1. 1 Addressing the interests of researchers and sponsors: Approaches to eliciting and reviewing benefits which might compromise research integrity Ray H. Elliott NHMRC Ethics in Human Research Conference, Canberra, May 2005: Concurrent Session 1 – Presentation 3

2. 2 Ray Elliott, MAPS, FAHRI Organisational Psychologist Research Fellow, International Centre for Corporate Governance, Faculty of Business and Law, Victoria University Director – OEC : Organisation Enhancement Consultancy MLQ PL : Leadership Assessment Services NHMRC Ethics in Human Research Conference, Canberra, May 2005: Concurrent Session 1 – Presentation 3

3. 3 Issues to be addressed in ethical review – researcher and sponsor interests and their context The total context of research: * Research and sponsor interests and benefits * The ‘Relational Context’ for researchers and sponsors * Third parties This is a legitimate / required area for ethical review. * Commercial and other benefits from research outcomes * The ‘academic paradigm’: transparency in practice

4. 4 The “how” in the conduct of ethical reviews: Corporate Governance issues Institutional HRECs and the independence Open, critical, informed and transparent review. Appointments and structures * Independent representation on the HREC from outside the Agency or institution * Independent chair Securing the services of such people Quality ethical research conduct and review is the objective

5. 5 Committee processes in ethical review Committee processes – Active review and not merely a reactive compliance- driven mentality Proactive positive developmental engagement is required by researchers and reviewers This entails good communication to supplement protocols where necessary The creative shepherding role Enabling the exploration of researcher and sponsor relational contexts.

6. 6 Appropriate disclosure of researcher and sponsor interests, relationships and their contexts. Why the need for increased disclosure about researcher and sponsor interests: * Supporting the genuine freedom of the researcher from limiting constraint * Clarifying multiple roles and possible dependencies between researchers, sponsors and third parties * The researcher has basic responsibility for the conduct of research – but this can be compromised * Clarifying the interests of the sponsors and stakeholders. Outcome effects: research participants and quality

7. 7 The importance of ethical review including researcher and sponsor interests, relationships and contexts. Current practices – * Filling the information gaps … or ignoring them: …. HREC guesses and extrapolotations from experience * Present National Statement guidelines inadequate * Changing researcher expectations and the research culture to ethical review: …. * Moving from compliance to active ethical awareness, responsibility and quality.

8. 8 Utilising a researcher and sponsor interest and context audit template within the committee. An Audit Template to Assist HREC Review of researcher and sponsor relational contexts: Six major areas: 1. The category of researcher 2. Possible interests of the researcher 3. Associated sponsors 4. Possible sponsors interests 5. The relationship between researcher and sponsor(s) 6. The degree of evident transparency in the protocol.

9. 9 Approaches to eliciting and reviewing researcher and sponsor interests and their relational contexts Recommendation 1: Committee independence in the ethical review of research with humans. Recommendation 2: Proactive supportive review – active communication between researcher and committee where appropriate and needed. Recommendation 3: Actively elucidating interests: an Audit Template for Research / Sponsor Interests & Relational Contexts.

10. 10 Thank you! Your balanced critique is sought and invited

11. 11 Ray Elliott, MAPS, FAHRI Email: rayelliott@oecy.com.au Director - OEC : Organisation Enhancement Consultancy www.oecy.com.au www.oecy.com.au MLQ PL : Leadership Assessment Services www.mlq.com.au www.mlq.com.au For contact …