# Presentation: 948685

## Implications of Data Distinctions on Data Sharing

## Follow the Data

- Data generation
- Potential Intellectual Property
- Patient Clinical data
- Clinical Researcher D creates a hypothesis based on bench research, clinical research, and population research (this is from survey of the literature, searches of electronic databases, and interactions with colleagues.)
**A retrospective query ****is performed on a ****research data repository ****(with IRB approval if necessary) to determine feasibility of the study.**
- D writes a clinical protocol for validation of a biomarker as predictive of tumor shrinkage in the context of treatment and submits it to the sponsor.
- The protocol is approved and the trial is initiated.
- Patients either apply for a study or are recruited by a clinician.
- Participants are screened on the basis of eligibility.  Screening data and sample are supplied to clinical trial coordinator (coordinator) for enrollment evaluation.
**Coordinator sends ****sample**** to the basic scientist for biomarker screening. **
**Basic scientist sends the ****result of biomarker screening ****to the coordinator.   **
- Based on eligibly criteria and biomarker results, the coordinator sends the enrollment notification to patient.
- Clinical coordinator refers patient to radiologist for imaging.

## Still following:

**Radiologist acquires ****MR images****. **
- Radiologist analyzes images and creates image annotations and passes along to the coordinator.
- Clinical coordinator collects tissue samples and sends to the pathologist (for diagnosis and for distribution to the basic researcher (biomarker assessment).
- Basic researcher runs the biomarker assays and sends analysis results to coordinator.
- The pathologist sends staging and grading to the coordinator. (This is repeated throughout the study.)
**The coordinator starts the ****treatment****, ****and the cycle of image collection, tissue collection and molecular data collection ****continue throughout the trial, and ****all information ****is available to the coordinator throughout the duration of the trial.**
- The trial closes and all the data are provided to the statistician.
- Statistician communicates the clinical significance of and evidence for biomarker response prediction.
- The statistician, approved by the P.I., sends the report to the sponsor
- Clinical Researcher, basic scientist and statistician write a scientific paper reporting the results.
**Supporting data ****is made available via an appropriate ****repository**** as per the data sharing plan approved by the sponsor.**

## DSIC Issues

**May the owner or custodian of specimens/data (“materials”) transmit the materials to a requestor?**
**It depends.**
**Critical considerations:**
- What is the provenance of the materials (under what circumstances were they collected and who holds them now)?
- Were the materials collected during routine clinical care, or as part of an unrelated research project, or specifically for this one?
- Did original consents, if any, prohibit or restrict redisclosure?  Is IRB approval for the provider’s and/or recipient’s activities necessary and, if so, has it been secured?
- Do materials include identifiable human specimens or data?  Is identification necessary to perform the current project?
- Do relevant contracts (e.g., clinical trial agreements, MTAs, consortia agreements, licenses, etc.) permit or prohibit/restrict the anticipated disclosure/use?
- Are there other limitations or restrictions on disclosure (e.g., concern about publication, patent prosecution, etc. vs. incentives to share)
- Are the providers involved in the research?
- Who is requesting the materials and for what purpose?

## caBIG® Data Sharing and Security Framework (DSSF)

**caBIG****®**** Data Sharing ****and Security Framework (DSSF)**

## Executive Summary

**Executive Summary**

**Four separate analyses contribute to an understanding of the nature of any mandatory legal restrictions on data sharing and agreements, if any, necessary to facilitate proposed exchanges.**** **
**The analyses are conducted locally to assure institutional compliance with state law and institutional policy.**** **
**Future state:**
- Any necessary agreements are incorporated into the various applications to facilitate rapid data exchange and eliminate the need for bilateral or multilateral written agreements in most cases.
- Security framework supports authentication and authorization needs consistent with HIPAA, Common Rule/FDA, industry confidentiality/security requirements and standards.

