. (2004) prevalence and impact of extracolonic findings in patients undergoing CT colonography. Journal of clinical gastroenterology 38(9): 767-771.

Westbrook JT, Braithwaite J, McIntosh JH. (1998) The outcomes for patients with incidental lesions: serendipitous or iatrogenic? American Journal of Roentgenology 171(5): 1193-1196.

Yoshida H, Dachman AH. (2005) CAD techniques, challenges, and controversies in computed tomographic colonography. Abdominal Imaging 30(1): 26-41.

Youserm DM, Huang T, Loevner LA, Langlotz CP. (1997) Clinical and economic impact of incidental thyroid lesions found with CT and MR. American Journal of Neuroradiology 18(8): 1423-1428.


Sharing Results

Amdur RJ, Biddle C. (1997) Institutional review board approval and publication of human research results. JAMA 277(11): 909-914.

Baks TM. (2000) Misusing informed consent: a critique of limitations on research subjects’ access to genetic research results. Saskatchewan Law Review 63(2): 539-580.

Berlin JA. (2005) Why industry should register and disclose results of clinical studies – perspective of a recovering academic. BMJ 330(7497): 959.

Cooper RJ, Wears RL, Schriger DL. (2003) Reporting research results: recommendations for improving communication. Annals of Emergency Medicine 41(4): 561-564.

Fawcett J. (1998) Reporting research results: lets not forget clinical significance. Nurse author & editor 8(4): 1-4.

Fernandez CV, Kodish E, Shurin S, Weijer C, Children's Oncology,Group. (2003) Offering to return results to research participants: attitudes and needs of principal investigators in the Children's Oncology Group. Journal of Pediatric Hematology/Oncology 25(9): 704-708.

Fernandez CV, Kodish E, Weijer C. (2003) Importance of informed consent in offering to return research results to research participants. Medical & Pediatric Oncology 41(6) 592-593.

Fernandez CV, Kodish E, Weijer C. (2003) Informing study participants of research results: an ethical imperative. IRB: a review of human subjects research 25: 12-19.

Lyles A. (2003) Research results: balancing access with relevance for patient decisions. Clinical therapeutics 25(9): 2450-2452.

Maynard R, Cohen AJ. (2003) Public health significance of research results. Toxicology & Environmental Health Part A 66(16-19): 1877-1878.

Partridge AH, Burstein HJ, Gelman RS, Marcom PK, Winer EP. (2003) Do patients participating in clinical trials want to know study results? Journal of the National Cancer Institute 95(6): 491-492.

Partridge AH, Winer EP. (2002) Informing clinical trial participants about study results. JAMA 288(3): 363-365.

Partridge AH, Wong JS, Knudsen K, Gelman R, Sampson E, Gadd M, Bishop KL, Harris JR, Winer EP. (2005) Offering participants results of a clinical trial: sharing results of a negative study. Lancet 365(9463): 963-964.

Racine E. (2003) Discourse ethics as an ethics of responsibility: comparison and evaluation of citizen involvement in population genomics. Journal of Law, Medicine & Ethics 31(3): 390-397.

Rigby H, Fernandez CV. (2005) Providing research results to study participants: support versus practice of researchers presenting at the American Society of Hematology annual meeting. Blood 106(4): 1199-1202.

Shalowitz DI, Miller FG. (2005) Disclosing individual results of clinical research: implications of respect for participants. JAMA 294(6): 737-740.

Wilde H, Sitprija V. (2001) Who has the ultimate responsibility for publishing clinical research results? Journal of the Medical Association of Thailand 84(8): 1217-1220.


Garcia J. (1987) Sharing research results with patients: the views of care-givers involved in a randomized controlled trial. Journal of Reproductive & Infant Psychology 5.

Grosfeld FJ, Beemer FA, Lips CJ, Hendriks KS, ten Kroodle HF. (2000) Parents’ responses to disclosure of genetic test results of their children. American Journal of Medical Genetics 94(4): 316-323.

Hamilton RJ, Bowers BJ, Williams JK. (2005) Disclosing genetic test results to family members. Journal of Nursing Scholarship 37(1): 18-24.

Lewin T. (July 21, 2000) Boom in gene testing raises questions on sharing results. New York Times, A1, A16.

Longo MM. (1997) Legal and ethical issues of patient access to laboratory results. Clinical Laboratory Science 10(2): 64-67.

Mattson ME, Curb JD, McArdle R. (1985) Participation in a clinical trial: the patient’s point of view. Controlled Clinical Trials 6(2): 156-167.

National Bioethics Advisory Commission. (1999) Research Involving Human Biologic Materials: Ethical Issues and Policy Guidance.

Office of Human Research Protection. (2005) Protection of Human Subjects. Code of Federal Regulations, 45(46). Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

Wang L. (2002) Researchers push for sharing of trial results with participants. Journal of the National Cancer Institute. 94(14): 1049-1050.

Weber F, Knopf H. (2005) Incidental Findings in Magnetic Resonance Imaging of the Brains of Healthy Young Men. Journal of the Neurological Sciences. Article in press.


Case Law on Sharing Research Results and the Duties of Physician and Non-Physician Researchers

Abdullahi v. Pfizer, Inc. Slip Opinion WL 1870811 (2005).

Grimes v. Kennedy Krieger Institute, Inc. 366 Md. 29, 782 A.2d 807 (2001).

Pate v. Threikel S.2d 278 (1995).

Safer v. Estate of Pack 677 A.2d 1188 (1996).

Suthers, et. al. v. Amgen, Inc. No. 05-CV-4158 (Slip opinion)

Tarasoff v. Regents of the University of California 17 Cal.3d 425 (1976).

Whitlock v. Duke University 637 F.Supp. 1463 (1986).

 

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