Do we really need Human Research Ethics processes in Community Health? John Bamberg (Research and Evaluation Consultant)

Western Region Health Centre -Situated in western suburbs of Melbourne. -Service a community population of 696,728 people. -Catchment area covers 3,400 square kilometres. -Employs 350 staff. -Services are delivered through 17 sites. 2

3 Examples of Ethics Violations -Dr. Albert Neisser (1898) -Thalidomide (Late 1950’s) -Tuskegee Study ( ) -Radiation Experiments (1940’s-1950’s) -Willowbrook State School (Early 1950’s) -Gulf War (1990)

Researcher’s Liability Litigations against researchers have included: - Breaches of confidentiality. - Issues related to insufficient informed consent. - Infliction of emotional distress. - Assault. - Violation of privacy. Singh, J.S. (2009). Research and Legal Liability. Acta Tropica. 112s, s71-s75 4

Institutional Liability Institutions have been sued for: -Not ensuring that researchers obtained informed consent. -Not providing sufficient supervision of researchers to ensure ethical research practice is not breached. Singh, J.S. (2009). Research and Legal Liability. Acta Tropica. 112s, s71-s75 5

6 Publishing Research and Evaluation Findings -Many Journals are now requiring authors to inform editors as to whether research and/or evaluation projects have approval from a HREC before a manuscript will be published. -Authors are also required to provide the name of the HREC.

7 How do CHC Obtain Ethics Approval? -Manager approves the research and evaluation projects. Projects that present difficulties are referred to other Managers for a collective approval. -Conduct research and evaluation in partnership with other institutions. -Have their own committee but find it difficulty to sustain. -Do not involve ethics processes.

How do CHC Obtain Ethics Approval? -Use staff ethical code of conduct. -The organisation does not seek ethics approval in the cases of evaluation. -Outsource their research and evaluation. -Seek Ethics approval through State. Government Health Ethics Committee. 8

Reported barriers to implementing an ‘Ethics’ Process -The forms take to long to fill out. -Don’t have the time. -Too complicated. -Too academic. -Too much paperwork. -Too long to wait for approval. -Don’t understand the questions on the form. 9

10 What We Did at WRHC -Developed Human Research Ethics policies and procedures. -Provided resources. -Training. -Created a Human Ethics Advisory Group (HEAG). -Formed an association with a University in suburban Melbourne, Victoria.

HEAG Functions and Responsibilities  To assess and approve low, negligible and no-risk research and evaluation proposals.  To asses and approve “Project-within-Program” proposals, of low, negligible and no-risk, associated with previously approved human ethics applications.  To forward and advise a Human Research Ethics Committee regarding proposals carrying high ethical risks.  To monitor research and evaluation projects to ensure compliance to the NHMRC National Statement on Ethical Conduct in Research Involving Humans.  To ensure members of the committee are appropriately qualified to assess human ethics research and evaluation proposals.  To provide training to HEAG members and Centre staff in the policy and procedures when conducting research and evaluation projects.  To ensure the safe keeping and safe disposal of confidential data collected for the purpose of research and evaluation.  To keep appropriate records of meetings and proposals considered. 11

HEAG reviews the application at monthly meeting Staff Member completes and submits ethics application Application is sent to Research and Evaluation Consultant HEAG determines project to be of low or no risk HEAG determines project to be of moderate or high risk or is unsure. Application is submitted to the University’s Human Research Ethics Committee Application is approved or approved after additional information is provided

In Conclusion -People working in the community health sector are committed to assisting those in need of their services. -Research and evaluation is a great benefit to practice. -Ethics reviews are an unknown entity, are often daunting and are frequently misunderstood. -Community health services may not have determined the importance of identifying, assessing and lessening the risks associated with research and evaluation projects. 13

In Conclusion -More attention should be paid to research and evaluation projects being conducted in an ethical manner. -We should learn from past ethics violations and develop more accountability through developing Human Research Ethics policies, procedures and processes within community health services. -It would be helpful if more academic institutions, such as universities, can collaborate with community health centres to achieve this aim. 14

Do we really need Human Research Ethics processes in Community Health? I think we do. I hope you agree. 15