Table 10: Examples of comments from an Ethics Review Committee on an IR protocol
General comment: The committee considered this an interesting study that may help optimize current preventive approaches and improve the clinical algorithm for cystic echinococcosis (CE) in the country.
Specific comments: Requires response and protocol amendments
1. Protocol
1.1 Please provide an amended proposal specifying the version number and/or date on each page.
1.2 It is understood from the protocol that only adults will be included in the study and that for the collection of information on paediatric patients, their parents/caregivers (above the age of 18) will be asked to take part in the interview. Please specify the actions that the study team will take in cases where the parent/caregiver of the child is below the age of 18 (e.g. will another family member above 18 be asked to take part in the interview? Will information on that child not be collected? etc.).
1.3 According to the protocol, women have more exposure to domestic animals and are therefore at higher risk of CE. In order to ensure that the risks and benefits of the study are fairly distributed in the population:
1.3.1 Please describe the steps that the research team will take to promote adequate representation of women among the 50 patients that will participate in the interviews per province.
1.3.2 Please explain how the sample size of 50 was determined.
1.3.3 Please specify whether gender-based analysis on the data obtained will be applied in order to inform the development of gender-sensitive CE control programmes in the future.
1.4 Please specify the measures that researchers will take cases where interviewed patients have not yet received adequate care and treatment of CE.
1.5 In terms of data confidentiality:
1.5.1 As per the protocol, “an in-depth assessment in five provincial hospitals to register newly diagnosed cases” will be conducted. Please specify whether researchers will be given access to this data or whether health personnel whose daily activities relate to clinical record management will extract this information, anonymize it and thereafter provide it to the study team.
1.5.2 Please specify where data collected in the study will be stored, who will have access to it and when it will be destroyed.
2. Informed Consent Forms
2.1 The consent documents use technical words that may not be understood by lay people (e.g. CE, zoonosis, ultrasonographic imaging, etc.). These terms should be defined and/or replaced so that prospective participants can fully understand the study.
2.2 Consent form for patient-based survey:
2.2.1 Under the section Participant Selection, please explicitly state that if the patient is a minor, then the interview will be conducted with her/his parents/caregivers.
2.2.2 The consent form should reflect that children may be indirectly included in the study. For example, the sentence: “I consent voluntarily to be a participant in this study” could be replaced by: “I consent voluntarily to be a participant in this study [and to respond to the interview regarding my health or that of my child]”.