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Browsing: How to ensure truly informed consent for participation in research involving MISST technologies
Rebeca Espinoza G...
How do we ensure that participants in research studies, particularly those of low SES, are truly informed in the consenting process for studies involving MISST research for which they have no previous exposure/familiarity? What is the best method to explain MISST technologies to research participants without burdening them (time burden) during the informed consent process?
Camille Nebeker
Great questions ... I don't think we can ever ensure informed consent. With low SES who are unfamiliar with technology, perhaps the consent process should include examples of what the data looks like so people can see what the devices collect? Learning what works to achieve meaningful consent would likely require an experiment on the informed consent process.
Sara Meeder
My group is creating additional materials that can be used as teaching tools during the consent process. We're working on short documents to explain concepts like metadata, data security and the types of data being collected for a study that involves, among other things, collection of location, financial and social media information, metadata for communications and, eventually, biosample collection. We're in the development stage now, but as items get approved by the IRB, I should be able to make some of them available to the group. We're also going to be testing some of the documents in focus groups, so hopefully we'll get some good feedback that I can share.
Camille Nebeker
Sara,
This is great news and very pleased to hear that you will share with the CORE Network community. Once you have some of the content developed, please let us know if you'd like for us to assist with testing the terminology and concepts with folks from culturally diverse communities.
Camille
Sara Meeder
That would be fantastic. One of the things we're discovering is that use of traditional consent language can be too vague to really inform people about what activities and potential risks are involved in the study. My initial assay at adult consent language for the pilot study we'll be running was roundly and deservedly criticized for using terms like bluetooth and encryption. The criticism was that the general public might think they know what those terms mean, but the majority would probably have an incorrect or only very general idea. As was proven when I was asked what type of device Nest is. Point taken.
The more eyes on these documents before they go live, the better.
Rubi Linares-Orozco
"How do we ensure that participants in research studies, particularly those of low SES, are truly informed in the consenting process for studies involving MISST research for which they have no previous exposure/familiarity? What is the best method to explain MISST technologies to research participants without burdening them (time burden) during the informed consent process?"
Like Camille mentioned you cannot ensure that a subject truly understands. 21 CFR 50.20 states an "investigator shall seek consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representatvie shall be in lanaguage understandable to the subject or the representative."
Complex scientific concepts should be written or described in simple concepts that the typical subject can read and comprehend (typically 8th grade reading level).
Informed consent is more than just a signature on a form, it is a process of information exchange that may include, in addition to reading and signing the informed consent document, subject recruitment materials, verbal instructions, question/answer sessions and measures of subject understanding.