Whenever possible, you should verbally explain your study to potential subjects in addition to providing them with an information sheet. The following are some techniques that you can employ to optimise understanding and ensure voluntariness when obtaining consent:
Rehearse a mock consent procedure and obtain feedback for improvement.
Ensure privacy.
This is especially important when the study involves a sensitive research topic.
For example, when conducting research on victims of domestic abuse, you should avoid recruiting subjects when their abusers are likely to be present.
Always introduce yourself by stating your name and role.
Provide an estimation of how long the process will take.
Ask if the potential subject would like anybody else to be present.
Ascertain which language(s) a potential subject prefers you to converse and write in.
Then use it for the rest of the consent process (and all your future correspondences).
If they speak in a language or dialect that you do not understand, involve a translator.
Give sufficient time for potential subjects to read the PIS themselves, then go through it with them again.
If (s)he cannot read, involve an independent witness.
For example, a nurse who is not part of your research team.
The witness should sign the consent form to confirm that whatever you told the subject matches what was written in the PIS and consent form.
If the subject cannot provide a signature or thumbprint on the consent form, involve an independent witness.
The witness should sign to confirm that the subject has provided voluntary consent to participate in the study.
If someone has visual, hearing or speech impairment, use communication aids.
For example, larger prints, hearing aids and sign language interpreters.
Provide information in small chunks and check understanding frequently.
For example, you can ask potential subjects to repeat, in their own words, what you have just told them. You may also quiz them about the study (e.g. “How many times do you have to come for follow-up?”).
Make use of models, visual aids, videos, etc. to help explain complex procedures.
Reiterate any important points, such as the voluntary nature of participation.
Do not skip any information just because someone is ready to sign the form.
Tell them that it is important for you to go through all the information with them.
If they appeared tired, distracted or are in a rush, ask if you can book another appointment with them.
Encourage questions.
Ask if they would like you to explain anything again. Make sure that you clarified all uncertainties before you get them to sign the consent form.
Give ample time and space for potential subjects to decide.
The following video demonstrates how valid, informed consent should be sought from a subject who is deemed competent to make his own decision: (13-minute length) (12)
U.S. Department of Health and Human Services. OHRP: General Informed Consent Requirements [Internet]. 2010. Available from: https://www.youtube.com/watch?v=URo4x4pv68A&t=0s&index=12&list=PL-PYqw3Y3NFsy9-3McTUQakPqqfVIslnb