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Do we really need Human Research Ethics processes in Community Health?
Author:
John Bamberg,
Research and Evaluation Consultant
Western Region Health Centre,
81 Paisley St,
Footscray,
Melbourne, 3011.
Ph: 0396801103
Email: johnb@wrhc.com.au
This paper was presented at the Australasian Evaluation Society International Conference, Sydney, Australia, 29th August 2nd September 2011.
Abstract
Western Region Health Centre (WRHC) has conducted a project that built the capacity to conduct Research and evaluation and ensure our practices are evidence based. To accomplish this goal I was employed to build our capacity so that it could be included in staffs daily practice. A frequent question that arose was whether Ethics approval was necessary to conduct evaluation. To find an answer I surveyed 13 community based services to explore how this sector fulfilled their Human Research Ethics responsibilities.
The survey results indicated that many community health services failed to implement the NHMRC guidelines and could be viewed as not conducting evaluations based in ethical practice. At WRHC we developed a strategy by which ten staff members received university based training in appraising Human Research Ethics applications. Following the training, we established a Human Ethics Advisory Group that could approve no or low risk projects. To accommodate risks greater than no or low we have formed an association with a local universitys Human Research Ethics department.
In what follows I will present the development of WRHCs Human Research Ethics policy and procedures and why involving Ethics processes in conducting evaluation projects in community health centres is important.
Introduction
When conducting research and evaluation involving humans things can go wrong irrespective of the best plans and intentions. On rare occasions, research with human subjects has included terrible violations of human rights such as that known to have occurred in the detention and concentration camps during World War Two. These violations of human rights were the focus of the Nuremberg judgments that led to the development of the ethical processes necessary for conducting human research projects today ADDIN EN.CITE National Health and Medical Research Council2007389(National Health and Medical Research Council, 2007)38938946National Health and Medical Research Council,National statement on ethical conduct in human research2007( HYPERLINK \l "_ENREF_6" \o "National Health and Medical Research Council, 2007 #389" National Health and Medical Research Council, 2007).
Human research is defined as research which is conducted about people, their data/information or tissues ADDIN EN.CITE National Health and Medical Research Council2007389(National Health and Medical Research Council, 2007)38938946National Health and Medical Research Council,National statement on ethical conduct in human research2007( HYPERLINK \l "_ENREF_6" \o "National Health and Medical Research Council, 2007 #389" National Health and Medical Research Council, 2007). Equally, ethics has been described as a branch of philosophy that involves the morality of human behaviour and actions ADDIN EN.CITE Tangwa2009975(Tangwa, 2009)97597517Tangwa, G.B.Ethical principles in health research and review processActa TropicaActa TropicaS2-S7112Supplement 12009( HYPERLINK \l "_ENREF_8" \o "Tangwa, 2009 #975" Tangwa, 2009). Tangwa (2009) goes on to note that ethics is limited to free acts, actions and behaviours that are intentional, purposeful and liable to affect other creatures.
Currently in Australia, the Human Research code of ethics is governed by the National Health and Medical Research Council (NHMRC) which published a framework by which research and evaluation proposals are judged. This framework also takes heed of state and territory legislation regarding the ethical responsibilities of those proposing to conduct research or evaluation studies.
The NHMRC human research ethics guidelines are well established in universities and health and medical institutions such as larger sized hospitals. Equally the various State Government Departments such as the Victorian Department of Health also have Human Research Ethics Committees. However, community health centres, such as Western Region Health Centre (WRHC), have in the past not been successful in implementing policies involving formal Human Research Ethics procedures and processes. At WRHC, ethics approval for research and evaluation projects was gained mainly by contracted researchers and evaluators from the institutions they represented which normally consisted of universities. The small amount of research and evaluation conducted by staff members was either conducted with ethics approval gained through the Department of Health ethics committee or approval was not sought. When ethics approval was not sought, the management of WRHC received little information regarding how a research or evaluation project influenced and impacted on the participants, the staff members, the organisation and the community. Nor was WRHC management able to calculate the risks, if any, the research and evaluation projects presented to participants.
When the organisations research and evaluation capacity increased, the issues relating to Human Research Ethics approval also increased. However, implementing an ethics process met with some resistance. WRHC staff members stated that completing an ethics application was very time consuming, involved a lot of paper work and gaining approval often took considerable time. The issue of time was especially important as research, and in particular evaluation projects, had to be completed within a set time frame as demanded by funding bodies. For example, an evaluation that should be completed over a 12 month period becomes more difficult if gaining ethics approval for the project took 3 months. As evaluations are conducted additional to daily work requirements, the decrease in available time can increase staff member stress, reduce staff members motivation to conduct research and evaluation and decrease the depth and quality of the research and evaluation conducted.
