Quality Metrics of Performance of Research Ethics Committees Cristina E. Torres, PhD FERCAP Coordinator

IRB/ REC as a social construct Meant to provide a social service for the protection of humans in research Ensures scientific and ethical soundness of research protocols Ensures good data for evidence based medicine Improves the social value of research

Measurement of performance of social/ public services 3 Es of social/ public services Equity Efficiency Effectiveness

Social Equity Commitment to promote fairness, justice and equity in the provision of public/ social services “Absence of systematic health disparities among social groups with different levels of underlying social advantage/disadvantage” In health research, it refers to –Respect to human participants –Beneficence –Distributive justice in the allocation of benefits of research

Efficiency Focuses on getting the maximum results with minimum cost/ resources and time Scientifically, it is defined as the output to input ratio Process oriented, refers to ‘means of doing things’ in the right manner Often measurable as ability to avoid wasting materials, energy, efforts, money, and time For IRB performance, it means –Quality review at the shortest time

Effectiveness Refers to doing the ‘right things’ Constantly measures if the actual output meets the desired output Focuses on achieving the ‘end’ goal May also be achieved through inefficient processes IRB goal: Protection of human participants in research

3Es in the FERCAP/ SIDCER Assessment of IRBs Assessment areas 1.Structure and composition of the IRB 2.Adherence of SOPs to international and national guidelines 3.Review procedures 4.Post approval procedures 5.Documentation and archiving

1. Structure and composition of IRB Equity issues Composed of medical/ scientific and non medical/ non scientific members Medical/ scientific members conduct technical review of the protocol Non medical and non scientific members review the consent forms Community/ patient representatives provide inputs about the protocols

2. Efficiency in good IRB SOPs Standard operating procedures account for efficient review –Standardized procedures derived from good practice Expedited/ full board review Primary review system Standard meeting procedures Standard approval process –Systematic review through use of standard forms and checklists

Efficiency in good IRB SOPs Standard operating procedures account for efficient review –Systematic review through use of standard forms and checklists Application form Reviewer assessment form Templates for Approval certificates, agenda, meeting minutes –Defining timelines for submission, review and approval

3. Effectiveness in comprehensive initial review procedures Competent primary reviewers –Diligently reads the protocol related documents –Conducts literature/ internet search –Fills up the assessment forms with relevant comments to ensure comprehensive review –Leads the discussion during full board meetings –Makes appropriate recommendations to improve the protocol/ ICF

Good review procedures Good Assessment Form Enables appropriate review of technical issues – Objectives –Design and methodology –Inclusion/ exclusion criteria –Scientific tools –Sample size –Analysis plan

Good Protocol Review Good Assessment Form Enables appropriate review of ethical issues –Appropriate risk/ benefit ratio Ethically sound design and methodology Appropriate Inclusion/exclusion criteria Addresses vulnerability issues Addresses conflict of interest Maintains confidentiality Qualified research team Appropriate site

Good ICF Review Good ICF review checklist based on essential ICF elements Full disclosure of information –Same information found in the protocol –Compensation, medical care –Patient responsibilities Comprehension –Use of simple terms and local language Voluntariness

Good board meeting dynamics Chair presides and on top of discussion Members actively participate Medical/ scientific members provide technical and ethical comments Non medical comment about ICF and patient rights and safety Members freely give opinions Consensus/ decisions arrived at

4. Effectiveness in appropriate IRB monitoring procedures IRB post review procedures Continuing risk/ benefit assessment of –Protocol and ICF amendments –Progress reports –SAE reports –Protocol deviation/ violation reports –Final reports Appropriate IRB decisions during review of reports

Good IRB monitoring procedures Continuing/ post approval review Appropriate channel for review (expedited/ full board) Reviewers familiar with initial review issues Maintain appropriate risk/ benefit ratio Linked to initial EC approval Patient safety is the primary concern

Good continuing review Submission of annual report to renew approval Protocols initially reviewed at full board should have continuing review done at full board (Expedited protocols go to expedited review.) Key issues for review –Risks/ benefit assessment –Adequacy of ICF/ reconsent –Local issues –Total subject enrollment.

5. Evidence of effectiveness in good documentation and archiving Complete and timely documentation of each protocol file Quality minutes SAE files SOPs Membership files Updated IRB database

Final measures Primary outcome Protect subjects in human research Credible research data Other outcomes are secondary Increase in the number of clinical trials reviewed Not about increase of IRB income

Current REC Challenges FERCAP/ SIDCER recognition helps address the ff. Need to address growing public mistrust of research Need to develop capacity for quality review Need to harmonize IRB requirements in different parts of the world (developed and developing countries) Need to develop ethical review systems that involve research stakeholders (regulatory authorities, industry, academe, patient groups)