Informed Consent

    The bio specimen resource should track whether appropriate informed consent is present or the reason why informed consent is not necessary and should seek to resolve any discrepancies in the consent status for stored bio specimens (See the Office for Human Research Protections [OHRP] Web site for guidance on informed consent: http://www.hhs.gov/ohrp/policy/index.html#informed (Links to an external site.), and checklist http://www.hhs.gov/ohrp/policy/consentckls.html (Links to an external site.) Below is the IC for The Cancer Genome Atlas (TCGA) project. 6.3.1.1_TCGA.Model.InformedConsent.Form.Prospective_Nov2011_508.pdf http://cancergenome.nih.gov/pdfs/6.3.1.1_TCGA.Model.InformedConsent.Form.Prospective_Nov2011_508.pdf (Links to an external site.), downloaded from the TCGA webpage: http://cancergenome.nih.gov/abouttcga/policies/informedconsent (Links to an external site.) It is an example of informed consent to use by biorepositories that collaborate with NCI and NHGRI and NIH. This text has been created in 2011. A. Please review carefully the text and determine whether the IC meets the NCI Best Practices guidelines for Informed consent: http://biospecimens.cancer.gov/bestpractices/elp/ic.asp (Links to an external site.) (40 points) B. Please answer the following questions (30 points) 1. Is this a tiered consent? 2. Is this a broad consent? 3. Could children younger than 18 years old participate in the project? Regardless of the level of involvement in the informed consent process, bio specimen resources should ensure that the research uses of biospecimens are consistent with the informed consent of the human research participant. 4. Could samples collected with this Informed Consent be used for diabetic research? 5. What is the readability score of the Informed Consent document? (10 points)