fully accredited since 2006 February 25 & 27, 2014

Biobanking & Future Research: Addressing the “Unknown” in the Protocol & Consent

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WEBINAR HOUSEKEEPING

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ABOUT QUORUM REVIEW IRB

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THE QUORUM ADVANTAGE

Quorum Review Regulatory Attorney J. Claire Carbary, JD, CIP

IRB Experience Joined Quorum Review IRB in September 2009 WIRB prior to Quorum CIP certification since 2010 Member of the Northwest Association for

Biomedical Research (NWABR) and Public Responsibility in Medicine and Research (PRIM&R)

Legal Background Juris Doctor from Seattle University Member of the Washington State Bar Association (WSBA) Member of the Health and Corporate Law Sections of the WSBA

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ABOUT THE PRESENTER

Biobanking & Future Research: Addressing the “Unknown” in the Protocol & Consent

Legal Requirements for Collection and Use of Samples and Data for Research 14 U.S. Laws and Regulations 15 U.S. Regulatory Requirements for Use of “De-Identified” Samples 23 Canadian Laws and Regulations 26

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WEBINAR OVERVIEW

Addressing Future Research and Biobanking in the Protocol and Consent Form 35 Research Use of Stored Data or Tissues 36 IRB Review of “Future Research” & Biobanks 37 Consent Forms and Future Research/Biobanking 38

Biobanking & Future Research: Addressing the “Unknown” in the Protocol & Consent

Return of Results to Study Participants 43 Determining When to Return Results 44 Addressing Return of Results in Consent 47

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WEBINAR OVERVIEW (CONT’D)

• Recognition that genetic information is distinct from other kinds of health information, in terms of predictability and discriminative power as well as in scope: the information gained from analysis of biological material is relevant for family members or population groups as much as for individuals

• Risk in providing a sample is low relative to a participant in a clinical trial but the risk of “informational harm” is not negligible

• Privacy and confidentially risks posed by the combination of biological material and/or clinical information and information from other sources and identifiability

What’s “Different” about Biobanking and Future Use of Samples?

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Citation: Solbakk, Jan Helge. et. al., ed. “Introduction.” The Ethics of Research Biobanking. London: Springer, 2009. Print.

Use of Samples in the News

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Legal Requirements

Samples & Data for Collection and Use of

for

Research

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“Quote involving children in research…”

Defining U.S. Laws &

Regulations

FDA & HHS Human Subjects Protection Regulations

• HHS and FDA regulations regarding consent were designed for interventional studies

• Several consent requirements are relevant to biobanks and future research: - Procedures - Foreseeable risks - Benefits - Confidentiality

• The challenge lies in fully addressing these elements with respect to banking and future use of samples

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Human Subjects Protection Regulations

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“Quote involving children in research…”

Defining HIPAA

HIPAA Applies to covered entities and business associates:

• “Covered Entity”- health plans, health care clearing houses, and some health care providers

• “Business Associate” - a person or entity that performs certain functions or activities that involve the use or disclosure of protected health information on behalf of, or provides services to, a covered entity.

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• Names • All geographic subdivisions smaller than a state (limited exceptions for zip codes) • All elements of dates (except year) for dates directly related to an individual, including birth date, admission

date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older

• Telephone numbers • Facsimile numbers • Electronic mail addresses • Social security numbers • Medical record numbers • Health plan beneficiary numbers • Account numbers • Certificate/license numbers • Vehicle identifiers and serial numbers, including license plate numbers • Device identifiers and serial numbers • Web universal resource locators (URLs) • Internet protocol (IP) address numbers • Biometric identifiers, including fingerprints and voiceprints • Full-face photographic images and any comparable images • Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule

for re-identification

HIPAA Identifiers

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HIPAA Authorizations for Biobanking and Future Research • Both a “conditioned” and

“unconditioned” authorization may be included in the informed consent

• Must clearly differentiate between the conditioned and unconditioned research components and

• Provide the prospective subject with an opportunity to opt in to the unconditioned research activities

• Flexibility for covered entities and researchers for how to set this up

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Citation: 78 Fed. Reg. at 5, 609-613 (Jan. 25, 2013), available at: http://www.gpo.gov/fdsys/pkg/FR-2013-01-25/pdf/2013-01073.pdf.

HIPAA Authorizations for Biobanking and Future Research - Specificity

• HHS reversed its previous position that a research authorization must be study specific and could not include an authorization for unspecified future research

• The authorization must include a description of the future research to “adequately describe such purposes such that it would be reasonable for the individual to expect that his or her PHI could be used or disclosed for such future research.”

• IRBs, researchers, and covered entities have flexibility for how to address depending on the nature of the planned research

• Note: Covered entities and researchers may rely on an IRB-approved consent obtained prior to the effective date of the final rule that reasonably informs individuals about future research, as long as the informed consent was combined with a HIPAA authorization (even if the authorization was specific to the original study or creation and maintenance of a repository).

