Regulatory considerations for biorepositories webinar

Clinical Research Management Webinar Series:

Regulatory Considerations for

Biorepositories: Navigating HHS, FDA,

HIPAA and Informed Consent Wednesday, December 19, 2012

12:00 p.m. - 1:00 p.m. CT

Disclaimer

2 © 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.

The views expressed in this presentation are the views of the speakers and do not

necessarily reflect the views or policies of the companies they represent. This

presentation is intended for educational purposes only and does not replace independent

professional judgment. Neither Huron Consulting Group or Van Andel Research Institute

endorse or approve, and assume responsibility for, the content, accuracy or

completeness of the information presented.

Attendees should note that sessions are audio-recorded and may be published in various

media, including print, audio and video formats without further notice.

A Bit About Our Speakers

Madeleine Williams Director

P 312. 479. 3374

[email protected]

Maddie has over 10 years of research experience and assists clients with

research biorepository design and development, institutional review board (IRB) assessments

and operational support, regulatory compliance evaluations, and human research protection

program evaluation and accreditation.

Scott Jewell, Ph.D. Deputy Director for Research Resources

Professor and Director, Program for Biospecimen Science

Van Andel Research Institute

P 616. 234. 5435

[email protected]

Dr. Jewell is Deputy Director of Research Resources and Professor and Director for the

Program of Biospecimen Science at the Van Andel Research Institute. He has served as

President of the International Society for Biological and Environmental Repositories (ISBER)

and has spent more than 25 years in the collection, banking, distribution and analysis of

biospecimens for basic and clinical research.


mailto:[email protected]

mailto:[email protected]

Agenda

Recommended biorepository model

When DHHS, FDA and HIPAA regulations apply

When informed consent is not required

Pros and cons of different informed consent approaches

Q&A / Wrap-up


Regulatory Considerations

Applicable research and privacy regulations

• DHHS

• FDA

• HIPAA

• Other state and local laws

Goal should be to set up a biorepository that utilizes the

flexibility in the regulations

• Appropriate set up for collection and coding of samples and data

• Governance model for review and distribution of samples and data

to researchers

• Work with the IRB to design


Polling Question #1

What kind of biorepository activities are currently

ongoing at your institution?

a. We have a central biorepository “core” that supports all banking for

the institution

b. We have a central biorepository but also have decentralized individual

investigator biorepositories

c. We just have decentralized individual investigator/department

biorepositories at our institution

d. We only participate in external banking protocols (i.e. cooperative

group studies) and send our samples off site

e. We do not participate in any biobanking right now

f. Not sure what biorepository activities are ongoing 6 © 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.

Recommended Biorepository Model

7

Step 1

Step 2

The Model is a Two-Step Process

Step 1: Procedures for collection and banking of

specimens

Step 2: Procedures for use of specimens

Note that “specimens” may be:

• Tissue

• DNA

• Images

• Text


The Model Separates the Known and Unknown

Activities

Oversight must be based on actual uses of

specimens

Step 1:

• Known use: Specimens will be collected and banked

for research

Step 2:

• Unknown uses: Specific research studies that

specimens will be used for


Step 1: DHHS and OHRP

OHRP considers the collection of specimens or data for

research purposes to be research and guidance

recommends that human tissue repositories supported by

HHS should be subject to oversight by an Institutional

Review Board (IRB).

The IRB should determine if:

• The activity is research as defined by the Common Rule

• If so, whether the research involves human subjects as defined by

the Common Rule

10

OPRR, Issues to Consider in the Research Use of Stored Data or Tissues, November 7, 1997

OHRP, Guidance on Research Involving Coded Private Information or Biological Specimens, October 16, 2008

© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.

Step 1: DHHS and OHRP

If the repository involves human research, the IRB should

review:

• Conditions under which data and samples are collected and shared

• Provisions to protect privacy

• Provisions to maintain confidentiality of data

OHRP has guidance as to when coded private information or

samples are not identifiable so that research on that

information does not involve human subjects.

• Impact on Step 2 and the need for IRB review

11

OPRR, Issues to Consider in the Research Use of Stored Data or Tissues, November 7, 1997

OHRP, Guidance on Research Involving Coded Private Information or Biological Specimens, October 16, 2008


Step 1: Other Considerations

Use of an honest broker when collecting identifiable

information

• An individual, organization or system collects identifiable data and

replaces identifiers with a code, and releases only coded

information to the researcher or to be stored in the repository.

• The honest broker is the only person who can link a subject with the

code that identifies that subject.

• Useful when collecting and adding long-term follow up data to a

repository.

Obtaining a Certificate of Confidentiality for repository

samples and data


When is Collection/Storage in Step 1 Not

Research?

Not all specimen or data collection/storage is

research even if specimens are used for research

• Pathologic lab archive

• Radiology film library

• Medical record


When Does Collection/Storage in Step 1 Not

Involve Human Subjects?

Not all research biorepository storage and collection

involves human subjects

• Collection of de-identified specimens

• Collection of already coded specimens

• Collection of autopsy specimens


The Model Minimizes Regulatory Burden

Steps 1 and 2 may have different regulatory

statuses

Step 1:

• Usually human research

• Usually subject to HIPAA

Step 2: (when properly designed)

• Usually not human research

• Usually not subject to HIPAA


Step 2: Does the research involving human

subjects?

