john heldens, cip, ccrp director richard wagner, ma, cip, ccrp associate director michael thomas,...

John Heldens, CIP, CCRPDirector

Richard Wagner, MA, CIP, CCRPAssociate Director

Michael Thomas, CIP, CCRPManager

Melanie Mace, MA, CIP, CCRPEducation Coordinator

415-476-1814www.research.ucsf.edu/chr

Human Research Protection Program

HRPP Town Hall Meeting

May 31, 2012


2

Outline for Today• Reviews by Western IRB for Some Clinical Research

• Extended Approvals for Minimal Risk Research Projects That Have No Federal Oversight

• Exempting More Research and Exempt Consent Templates

• Simplifying Signature Requirements When Consenting Non-English Speakers


3

HRPP Mission StatementThe Mission of the HRPP is

• to promote the welfare and rights of human research participants

• to facilitate excellence in human research and

• to provide timely and high quality education, review and monitoring for human research projects.


Western IRB

• Why did we decide to rely on WIRB?

• What studies are eligible for review by WIRB?

• What the process for IRB review?

4


Why Rely on WIRB?

• HRPP has been pursuing IRB reliances with other IRBs for many years for multicenter research

• Many industry-funded clinical trials have already been approved by private IRBs before being submitted to UCSF

• Relying on an AAHRPP-accredited private IRB is a logical next step, especially for research that must be approved by a UCSF scientific review committee.

5


Eligibility

• Phase III and Phase IV clinical trials

• Industry-funded

• Industry-authored

• Approval from UCSF scientific review committee

– Cancer Center Protocol Review Committee

– CTSI Advisory Committees

6


Exceptions

Research involving the following must be reviewed by CHR:

• Surgical techniques or procedures

• Transplant research

• Neonates

• Stem cell therapies

• Gene transfer, gene therapy

• Investigational radiologic procedures

• Research involving SFVAMC

7


HRPP reserves the right to make additional exceptions and has final say on whether research must be reviewed by CHR

8


Financial Issues

• Sponsor must pay all WIRB fees.

• HRPP will charge a fee for these studies, but it will be less than current fee. Fee has not yet been approved.

• Contracts may not be signed until WIRB approval has been received.

9


HRPP Process overview

1. PI submits an abbreviated CHR application through iMedRIS

2. HRPP staff review to confirm eligibility, including scientific review

3. HRPP notifies PI and WIRB of eligibility

4. PI submits application to WIRB

5. WIRB reviews

6. WIRB notifies PI and HRPP of approval

10


Additional information

1. Only one submission to HRPP is necessary. Once eligibility has been confirmed, all future submissions and reporting are between PI and WIRB

2. HRPP will communicate with PRC or AC regarding scientific review.

3. Studies involving the CTSI Clinical Research Services will automatically be routed for AC review with CHR submission

4. PI can submit to HRPP, WIRB and scientific review in parallel

5. WIRB will not review until HRPP confirms eligibility

11


Details:Sections of CHR Application• 1.0 General Information

• 2.0 Setup Department Access

• 3.0 Grant Key Personnel Access

• 4.0 Qualifications of Key Study Personnel

• 5.0 Initial Screening Questions

• 6.0 Funding

• 7.0 Statement of Financial Interest

• 8.0 Sites

• 9.0 Relying on Another IRB

• 10.0 Drugs and Devices*

• 11.0 Other Approvals and Registrations

• 12.0 Subjects

• 13.0 CTSI Screening Questions*

12


Initial Screening Questions

13


Relying on Another IRB

14


Attachments

• Sponsor’s protocol is the only attachment HRPP needs to receive

• The consent form submitted to WIRB must follow UCSF template

• WIRB is responsible for ensuring consistency with that template

15


Other Reviews

• Conflicts of Interest

– HRPP will forward COIAC findings and management plans, if any, to WIRB. WIRB has final say on management plan for research they oversee. Management plan may require a modification to the study.

• Radiation Safety Committee

– Radiation Safety may require specific consent form wording. This may require a modification to the study.

16


Training

• HRPP will publish a web page shortly

• WIRB is responsible for training users on their system

17


Questions about WIRB?