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Citation: 78 Fed. Reg. at 5, 609-613 (Jan. 25, 2013), available at: http://www.gpo.gov/fdsys/pkg/FR-2013-01-25/pdf/2013-01073.pdf.

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U.S. Regulatory Requirements

For Use of

“De-Identified” Samples

In general, OHRP considers private information or specimens to be individually identifiable as defined at 45 CFR 46.102(f) when they can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems. Conversely, OHRP considers private information or specimens not to be individually identifiable when they cannot be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems. For example, OHRP does not consider research involving only coded private information or specimens to involve human subjects as defined under 45 CFR 46.102(f) if the following conditions are both met: 1. the private information or specimens were not collected specifically for the currently proposed research project through

an interaction or intervention with living individuals; and

2. the investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain because, for example:

a. the investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased (note that the HHS regulations do not require the IRB to review and approve this agreement);

b. there are IRB-approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased; or c. there are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased.

OHRP Guidance Use of samples without Identifiers

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Citation: OHRP Guidance on Research Involving Coded Private Information or Biological Specimens, October 16, 2008, available at: http://www.hhs.gov/ohrp/policy/cdebiol.html.

Waiver of Consent is not allowed for FDA- regulated research EXCEPT emergency research and research using leftover specimens that are not “individually identifiable” for testing of In Vitro diagnostic devices

Requirements related to the sample:

• The study uses leftover specimens, remnants of specimens collected for routine care or analysis that would have been discarded. Could also use specimens obtained from repositories or those previously collected for other research purposes.

• The specimens are not individually identifiable, i.e., the identity of the subject is not known to and cannot readily be ascertained by the investigator or any other individuals associated with the investigation, including the sponsor. If coded, no one associated with the investigation or the sponsor can have access to the link between the specimen and the subject

• The specimens may be accompanied by clinical information as long as the information doesn’t make the specimen identifiable.

• Individuals caring for the patients are not investigators and do not share information about the patient with investigators.

• The specimens have no identifiers and the supplier has policies and procedures to prevent the release of personal information.

Citation: Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, April 25, 2006, available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm078384.htm.

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FDA Guidance on IVD Research and Waiver of Consent

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Canadian Laws &

Regulations

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PIPEDA

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PIPEDA (Personal Information Protection and Electronic Document Act)

• Applies to personal information collected, used or disclosed by organizations engaged in commercial activities

• Some private enterprises in British Columbia, Alberta, and Québec are covered by provincial statutes instead of PIPEDA

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PIPEDA (cont’d) • The organizations must advise individuals about

their intent to collect and use personal information, and obtain their consent. They must also manage information in a way that safeguards the individual’s privacy and lessens the chances that personal information will fall into the wrong hands

• Personal information includes: (a) Name, race, ethnic origin, religion, marital status, educational level

(b) E-mail address and messages, IP (Internet Protocol) address

(c) Age, height, weight, medical records, blood type, DNA code, fingerprints, voiceprint

(d) Income, purchases, spending habits, banking information, credit/debit card data, loan or credit reports, tax returns

(e) Social Insurance Number (SIN) or other identification numbers

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Privacy Act

The

• Governs the personal information handling practices of the federal government

• Applies to 250 federal government departments and agencies to respect privacy rights by limiting the collection, use and disclosure of personal information

• Gives individuals the right to access and request corrections of personal information about themselves held by these federal government organizations

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The Privacy Act

• Human Biological Materials include: tissues, organs, blood, plasma, skin, serum, DNA, RNA, proteins, Cells, hair nail clippings, urine, saliva and other body fluids

• An individual whose data and/or biological materials are used in research becomes a participant (note the difference between this and the U.S. standard)

Citation: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans 2010, Chapter 12, Human Biological Materials Including Materials Related to Human Reproduction

TCPS2 Requirements related to Human Biological Materials

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TCPS2 Requirements related to Human Biological Materials (cont’d)

Consent is required for prospective sample collection and must include:

(a) the type and amount of biological materials to be taken;

(b) the manner in which biological materials will be taken, and the safety and invasiveness of the procedures for acquisition;

(c) the intended uses of the biological materials, including any commercial use;

(d) the measures employed to protect the privacy of and minimize risks to participants;

(e) the length of time the biological materials will be kept, how they will be preserved, location of storage (e.g., in Canada, outside Canada), and process for disposal, if applicable;

(f) any anticipated linkage of biological materials with information about the participant; and

(g) the researchers’ plan for handling results and findings, including clinically relevant information and incidental findings.

Citation: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans 2010, Chapter 12, Human Biological Materials Including Materials Related to Human Reproduction

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TCPS2 Requirements related to Human Biological Materials (cont’d)

Researchers who have not obtained consent from participants for secondary use of identifiable human biological materials shall only use such material for these purposes if the REB is satisfied that:

(a) identifiable human biological materials are essential to the research;

(b) the use of identifiable human biological materials without the participant’s consent is unlikely to adversely affect the welfare of individuals from whom the materials were collected;

(c) the researchers will take appropriate measures to protect the privacy of individuals and to safeguard the identifiable human biological materials;

(d) the researchers will comply with any known preferences previously expressed by individuals about any use of their biological materials;

(e) it is impossible or impracticable to seek consent from individuals from whom the materials were collected; and

(f) the researchers have obtained any other necessary permission for secondary use of human biological materials for research purposes.