## Privacy Considerations

**Do federal or state laws, or your institution’s privacy or confidentiality policies, restrict use or disclosure for research (research/IRB policies are addressed separately under “ethics”)?**
**Questions/Issues**** **
*Are data collected primarily for health care operations (e.g., disease management, quality improvement), rather than research?*
- Are data to be shared completely de-identified (per HIPAA definition)?  Do they qualify as a “limited data set”?
- Are the data otherwise identifiable (linkable) to individuals (e.g., SNP data where there is some reference dataset reasonably available to recipients)?
- Do state laws further restrict disclosure?
- Do institutional _privacy/confidentiality_ policies further restrict disclosure?
- Are there any mandates to disclose (e.g., funding agencies, ICMJE, www.clinicaltrials.gov, BMT)

## De-Identified Data

- HIPAA permits a deidentified data set (“DDS”) – one that omits all direct and indirect identifiers – to be shared with researchers without restriction.  To be considered de-identified, the data set must exclude the following elements with respect to an individual or the individual’s relatives, employers, or household members:

- Name
- Address, city, and other geographic information smaller than state (3-digit zip code may be included only for an area where more than 20,000 people live)
- All elements of date (except year), plus age and any date, including year, if age is over 89 (date or age ranges may be included)
- Telephone, fax, e-mail, web URL, IP address
- Social security number, medical record number, health plan beneficiary number, account number, certificate or license number
- Vehicle identifier (e.g., license plate or serial number)
- Device identifier (e.g., serial number)
- Biometric identifier (e.g., finger print or voice print – DNA is *not* considered a direct or indirect identifier under HIPAA)
- Full-face photograph or comparable image
- Any other unique identifying number, characteristic, or code (except a code used for linking purposes as prescribed by HIPAA).

- Alternatively, a dataset is de-identified if an appropriately qualified statistician determines that the risk is very small that the information could be used, alone or in combination with other reasonably available information, by an anticipated receipient to identify an individual who is the subject of the information; and documents the methods and results of the analysis.
*NOTE: Even if deidentified as provided above, if the covered entity has actual knowledge that the dataset could be used alone or with other information to identify an individual who is the subject of the information, the data are not considered**to be deidentified.  In addition, state laws or institutional policy may further restrict disclosure.*

## A limited data set (“LDS”) is similar to a de-identified data set but may include geographic information other than street address; dates and ages; and other unique identifying numbers, characteristics, or codes.   
An LDS may be shared with researchers who sign a data use agreement to assure that they will:
Use the data only for the designated research
Protect the data against inappropriate disclosure
Not use the information to re-identify the included individuals. 
HIPAA prescribes very specifically the requirements for a data use agreement.  An agreement that meets HIPAA’s standards is under development by DSIC. 

NOTE: State laws or institutional privacy policies may further  restrict use or disclosure.

**An LDS may be shared with researchers who sign a *****data use agreement***** to assure that they will:**
- Use the data only for the designated research
- Protect the data against inappropriate disclosure
- Not use the information to re-identify the included individuals.
**HIPAA prescribes very specifically the requirements for a data use agreement.  An agreement that meets HIPAA’s standards is under development by DSIC. **
***NOTE: State laws or institutional privacy policies may further  ******restrict use or disclosure.***

**Limited Data Set**

## Identifiable Data

**HIPAA generally permits an identifiable data set to be shared only:**
- With the specific written agreement (“authorization”) of the individuals whose data will be disclosed, or
- Under a waiver of authorization approved by an IRB or privacy board
- Preliminary data reviews “preparatory to research,” and research involving
- information of only deceased subjects are also permitted with appropriate
- certifications but typically are not relevant in this context.
**Even with written authorization, most institutions will share identifiable data only under agreements that assure confidential treatment of the data to be exchanged.  These agreements may be simple or more complex, depending on other considerations.**

## Additional Privacy Considerations

**Do state laws further restrict disclosure?**
- Some states have enacted laws considered to be “more restrictive” than HIPAA, typically to provide additional protection to particularly “sensitive” data:
-    Genetic testing
-    Cancer diagnosis
-    HIV/AIDS and other serious communicable disease information
-    Substance abuse or mental health treatment
- 	Many of these laws include exceptions for research uses of the data or for data sets that have been de-identified.  Some may require contracts supporting exchange of sensitive data to include certain language.
- Because institutions determine at the local level whether to share any particular data set, they are responsible for interpreting these state laws and are not placed in the position of relying on others who might have different interpretations.
**Do institutional policies further restrict disclosure?**
- Research institutions rarely restrict data exchange beyond the requirements of federal or state law for _privacy_ reasons (analysis of other elements of the framework is included in the other sections of this presentation and other DSSF materials).
**Are there mandates for disclosure (e.g., from funding agencies, ICMJE/FDAAA, public health registries, etc.)?**

