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Resources

Welcome to the archival database of the Research Ethics Consultation Service (RECS). Included are ethical, social, and policy related resources such as reports, articles, web links, and webinars from both national and international sources. This site is continuing to grow with new material added frequently. If you would like to suggest something to be added to our database please contact us at recs@unc.edu.

Please select one of the links below to see the resources posted on that topic thus far.

• Education - Genetics
• FDA
• GINA
• Human Specimen Banking
• Informed Consent
• OHRP
• Privacy

Education - Genetics

GA. Making Sense of Your Genes: A Guide to Genetic Counseling: Genetic Alliance; 2009.

NLM. Genetic home Reference: Your Guide to Understanding Genetic Conditions [web resource]. March 2, 2009. Accessed 3-4, 2009. 
Web Address: http://ghr.nlm.nih.gov/

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FDA

FDA. Title 21 - Food and Drugs, Chapter I - Food and Drug Administration, Department of Health and Human Services, Subchapter A - General, Part 50 Protection of Human Subjects. In: Food and Drug Administration, ed. Vol 21CFR50.

FDA. Title 21 - Food and Drugs, Chapter I - Food and Drug Administration, Department of Health and Human Services, Subchapter A - General, Part 56 Institutional Review Boards. In: Food and Drug Administration, ed. Vol 21CFR56.

FDA. Title 21 - Food and Drugs, Chapter I - Food and Drug Administration, Department of Health and Human Services, Subchapter A - General, Part 812 Investigational Device Exemptions. In: Food and Drug Administration, ed. Vol 21CFR812.

FDA. Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable - Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety; April 25 2006.

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GINA

GA. Impact of GINA: Genetic Alliance; 2008.

Impact of GINA.mp3

GINA – Employment

GINA – Health Information Technology

GINA – Genetic Testing

Webinar Q and A

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Human Specimen Banking

CRpac. Clinical Research Policy Analysis and Coordination Program. NIH Office of Biotechnology Activities. Available at: http://oba.od.nih.gov/policy/research_policies.html. Accessed Feb 12, 2009.

Dressler L. Human Specimens, Cancer Research and Drug Development: How Science Policy can Promote Progress and Protect Research Participants: Commissioned paper prepared for the National Cancer Policy Board, Institute of Medicine and Research Council of the National Academies March 2005.

NBAC. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance - Volume 1 Report and Recommendations of the National Bioethics Advisory Commission: National Bioethics Advisory Commission; August 1999.

NCI. National Cancer Institute Cancer Diagnosis Program: 50-State Survey of Laws Regulating the Collection, Storage, and Use of Human Tissue Specimens and Associated Data for Research. Washington DC: National Cancer Institute Cancer Diagnosis Program; 2004.

NCI. Providing Your Tissue for Research: What You Need To Know. Washington DC: National Cancer Institute; December 2005.

NIH. Research Repositories, Databases, and the HIPAA Privacy Rule: National Institute of Health, Department of Health and Human Services, Office for Civil Rights; July 2 2004.

PRIM&R. Report of the Public Responsibility in Medicine and Research (PRIM&R) Human Tissue/Specimen Banking Working Group: PRIM&R; March 2007.

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Informed Consent

ASHG. Statement on informed consent for genetic research. The American Society of Human Genetics. Am J Hum Genet. Aug 1996;59:471-474.

NCI. National Cancer Institute National Action Plan on Breast Cancer Model Informed Consent and Patient Brochure. Washington DC: National Cancer Institute National Action Plan on Breast Cancer.

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OHRP

OHRP. Code of Federal Regulations, Title 45, Part 46. Subpart A. Federal Policy for the protection of human subjects (basic DHHS policy for protection of human research subjects). Federal Register. June 18, 1991 1991;56:28012-28018.

OHRP. Code of Federal Regulations, Title 45, Part 46. Subpart A. Federal Policy for the protection of human subjects (basic DHHS policy for protection of human research subjects): Office for Human Research Protections; June 23 2005.

OHRP. Guidance on Research Involving Coded Private Information or Biological Specimens 2008.

OHRP. Guidance on Engagement of Institutions in Human Subjects Research: Office for Human Research Protections, Department of Health and Human Services; October 16, 2008.

OHRP. International Compilation of Human Research Protections: Office for Human Research Protections, U.S. Department of Health and Human Services; 2009.

OHRP. Recent Compliance Oversight Determinations: Office of Human Research Protections; Feb 4 2009.

OPRR. Issues to Consider in the Research Use of Stored Data or Tissues: Office for the Protection from Research Risks; November 7 1997.

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Privacy

Standards for Privacy of Individually Identifiable Health Information; Final Rule. Federal Register. August 14, 2002 2002;67:53182.

DOJ. The Privacy Act of 1974, 5 U.S.C. § 552a (2000). In: Department of Justice, ed; 1975.
Web Address: http://www.usdoj.gov/oip/04_7_1.html

HIPAA. HIPAA Privacy Rule. Office of Civil Rights. Available at: http://www.hhs.gov/ocr/hipaa.

IOM. Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. Washington DC: Insitute of Medicine; 2009.

NIH. Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule: National Institute of Health, Department of Health and Human Services, Office for Civil Rights; April 14 2003.

NIH. Institutional Review Boards and the HIPAA Privacy Rule: National Institute of Health, Department of Health and Human Services, Office for Civil Rights; August 2003.

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The Center for Genomics and Society is supported by the ELSI Research Program of the National Human Genome Research Institute of the National Institutes of Health, Grant Number P50HG004488.