18


19

Extended Approvals: Background and Policy• UCSF’s Federalwide Assurance (FWA) allows

some flexibility in applying human subjects federal regulations to non-federally supported research.

• HRPP has implemented a procedure for granting approval for up to 3 years for research projects that:

a) involve no more than minimal risk to participants (as defined by 45 CFR 46.102)

and

b) are not subject to federal oversight.


20

Studies Not Eligible for Extended ApprovalResearch Subject to Federal Oversight: Projects that receive federal support, that are implemented at the direction of federal agencies, or otherwise subject to federal oversight are excluded.

Examples include:

•Federal sponsorship (directly or indirectly) including federal training and program project grants

•Research directed or overseen by a federal agency that has signed on to the Common Rule, including every agency within Department of Health and Human Services


21

Studies Not Eligible for Extended Approval (cont.)

• Student projects when the faculty sponsor uses federal funding for the student’s project

• Federal no-cost extensions

• Studies subject to FDA oversight

• Studies seeking or obtaining Certificates of Confidentiality (which are granted by NIH)


22

Studies Not Eligible for Extended Approval (cont.)Studies where the CHR is serving as the IRB of record for an institution that applies the federal standards to all research regardless of funding source.

– San Francisco VAMC

– (NCIRE) Northern California Institute for Research and Education

– Lawrence Berkeley National Laboratory

– San Francisco Department of Public Health

– Ernest Gallo Clinical and Research Center

– J. David Gladstone Institutes

– The Jewish Home

– Institute on Aging

– Blood Centers of the Pacific

– Blood Systems Research Institute


23

Studies Not Eligible for Extended Approval (cont.)

Other Exceptions and Exclusions:

• Studies that involve greater than minimal risk.

• Studies that involve the following:

– Contractual obligations or restrictions that preclude eligibility in this policy, e.g., nonfederal sponsor or funder requires an annual review.

– UCSF is serving as IRB of record for an institution not mentioned above that requires annual review

– Involves prisoners or parolees as subjects

– Funded by the CIRM (California Institute for Regenerative Medicine)


The HRPP reserves the right to make exceptions to this policy, and inclusion/exclusion of any research project under this procedure will be at the HRPP’s discretion.

24


25

Post-approval Submission RequirementsStudies with extended approval periods will continue to have the same post-approval submission requirements. PIs continue to be responsible for submitting:

•modifications;

•reports of adverse events, protocol violation/ incidents, and other safety information meeting HRPP reporting criteria;

•continuing review submissions; and

•a closeout report when the study is complete.


26

IMPORTANT NOTE If the study becomes ineligible for an extended approval period because of new federal funding or other changes, the PI is responsible for promptly submitting a modification to notify CHR. The CHR will issue a new approval letter with a shortened approval period, as appropriate.


Questions about the extended approval policy?

27


28

Exemptions: Regulatory Status the Same• 4 Exempt Categories

– #1: Research conducted in established or commonly accepted educational settings, involving normal educational practices

– #2: Educational tests, survey procedures, interview procedures, or observations of public behavior, except when collecting identifiers and information that could place subjects at risk

– #3: Educational tests, survey procedures, interview procedures, or observations of public behavior when subjects are elected or appointed public officials or candidates for office

– #4: Collection or study of existing data, documents, records, specimens, if sources are publicly available or if the information is recorded so that subjects cannot be identified, directly or indirectly


Regulatory Status the Same

• CHR does not approve exempt research, but reviews and certifies that the study qualifies for exemption

• Investigators cannot self-certify study as exempt

• CHR certifies exemptions for 3 years

29


Expanded UCSF Definitions of What CHR Will Consider Exempt

Contact with outpatients at UCSF or affiliated health care facility

Some educational, survey, or interview research involving outpatients may now be exempted

– Exclude inpatients

– May not collect or record Protected Health Information (PHI) even for recruitment

30


Expanded UCSF Definitions of What CHR Will Consider Exempt

Review of Medical Records or other use of Protected Health Information (PHI)

– If collected prior to research for purpose other than the proposed research, and

