Navigating the UCLA IRB Review Process

OHRPP presentation toSchool of Nursing

June 25, 2012

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Who is(are) the UCLA IRB(s)?Who is(are) the UCLA IRB(s)?

Faculty with scientific expertise Community non-scientific members Wh t d th OHRPP t ff d ? What does the OHRPP staff do?

UCLA IRB Descriptions: phttp://ohrpp.research.ucla.edu/pages/irb-descriptions

UCLA IRB Member Rosters: http://ohrpp.research.ucla.edu/pages/irb-members

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When is review required?When is review required?

• UCLA Policy 991http://www.adminvc.ucla.edu/appm/public/991.pdf

• All faculty and staff who are conducting studies involving human participantsAll faculty and staff who are conducting studies involving human participants within the course and scope of their duties, as well as UCLA students who are conducting studies involving human participants within the course of their studies, regardless of the source of the funding, or even in certain cases in which no funds are involved, are required without exception to h i l f th IRB b f R h i i iti t dhave prior approval from the IRB before Research is initiated.

• Regardless of percent of effort, prior approval of the IRB is required, without exception, when human participants research studies conducted by UCLA f lt t ff t d t UCLA UCLA ffili t d f ilitifaculty, staff or students access any UCLA or UCLA-affiliated facilities, patients, personnel, or students and/or when the human Research is supported either by extramural funds granted to, or applied for through, The Regents of the University of California, or for Research conducted with UCLA funding at non-UCLA sites

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UCLA funding at non-UCLA sites.

Is it research?Is it research?

OHRP guidance dictates the order in which activities should be assessed to determine what regulations are applicable and what level of review may be necessary:applicable and what level of review may be necessary:

1. Research2. Involving human subjects3. Engagement of institution (UCLA)

At UCLA, these determinations are responsibility of the Office of the Human Research Protection Program’s

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(OHRPP) (a.k.a., IRB office).

“Research” defined“Research” defined

Research:A systematic investigation including research development testingA systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

45 CFR 46.102(d)

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Research vs QIResearch vs. QI

• Federal guidance: OHRP Frequently Asked Questions: Quality Improvement Activitieshttp://www.hhs.gov/ohrp/policy/qualityfaqsmar2011.pdfp g p p y q y q p

• Call or email the UCLA OHRPP for case-specific determinations of whether (an) activity(ies) require UCLA IRB review or certification of exemption from UCLA IRB review.

Alison Orkin (310) 206-3969 aorkin@research ucla eduaorkin@research.ucla.edu

Augustine Fernandes (310) 983-3155 augustine.fernandes@research.ucla.edu

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g @

Now I know it’s “Research”Now I know it’s “Research” …

If proposed activities t th d fi iti f “ h”meet the definition of “research”,

the next step is to determine whether they involvedetermine whether they involve

“human subjects.”

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“Human subject” defined“Human subject” defined

• Human Subject (participant)

A living individual about whom an investigator (whether professional or student) conducting research obtains:

• data through intervention or interaction with the individual, orid tifi bl i t i f ti [45 CFR 46 102(f)]• identifiable private information. [45 CFR 46.102(f)]

Note: HUMAN SUBJECTS may include the person(s) about whom ti i t id i f tia participant provides information

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“Human subject” defined“Human subject” defined

I iIntervention:• physical procedures and manipulations of the subject’s environment

performed for research purposes.

Interaction:• includes communication or interpersonal contact between

investigator and subject

Private Information:• includes information about behavior that occurs in a context in which

an individual can reasonably expect that no observation or recordingan individual can reasonably expect that no observation or recording is taking place, and information has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public.

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OHRP: “Not human subjects”OHRP: “Not human subjects”

OHRP Guidance on Research Involving Coded Private Information or Biological Specimens O t b 16 2008 )October 16, 2008 )http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf

• OHRP does not consider research involving only coded private information or specimens to involve p phuman subjects as defined under 45 CFR 46.102(f) if the following conditions are both met:

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OHRP: “Not human subjects”OHRP: “Not human subjects”

…• (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– (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 it d t t t th t hibit th l f th k t threpository 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.

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Research + / Human SubjectsResearch + / - Human Subjects

If proposed activities = “research” + do NOT involve “human subjects”, neither UCLA IRB review nor certification of exemption

from UCLA IRB review is required. No further contact with OHRPP/IRB necessary.

If proposed activities = “research” + DO involve “human subjects”, then the next step is to complete and submit

an application in UCLA’s online webIRB system.pp yhttp://webIRB.research.ucla.edu

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webIRBwebIRB

• webIRB online application for exempt, expedited, and full committee review

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IRB Processes & RequirementsIRB Processes & Requirements

• Levels of review:– Certification of Exemption from IRB Review– IRB Review - Expedited ReviewIRB Review Expedited Review– IRB Review - Convened IRB ("Full Committee Review")– Reliance on External IRB (only occasionally appropriate)

• Any changes in the research must receive prospective review and approval, such as– Modifications to surveys

F ll i t i dd d– Follow-up interviews added– Change in purpose of study

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Timing & duration of approvalTiming & duration of approval

• Current IRB approval or certification of exemption must be obtained PRIOR to initiating contact with participants and/or access to or collection of data about subjects

• Exempt research is certified for five years unless there are changes in the project

• Regulations do not allow for more than 365 day approval of non-exempt research

• Continuing review of IRB approved research must be conducted at least annually.