For the reasons mentioned above the formulation of a Human Research Ethics policy and procedures at WRHC was very important in building research and evaluation capacity. The aim of developing an ethics process was to make the process simpler, less time consuming and more accountable and was therefore integral to building the organisations capacity to conduct its own research and evaluation projects.
In what follows I will present what a Human Ethics Advisory Group is and what WRHC accomplished in developing Human Research Ethics protocols in the organisation. I will focus on the ethical considerations relevant to research and evaluation projects normally conducted in community health such as human research, but refrain from discussing other research such as medical, animal and genetic research. Equally I will refrain from detailing what the Ethics guidelines entail as the guidelines are freely accessible from the NHMRC.
Ethics procedures in Community Based Health Agencies
Human Research Ethics Committees in Australia are mainly facilitated in academic institutions, such as universities, or larger medical hospitals ADDIN EN.CITE Berends2007187(Berends, 2007)18718717Berends, L.Ethical decision-making in evaluationEvaluation Journal of AustralasiaEvaluation Journal of Australasia40-45722007Ethics( HYPERLINK \l "_ENREF_1" \o "Berends, 2007 #187" Berends, 2007). These academic and hospital based Human Research Ethics Committees frequently apply ethical codes that are conservative and may not be realistic in practice settings ADDIN EN.CITE Richards2002956(Richards and Schwartz, 2002)95695617Richards, H.M.Schwartz, L.J.Ethics of qualitative research: are there special issues for health services research?Family PracticeFamily Practice135-1391922002( HYPERLINK \l "_ENREF_7" \o "Richards, 2002 #956" Richards and Schwartz, 2002). Human Research Ethics Committees impose ethical codes and standards that are based on the medical model and yet may review ethics proposals that involve a wide range of disciplines engaged in the social sciences such as social work and psychology ADDIN EN.CITE Berends2007187(Berends, 2007, Mauldon, 2005)18718717Berends, L.Ethical decision-making in evaluationEvaluation Journal of AustralasiaEvaluation Journal of Australasia40-45722007EthicsMauldon200595995995917Mauldon, E.Making ethics work in collaborative projectsAustralian Journal of Primary HealthAustralian Journal of Primary Health1132005( HYPERLINK \l "_ENREF_1" \o "Berends, 2007 #187" Berends, 2007, HYPERLINK \l "_ENREF_4" \o "Mauldon, 2005 #959" Mauldon, 2005). Mauldon (2005) argues that enforcing unrelated, externally determined ethical standards on health professional practices can weaken the assertion that such people can bring the benefit of their personal knowledge of their work to the research or evaluation process.
Mostly, health professionals do not consider research and evaluation as a pertaining to their daily work practice ADDIN EN.CITE ADDIN EN.CITE.DATA ( HYPERLINK \l "_ENREF_2" \o "Harrison, 2005 #87" Harrison, 2005, HYPERLINK \l "_ENREF_3" \o "Kegeles, 2005 #16" Kegeles, Rebchook and Tebbetts, 2005) and therefore Human Research Ethics is also not considered a priority. Equally, health professionals are usually not trained in the theoretical aspects of the ethical judgments within health research ADDIN EN.CITE Richards2002956(Richards and Schwartz, 2002)95695617Richards, H.M.Schwartz, L.J.Ethics of qualitative research: are there special issues for health services research?Family PracticeFamily Practice135-1391922002( HYPERLINK \l "_ENREF_7" \o "Richards, 2002 #956" Richards and Schwartz, 2002). Health professionals may have had contact with a Human Research Ethics committee when studying at a university in order to gain qualifications but may not have been involved in an ethics process for some time if at all. This led me to the question of how do community based health services manage their Human Research Ethics reviews.
To gain an understanding of how the community health sector managed their Human Research Ethics reviews, I contacted a number of services and peak bodies, who advised the health sector on health related issues and projects. The community based health agencies I contacted reported that they dealt with ethics issues in a variety of ways. The agencies reported the following methods of addressing human research ethics reviews.
The research or evaluation project is approved by a manager. If the project was
considered to be difficult, other managers in the organisation were consulted.
