The following criteria should be considered when an investigator is preparing a protocol for submission for Human Research Ethics Committee review: Synopsis or Executive Summary With the exception of the two or three primary reviewers, remaining Committee members rely on the synopsis and supporting materials (informed consent forms, questionnaires, recruitment aids) to evaluate a proposal. As a rule, all-purpose sponsor-produced synopses are too general and lack enough relevant detail, specific to the local site, to allow the committee to undertake a thorough ethical assessment. It is therefore in researchers’ interests to include in the synopsis sufficient information for Committee members to evaluate the proposal independently of any other protocol documentation. The synopsis must: Be written in simple, non-technical and jargon-free language which is readily understood by Committee members who include non-scientists, non-experts in the field and who represent the community. Acronyms must be spelt out when used for the first time. Specify how the research will be conducted at the trial, i.e. the principal investigator’s, site; for example, what is the socio-demographic and educational background of participants at the local site, where will participants be recruited for research at this site, how will the study advance health and scientific knowledge in this population. Describe the objectives of the and hypotheses being tested. Succinctly identify the study’s purpose in the context of currently available and relevant knowledge. Explain the design of the study. In the case of clinical research, carefully distinguish experimental interventions from the standard of care. Provide a brief overview of inclusion and exclusion criteria. Describe how participants will be recruited. Specifically address how, when, where and by whom participants will be identified and approached. Describe the frequency, severity, duration and reversibility of foreseeable harms: physical, psychological, social and economic. Describe site-specific measures to protect participants’ privacy and the confidentiality of the collected data. Explain how will be minimised and how safety will be protected. Describe expected benefits to individual participants and potential societal benefits within the local setting. Indicate whether post-trial treatment will be available for local participants and, if not, why not. Explain how, when, where and by whom consent and assent will be obtained. Clarify special protections for vulnerable participants such as children, cognitively impaired, terminally or critically ill.
The following criteria should be considered when an investigator is preparing a protocol for submission for Human Research Ethics Committee review: Synopsis or Executive Summary With the exception of the two or three primary reviewers, remaining Committee members rely on the synopsis and supporting materials (informed consent forms, questionnaires, recruitment aids) to evaluate a proposal. As a rule, all-purpose sponsor-produced synopses are too general and lack enough relevant detail, specific to the local site, to allow the committee to undertake a thorough ethical assessment. It is therefore in researchers’ interests to include in the synopsis sufficient information for Committee members to evaluate the proposal independently of any other protocol documentation. The synopsis must: Be written in simple, non-technical and jargon-free language which is readily understood by Committee members who include non-scientists, non-experts in the field and who represent the community. Acronyms must be spelt out when used for the first time. Specify how the research will be conducted at the i.e. the principal investigator’s, site; for example, what is the socio-demographic and educational background of participants at the local site, where will participants be recruited for research at this site, how will the study advance health and scientific knowledge in this population. Describe the objectives of the and hypotheses being tested. Succinctly identify the study’s purpose in the context of currently available and relevant knowledge. Explain the design of the study. In the case of clinical research, carefully distinguish experimental interventions from the standard of care. Provide a brief overview of inclusion and exclusion criteria. Describe how participants will be recruited. Specifically address how, when, where and by whom participants will be identified and approached. Describe the frequency, severity, duration and reversibility of foreseeable harms: physical, psychological, social and economic. Describe site-specific measures to protect participants’ privacy and the confidentiality of the collected data. Explain how will be minimised and how safety will be protected. Describe expected benefits to individual participants and potential societal benefits within the local setting. Indicate whether post-trial treatment will be available for local participants and, if not, why not. Explain how, when, where and by whom consent and assent will be obtained. Clarify special protections for vulnerable participants such as children, cognitively impaired, terminally or critically ill. trial,