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Last Updated: 03/29/16

Web Resources

Biological Material Transfer Agreement

Uniform Biological Material Transfer Agreement Federal Register
http://www.bioinfo.com/ubmta.html

Code of Federal Regulations

Government Printing Office Access
http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR

Conflict of Interest

Conflict of Interest, NIH Office of Extramural Research
http://grants.nih.gov/grants/policy/coi/

Conflict of Interest Information and Resources, NIH
http://www.nih.gov/about/ethics_COI.htm

Electronic Records and Electronic Signatures

Electronic Records; Electronic Signatures
Office of Regulatory Affairs, U.S. Food and Drug Administration
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1

Health Information Portability and Accountability Act of 1996

HIPAA Security Rule
Centers for Medicare and Medicaid Services
Department of Health and Human Services
http://www.cms.gov/HIPAAGenInfo/

Medical Privacy — National Standards to Protect the Privacy of Personal Health Information
Office for Civil Rights — HIPAA
Office for Civil Rights
Department of Health and Human Services
http://www.hhs.gov/ocr/hipaa/

Human Subjects Regulations

Application for, and exemption from, IRB approval
Office for Human Research Protections
Department of Health and Human Services
http://www.hhs.gov/ohrp/policy/hsdc95-02.html

Frequently asked questions
Office for Human Research Protections
Department of Health and Human Services
http://answers.hhs.gov/ohrp/

Genetic Information Nondiscrimination Act of 2008
http://thomas.loc.gov/cgi-bin/bdquery/z?d110:h.r.00493:

Genetic Nondiscrimination Fact Sheet
http://www.genome.gov/10002328

Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards
http://www.hhs.gov/ohrp/policy/gina.pdf

Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable
Food and Drug Administration
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm078384.htm

Guidance on Research Involving Coded Private Information or Biological Specimens
Office for Human Research Protections
Department of Health and Human Services
http://www.hhs.gov/ohrp/policy/cdebiol.html

Human Subjects Policy Guidance
Office for Human Research Protections
Department of Health and Human Services
http://www.hhs.gov/ohrp/policy/index.html#human

Office for Human Research Protections
Department of Health and Human Services
http://www.hhs.gov/ohrp/

Informed Consent Policy Guidance

Issues to Consider in the Research Use of Stored Data or Tissues
Office for Human Research Protections
Department of Health and Human Services
http://www.hhs.gov/ohrp/policy/reposit.html

Office for Human Research Protections
Department of Health and Human Services
http://www.hhs.gov/ohrp/policy/index.html#informed

Policies for responding to requests for discontinuation of participation in research
Office for Human Research Protections
Department of Health and Human Services
http://www.hhs.gov/ohrp/policy/subjectwithdrawal.pdf
http://edocket.access.gpo.gov/2008/pdf/E8-28387.pdf

Informatics System Security

Risk Management Guide for Information Technology Systems
National Institute of Standards and Technology
http://csrc.nist.gov/publications/PubsSPs.html#800-30

Laboratory Practices

Clinical Laboratory Improvement Amendment (CDC web site)
http://wwwn.cdc.gov/clia/

Good Laboratory Practices
http://www.oecd.org/chemicalsafety/testing/goodlaboratorypracticeglp.htm

International Organization for Standardization (ISO9000)
http://www.iso.org/iso/home.htm

ISBER
http://www.isber.org

U.S. Food and Drug Administration (FDA) Quality System Regulation, 21 CFR 820
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820

National Cancer Institute

Biorepositories and Biospecimen Research Branch
http://biospecimens.cancer.gov/

Biospecimen Research Network
http://biospecimens.cancer.gov/researchnetwork/

Biospecimen Research Database
https://brd.nci.nih.gov/brd/

Biobank Economic Modeling Tool
http://biospecimens.cancer.gov/resources/bemt.asp

NCI Best Practices Frequently Asked Questions
http://biospecimens.cancer.gov/practices/faq.asp

Specimen Resource Locator
http://biospecimens.cancer.gov/locator

Symposium-Workshop on Custodianship and Ownership Issues in Biospecimen Research
http://biospecimens.cancer.gov/resources/publications/workshop/cow.asp

National Institutes of Health Policies and Guidelines

Certificates of Confidentiality Kiosk
Office of Extramural Research
National Institutes of Health
http://grants2.nih.gov/grants/policy/coc/index.htm

Conflict of Interest
Office of Extramural Research
National Institutes of Health
http://grants.nih.gov/grants/policy/coi/

Guidelines for Research Involving Recombinant DNA Molecules
Office of Biotechnology Activities
National Institutes of Health
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-052.html

NIH Data Sharing Policy
Office of Extramural Research
National Institutes of Health
http://grants.nih.gov/grants/policy/data_sharing/

NIH Genomic Data Sharing Policy
https://gds.nih.gov/03policy2.html

NIH Research Tools Policy
Sharing Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts
Office of Technology Transfer
National Institutes of Health
http://www.gpo.gov/fdsys/pkg/FR-1999-12-23/pdf/99-33292.pdf

Other Biospecimen Resource References

Case Studies of Existing Human Tissue Repositories — “Best Practices” for a Biospecimen Resource for the Genomic and Proteomic Era
http://www.rand.org/pubs/monographs/MG120/index.html

Handbook of Human Tissue Sources — A National Resource of Human Tissue Samples
http://www.rand.org/pubs/monograph_reports/MR954/

Standardized Systems for Clinical and Pathology Data

American Joint Committee on Cancer TNM Staging
https://cancerstaging.org/references-tools/Pages/What-is-Cancer-Staging.aspx
(close any pop-up box indicating sign-on is necessary)

Cancer Care Ontario Program in Evidence-Based Care
https://www.cancercare.on.ca/about/programs/pebc/

College of American Pathologists Cancer Protocols and Checklists
http://tinyurl.com/CAPProtocols

International Classification of Diseases
http://www.who.int/classifications/icd/en/

International Classification of Diseases for Oncology
http://www.who.int/classifications/icd/adaptations/oncology/en/index.html

National Comprehensive Cancer Network Guidelines and Clinical Resources
http://www.nccn.org/professionals/physician_gls/f_guidelines.asp

North American Association of Central Cancer Registries Data Standards and Data Dictionary
http://www.naaccr.org/LinkClick.aspx?fileticket=H7hn-uneaGc%3D&tabid=133&mid=473

Systematized Nomenclature of Medicine — Clinical Terms® (SNOMED CT)
http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html