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Human Research Protection Office Office for Research Protections

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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

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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

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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.

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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

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QUESTIONS?

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Consent language requirements

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Consent language requirements: Specificity

• Silence: Previously, CF

neither permitted nor prohibited use

Pre-2015: Silence Post-2015: Specific permission

• Spe

Specific ic P Perm rmissio ion: Now, CF must specifically dictate what will or MIGHT happen now or in the future Turning point is NIH GDS Policy, January 25, 2015

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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

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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

• f that specimen). [46.116 (c)(9)]

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4 Pieces of Information for Consent Forms

Genetic Risk GINA Commercialization Sharing with Others and Federal Repositories

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• Before joining the study, you may want to consider

discussing your plans and this study with your family 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].

Genetic Risk

https://www.genome.gov/27559024/

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• The risks associated with genetic studies include the potential

for a breach of confidentiality which could affect future 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.

Genetic Risk

https://www.genome.gov/27559024/

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Genetic Information Nondiscrimination Act of 2008: Prohibits discrimination in health coverage and employment based

• n 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

GINA

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Subjects should be told whether there may be any future commercial use

• f their samples and what will happen with products that are eventually

developed and sold for commercial purposes.

• 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

Commercialization

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• Give subjects information related to storing, sharing and

future use of data and samples

• 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

Sharing with Others and Federal Repositories

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Sample Language:

• We will store your samples and data (including genetic data)
• 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

Sharing with Others and Federal Repositories

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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.

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QUESTIONS?

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Process for obtaining an IRB Affirmation letter and Institutional Certification at Pitt

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Obtaining a GDS IRB Affirmation letter

• Follow our GDS guidance (in our A to Z guidance under G)

http://www.hrpo.pitt.edu/genomic-data-sharing

• Submit required documents/request to askirb@pitt.edu
• Complete our application for IRB Affirmation (NIH-

designated Genomic Data Repository form)

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Obtaining a GDS IRB Affirmation letter

• All versions of the consent used throughout the study

(specifically consents in the date range of inclusion) must be provided with the application

• Even if relevant wording did not seem to change. There

should be no gaps in dates for the time period from which you are pulling/using data

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Obtaining a GDS IRB Affirmation letter

• We will review everything and ask for missing

documents and clarifications.

• We will specifically review the consent forms and their

language relevant to your date range of inclusion

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IRB Verification

• Data submission and data sharing for

research purposes are not inconsistent with informed consent

• Consideration given to the risks to subjects

and their families as a result of the sharing

• Risks to groups or populations were

considered, when appropriate

• The investigator has a plan for management

and de-identification, consistent with GDS policy

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Obtaining a GDS IRB Affirmation letter

• The IRB Affirmation letter will include appropriate future

use of data as well as any restrictions based on consent language review

• In general, the initial review process may take up to two
• weeks. However, investigators should not expect rapid

IRB review in regards to long-ongoing studies with multiple protocol/consent versions

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Institutional Certification

• AFTER you obtain your GDS IRB Affirmation letter, you will then
• btain your Institutional Certification from the Pitt Office of

Sponsored Programs (previously Office of Research)

• Contact Pitt Office of Sponsored Programs: Clinical & Corporate

Contract Services

• clincorp@pitt.edu
• https://www.osp.pitt.edu/processing-teams/clinical-and-

corporate-contract-services

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QUESTIONS?

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Common Issues Encountered

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Common Issues Encountered

• Funding has been obtained but the relevant IRB

submission(s) have not been updated

• Not all versions of the consents are provided
• The date range of inclusion is not provided or not clear
• We are not made aware that it is for a JIT request
• The form is not complete or not signed/dated
• The OSIRIS/PittPro submission did not address sharing

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• 2. Describe where the specimens will be stored
• 3. How long will they be stored
• 4. How the specimens will be accessed and who will have access
• 5. List the data to be stored or associated with each specimen
• 6. Describe the procedures to release data or specimens, including: the process to request

a release, who can obtain data or specimens, and the data to be provided with the specimens

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Common Issues and Resolutions

• Certain consents in the submission did not include the

necessary language and data obtained using those consents could not be included.

• Addendums have been created/approved and

reconsent sought, as a condition in the affirmation letter

• For consents being used moving forward, modifications

to the consents have been required so that the necessary and appropriate wording is included

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• Words matter
• Think broadly
• Future use is often

unknown!

• Plan ahead, don’t restrict
• Become friendly with

“may” or “might”

General Summary

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QUESTIONS?