# Presentation: 324700

## Multi-IC Symposium IIApplication of Genomic Technologies to Population-Based Studies

- Panel 5:
**Informed consent and institutional approvals**

- Department of Health and Human Services			National Institutes of Health

## Panelists Group 5 Consent

- Richard Fabsitz NHLBI
- Kat Gwinn NINDS
- Bob Hoover, NCI
- Dan Levy, NHLBI
- Marcelle Morrison-Bogorad NIA
- Tony Phelps, NIA (in absentia)
- Laura Rodriguez, NHLBI (in absentia)
- Steve Sherry NCBI

- Department of Health and Human Services			National Institutes of Health

## Suggestions from Last Year

- Centralized IRBs? Or standardized language?
- FAQs for genetics/genetic epidemiology specifically?
- Sample consent language elements

- Department of Health and Human Services			National Institutes of Health

**Notes:**
McWilliams, 2003:
42 Cystic Fibrosis gen epi centers
Time delay for IRB review and approval avg 81.9 days (up to 252 days in some IRBs)
94% of multi-center sites require their own consent form
52% of IRB issues were genetic
27% felt study was minimal risk
Some requires DSMB though no intervention

## What We Are (and aren’t) Talking About

- Discussing Today:
- Consent and Approval Process in Context of Sharing Phenotypic and Genotypic Data
- in the trenches
- practical approaches
- Experiences
- Goal: sample elements for WGAS
- (Not today: GWAS or DHHS policy and guidelines being developed in other forums)

- Department of Health and Human Services			National Institutes of Health

## DbGaP Experiences

- Multiple levels of Permissions
- Given disease only
- Any disease of that broad category/in same organ
- Any disease
- Future Studies
- Allowed in some, not in others
- Collapsed to two groups:
- That disease category only
- Broadly (any disease)

**Notes:**
DbGaP Consent Issues--Example of Early Experience
Initial discussions with the IC revealed that for the experience worthy of discussion is that with was that we were originally told that the study of 600 subjects would have two consent groups: Any research use (90%), disease category specific only (10%).
When we reviewed the actual consent codes with the data coordinating center(S), however, there emerged five consent groups with the following frequencies in the dataset:
Code                                                                                                    Frequency
Same Disease Research Only, No Stage II Consent Form                          1
Any Research Project, Sample may be identifiable                                  453
Any Research Project IF Identifying Information Removed                        75
Participant Wishes to be Contacted for Different Disease Research          52
Same Disease Research Only, No Future Studies                                     19
We met with the IC and the DCC to discuss what groups were meaningful and which ones could be collapsed. The group concluded that there were essentially only two consent categories:
General Research Use                                                                           529
Same Disease Research Only                                                                   71

## GAIN Experience

- The TAG noted five areas that were of major importance re: whether project could be included in GAIN:
- Disease restrictions
- Any other restrictions (need to re-consent to share, inform if findings)
- Adequacy (genetics mentioned, future use, sharing)
- Withdrawal promises
- Commercial use

**Notes:**
focused on by TAG:
Disease restrictions
Any other Restrictions (any future use will be reviewed by this IRB for example)
Adequacy of consent (did it talk about genetics, future use of samples, sharing of health information and genetic information for future use)
Adequacy of withdrawal language (could all data be removed; of course database can’t do it)
Commercial use
Other things noted, that may fit under # 3 above: re-contact if significant results discovered: were they clear about what was going to be protected, and what would be shared.
International studies:
How can that be assessed post hoc?  How can cultural standards that apply be understood?
Is the way samples were consented and collected consistent with 45CFR 46 even if international?

## Other IC Experience

- Layered consent requires heavy documentation, tracking, and inefficiencies
- Do subjects really prefer them?
- Model Consent Forms very useful within a consortium (such as ADRC)
- Centralized Repositories for data and biologicals, facilitate sharing, uniform policy
- “Moving Target”
- As we learn what doesn’t work, changes are made

**Notes:**
See background Documents:
Lessons from CARE
NCRAD help form
NIA sharing plan
2007 Sample consent form AD genetics
NINDS Sample consent form
CDC consent form

## Questions

- How do we manage older consents, on archived materials or data?
- How do we avoid “silo-ing” collections as occurs with multiple projects/variable consents?
- What should be the triggers for re-consent vs. consulting IRB vs. finding acceptable?
- How do we inform PIs of changes in needed consent form language (Type 5?)?
- What else do PIs need to help guide them forward in this process?

## Model Consent or Sample Language?

- Sample consent
- useful to IRBs to allow standardization
- Decreases the broad variability in IRB review of documents (Multi IC mtg I)
- BUT decreased local flexibility, may not always be appropriate for certain study
- Sample language
- More adaptable to a variety of studies
- ? International studies?

## Straw Person:Sample Consent Elements

- Not disease or organ specific
- “this sample and associated data will be used to study many medical conditions (and normal variations)”
- Shared broadly
- “This sample and associated data may be shared with a number of investigators after all identifying information is removed”
- Discuss genetics
- “Genetics studies will be done to try to determine what genes might increase the risk of some diseases in some people”
- Discuss future use, sharing
- “this data (these samples) may be shared with researchers, without any information that will identify you individually”
- “this data will be housed in a public database”
- Do not promise that data will be discarded
- Comment on commercial use
- “investigators from both academic (university) and commercial (company) organizations will have access to this data”