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Minimal RiskMinimal Risk

Mi i l Ri kMinimal Risk [45 CFR 46.102(i)]

Where the probability and magnitude of harm or discomfortWhere the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered

i d il lif [ f h lth ]– in daily life [of a healthy person]

– or during the performance of routine physical or psychological examinations or testsexaminations or tests.

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Risk AssessmentRisk Assessment

• Risk (defined):

The probability of physical psychological social or economicThe probability of physical, psychological, social, or economicharm occurring as a result of participation in a research study.

Both the probability and magnitude of possible harm may vary f i i l t i ifi tfrom minimal to significant.

Note: The IRB will determine on a case by case basis the risk andNote: The IRB will determine on a case by case basis the risk and review level of each research project submitted to the OHRPP

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Ethical Basis for IRB RegulationsEthical Basis for IRB Regulations

The Belmont Reportwww.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

Key principles• Respect for persons - informed consent process• Beneficence - risk/benefit ratio• Justice - equitable selection

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Participant RecruitmentParticipant Recruitment

• Recruitment is the beginning of the consent process.

• Determine who will be inviting potential participants to participate d d t i h t ill th D t i h th t thand determine what will they say. Determine whether or not the

“recruiter” is appropriate/authorized to recruit your target population.

C id t ti l i f d i fl (• Consider potential coercion or appearance of undue influence (e.g. supervisor to recruit staff) when identifying methods of contact and recruitment.

• Provide the IRB copies of all contact materials (scripts, letters, flyers, etc.)

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Informed ConsentInformed Consent

i f i ti th t f ilit t d i i ki d• … is a process of communication that facilitates decision making and demonstrates respect for the dignity of the participant.

• Should empower participants to make their own decision about undertaking risks,

• MUST be in a language understandable to the participant.

• A non-response to a request to participate in research does not meet the regulatory requirements for informed consent.

• "Passive consent" or "implied consent" is not consent and requires• Passive consent or implied consent is not consent and requires IRB approval of a waiver of informed consent.

• Regulations allow IRB approval of consent/assent processes with or without participants’ signature as documentation

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participants signature as documentation.

Flexible Consent ProcessesFlexible Consent ProcessesNo documentation required

• Consent processes using letters, email, internet, and/or oral discussion can be approved IF

– The Research is minimal risk and involves no procedures which require signed consent outside of the research context,

OROR– the only record linking the subject and the research would be the

consent document and the principal risk [of the research] would be potential harm resulting from a breach of confidentiality.

[45 CFR 46.117(c)]

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Waiver of Informed ConsentWaiver of Informed ConsentNo consent required

Th IRB i f h i f bj ’ i f dThe IRB can approve a waiver of the requirement for subjects’ informed consent if:

– Minimal riskMinimal risk– Will not adversely effect the rights or welfare of the subjects– the research could not practicably be carried out without the

waiver – whenever appropriate, subjects will be provided with additional

pertinent information after participation

[45 CFR 46 116(d)][45 CFR 46.116(d)]

NOTE: This is NOT usually approved for research that involves contact with participants.

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p p

IRB review considerations Justice: Equitable Selection

Equitable selection:Recruitment strategy must help ensure that selection of research participants is equitable and appropriate for the study

Vulnerable Populations:The federal regulations require additional protections and g q pconsiderations for some defined participant populations:– Prisoners– Pregnant women, fetuses, and neonates– Children

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IRB review considerationsIRB review considerations

Vulnerable Populations

The federal regulations require additional protections and g q pconsiderations for some defined participant populations:

– PrisonersP t f t d t– Pregnant women, fetuses, and neonates

– Children

The IRB assesses all protocols to ensure that researchers haveThe IRB assesses all protocols to ensure that researchers have provided adequate protections for potential participants, and that regulatory requirements have been met for the above vulnerable (“protected”) populations.

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Confidentiality of recordsConfidentiality of records

Access to records is governed by:• CA Law• Federal regulations - e.g., FERPA• Institutional policies• Ethical principlesEthical principles

Records accessible to a researcher because of his/her employment responsibilities may not be accessed foremployment responsibilities may not be accessed for research purposes without express permission from the appropriate parties.

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ResourcesResources

• CITI training for Key Personnelincluding student PIs and faculty sponsorshttps://www.citiprogram.org/default.asp

• Consent templates:Consent templates: http://ohrpp.research.ucla.edu/pages/biomedical-informed-consent

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Contact UsContact Us

• Policies, training, questions, complaintsAlison Orkin (310) 206-3969aorkin@research.ucla.edu

• Is IRB review required? Exempt & expedited reviewExternal IRB review/relianceAugustine Fernandes (310) 983-3155 augustine.fernandes@research.ucla.eduaugustine.fernandes@research.ucla.edu

• SGIRB Full Committee ReviewGloria Varghese (310) 825-3969 gvarghese@research.ucla.edu

• SGIRB Amendments, Continuing Review, Campus ConsultsRobin McGrath (310) 794-9287 Diana Alcaraz (310) 206-7362 rmcgrath@research.ucla.edu diana.alcaraz@research.ucla.edu

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Staff list: http://ohrpp.research.ucla.edu/pages/girb-staff