## Overcoming Privacy Barriers

**Reduce Level of Identification of Data or Address HIPAA or State Law Restrictions Through Another Available Exception**
- Does the dataset to be shared include identifiable information?
- If so, can identifiers be removed to create a “limited data set” or a “deidentified data set” without compromising the integrity of the research (*note: a deidentified data set may include links or codes to facilitate re-identification*)?
- If identifiers cannot be removed, does disclosure meet another HIPAA exception
- Review of decedents’ information
- Review preparatory to research (no data off-site -> inapplicable)
- Waiver of authorization (granted by an IRB or privacy board)
**Protective Agreements: even if HIPAA (or applicable state law or institutional policy) restricts disclosure, restrictions generally can be addressed through use of appropriate agreements**
- Deidentified data set: none is generally necessary
- Limited data set: data use agreement
- Identifiable data: restrictive confidentiality agreements (not necessarily required from a federal regulatory perspective with subject authorization or if an authorization exception applies but practically important to assure subject protections and as industry “best practice”)

## IRB/Ethical Considerations

**Do the Common Rule, FDA regulations, or your institutional research or IRB policies restrict the proposed disclosure, or were the data collected under an informed consent document (or process) that would prohibit the disclosure? **** **
**Questions/Issues**
- Is the project “human subjects research” or a “clinical investigation” under the Common Rule, FDA, or local institutional policies?  Is the data provider “engaged” in the research?
- Is the research potentially eligible for an exemption from continuing IRB oversight; does it involve “secondary” use of data originally collected under consents that approved re-use or were silent or ambiguous?
- What were the circumstances of the original data collection (purpose, consent documents, etc.)?
- Are there any explicit restrictions on data sharing?
- Would disclosure be inconsistent with protocol or policies under which data originally were collected?
- Would disclosure be inconsistent with the original consent (or IRB-approved waiver of consent), or has consent been withdrawn?

## Research Policies Summary

## No Human “Subjects”

**No Human “Subjects”**

**Data to be shared relate solely to deceased individuals (individuals must be living to be considered “human subjects”)**
**8/2004 OHRP “coded” guidance: **
- Data originally were collected for purposes other than the current project; _and_
- Data are “coded;” _and_
- Investigators performing the research can’t readily ascertain the identity of the affected individuals (e.g., based on contractual terms agreed to by the recipients, or based on existing institutional or IRB policies prohibiting release of keys to recipients); _and_
- Data providers are not involved in the design, analysis, or
- 	publication of results of the current project; _and_
- No conflicts with original consents (implicit ethically and legally)
**12/2006 draft OHRP engagement guidance**
- Those disclosing the data are not involved in the design, analysis, or publication of results of the current project
- No conflicts with original consents
- No direct PHS award for conducting the research
- Note: data recipients may be (and likely are) engaged
***NOTE:**** if human specimens are to be exchanged, see further analysis below.*

## Exempt Research or “Master Protocol”

**Research is exempt from IRB oversight under the Common Rule if:**
- The data to be used already existed at the time the study started; _and_
- The data to be used are not directly or indirectly linked to individual subjects; _and_
- The IRB or other designated institutional office/official has approved the exemption
**No **_**new**_** IRB approval or informed consent (or waiver) is required if:**
- The project is proceeding under a “master” or “umbrella” protocol that covers a broad range of activities or multiple sub-studies
- The project is performed consistent with that protocol.

## Other Projects

**Other Projects**

**Prospective collection of data and/or specimens**
- Prospective IRB approval is required
- Informed consent (or IRB-approved waiver of consent) is required
**In vitro diagnostic studies**
- Prospective IRB approval is required
- Informed consent is not required if the specimens are de-identified per recent FDA guidance
- “**Secondary” research inconsistent with original consent**
- Consents may be silent on reuse or state that data/specimens collected will be used only for the primary project
- Depending on specific consent language and local policies and ethical considerations, data/specimens may not be used, or possibly may be used with prior IRB approval and re-consent or waiver of consent
**Consent withdrawn**
- There is some controversy about the meaning of the term “withdrawal” and different consent documents treat the issue differently.
- Examples of consent provisions related to withdrawals:
- If a participant withdraws from a study, previously collected information will be de-identified and may be used to continue the project or for other appropriate purposes
- Promise that data and specimens will be destroyed upon withdrawal.

