Instructions for this Zoom session This session will be recorded and may be posted on • our website. • You will have the opportunity to ask questions at certain time points throughout the presentation • Please keep your microphone muted, unless it is a designated Q&A timepoint • If you are not comfortable asking your questions verbally, you can use the chat feature to ask questions and we will periodically monitor the chat section. (Please only send your chat to the hosts, not to everyone) • Thank you for joining us for this education session Human Research Protection Office Office for Research Protections
Genomic Data Sharing: Words Matter Erin Holmes Grabowski, BS, CIP Quality Assessment Specialist Human Research Protection Office Human Research Protection Office Office for Research Protections
Objectives • Provide basic information about the NIH GDS policy • Provide language that should be included in consent forms • Review the process/requirements for obtaining an IRB affirmation letter/institutional certification • Discuss common issues encountered Human Research Protection Office Office for Research Protections
NIH Genomic Data Sharing Policy (GDS) January 25, 2015, effective/issued by NIH Requires broad sharing of genomic data Applies to NIH-funded studies that generate large- scale human genomic data Examples of “large-scale” projects: https://osp.od.nih.gov/wp- content/uploads/Supplemental_Info_GDS_Policy.pdf Human Research Protection Office Office for Research Protections
NIH Genomic Data Sharing Policy • Link to the NIH GDS Policy https://osp.od.nih.gov/scientific-sharing/genomic-data- sharing/ • It is imperative that investigators who do research with genetic sampling or analysis, (or with banking/sharing samples that could be used for genetic analysis) ensure that their consents are compliant with this GDS policy, regardless of current funding. Human Research Protection Office Office for Research Protections
Why should I comply if I don’t have an NIH grant? • Many journals are requiring investigators to deposit genetic data into federal repositories like dbGaP • Some collaborators require that you have an institutional certification and be able to deposit data and share broadly • You may not have NIH funding now, but you could seek it in the future for work with these samples/genetic data • You do not always know now what you may need (or want) to do in the future Human Research Protection Office Office for Research Protections
QUESTIONS? Human Research Protection Office Office for Research Protections
Consent language requirements Human Research Protection Office Office for Research Protections
Consent language requirements: Specificity Pre-2015: Silence Post-2015: Specific permission • Spe Specific ic P Perm rmissio ion: Now, CF must • Silence : Previously, CF specifically dictate what will or MIGHT neither permitted nor happen now or in the future prohibited use Turning point is NIH GDS Policy, January 25, 2015 Human Research Protection Office Office for Research Protections
Consent language requirements • Words really do matter • Certain information needs to be included in the consent form in order to meet the requirements of the NIH GDS policy • For new studies approved under the Revised common rule – comply with additional consent requirements Human Research Protection Office Office for Research Protections
Relevant Regulatory Requirements 45 CFR 46.116 (General Requirements for Informed Consent) • When biospecimens are collected, a statement whether: • Identifiers may be removed, and • if the de-information or biospecimens may or may not be used for future research or shared with other investigators [46.116 (b)(9)] • For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen). [46.116 (c)(9)] Human Research Protection Office Office for Research Protections
4 Pieces of Information for Consent Forms Genetic Risk GINA Sharing with Others and Commercialization Federal Repositories Human Research Protection Office Office for Research Protections
• Before joining the study, you may want to consider Genetic discussing your plans and this study with your family Risk members. • Because certain conditions and traits run in families and are inherited through genes, this study is recruiting biologically-related family members. This study will compare family members who have [disorder] and family members who do not have [disorder]. https://www.genome.gov/27559024/ Human Research Protection Office Office for Research Protections
• The risks associated with genetic studies include the potential Genetic for a breach of confidentiality which could affect future Risk insurability, employability, or reproduction plans, or have a negative impact on family relationships and/or result in paternity suits or stigmatization. • You may learn something about your genome that relates to the health of your relatives. If so, your relatives might want to know so that they can decide whether to get tested or follow up in other ways. It is also possible that they might not want to know. https://www.genome.gov/27559024/ Human Research Protection Office Office for Research Protections
Genetic Information Nondiscrimination Act of 2008 : Prohibits discrimination in health coverage and employment based GINA on genetic information • Only applies to genetic testing of diseases and disorders that have not yet manifest • Sample Language : A Federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies and group health plans to use genetic information in making decisions regarding your eligibility or premiums. GINA also makes it illegal for employers with 15 or more employees to use your genetic information when making decisions regarding hiring, promoting, firing, or setting the terms of employment. This new Federal law does not protect you against genetic discrimination by companies that sell life, disability, or long-term care insurance https://www.genome.gov/27565451/informed-consent-required-elements-of-the-consent-form/#4 Human Research Protection Office Office for Research Protections
Subjects should be told whether there may be any future commercial use of their samples and what will happen with products that are eventually developed and sold for commercial purposes. Commercialization • Pitt Language: Your data and specimens used in this research study may contribute to a new discovery or treatment. In some instances, these discoveries or treatments may be of commercial value and may be sold, patented, or licensed by the investigators and the University of Pittsburgh for use in other research or the development of new products. You will not retain any property rights nor will you share in any money that the investigators, the University of Pittsburgh, or their agents may realize https://www.genome.gov/27565451/informed-consent-required-elements-of-the-consent-form/#4 Human Research Protection Office Office for Research Protections
Sharing with • Give subjects information related to storing, sharing and Others and future use of data and samples Federal Repositories • Language will be dependent on what takes place in the study and for what purpose • Convey that data, samples and genetic data will be shared with others and federal repositories, de-identified • NIH expects that permission for future research use and broad data sharing will have been obtained even if the cell lines or clinical specimens are de- identified. https://www.genome.gov/27565451/informed-consent-required-elements-of-the-consent-form/#4 Human Research Protection Office Office for Research Protections
Sharing with Sample Language: Others and Federal • We will store your samples and data (including genetic data) Repositories indefinitely. Information will be shared with other researchers in the future but those researchers will not be able to identify you. Your data (including genetic data) and samples may be used in any type of research. Your samples, data and genetic data generated from the samples may be shared with others and federal repositories and will be shared without identifiers. https://www.genome.gov/27565451/informed-consent-required-elements-of-the-consent-form/#4 Human Research Protection Office Office for Research Protections
Consent language requirements • It’s important that this language is included in the consent form, so that the investigators are able to share/deposit the genetic data with federal repositories. • Even if the investigator does not currently have plans to deposit data, they will limit themselves regarding funding and future use of the samples if this language is not included in the consent forms. Human Research Protection Office Office for Research Protections
QUESTIONS? Human Research Protection Office Office for Research Protections
Process for obtaining an IRB Affirmation letter and Institutional Certification at Pitt Human Research Protection Office Office for Research Protections
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