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Addressing the interests Addressing the interests

of researchers and sponsors: of researchers and sponsors:

Approaches to eliciting and Approaches to eliciting and

reviewing benefits which might reviewing benefits which might

compromise research integritycompromise research integrity

Ray H. ElliottRay H. Elliott

NHMRC Ethics in Human Research NHMRC Ethics in Human Research Conference, Canberra, May 2005:Conference, Canberra, May 2005:Concurrent Session 1 – Presentation 3Concurrent Session 1 – Presentation 3

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Ray Elliott, Ray Elliott, MAPS, FAHRIMAPS, FAHRI

Organisational Psychologist Organisational Psychologist

Research Research FellowFellow, International Centre for , International Centre for Corporate Governance, Faculty of Business Corporate Governance, Faculty of Business and Law, Victoria Universityand Law, Victoria University

Director – Director –

OEC : Organisation Enhancement OEC : Organisation Enhancement Consultancy MLQ PL : Leadership Consultancy MLQ PL : Leadership Assessment ServicesAssessment Services

NHMRC Ethics in Human Research NHMRC Ethics in Human Research Conference, Canberra, May 2005:Conference, Canberra, May 2005:Concurrent Session 1 – Presentation 3Concurrent Session 1 – Presentation 3

3

Issues to be addressed in ethical review Issues to be addressed in ethical review – researcher and sponsor interests and – researcher and sponsor interests and their contexttheir context

The total context of research: The total context of research:

* Research and sponsor interests and benefits* Research and sponsor interests and benefits

* The ‘Relational Context’ for researchers and * The ‘Relational Context’ for researchers and sponsorssponsors

* Third parties* Third parties

This is a legitimate / required area for ethical This is a legitimate / required area for ethical review. review.

* Commercial and other benefits from research * Commercial and other benefits from research outcomesoutcomes

* The ‘academic paradigm’: transparency in * The ‘academic paradigm’: transparency in practicepractice

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The “how” in the conduct of ethical The “how” in the conduct of ethical reviews: Corporate Governance issuesreviews: Corporate Governance issues

Institutional HRECs and the Institutional HRECs and the independenceindependence

Open, critical, informed and transparent Open, critical, informed and transparent review. review.

Appointments and structuresAppointments and structures

* Independent representation on the HREC from * Independent representation on the HREC from outside the Agency or institutionoutside the Agency or institution

* Independent chair* Independent chair

Securing the services of such peopleSecuring the services of such people

Quality ethical research conduct and review is Quality ethical research conduct and review is the objectivethe objective

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Committee processes in ethical Committee processes in ethical reviewreview

Committee processes – Committee processes –

Active review and not merely a reactive Active review and not merely a reactive compliance-driven mentalitycompliance-driven mentality

Proactive positive developmental engagement Proactive positive developmental engagement is required by researchers and reviewersis required by researchers and reviewers

This entails good communication to This entails good communication to supplement protocols where necessarysupplement protocols where necessary

The creative shepherding roleThe creative shepherding role

Enabling the exploration of researcher and Enabling the exploration of researcher and sponsor relational contexts. sponsor relational contexts.

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Appropriate disclosure of researcher Appropriate disclosure of researcher and sponsor interests, relationships and sponsor interests, relationships and their contexts.and their contexts.

Why the need for increased disclosure Why the need for increased disclosure about researcher and sponsor interests:about researcher and sponsor interests:

* Supporting the genuine freedom of the * Supporting the genuine freedom of the researcher researcher from limiting constraintfrom limiting constraint

* Clarifying multiple roles and possible * Clarifying multiple roles and possible dependencies dependencies between researchers, sponsors between researchers, sponsors and third partiesand third parties

* The researcher has basic responsibility for the * The researcher has basic responsibility for the conduct of research – but this can be conduct of research – but this can be

compromisedcompromised

* Clarifying the interests of the sponsors and * Clarifying the interests of the sponsors and stakeholders.stakeholders.

Outcome effects: research participants and Outcome effects: research participants and qualityquality

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The importance of ethical review The importance of ethical review including researcher and sponsor including researcher and sponsor interests, relationships and interests, relationships and contexts.contexts.

Current practices – Current practices –

* Filling the information gaps … or ignoring * Filling the information gaps … or ignoring them: ….them: …. HREC guesses and HREC guesses and extrapolotations from extrapolotations from experienceexperience

* Present National Statement guidelines * Present National Statement guidelines inadequateinadequate

* Changing researcher expectations and the * Changing researcher expectations and the researchresearchculture to ethical review: …. culture to ethical review: ….

* Moving from compliance to active ethical * Moving from compliance to active ethical awareness, responsibility and quality.awareness, responsibility and quality.

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Utilising a researcher and sponsor Utilising a researcher and sponsor interest and context audit template interest and context audit template within the committee. within the committee.

An Audit Template to Assist HREC Review An Audit Template to Assist HREC Review of researcher and sponsor relational of researcher and sponsor relational contexts:contexts:

Six major areas:Six major areas:

1. The category of researcher1. The category of researcher

2. Possible interests of the researcher2. Possible interests of the researcher

3. Associated sponsors3. Associated sponsors

4. Possible sponsors interests4. Possible sponsors interests

5. The relationship between researcher and 5. The relationship between researcher and sponsor(s)sponsor(s)

6. The degree of evident transparency in the 6. The degree of evident transparency in the protocol. protocol.

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Approaches to eliciting and Approaches to eliciting and reviewing researcher and sponsor reviewing researcher and sponsor interests and their relational interests and their relational contextscontexts

Recommendation 1:Recommendation 1:

Committee independence in the ethical review Committee independence in the ethical review of research of research with humanswith humans..

Recommendation 2: Recommendation 2:

Proactive supportive review – active Proactive supportive review – active communication between researcher and communication between researcher and committee where appropriate and needed.committee where appropriate and needed.

Recommendation 3: Recommendation 3:

Actively elucidating interests: an Audit Actively elucidating interests: an Audit Template for Research / Sponsor Interests & Template for Research / Sponsor Interests & Relational Contexts. Relational Contexts.

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Thank you!Thank you!

Your balanced critique is Your balanced critique is

sought and invitedsought and invited

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Ray Elliott, Ray Elliott, MAPS, FAHRIMAPS, FAHRI

Email: rayelliott@oecy.com.auEmail: rayelliott@oecy.com.au

Director - Director -

OEC : Organisation Enhancement OEC : Organisation Enhancement ConsultancyConsultancy

www.oecy.com.auwww.oecy.com.au

MLQ PL : Leadership Assessment ServicesMLQ PL : Leadership Assessment Services

www.mlq.com.auwww.mlq.com.au

For contact …For contact …