## Overcoming Research Policy BarriersIRB Oversight

**Distinguish human subjects research from unregulated research**
- Human subjects are alive
- OHRP has issued guidance on “coded information and specimens” (http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.htm) and draft guidance on institutional “engagement” (http://www.hhs.gov/ohrp/requests/engage.html) that together define many activities currently regulated by IRBs as non-human subjects research
- In most institutions, non-human subjects research is not subject to IRB oversight, though who makes that decision with respect to any given project varies
**Determine whether the research is “exempt” or whether a proposed project or inquiry is covered under an existing “master” or “umbrella” protocol**
- Studies involving previously collected data that cannot be directly or indirectly linked to living individuals are eligible for exemption, which generally must be granted by the IRB
- IRBs may sometimes approve “master” or “umbrella” protocols that cover a broad range of individual projects or analyses
**For non-exempt human subjects research, consider alternatives to multi-institutional approval**
- CIRB
- Commercial IRB
- Defer or accept review under an IRB Authorization Agreement (_[http://](http://www.hhs.gov/ohrp/humansubjects/assurance/iprotsup.rtf)__[www.hhs.gov/ohrp/humansubjects/assurance/iprotsup.rtf](http://www.hhs.gov/ohrp/humansubjects/assurance/iprotsup.rtf)_)

## Overcoming IRB BarriersInformed Consent

**Explicit permission to share data with researchers via caGrid (or more broadly through a data/specimen registry) can help eliminate IRB or broader ethical barriers**** **
**Absent explicit permission, IRBs may permit retrospective research on data or specimens previously collected under clinical or research consent documents that were silent or ambiguous about future use for unspecified analyses conducted by the original research team or others**
- Many older consents include explicit language that restricts use of data or specimens to the current project
- Response varies: IRBs may permit reuse under a waiver if deemed consistent with original intent of the consent, may permit re-contact with subjects to solicit explicit permission, or may bar reuse and re-contact
**Explicit permission (or IRB-approved waiver) is required for prospective collection of data or specimens**
- Waiver may be difficult to secure because it requires a showing of “impracticability”

## Proprietary Considerations

**Does the need for protection **_**from an institutional and/or investigator**_** perspective restrict the proposed disclosure of research data?**
**Questions/Issues:**
- Do the data disclose a patentable invention? If so, is a patent intended?  Has it been filed and have the data been published by the patent office?  Are the data valueless from an IP perspective?
- What is the publication status of the project?  Are the results already in the public domain?  Are they published but not publicly accessible?  Do they remain unpublished?  Is additional work needed to assure full and accurate analysis by anticipated users?
- Does the data owner or steward have other legitimate reasons for restricting dissemination?

## IP Restrictions Summary

**IP Restrictions Summary**

## Sponsor Requirements

**Do the terms and conditions in any funding grants or contracts (from the government or private sources), or other agreements, prohibit or restrict disclosure?**
**Questions/Issues:**
- Do the terms of any agreements with sponsors governing the original data collection or creation delay or otherwise limit, restrict, or prohibit disclosure/
- Do the terms of any agreements with original data sources delay or otherwise limit, restrict, or prohibit disclosure?

## Sponsor Requirements Summary

**Sponsor Requirements Summary**

## Pulling it all Together ...

## DSSF Decision Support Tool

**DSSF Decision Support Tool**

## Retrospective Queries on Data Repositories: “Deposits”

**Clinical Data Repositories (Created for Routine Treatment, Payment, HC Operations)**
- No special approvals are required under HIPAA or the Common Rule to create or maintain a clinical data repository to treat patients, facilitate payment, perform peer review and quality improvement activities, and for other routine purposes
- Other administrative requirements apply, e.g., assuring data security and integrity
- Contracts or institutional policies may further limit/restrict deposits (sources, maintenance, access rights, uses, etc.)
**Research Repositories (Created Primarily for Research Purposes)**
- HIPAA
- Prospective authorization or IRB/Privacy Board waiver is required, unless primary purpose is not research
- Authorization covers only the deposit, not “unspecified future research”
- Common rule
- Provider institution is not “engaged” in recipients’ projects if not involved in the design, analysis, or publication of results; or if provides only coded information where recipient has no key to the code
- Even assuming engagement, creation of repository may be exempt from IRB review and oversight if only pre-existing (at the time the repository is initiated), de-identified/de-linked data are deposited
- Otherwise, prospective IRB approval and informed consent or IRB-approved waiver are necessary to create/make deposits to repositories
- Contracts or institutional policies may further limit/restrict deposits