Agencies sometimes used the organisations code of conduct as the research
ethics review process.
Some agencies contracted the projects out to external researchers and considered
ethics approval as the responsibility of the contractors.
Similarly, agencies were frequently asked by universities to participate in
research projects and relied on the university and their ethics committees to
consider the projects ethics issues.
At times research ethics was approved through agency partnerships in a similar
fashion as approval being granted by a manager as noted earlier.
Some of the health service agencies received funding from the Victorian
Governments Department of Health, and therefore had access to their
Human Research Ethics Committee.
One health agency reported having convened a properly constituted Human
Research Ethics Committee as set out in the NHMRC guidelines but found it
problematic to sustain. The agency reported that as members withdrew from the
committee, new participants were difficult to find which resulted in the
committee losing its viability and subsequently disbanding.
Some agencies questioned whether evaluation projects required an ethical review.
9. Some agencies reported that they did not seek Ethics approval for their projects.
As can be noted, community based health agencies vary considerably in the way they manage the ethical issues and processes in their research and evaluation practice. Although ethics procedures within community based health services remains challenging, it was universally agreed to by the people I contacted that the ethical review of potential research and evaluation projects within the health sector remained problematic and difficult to maintain. Similarly, the agencies acknowledged that they did not know what the solution was.
Developing Ethics procedures at WRHC
To initially track the research and evaluation projects conducted at WRHC, I developed a Research and Evaluation Proposal Form for the use by WRHC staff members. The Research and Evaluation Proposal Form, although not a formal ethics application document was never-the-less based on academic Human Research Ethics application guidelines. While attempting to complete the Research and Evaluation Proposal Form, I received a number of questions related to the completion of the form, which indicated that only a few staff members had experienced an ethics process and therefore required training in the understanding of what an ethics review was and what constituted a sound human research ethics proposal.
To assist staff members understand the ethics process, I explored the possibilities of enrolling interested staff members in an ethics training course. I contacted a representative of a Universitys Ethics Department with the aim of investigating the possibility for a select number of staff members to be trained in assessing the Human Research Ethics proposals submitted by staff members. The University Ethics Department graciously agreed and trained a select number of staff members in the issues governing human research ethics applications. Following the training we created a Human Ethics Advisory Group (HEAG) at WRHC.
What is a HEAG?
The main purpose of a HEAG is to assess the research proposals submitted by university staff and students and advice the universitys Human Research Ethics Committee as to the ethical issues identified in the proposals ADDIN EN.CITE Melbourne Research Human Ethics - University of Melbournen.d.99199199143 Melbourne Research Human Ethics - University of Melbourne,Human Ethics Advisory Groupsn.d.http://www.research.unimelb.edu.au/humanethics/membersadmins/roles/heag( HYPERLINK \l "_ENREF_5" \o "Melbourne Research Human Ethics - University of Melbourne, n.d. #991" Melbourne Research Human Ethics - University of Melbourne, n.d.). The HEAG is a concept that has been accepted by a number of universities in Victoria and is normally faculty based.
The responsibilities of a HEAG are as follows:
To consider and approve Project-within-Project proposals.
To consider and approve no, low and negligible risk proposals and provide a
report to the Human Research Ethics Committee.
To ensure that those conducting the research are appropriately qualified.
To ensure the data collected during the research project is correctly and
securely stored and disposed of.
To monitor the research projects regarding adherence to the NHMRC guidelines.
To provide ethics training to staff, researchers and HEAG members.
To attend training sessions provided by the Human Research Ethics Committee.
To keep suitable and appropriate records of assessed proposals for the purposes of
compliance and audits.
ADDIN EN.CITE Melbourne Research Human Ethics - University of Melbournen.d.99199199143 Melbourne Research Human Ethics - University of Melbourne,Human Ethics Advisory Groupsn.d.http://www.research.unimelb.edu.au/humanethics/membersadmins/roles/heag( HYPERLINK \l "_ENREF_5" \o "Melbourne Research Human Ethics - University of Melbourne, n.d. #991" Melbourne Research Human Ethics - University of Melbourne, n.d.)
WRHCs HEAG
On exploring the role of a university based HEAG, I felt confident that such an ethics process was able to be implemented at WRHC. I also felt confident that WRHC could fulfil the responsibilities of a HEAG as outlined above. However, implementing a HEAG within a community health centre such as WRHC required further considerations in relation to an affiliation with an institutional Human Research Ethics Committee. Such an affiliation was necessary in order to review and approve research and evaluation projects that constituted risks greater than low or negligible in regarding to projects for which a HEAG was not suitable.
