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ETHICS REVIEW FORM

For ERC MEMBER to complete

[Version: January 2014]

Review of: [Project name]

Review by: [name of ERC Member completing the form]

Review for: [Name of lead coordinator of review to who this form will be submitted]

1. Rationale
Importance / relevance of the research / YES / NO / N/A / Comments
1.1. Are objectives of the research clearly stated?
1.2. Will the study result in improved human health and well-being or increase knowledge?
1.3. Are the study aims relevant to national priorities and the study community’s needs? / If yes, how?
1.4. Has this research / investigation been done previously? / If yes, is repeat justified?
1.5. Are there any potential conflicts of interest or partiality? / If yes, have they been made explicit?
1.6. Has the research protocol been approved by another competent body (ERC / IRB)? (If so is the approval provided?) / Please summarize:
2. Equipose
Risk / Benefit assessment / YES / NO / N/A / Please specify
2.1. Is the involvement of human participants necessary to obtain information sought?
2.2. Is the standard of care the best available in the local country context?
2.3. Is the medical and psychological support for the participants adequate, both during and after the research?
2.4. Is there potential harm to human participants?
2.5. Are measures in place to avoid or reduce potential harm to participants?
2.6. Is there provision for compensation for participants who sustain injury?
2.7. Will the research result in new knowledge relevant to the health or well-being of the population involved?
2.8. Are there measures in place to avoid or reduce potential harm to staff?
2.9. Is the favourable risk / benefit ratio?
3. Country and Community Participation
Have safeguards been put in place to... / YES / NO / N/A / If YES, specify how. If NO, justify
3.1. Is ‘community’ defined in the context of this study?
3.2. Are the study findings expected to be relevant to this community?
3.3. Is there evidence of consultation with the above defined community on a) the importance of the topic of research and b) how the research will be conducted (including discussion of risks and benefits to said community)?
3.4. Are mechanisms in place to receive and address complaints or concerns about the research?
4. Study design
YES / NO / N/A / Provide justification
4.1. Is the study design the most appropriate to realise the research objectives?
4.2. Are sample techniques used clarified?
4.3. Is the sample size sufficient to attain the research objectives, and not so large it will waste money and participants’ time?
4.4. Are conflicts of interest addressed and resolved?
4.5. Is training of interviewers/data collectors adequate and does training cover relevant issues?
4.6. Is interview guide(s) appropriate?
5. Participant selection
YES / NO / N/A / Provide justification
5.1. Has the study population been determined based on scientific goals of the study, rather than on convenience?
5.2. Are inclusion / exclusion criteria appropriate?
5.3. Is contact and recruitment of human participants appropriate and non-coercive?
6. Informed consent
YES / NO / N/A / Comments / Explanations
6.1. Is the process for obtaining informed consent appropriate?
6.2. Is a copy of the information provided to participants attached?
6.3. Are participants informed in clear, simple language about the purpose, methods and possible uses of the research?
6.4. Are participants informed in clear, simple language what their participation in the research entails and what risks are involved?
6.5. Does the information provided to participants confirm their participation is voluntary and free from coercion?
6.6. Does the information provided to participants address their right to refuse or withdraw consent at any time?
6.7. Is information provided in both oral and written form, in terms easily comprehensible and culturally appropriate to the potential participants?
6.8. Do participants have adequate time to consider their participation and discuss the information with family members if they wish before deciding to consent?
6.9. Do potential participants have the opportunity to ask questions regarding the research?
6.10. Are procedures in place to record participants’ withdrawal of consent, and to ensure that data collected from him or her is not used?
6.11. Have community information sessions on the research been organised to raise pre-enrolment awareness and help people decide if they want to participate?
6.12. Is a copy of the Consent Form attached?
6.13. Is the Consent Form in a format that is culturally and linguistically appropriate to potential participants?
6.14. If it is not possible to obtain consent in writing, is participants’ verbal consent to be confirmed in writing by a witness of the same sex and speaking the same language?
6.15. Will undue pressure be minimised? E.g. Are incentives justified as appropriate and proportional? Have community members been consulted in deciding appropriate incentives?
6.16. Will fresh informed consent be obtained if the procedures change during the research?
7. Confidentiality, privacy and data protection
YES / NO / Explain how
7.1. Is all the data collected relevant to the objectives of the research?
7.2. Is information supplied by participants kept confidential?
7.3. Is anonymity of respondents respected?
7.4. Is electronic data secured?[1]
7.5. Is confidentiality of body fluids / tissue samples protected?
7.6. Are data / sample storage and disposal procedures adequate?
7.7. Will participants be informed about destruction of samples or possible future uses?
7.8. Is any storage of personal data on laptops / USBs / external hard drives temporary only and to be removed as soon as possible pending upload onto secure server or desktop?
7.9. Are any personal data (temporarily) stored on laptops / USBs / external hard drives encrypted?
7.10. Will identification of participants be protected in data which is released?[2]
8. Continuation and dissemination
YES / NO / Explain how
8.1. Will findings be fed back to participants and the wider community?
8.2. Will the data collected be disseminated?
8.3. Will the product of the study be made available to participants following the research?
9. Clinical Trials (skip this section if not relevant)
YES / NO / If NO, explain why not
9.1. Has the trial been registered on a public website?[3]
9.2. Is there sufficient justification for using a control arm?
9.3. Will participants in the control arm receive the best treatment / intervention available for the disease / condition of interest?
9.4. Has information on post-trial access for effective drugs or interventions been given to participants, including those in the control arm?[4]
9.5. Is the procedure for dealing with and reporting adverse events adequate?
10. ETHICS REVIEW COMMITTEE MEMBER DECISION
What is your recommendation? / Grounds for decision
 / Approve as submitted
 / Approve subject to meeting specified conditions
 / Reject on ethical grounds
Comments (please number these and divide them into Major and Minor points):
Please mention any good practice examples from the Protocol, if any, in terms of its presentation and/or the research ethics proposed therein:

Ethics Review Committee Member:

Signature:

Date:

[1] Electronic data here includes, for instance, data stored on hard drives, portable devices, email and databases.

[2] For instance, will identification of participants be protected within results tables with small numbers of participants?

[3] Eg.clinicaltrials.gov

[4] For instance, actual giving of drugs after the trial has finished is not an ethical requirement, although giving information on where to obtain them, for both intervention and control is an ethical requirement.