Citation: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans 2010, Chapter 12, Human Biological Materials Including Materials Related to Human Reproduction

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Addressing Future

Biobanking Research &

in the

Protocol &

Consent

Research Use of Stored Data or Tissues

Citation: Issues to Consider in the Research Use of Stored Data or Tissues, OPRR (November 7, 1997), available at: http://www.hhs.gov/ohrp/policy/reposit.html

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IRB Review of Future Research & Biobanks

IRB Review of “Future Research”

• May not be required under law in U.S. for “de-identified” samples - depends on the nature of the research

• Requirement for review in Canada turns on use of samples - not whether they are “identifiable”

IRB Review of Biobanks

• How are materials entered into the bank?

• What are the conditions in which researchers can access materials in the bank?

• Issues related to the information collected and stored (access-rights, disclosure, confidentiality, data security, and data protection)

An IRB may evaluate an existing consent to determine whether the use proposed was covered by an old consent:

• Does the language or context of the consent form indicate that the source was interested in aiding the type of research being proposed?

• If the individual consented to the sample being used in unspecified future studies, is that consent adequate for the type of research being planned, given the circumstances under which the sample was collected (e.g., whether the sample was requested by a treating physician or whether the consent form offered alternatives to allowing the sample to be used in future studies)?

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Previous Consents

Citation: Adapted from Research Involving Human Biological Materials: Ethical Issues and Policy Guidance

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Consenting to Future Research • In the typical ICF for research, it is possible

“to inform the potential research participant about the exact nature and purpose of the research project in considerable detail. However in the context of research biobanking, this level of specification is hardly achievable, because the research performed on banked material is by nature, open ended” (EORBB)

• Practically challenging to ask permission for each individual research project - though with certain technological interfaces - that could be possible

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Consent Forms: Explaining the Concept of Future Research If the future research is planned on samples that are taken as part of another study - think about the consent approach:

• Keeping the future research consent separate to avoid confusion of issues and lack of consideration of future research

• Could it be obtained at a later date?

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Generally, a consent form should address: • Unspecified future research • Storage for an indefinite period of time • Confidentiality and privacy • Access to medical records • Contact for future research • Scope of sharing between entities,

investigators • How individuals/researchers gain access to

information • Development of commercial products • Confidentiality protections • Access to results • Ability to withdraw

Consent Forms: Explaining the Concept of “Biobank”

In a study, participants, IRB members, and investigators were asked to review a biobanking consent and highlight “important” information

• IRBs selected significantly more content than study participants

• While ethics boards have certain specific obligations, they should be reviewing literature and research about consent preferences- not based on dated regulatory requirements

Citation: Beskow, Laura M. Informed Consent for Biobanking (March 22, 2012), Duke Institute for Genome Sciences & Policy, slides available online: http://www.niehs.nih.gov/news/assets/docs_f_o/informed_consent_for_biobanking.pdf

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What information is “Important”

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Return of Results Study to

Participants

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Determining When to Return Results

• What is the potential that the results are inaccurate? Is it possible to re-test prior to returning results - though depending on the sample (quantity/quality)?

• What can the “results” tell them about their health?

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Negative Impact- Return of Results • How could this information

negatively impact the individual or their family?

- Anxiety, depression, and stress to individual and their family (increased risk if they aren’t able to interpret results)

- The results could relate to the individual and also the health of a family member

- Procedures or treatments that are risky or expensive but may not offer much benefit

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Positive Impact-Return of Results • How will knowing this information help them/ their family?

- Could they potentially avoid triggers or substances that are likely to increase their chance of having a disease /condition (e.g. alcohol and tobacco)

- Could they plan to help ensure the financial security of themselves and their family (obtain insurance coverage, adjust savings habits, etc.)

- Could they plan other tools - healthcare POA, wills, etc. in advance

- Could there be treatments or preventative action that can be taken to mitigate the impact of the disease or chance of getting a disease (this could become available later)

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Addressing Return of Results in Consent

• Opt-out

• Tiered Consent Approach

• All or Nothing:

• Results will be returned/Results will not be returned

• You may submit questions during our webinar survey, or…

• You may email your questions to: clientrelations@quorumreview.com

• We will do our best to follow-up with each question individually

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ADDITIONAL QUESTIONS

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• We value your opinion – please take our SURVEY and provide us with feedback

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WEBINAR FOLLOW-UP

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Thank you for your time!

THANK YOU FOR ATTENDING!

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fully accredited since 2006 February 25 & 27, 2014

Biobanking & Future Research: Addressing the “Unknown” in the Protocol & Consent