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Views from the Field No. 8 | What are the key elements of a consent form for a household survey?

Oct 12, 2018 | From the Field

 

Johanna Choumert-Nkolo

 

Research respondent protection and data protection has always been central to EDI’s ethos. Obtaining informed consent is key to the process of protecting survey respondents and to the validity of the research. Informed consent is a “legally-effective, voluntary agreement that is given by a prospective research participant following comprehension and consideration of all relevant information pertinent to the decision to participate in a study” (NIH Office of Extramural Research).

What are the key principles a consent form should follow?

  • Voluntariness
  • Comprehension
  • Disclosure

Said differently,

  • Investigators must “obtain legally effective informed consent from prospective participants in a way that allows them to consider whether or not to participate and that minimizes the possibility for coercion or undue influence” (HHS regulations, 45 CFR 46.116);

  • “Potential participants must understand that enrolling in the research is voluntary and that they may withdraw from the study at any time without penalty or loss of benefits” (HHS regulations, 45 CFR 46.116(a));

  • Potential respondents should be able to make an informed decision on whether they wish to participate in the survey.

What should your consent form contain?

  • Details of the organisation/institution employing the interviewer
  • Organisation/institution of the researchers involved
  • Funders and sponsors of the research
  • Research clearances and associated permits obtained
  • Statement that data collection is for research
  • Description of the research
  • Content and anticipated duration of the interview
  • Procedures for audio/visual recording if relevant
  • Statement that participation is voluntary
  • Statement that refusal to participate will not lead to penalty or loss of benefits
  • Statement that the respondent can withdraw at any time
  • Information on confidentiality and data privacy
  • Contact information for questions regarding the study and respondents’ rights

Language matters

The language (including translations) should be appropriate and understandable for all potential respondents.

What should the format be?

  • Interviewers should read the consent form and offer potential respondents the possibility to discuss any question they may have;
  • Interviewers can provide additional material such as brochures;
  • Interviewers can play an audio or video recording to potential respondents;
  • Respondents should receive a written copy of the consent form.

Training and monitoring field teams

Researchers and field teams must be trained in research ethics. At EDI, our researchers, field coordinators and data processing officers have all completed the National Institutes of Health (NIH) Office of Extramural Research training course “Protecting Human Research Participants”.

During training of field teams, we always spend time training on the consent form and on how to handle refusal for consent as “data is only as reliable as the people collecting it”, which also means that field teams are the first people in charge of protecting respondents.

Lastly, when teams are in field, their careful reading of consent forms should be closely monitored, in three ways:

  • Direct observations from field supervisors who can provide feedback on the pace and tone of the reading;
  • Back-checks (in person or over the phone) that include a question on whether the full consent form was read to the respondent;
  • Monitoring of timestamps, which can be included electronic surveys to monitor the time taken to read the consent form and check that it has been read in its entirety.

Useful references

  • Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979)
  • HHS, OHRP. 2004. Guidance on Research Involving Coded Private Information or Biological Specimens
  • Institutional review boards (IRB) and Federalwide Assurances (FWA), OHPR Online course on “Protecting Human Research Participants”, National Institutes of Health (NIH) Office of Extramural Research