## Retrospective Queries on Data Repositories: “Withdrawals”

**HIPAA**
- Automated query (no individual identifiers accessed or received) does not require authorization or IRB/Privacy Board waiver
- Disclosure of identifiable data will require:
- Prior authorization (unlikely to be practical); or
- Waiver (IRB or privacy board); or
- Certification of review preparatory to research (of limited use)
- Disclosure of a limited data set requires a data use agreement
- Disclosure of a de-identified data set requires no permission and no agreement under HIPAA
**Common Rule: Three Possibilities (See Above Analysis)**
- No human subjects research
- Recipient not engaged
- Research regulated/IRB oversight required
**Contracts or institutional policies may further limit/restrict withdrawals**

## “Secondary Use” Scenarios- No Access to Identifiable Data

_**Scenario**_**:****	**Researchers run a computer query against a caGrid instance to create a new dataset that contains no links back to individual identifiers.  The data available via the caGrid instance were not created/collected for purposes of the current study.  The researchers are unable to link any private data in the dataset to identifiable living individuals (i.e., there is no key to the code).
_**Result**_**:****	**OHRP likely would not consider the data to be “coded” because nobody holds any key to the code that would allow linkage of the data to identifiable living individuals.  The research also should not be considered to involve “human subjects” because the investigators are not performing an interaction or intervention and are not obtaining identifiable information.
*Recommendation: written procedures should include specifications for querying existing*
*databases in this manner for research.  Approval of these procedures by an IRB is not*
*required from a regulatory perspective but may be useful to document institutional buy-in.*

## “Secondary Use” Scenarios- Creation of Coded Datasets

_**Scenario**_**: ****	**Researchers run a query against a caGrid instance to create a new coded dataset.  A key is created and maintained by the researchers that would allow linkage of the coded data to identifiable living individuals, if the data providers disclosed the code.  However, the data providers are not involved in the conduct of the research (they are not co-investigators and will not be involved in the design, analysis, or publication of results (e.g., via authorship credit).
_**Result**_**:**	OHRP would not consider the research to involve human subjects _if_ the information were not collected specifically for the current project through an “intervention” or “interaction” with living individuals _and_ the researchers cannot easily ascertain the identity of the individuals to whom the coded data pertains because, for example:
- 	* the key is destroyed before the research begins; or
- 	* those who hold the key enter into an agreement prohibiting its release; or
- 	* there are written IRB-approved policies for a repository or other legal requirements that prohibit the key’s release.
*Recommendation: Secure a formal written statement from the IRB confirming that research*
*performed consistent with any of the above procedures via caGrid is not subject to IRB oversight (for*
*use by investigators submitting results for publication).*

## “Secondary Use” Scenarios- Regulated Research

_**Scenario**_**: **	Researchers run a query to create a coded dataset that is to be provided to their collaborating colleagues, who are also data providers.  A key is created and maintained by the collaborators that would allow linkage of the coded data to identifiable living individuals.  The collaborators also are involved in the conduct of the research (i.e., in the design of the research or analysis or publication of results).
_**Result**_**: ****	**OHRP likely would consider the research to involve human subjects, and the research would not be exempt from prospective IRB approval and continuing review.  Full IRB review (sometimes via expedited procedures) and either informed consent or IRB-approved waiver typically will be required prior to study initiation.
*Recommendation: consider use of central IRBs, master protocols, and other mechanisms to minimize*
*administrative burden of engaging in these types of research activities.*

