Obtaining ethical approval

The final protocol and draft of the survey questionnaire should be submitted for national ethical review and approval to ensure that participants’ rights and welfare are protected. Ethical clearance procedures vary from country to country, but are usually required for a micronutrient status survey. If for some reason ethical review is not required in the country, all internationally recognized ethical procedures should be followed.

The review process, relevant ethical approval body or institutional review board should be identified early in the planning process, and time for the review needs to be factored into the timeline. Some ethics committees may meet only infrequently, some national approval processes may require review and approval from multiple committees or groups and, depending on the stakeholders involved in the survey, different types of ethical review may require different approvals.

Questions to answer when developing the request for ethical approval may include:1

  • How will the survey affect respondents?
  • Although the harm respondents must always be avoided or minimized, it is never possible to eliminate all risk, and risks should be specified during the informed consent process.

  • What is the population under study?
    • If participants include vulnerable populations, this needs to be indicated. Vulnerable populations include individuals who are not able to provide full consent or who are particularly susceptible to harm, including minors, prisoners, pregnant women, or people with a mental disability.
  • How will the survey results be used?
    • It should be specified whether survey results will be shared or published, whether the survey procedures will be confidential, and if data management will include removal of identifiers.
    • Although household surveys cannot be completely anonymous at the point of data collection, care should be taken during training to ensure that enumerators are fully aware of requirements for ethical conduct and for data and biological specimen collection. Procedures can be designed to minimize the risk of specific details about individuals becoming available and ensuring that data remain confidential.
  • Will individual results of some or all biomarker tests be shared with the participants? Who will have access to the raw data and procedures in place to protect this?
    • The greater the number of individuals who have access to identifiable data, the greater the risk that confidentiality will be compromised. The steps that will be taken to minimize this risk should be described.
    • All who do have access to full identifiable data or direct contact with human subjects should have completed certification in an approved human subjects’ research training programme.

The free online training and certification “Protecting human research participants”, available at https://grants.nih.gov/sites/default/files/PHRP_Archived_Course_Materials_English.pdf, covers many of the points above. Issues of particular concern to the ethical review process are discussed in the following sections.

It is important to document the procedures for securing individual and community-level informed consent and the training that will be ensured for enumerators, supervisors and all others who will have access to the participants or their data. The survey protocol should describe whether consent will be oral or written, how it will be obtained for those who are not literate and whether assent is required for minors. Procedures usually include informing participants about the purpose of the study, about what participation involves, that participation is voluntary, that consent can be withdrawn at any time, about how participant identity will be protected, and about whom to contact with questions or concerns. Informed consent is a standard expectation of participation in a micronutrient survey, regardless of whether it is required by an ethical committee. When a participant does not consent to participate in the collection of biologic specimens, informed consent for the survey questionnaire is still required.

Confidentiality

The survey protocol should document the training that will be provided to all staff to ensure that confidentiality is maintained at the individual level, including consequences should confidentiality not be maintained. It should also describe the de-identification process for collected data so that all results are confidential, where the data will be securely stored, for how long data will be stored, who will have access to the data, whether and how paper or electronic data will be destroyed, and any plans for public data release.

Identification of a Health Condition

The survey protocol should describe which results will be provided to survey participants, together with the biomarker cutoff values (international or national) to determine whether a referral is required (for example, haemoglobin <70 g/L or a positive result to a malaria rapid diagnostic test). Referral procedures should always be developed in conjunction with and approved by the ministry of health and detailed in the protocol. Participants should not be referred to the health facility for conditions that would not be treated. Health facility staff in survey areas should be aware of the survey, the tests that will be done, the possibility of referrals, and the process for referral. Participants should be informed about which referrals will be made and how, which individual test results they will and will not receive, and why.