I am not convinced that an IRB will allow you to verbally consent these potential study subjects. The purpose of a written consent is to be able to have "proof" that these people understood exactly what they would be asked to do, how their information would be used, and what are the potential harms that may occur as a result of their participation.

A verbal consent does not provide a paper trail, it does not ensure that the patients actually were told everything they need to know about the study, and in the end, you can be held liable for providing misleading information to these people. 

A written consent protects the participant as well as protecting the researcher.

Ariel

This is an interesting question. I agree, there could be problems in getting approval for such a study and you need to be able to protect all participants, but from a moral standpoint, something with the potential to be inclusive, allowing vulnerable populations to participate in research that could be benefit to them is clearly a good thing. Written consent (which is often legalistic) could act as a barrier to participation in a situation such as you describe. I have limited faith in the value of written consent as proof of understanding, so it is good that you are being encouraged to look for creative solutions and consult with colleagues. I have done a great deal of policy work on consent (mostly in the UK) and am mindful of the cultural differences and expectations that could be at work here. A recent migrant could be troubled on two counts. One as you say because of the legality (or not) of their status, and two because written consent may not be so widely considered the 'norm' (e.g., in Mexico). Whether anything could be done via a third party might be worth considering. If an independent representative is present at the interviews and speaks to participants beforehand, then a proxy consent could work, and this person could orally attest for comprehension on the part of study participants. Whether or not this is acceptable could depend on the end-use of data, but in that you are looking at barriers to screening, it would be odd in a way to compound those barriers by making it difficult for those vulnerable groups to take part.

Dear Ariel and Roger,

Thank you so much for your feedback! I had an email exchange with a former colleague in Arizona who works with migrant Mexican folks and her experience has been that the researchers go over a consent document with the participant, the person provides verbal consent, and the document is left with the participant without their signature.  Another colleague who works with IV drug users records the consenting piece of the research and the verbal consent is recorded. 

Again thanks for the feedback!

Great issue. I have had several colleagues researching in areas such as drug use or teenagers living on the street  where verbal consent is used.  My colleagues claim that the paper consent is more appropriate as anything  written is regarded with suspicion. In addition, the consent is a 'rolling process' in the sense that should the person disclose something that the researcher feels may be compromising, then the consent is renewed , allowing the interviewee to revoke such disclosure . This is particularly important if they name someone else involved in an illegal activity. 

Dear Michelle, All your respondents' replies are, in my view, accurate and perceptive. I'd humbly like to suggest you have a look at pages 30-36 in a commissioned report I did for the European Commission on "Research Ethics in Ethnography and Anthropology"- it's available in my publication list. The need for such a discussion grew out of our experience in ethics review committees dominated by reviewers with predominantly biomedical experience not knowing how to handle qualitative research and insisting on written informed consent when it was not only inappropriate and unnecessary but potentially more risky to the respondents as your previous commentators have pointed out.

Dear Victoria and Ron,

Thank you so much for your feedback! Ron-- I will most certainly have a look at your report.

Mil Gracias!

Michelle

For what it is worth, I have archived on ResearchGate a publication that addresses the consent issues relating to all decisionally-impaired populations: Noble JH, Sharav VH. Protecting People With Decisional Impairments and Legal Incapacity Against Biomedical Research Abuse. Journal of Disability Policy Studies 03/2008; 18(4):230-244. DOI:10.1177/1044207307311532

Dear Michelle

Thank you for your question.  You could consider preparing a plain language information sheet for both the focus group and the information interviews which includes all the key components of a participant consent form.  Producing these information sheets in Spanish (and other languages potential participants may speak), having them reviewed 1:1 with participants by a third party who is not involved in any way with your research, and following up with a comprehension sheet may be appropriate.  Consent can be obtained (or rejected) by the third party going through the comprehension check list to ascertain whether or not the participant understands the purpose of the study, their rights as a participant, who to contact if they have questions or issues after the fact, confidentiality, etc.  If a potential participant is unclear on any area, the third party can review the relevant information again.  The verbal consent process is documented by the third party on the comprehension check list.  The participant is provided with a copy of the study information sheet.  I had this form of consent approved by an IRB of large teaching hospital while working with homeless, pregnant young women.  It should be stressed however that consent is an ongoing process.  In the project I just referred to we had ongoing discussions about consent as the participants made decisions about their activities in this participatory action research project.  Project staff prepared field notes of these discussions.

I also recently conducted a study promoting awareness of breast and cervical cancer screening for immigrant, refugee and newcomer women representing 20 language groups.  The hospital IRB approved information sheets in women's native languages and a verbal consent process for participation in information sessions.  We were able to use written consent forms for focus group participation. I hope this helps in some way.  Delighted to hear about your research!

Catherine Moravac

Michelle, you  pose an interesting dilemma since vulnerable populations are at particular risk in research on both sides of your question.  You have to weigh the potential of their perception of threat with an IRB's concern for documentation that consent was properly executed.   I agree with Ariel that many IRBs are likely to squirm at the prospect of verbal consent with  no tangible evidence. However, we all know that a signature on a form is no guarantee of an informed consent anyway.

I also appreciate Catherine's suggestion of an information sheet with a checklist.  A couple of additional suggestions that mediate between these two might include at least having the participant initial or use a coded alias on the checklist as well as the possibility of orally recording the consent, again with a coded identifier rather than full name.  Both would show a verifiable good faith effort to ensure informed consent without explicit identification of the individual subject.