In addition, associating the HEAG with a universitys Human Research Ethics Committee offered greater legitimacy and support for the research and evaluation projects proposed by WRHC staff members. The institutions that most commonly incorporate a Human Research Ethics Committee are the universities and consequently it was a local university I contacted.
I contacted the manager of the ethics department at a local University in Victoria, and arranged a meeting to discuss the possibility of the WRHC HEAG associating with their ethics committee. The ethics manager was hopeful of my proposal of associating the WRHC HEAG with the universitys ethics committee and agreed to consult with the ethics committee chair and present my proposal. After presenting my proposal, the manager reported that the chair of the ethics committee considered my proposal favourably and a meeting between two senior representatives of the Ethics department, a senior manager of WRHC and myself occurred in early, 2011, at which time the proposal was presented and discussed. As the discussion progressed a decision was reached in which the WRHCs HEAG would approve no, negligible and low risk ethics applications and refer application with a higher risk to the universitys ethics committee for review. We agreed to limit the number of referrals to around five per year and as approximately 85% of the applications at WRHC involved no or low risk evaluation projects, the proposed number of referrals was acceptable. Another condition involved that the referral of high risk ethics applications be sponsored by a person involved with the university. It was decided that I should be that person due to my involvement with research and evaluation at WRHC.
We decided that the above agreement would be piloted over the remainder of 2011 and, if successful, we would move towards a more formal agreement. In addition to the above conditions, the universitys representatives requested that a WRHC staff member become a member of universitys ethics committee and provide a community health perspective to the committee when reviewing applications. An agreement was made by WRHC that I be the staff member representing the organisation on universitys faculty Human Research Ethics committee.
Conclusion
In conclusion, it is of great benefit for community health services to engage in the research and evaluation of their practices, interventions and services. However, more attention should be paid to the research and evaluation projects being conducted in an ethical manner as determined by the NHMRC. I recognise that for a number of people employed in the community health sector, Human Research Ethics reviews are often an unknown entity, are often daunting and are frequently misunderstood.
There is little doubt that the people working within the community health sector do so with commitment and with a principle for assisting those in need of their services. However, it is with interest that my study found community health services that had not determined the importance of identifying, assessing and lessening the risks to the confidentiality and the physical, emotional, psychological, social and spiritual safety of those participating in research and evaluation projects. Such an opportunity to understand, identify, assess and lessen the risks associated with research and evaluation projects is offered by the Human Research Ethics guidelines published by the NHMRC.
It is my belief that we should learn from past violation of the human rights committed by research and evaluation projects and develop policies, procedures and processes within community health services that allow for greater accountability and safety for those that participate in research and evaluation projects and those that utilise community health services. It would be helpful if more academic institutions, such as universities, can collaborate with community health centres to achieve this aim in a similar way as the collaborative understanding achieved between the above University and Western Region Health Centre.
References
ADDIN EN.REFLIST BERENDS, L. 2007. Ethical decision-making in evaluation. Evaluation Journal of Australasia, 7, 40-45.
HARRISON, R. A. 2005. Barriers and opportunities to developing research capacity in primary care trusts: the views of staff attached to a primary care trust. Primary Health Care Research and development, 6, 185-189.
KEGELES, S. M., REBCHOOK, G. M. & TEBBETTS, S. 2005. Challenges and facilitators to building program evaluation capacity among community-based organizations. AIDS Education and Prevention, 17, 284-299.
MAULDON, E. 2005. Making ethics work in collaborative projects. Australian Journal of Primary Health, 11.
MELBOURNE RESEARCH HUMAN ETHICS - UNIVERSITY OF MELBOURNE. n.d. Human Ethics Advisory Groups. Available: HYPERLINK "http://www.research.unimelb.edu.au/humanethics/membersadmins/roles/heag" http://www.research.unimelb.edu.au/humanethics/membersadmins/roles/heag.
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL 2007. National statement on ethical conduct in human research.
RICHARDS, H. M. & SCHWARTZ, L. J. 2002. Ethics of qualitative research: are there special issues for health services research? Family Practice, 19, 135-139.
TANGWA, G. B. 2009. Ethical principles in health research and review process. Acta Tropica, 112, S2-S7.
Disclaimer
The views presented in this paper are those of the author rather than the organisation and does not necessarily reflect the views of WRHC or any other agency or service.
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