## Consent Issues

**Enrollment in Clinical Trial:**
- Participants must provide consent and, if applicable, authorization for prospective study
- Must include permission to create, receive, maintain, and access related information
- HIPAA beware: blanket and compound authorizations
**Related DSIC Tools (Posted at KC Site)**
- Required elements of informed consent and authorization: _[https://cabig-kc.nci.nih.gov/DSIC/KC/images/c/c1/HIPAA%2BCR%26FDA-Auth%26Consent.doc](https://cabig-kc.nci.nih.gov/DSIC/KC/images/c/c1/HIPAA%2BCR%26FDA-Auth%26Consent.doc)_
- Model informed consent/authorization form for correlative or stand-alone specimen/data studies: _[https://cabig-kc.nci.nih.gov/DSIC/KC/index.php/DSIC_Tools](https://cabig-kc.nci.nih.gov/DSIC/KC/index.php/DSIC_Tools)__ (also includes summary of standardization and simplification projects) _

## Research/Clinical Care Issues

**Research/non-clinical analysis**
- Typically may be performed by licensed or unlicensed individuals, appropriately qualified per institutional policies or IRB standards
- NOT used to make clinical treatment decisions
- Results NOT necessarily reported to participant/treating provider (unless HIPAA applies, in which case results must be disclosed at the participant’s request no later than the end of the study)
**Clinical analysis**
- Generally must be performed by or under the supervision of licensed health professionals in appropriately accredited/certified facilities (e.g., CLIA for pathology)
- May be used to make clinical treatment decisions
- Results generally must be concurrently reported to the participant and/or treating provider concurrently

## (Don’t Forget) Clinical Trial Registration and Reporting

**Within the next few years, significant amounts of data – including detailed protocol information and AE and results information – will be required to be reported to the US government and made publicly available via the Internet.**
**Congress gave passing consideration to the idea that raw data may be misleading, particularly to uninformed providers and laypeople, by requiring consultation with risk communications experts and creating a pilot QC study.**
**Deadlines for results reporting are in reality very tight, yet submission of data deemed to be inaccurate or misleading will be punishable with significant financial and other penalties.  This primarily affects sponsors, but may affect PIs, e.g., where researchers agree to do the reporting under their CTAs or for investigator-initiated studies.**

## Results Database: Basic Information for Certain Registered Trials 

**Deadline: September 2008**
**Application**
- Registered trials that form the basis of an efficacy claim
- Registered trials of approved drugs/devices
**Content**
- A table of the demographic and baseline data collected overall and for each arm of the clinical trial to describe the patients who participated in the clinical trial, including the number of patients who dropped out of the clinical trial and the number of patients excluded from the analysis, if any.
- “Primary and secondary outcome measures” and a table of values for each of the primary and secondary outcome measures for each arm of the clinical trial, including the results of scientifically appropriate tests of the statistical significance of such outcome measures.
- Point of contact
- Publication restrictions
**Coming Next**
- More detailed registration and results reporting
- AE reporting

## Registry/Database Submission Deadlines

**Registry Information**
- Submitted by sponsor (or PI) no later than the later of:
- December 27, 2007
- 21 days after first patient is enrolled
- September 27, 2008 (only for trials that are NOT for serious or life-threatening diseases/conditions and that ARE ongoing as of September 27, 2008
- Posted by NIH no more than 30 days later (except for unapproved device trials, for which posting must be delayed until clearance or approval if the device previously was not cleared or approved)
**Results submissions are generally due **
- Within 12 months of estimated or actual completion (whichever is _**earlier**_), not more than 18 months (“completion date” is defined to be the last day the last subject was examined or received an intervention for final collection of PRIMARY outcome data)
- Within 30 days after approval (new drugs/devices)
- Within 30 days after approval or disapproval (new labeling)
**Updates **
- Required at least every 12 months (unless information remains unchanged); and within 30 days after change in recruitment status
- Notification of completion must be submitted within 30 days of completion
- NIH is responsible for assuring that updates do not generally overwrite previously reported information
**Posting generally follows within 30 days of submission**

**Questions?**
**caBIG****®**** DSIC Knowledge Center**
**Help Desk: 866-969-8383**
_**[https://cabig-kc.nci.nih.gov/DSIC/KC/index.php/Main_Page](https://cabig-kc.nci.nih.gov/DSIC/KC/index.php/Main_Page)**_** **
**Co-Directors:**
**Elaine Brock, JD, MHSA****	****Rachel Nosowsky, Esq.**
**University of Michigan****	****Miller Canfield Paddock & Stone PLC**
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**Ann Arbor, MI  48109****	****Ann Arbor, MI  48104**
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