Research ethics paperwork: what is the plot we seem to have lost?
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《英国医生杂志》
1 Department of Primary Care and Social Medicine, Imperial College, London W6 8RP jamrozik@imperial.ac.uk
The standardisation of applications to local research ethics committees seems likely to make ethical approval less efficient and more time consuming for everyone
Introduction
The first step is to determine the essential information required for ethical approval. Based on my experience as a member of three ethics committees in two countries, I think that members ask themselves four basic questions:
What hazards are raised by the research protocol?
Can the protocol be redesigned to reduce these hazards without compromising its ability to answer the research question?
Have the investigators taken reasonable steps to minimise the chances that the (remaining) hazards result in harm?
Are either the hazards or the risk of their resulting in harm disproportionately great in relation to the apparent importance of the knowledge to be gained?
What are the hazards?
Local research ethics committees effectively match their collective wits against the applicant's to see whether the study question can be answered with equal or greater validity at lower risk to the participants. These deliberations require not only knowledge of ethical principles but also familiarity with the strengths and weaknesses of different study designs and at least some insight into the research topic. Single members of an ethics committee rarely have expertise in all of these domains for a given application, but the combined membership of many committees will.
Strategies to minimise the realisation of risks
Even well crafted applications cannot be passed without some consideration of the balance between the chances of harm and the value of the new information to be gained. This assessment again requires an understanding of the research topic, but it is made easier if the applicant has provided a lucid rationale for undertaking the study. The summary for the intelligent layperson, which is required on many grant applications, will often fulfil this role. There is no guarantee, however, that the investigator and the ethics committee will agree on the importance of the work in view.
Improving applications
Ah-See KW, MacKenzie J, Thakker NS, Maran AG. Local research ethics committee approval for a national study in Scotland. J R Coll Surg Edinb 1998;43: 303-5.
Dunn NR, Arscott A, Mann RD. Costs of seeking ethics approval before and after the introduction of multicentre research ethics committees. J R Soc Med 2000;93: 511-2.
Al-Shahi R, Warlow CP. Ethical review of a multicentre study in Scotland: a weighty problem. J R Coll Physicians Lond 1999;33: 549-52.
Maskell NA, Jones EL, Davies RJO, BTS/MRC MIST steering committee. Variations in experience in obtaining local ethical approval for participation in a multi-centre study. Q J Med 2003;96: 305-7.
Department of Health. Research governance framework for health and social care. London: Department of Health, 2001.
Working Group on Ethical Review of Student Research in the NHS. The ethical governance and regulation of student projects: a draft proposal. London: Central Office for Research Ethics Committtees, 2004. www.corec.org.uk/applicants/docs/SPECs_proposal_DRAFT.doc (accessed 29 Jun 2004).
Jamrozik K. The case for a new system for oversight of research on human subjects. J Med Ethics 2000;26: 334-9.(Konrad Jamrozik, professo)
The standardisation of applications to local research ethics committees seems likely to make ethical approval less efficient and more time consuming for everyone
Introduction
The first step is to determine the essential information required for ethical approval. Based on my experience as a member of three ethics committees in two countries, I think that members ask themselves four basic questions:
What hazards are raised by the research protocol?
Can the protocol be redesigned to reduce these hazards without compromising its ability to answer the research question?
Have the investigators taken reasonable steps to minimise the chances that the (remaining) hazards result in harm?
Are either the hazards or the risk of their resulting in harm disproportionately great in relation to the apparent importance of the knowledge to be gained?
What are the hazards?
Local research ethics committees effectively match their collective wits against the applicant's to see whether the study question can be answered with equal or greater validity at lower risk to the participants. These deliberations require not only knowledge of ethical principles but also familiarity with the strengths and weaknesses of different study designs and at least some insight into the research topic. Single members of an ethics committee rarely have expertise in all of these domains for a given application, but the combined membership of many committees will.
Strategies to minimise the realisation of risks
Even well crafted applications cannot be passed without some consideration of the balance between the chances of harm and the value of the new information to be gained. This assessment again requires an understanding of the research topic, but it is made easier if the applicant has provided a lucid rationale for undertaking the study. The summary for the intelligent layperson, which is required on many grant applications, will often fulfil this role. There is no guarantee, however, that the investigator and the ethics committee will agree on the importance of the work in view.
Improving applications
Ah-See KW, MacKenzie J, Thakker NS, Maran AG. Local research ethics committee approval for a national study in Scotland. J R Coll Surg Edinb 1998;43: 303-5.
Dunn NR, Arscott A, Mann RD. Costs of seeking ethics approval before and after the introduction of multicentre research ethics committees. J R Soc Med 2000;93: 511-2.
Al-Shahi R, Warlow CP. Ethical review of a multicentre study in Scotland: a weighty problem. J R Coll Physicians Lond 1999;33: 549-52.
Maskell NA, Jones EL, Davies RJO, BTS/MRC MIST steering committee. Variations in experience in obtaining local ethical approval for participation in a multi-centre study. Q J Med 2003;96: 305-7.
Department of Health. Research governance framework for health and social care. London: Department of Health, 2001.
Working Group on Ethical Review of Student Research in the NHS. The ethical governance and regulation of student projects: a draft proposal. London: Central Office for Research Ethics Committtees, 2004. www.corec.org.uk/applicants/docs/SPECs_proposal_DRAFT.doc (accessed 29 Jun 2004).
Jamrozik K. The case for a new system for oversight of research on human subjects. J Med Ethics 2000;26: 334-9.(Konrad Jamrozik, professo)