10th December 2009 at 5:33 am #5299Simon DaviesMember
I have what is probably a rather simple question about a patient satisfaction project, and wondered if anyone could provide us with some guidance.
We are planning to have some students help us to administer questionnaires in structured interviews, and want to ensure that the results remain as anonymous as possible.
We have the following documents:
– Consent form with patients name and signature but no participant code
– Questionnaire with participant code but no name etc.
– Participant information sheet with no participant details
We were then planning to keep a separate register linking codes to patients.
To what lengths then must we go to ensure that these documents are not seen together by people outside of the research group?
If we simply ask the students to keep the paperwork safe and bring it to our department as quickly as possible, there is a risk that papers are muddled up and we cannot later link consent forms to questionnaires.
As we are performing some work at another site it will be logistically challenging to ask them to initially gain consent, then return this form to us, whereby we would record the info and supply them with a coded questionnaire.
Have I made sense? Is there some kind of happy medium here?
Please note that we are working in a developing country and have very limited resources with regards to time and money.
Simon11th January 2010 at 11:18 am #5300Carol VigursParticipant
I was working on a randomised contriol trial recently and these were our procedures for ensuring anonymity of our paticipants. Researchers were also off site and had to return the completed questionnaires and consent forms.
the participant code was composed of a 2 digit number for the clinic identifier, the list of which was kept at the study centre, 1 or 2 signifying sex and a 3 digit code indicating the number of the recruit from that clinic – so – researchers were able to record this quite simply on the completed questionniare AND the consent form, provided they knew what the previous recruit number was. So say the third recruit at “Donchester” was a boy – the number would be 12 (Donchester’s code) 2 (for a boy) 003 (for the third recruit at that clinic) 122003.
each number is unique, it can be figured out as it has a logic to it, the consent and questionnaires can be matched up if needed, otherwise can be kept seperately.
In addition, all paperwork that has personal information is stored in a locked filing cabinet. Any emails or communication that referred to patients was referred to by initials and DOB only (this is not considered personal information).
Initials and DOB of eligible patients were recorded on a sheet for the researcher to take to clinic, s/he then compared this to the list of patients expected that day to see who they were due to meet.
Any electronic information with personal details was kept on a memory stick, also in the locked filing cabinet (never stored on the hard drive).
Dont know if that helps? I sure there must be other approaches, but this seemed to work fairly well!
all the best with your project!
institute of Education, London
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