Both DHHS and FDA regulations may apply.

• Systematically consider both.

First consider:

• Is there “research” as defined by DHHS?

• Is there “research” as defined by FDA?

If NO to both, stop. (If no research, no human

subjects)

Then consider:

• If DHHS “research” are there DHHS “human subjects”?

• If FDA “research” are there FDA “human subjects”? 16 © 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.

Human Research Flowchart

17

Is activity “Human Research”

as defined by DHHS?


as defined by FDA?

“Human Research”

under DHHS and FDA


as defined by FDA?


under DHHS only

NOT



under FDA only

No

NoNo

Yes

Yes Yes

START


Step 2: Readily Identifiable Information

OHRP guidance on biologic specimens and OHRP

guidance on engagement provides examples where

OHRP considers information to be NOT “readily

identifiable”: • The investigators and the holder of the key enter into an

agreement prohibiting the release of the key to the investigators

• IRB-approved written policies and operating procedures for a

repository or data management center prohibit the release of the

key to the investigators

• Legal requirements prohibit the release of the key to the

investigators


Step 2: Coded Samples and Data

If the biorepository releases coded samples and

data to investigators for specific research studies, in

most cases this will not meet the definition of human

subjects research

Should have appropriate governance structure in

place

• Scientific committee to review and approve requests for

samples/data


Scenario and Polling Question #2

20

An investigator is conducting research on diabetes. She

wants to develop an assay to screen for the presence of a

biomarker than is linked with type 2 diabetes. She will obtain

blood samples and data from a diabetes repository with no

identifying information. She will use these blood samples to

develop the assay.

Polling question:

Is IRB review required? A. Yes

B. No

C. Not Sure


Follow Up For Polling Question #2

21

Yes

FDA considers data regarding the use of a device on human

specimens (identified or unidentified) to be a clinical investigation if it

will be submitted to or held for inspection by FDA as part of an

application for a research or marketing permit

Relevant to specimens:

• Individual who serves as a control

• An individual on whose specimen a device is used

Important to consider both DHHS and FDA

Scientific review can monitor for this to trigger when IRB review is

needed


HIPAA

Applies if samples and data are collected within or received by a covered

entity

Most likely scenarios for repository data, sample labeling:

• Identifiable

– Authorization from the patient OR

– Waiver of authorization from IRB/Privacy Board

• Limited Data Set

– Data Use Agreement is in place

• De-identified (all PHI removed)

– If samples are coded to achieve de-identification, HIPAA states that the code

may not be derived from or related to the information about the individual and is

not otherwise capable of being translated to identify the individual.

– For example, the code may not be derived from the individual’s name (i.e.

initials), social security number or medical record number.


“De-identified” versus “not readily identifiable”

HIPAA defines identifiers that need to be stripped

from data to make protected health information de-

identified.

However, an investigator cannot readily identify the

individual from whom the following was obtained:

• Zip code

• Fingerprints

• Dental records


Informed Consent

24

Human Subject Research Regulations (HHS and FDA)

• Informed consent is not required if :

1) the research does not meet the definition of human subjects research under

HHS;

2) is exempt from the HHS regulations;

3) the research has been granted a waiver of consent by the IRB; or

4) if the FDA-regulated research involves anonymous tissue specimens where

FDA does not require consent (FDA enforcement discretion*)

OHRP Guidance

• The IRB should review and approve a sample informed consent

document for distribution to tissue collectors and their local IRBs

* FDA Guidance, Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, April 25, 2006


Informed Consent

25

NCI and ISBER Best Practices

• Informed consent information describing the future research should

be as specific as possible

• Obtain informed consent whenever possible

• Consent may be obtained for unspecified future research;

mechanisms should be in place to assure that future research uses

of identifiable specimens are consistent with the original consent

• Subjects should have the right to withdraw consent and to have

their unused specimens and data removed from the repository

unless the specimens and data are anonymous (no link).


Informed Consent Approaches

26

General consent for biorepository

• Can get consent from subjects to bank specimens (Step 1) and

indicate that for future research (Step 2) either their specimens will

not be identified, an IRB will waive consent, or their consent will be

obtained

• Cannot get “blanket” consent from subjects for unspecified future

research with identifiable specimens

Tiered consent for biorepository

• Subjects can specify the types of research for which their

samples/data will be used

• Have to be able to track subject choices

Research study specific consent © 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.

HIPAA Authorization

27

A HIPAA authorization may not seek permission to use or

disclose PHI for future unspecified research uses of health

information.

Authorization can be obtained to create a repository (Step 1) but

that authorization does not cover subsequent research uses of

identifiable data.

Recommend that data used for future research from the

repository (Step 2) be a LDS or de-identified (authorization not

required).


Questions?

Thank you!

For further information, please contact:

Scott Jewell

Van Andel Research Institute

P 616. 234. 5435

[email protected]

Madeleine Williams

Director, Huron Consulting Group

P 312. 479. 3374

[email protected]

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Regulatory considerations for biorepositories webinar

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