– Investigator does not record any identifiers

Access to PHI is not exempt from HIPAA, so CHR must provide privacy board review and documentation

31


Minor Changes to Exempt Research Are Allowed Without Notifying CHR

– Editorial or administrative changes to consent forms or other documents

– Adding non-sensitive questions to survey or interview guide, or revising current questions

– Adding new recruitment material following CHR guidelines

– Increasing or decreasing number of subjects (but not adding a new subject population)

32


Significant Changes Still Must Be Submitted for Review

– Adding a new subject population

– Adding new procedures

– Adding a new funding source

– Adding questions about sensitive aspects of the subjects’ behavior – such as illegal conduct, drug use, sexual behavior, or use of alcohol – to a survey or interview

– Disclosing a new financial interest

– Any change that makes the study no longer eligible for exemption

33


Exempt Research Consent Guidance and Templates Available

– If study involves interaction with subjects, you usually should have a process to ask subjects to participate and confirm their agreement

– Signed consent is not required

– Process and documents can be simpler than for non-exempt studies

– CHR website has several short consent templates as well as a verbal consent script

34


Questions about the changes to exempt research?

35


36

Consenting Non-English Speaking Subjects

#1 Preferred Method – Use this method if many potential subjects

are non-English speakers.

– Obtain written translations of the consent form(s) after the study is approved and submit to CHR for approval.

– Qualified interpreter facilitates the consent discussion.


37

Preferred Method Documentation

Translated Informed ConsentCHR Approved

Experimental Subject’s Bill of RightsDownload in the subject's language – contact CHR for add’l

translations

Signatures required:1.Subject 2.Person obtaining consent

Document in the research file that an interpreter was used.

Give a signed copy to the subject.

Signatures required: None

Give a copy to the subject.


38

Consenting Non-English Speaking Subjects

#2 Short-form Method – Only use for the occasional and unexpected

enrollment of a non-English-speaking subject.

– A qualified interpreter verbally presents the English-language consent form to the subject and facilitates the consent discussion.


39

Short Form Method DocumentationEnglish-Language Consent

CHR ApprovedExperimental Subject’s Bill of Rights

Download in the subject's language

Signatures required:1.Person obtaining consent 2.Witness

Document in the research file that an interpreter was used.


Signatures required:1.Subject 2.Witness

Write a statement on the Bill of Rights that the elements of consent were presented orally.



40

Updates to the Short Form Method• Witness Can Sign Instead of Interpreter With

Short Form Consent Method

– The witness can be the interpreter or another person who witnesses the involvement of an interpreter.

– Should be someone other than the person obtaining consent.


41

Updates to the Short Form Method• What if your consent includes a “Translator” signature

line?

– Suggest you replace the “Translator” signature line with a “Witness” signature line. Submit to CHR as a minor modification.

– In the meantime, add a “Witness” signature line and date line by hand, when necessary.

Date Witness – Only required if the participant is

a non-English speaker


42

Using Interpreters• Who is a qualified interpreter?

– Medical interpreters

OR

– Fluent investigators or knowledgeable Key Personnel

– Strongly discourage using bilingual family members as medical interpreters.

• Interpreting via phone is OK

– If used for short form method, a witness should sign the consent and Bill of Rights.


43

HIPAA and Non-English Speakers• UCSF HIPAA Authorization form is now available

in 19 languages

• If a translated HIPAA authorization form is available:

– Subject signs the translated version.

– A translator should be available to speak with the subject about the form, but does not need to sign the form.

– Document that a translator was available in research file.


44

HIPAA and Non-English Speakers• If a translated authorization form is not available:

– An interpreter verbally presents the English-language form.

– The subject, interpreter, and a separate witness sign the form.

Check your CHR approval letter for HIPAA determinations.


45

Quick Guides (available in the Recruitment and Consent section):

– Consenting Non-English Speaking Subjects

– Consent Process and Documentation


46

john heldens, cip, ccrp director richard wagner, ma, cip, ccrp associate director michael thomas,...

Documents

human research projects

human research andto

ac review

minimal risk research

hrpp of approval

wirb approval

wirb of eligibilitypi

wirb fees