Role of the research regulatory agencies-IRBs 1 B R AN D O N B R - - PowerPoint PPT Presentation

Role of the research regulatory agencies-IRBs

B R AN D O N B R O W N D I R E C TO R O F G H R E AT U C I RV I N E P R O G R AM I N P U B L I C H E ALT H I RV I N E , C A U S A 1

IRBs

IRB=Institutional Review Board (ethics committee) created as a direct response to Nuremberg and

Tuskeegee

safeguard the rights, safety, and well-being of trial subjects 3 ethical principles in the Belmont report

Beneficence, justice, respect Voluntary study participation

Declaration of Helsinki Distinction between care and research

HIV testing and treatment

• research or care?

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IRB function

Gatekeepers to starting your study

Nothing happens without IRB approval

Human subjects protection focus

They don’t try to change science

Investigators often don’t like IRB applications

Cumbersome Causes delays in starting studies Barrier to funding BUT They help protect the PI and also the University

Lawsuits, ethical violations, etc

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Criteria for IRB Approval-UCI

BENEFICENCE JUSTICE RESPECT FOR PERSONS

Experimental Design Risk/Benefit Analysis Data Safety Qualifications of Researchers

45 CFR 46.111, 21 CFR 56.111

Privacy & Confidentiality Vulnerable Populations Informed Consent Surrogate Consent Parent Permission / Assent Subject Selection Inclusion/exclusion Recruitment Fair Distribution

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IRBs-Specific attention in reviewing HIV Prevention Protocols

Cultural issues

sensitivity to the environment the research would be

conducted in, and the specific subject population

How are ppl w HIV treated/viewed/respected?

Subject privacy issues

how prospective subjects are approached for participation Assumed high risk group-approached in public Participation=stigma (known HIV study)

Confidentiality of data

risk to subjects if exposed as involved in HIV prevention study Stigma, criminal charges, death, loss of social status/employment

Specifics to HIV protocols continued-consent

Consent

Understandability Risk and benefits Clinical trial may not actually lead to prevention of HIV Re-consenting over long periods

Longitudinal understanding

• how vaccine study affects rapid HIV test results

Tell all potential risks ‘illness/death is possible from the drug/vaccine Sample use Future research for HIV related work?

IRB approval!

Usually approval pending other site approvals

For studies in several countries

The last time you need to deal with the IRB?

Think again Amendments common Report adverse events as they occur Scientific advances Research today=standard of care tomorrow

How to make the transition

The audit-deviations and misconduct Someone from IRB sent to oversee activities Can pull the plug on your study

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MISCONDUCT in HIV prevention projects (breaking the rules)

Study not occurring

Money being spent/pocketed

Maintaining bad records

No security Appropriate amount of time Or no records

Misrepresenting speculation as fact to participants

‘Sure this vaccine/treatment will work’

Changing randomization assignment

Feel that it will help this person

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Preventing misconduct (Oversight Needs)

Ethics violations

during implementation of the research, management at

the study site, or study closure

IRB role

May observe the consent process and/or the research May embargo of publications/presentations May suspend or terminate approval of research not conducted in accordance with the regulations

Post approval monitoring (PAM) to identify

violations at an early stage

Threat of IRB oversight can prevent violations

IRB has this option

PAM in HIV Prevention Research

In HIV research taking place in another country, a

site visit from a collaborating IRB is more difficult

Potential barrier to regulatory oversight barrier may be overcome by the use of digital technologies most of the world has at least remote access to the internet

Skype, face time, google chat

Use of PAM Technology in HIV Prevention research

Reduced expenses and facilitation of communication

Save on the cost of an in person visit-air ticket every X months May further help reduce ethical violations Communication is key

Funds written into grants to support technology

needed for PAM and to provide human subjects training to research collaborators

Consider as a requirement for future federally funded

international research

Creation of PAM Ambassadors at IRBs and research sites One option we have to make our studies more ethical