Informed Consent Documents
The process of doctors talking with their patients about participation in a research project, like a clinical trial, and the ultimate agreement to participate is called informed consent. Any time patients are involved in research they must understand the risks and benefits of participation. Informed consent for genomics studies require special attention due to the large amount of information obtained and the potential risks to privacy and confidentiality when such information is shared. This resulted in the establishment of new policies and documents to help patients and doctors better decide if donating their tissue samples to The Cancer Genome Atlas (TCGA) is right for them. More information on the informed consent .
The National Cancer Institute (NCI) and National Human Genome Research Institute (NHGRI) work with physicians who collect tissue for TCGA to gain approval with local Institutional Review Boards (IRBs). An IRB is a group of scientists, doctors, clergy and consumers who review and approve the research proposal for every research project that involves human subjects. These boards ensure that the research is well designed, legal and ethical, and does not involve unnecessary risks to patients.
The TCGA Project Team along with Ethics, Law and Policy Group, developed an informed consent guidance document for prospective collections:
Guiding Federal Policies Related to Human Subjects Protection:
- 45 CFR 164.514 (b): HIPAA De-Identification Safe Harbor
- 45 CFR 164.514 (e): HIPAA Limited Data Set Specification
- OCR Guidance on HIPAA About Limited Data Set Disclosures
- HHS Commentary and Response in Federal Register on LDS Disclosure as Part of Privacy Rule Modifications
- OHRP Guidance on Research Involving Coded Private Information or Biological Specimens