330 likes | 748 Vues
Informed Consent for Registries and Genetic Research Ranjodh Gill, M.D., F.AC.P. VCU School of Medicine Richmond, VA Objectives Future Research Recontacting subjects in future Withdrawal from future studies Specimen banking/Genetic research Future Research
E N D
Informed Consent for Registries and Genetic Research Ranjodh Gill, M.D., F.AC.P. VCU School of Medicine Richmond, VA
Objectives • Future Research • Recontacting subjects in future • Withdrawal from future studies • Specimen banking/Genetic research
Future Research • What does future research entail? • Is future research scientifically responsible? • Is there a time frame? • Where are samples stored – biospecimen resource?
What is Future Research? • Sometimes, it is anticipated • Often unknown – biggest challenge • ICF may be exempt under 45 CFR part 46 (a) • Using original consent vs. reconsenting
Type of Future Research • It may be fully known in which case it should be described. • If it is unknown, it must be stated so • Tiered – specific aims • Non-tiered – broad in scope • Each has its pros and cons
Nature of Future Research • It must be scientifically responsible • It must be within the scope of original research • Interest and welfare of subjects should be foremost
Time Frame of Future Research • No clear guidelines • If known, it should be specified as to how long specimen will be stored
Biospecimen Resource - Examples • Blood bank • Tissue bank • DoD DNA bank • Commercial DNA banks • Sperm, ovum, embryo banks • Umbilical cord blood bank • Tumor registries
Biospecimen Resource • Policies and Procedures for safeguard of biospecimens • Ensure consistency of research use of specimen with informed consent • Provision for discontinuation of research or participation at the request of subject or authorities
Biospecimen Resource • Description of resource • Information about de-identification • Information about linking of research to clinical data • Who has access to samples? • Mechanism for sharing? • Conditions in which sample will be released to investigators
Biospecimen Regulations • Establishing custodianship • Federal and state regulations • Periodic review (funding renewal, etc.) • Conflict of interest per 42 CFR Part 50 Subpart F
Biospecimen Record Keeping • Procedures for protecting privacy • Procedures for protecting confidentiality • Nature and purpose of research, where known • Consequences/potential risks of DNA typing for self and family members, if applicable
Biospecimen Record Keeping • Secure site administered by institution • Remote sites • Plan for storage and retrieval • Audit logs • Unique identifier
Recontacting Subjects in Future • Wherever possible, information should be disseminated in the informed consent form • Consent should be obtained for future contact and preferably a separate check box should be created. • Issue of public records and whether or how to contact in future if not mentioned in the ICF
Recontacting Subjects in Future • Maintenance of a log of subjects that have discontinued participation • Any new information about study should be disseminated to all remaining participants as it becomes available
Recontacting Subjects in Future • Pediatric studies should consider need for reconsent when child reaches legal age to consent. • Such provision should, ideally, be considered at time of initial review. • There is no universal policy
Withdrawal from Studies in Future • Conditions for withdrawal should be specified in the consent form • Withdrawal can be initiated by either party. • Conditions for investigator initiated withdrawal must be included in ICF and explained well
Withdrawal from Studies in Future • Subjects should be free to withdraw at any time during study without fear of retaliation. • Contact information of PI and responsible IRB should be included in the consent form • Repository information should also be provided wherever possible.
Withdrawal from Studies in Future – What to do with Specimen? • Stop using specimen • Stop using subject’s information in the study • Remove subject’s individual information from specimen • Eliminate subject’s private information • Destroy or if specified, return specimen to subject for proper disposal
Genetic Research - Application • Human genomics • Proteomics • Pharmacogenomics • Stem cell research
Genetic Research Types Tumor-specific genetic research – Tumor registries Germ cell /Stem cell research
Tumor Registries • A cancer data system • Follow up of all registered cancer patients in a given location, hospital, state or at national level • Basic information about subjects and medical history • Tissue specimens • May be used for either education or research or both
Tumor Registries • NCI – Examples, Breast and colon cancer family registries National Familial pancreas, brain tumor tumor reg. • Surveillance, epidemiology and end results program (SEER) • State – NY and CA state tumor reg.
Germ Cell Research • Controversial • Very tightly regulated • Stem cell types • Toti-potent cells,. E.g., fetus • Multi-potent cells • Pluri-potent cells
Germ Cell Research Regulation • Conducted or supported by DHHS • Subject to HHS human subjects protection regulations (Title 45 CFR Part 46, including Subpart B, 45 CFR 46.206) • Research involving the derivation and use of human embryonic germ cells from fetal tissue may be conducted with Federal support.
Germ Cell Research Regulation • Transplantation of cells from human fetal tissue into human recipients is subject to Public Law 103-43, “Research on Transplantation of Fetal Tissue” (42 U.S.C. § 289g–2(a)). • Other Federal, State or local laws may also apply to transplantation or other research involving these cells or test articles.
Germ Cell Research Regulation • Research on existing human embryonic stem cell lines may be conducted with Federal support if the cell lines meet the U.S. President’s criteria which he announced on August 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html).
Germ Cell Research Regulation • Research involving the derivation of new stem cells from human embryos or the use of human embryonic stem cells that are not listed on the NIH Human Embryonic Stem Cell Registry may not be conducted with Federal support.
Guidance for ICF for Genetic Research • Regulatory bodies • Office for Human research protections (OHRP) • OHRP governs IRBs • National Bioethics Advisory Committee (NBAC) • Department of Health and Human Services (DHHS)
Guidance for ICF for Genetic Research • Review of Protocol • Review of ICF
Guidance for ICF for Genetic Research • Assess potential for profit by institution, investigator or sponsor • Rights and limitations of subjects regarding privacy of sample and data • Rights and limitations of subjects regarding destruction of sample and data in future • Statement about disclosure of information to subject or third party
Guidance for ICF for Genetic Research • Information disclosure should be in a manner commensurate with subject’s level of knowledge • Availability of genetic counseling in case of genetically important information, e.g., birth defect • When a child subject attains age of majority, consideration should be given to disclosing information to the now adult subject.
Guidance for ICF for Genetic Research • Tiered vs. non-tiered ICF • Information about contacting or recontacting in future • Provision for withdrawal from studies at any time during or after study is completed.