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 1 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

IRBs 2 � 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?

IRB function 3 � 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

Criteria for IRB Approval-UCI 4 45 CFR 46.111, 21 CFR 56.111 BENEFICENCE JUSTICE Subject Selection Experimental Design Risk/Benefit Analysis Inclusion/exclusion Data Safety Recruitment Qualifications of Researchers Fair Distribution RESPECT FOR PERSONS Privacy & Confidentiality Vulnerable Populations Informed Consent Surrogate Consent Parent Permission / Assent

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! 7 � 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

MISCONDUCT in HIV prevention projects (breaking the rules) 8 � 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

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