Improving, Expediting and Tracking Informed Consent seminar

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Improving, Expediting and Tracking Informed Consent: University of Michigan and US National Initiatives
 Professor Nicholas H. Steneck of the University of Michigan and Office of Research Integrity in the US gave a seminar on 28th June on issues surrounding research ethics, particularly ways of improving methods of giving informed consent. Professor Steneck began by discussing his work in general, which focuses mainly on the ethical issues of translational research, and particularly issues such as community engagement, promoting collaboration in ethics, how the quality of Research Ethics Committees can be judged, and so on.
Professor Steneck asserted that human subjects research generally appears relatively uncomplicated, and with little risk for participants for the most part. However, he presented an excellent example of a study with underlying ‘risks’, as shown by a group who were interested in re-using pacemakers. The re-use of pacemakers is illegal in the US, but the group wanted to take used US pacemakers, have them checked and certified as sound, and then donate them to other developing countries where the use of pacemakers is less frequent due to higher costs. Professor Steneck asked the audience whether there appeared to be any ethical issues with this proposal; the audience could think of none. Professor Steneck then suggested that the study was unethical because it was assuming that it was acceptable to treat other developing countries differently to the US, simply because of their lack of the same law as the US in this case. Secondly, he noted the high cost of implementing pacemakers in patients, which was actually not at all cost-effective in developing countries, where other smaller changes to healthcare could yield greater results for a higher proportion of people.
Professor Steneck moved on to discuss the issue of informed consent forms, which in general tend to be longer, the more complex the research; however, studies have shown that the longer the consent form, the lower the understanding of subjects. Therefore this presents a problematic paradox: the need to document patients’ understanding (by having a signed consent form) has actually reduced their understanding of the research.
The presentation then moved on to discuss a specific study which Professor Steneck’s team is working on, which contained a simplified informed consent process designed by his team; this related to a biobank – a ‘library’ of tissue samples donated by subjects in the local area, which could be used for genomic research. Professor Steneck’s team wanted to see if they could set up a biobank (theirs was dubbed the ‘Biolibrary’ to aid people’s understanding of the concept of giving their tissue samples for future use), in a ‘scientifically useful and ethically responsible’ manner.
There were three options for approaching the issue of informed consent for subjects:
1) when signing a form at a health visit, subjects could tick an ‘opt-out’ box – i.e. their sample will be included in the biolibrary unless they tick the box – this would not need an REC approval
2) as above – but with REC approval
3) when signing a form at a health visit, subjects tick an ‘opt-in’ – i.e. their sample will not be included in the biolibrary unless they tick the box – this will have REC approval.
The goal was to find the option with the greatest efficiency, but without compromising ethics.
Option 1 was considered quite practical because it would use excess material from health visits, which could be de-identified. However, this option means that patients don’t get the information on what’s going on, which research has shown is what they want – also, there is no evidence that they actually understand or have read the tick box, which could be unethical.
Option 2 is similar to option 1. Professor Steneck noted here that there’s a further issue, in that ethics committees may ask why an opt-out box has been used instead of an opt-in box – the answer of course being that the researcher thinks that more patients will allow their samples to be used if they’re opting out rather than opting in; therefore this is unethical because the method of the research is based around the priorities of the researcher and not those of the subject.
Option 3 is clearly the most ethical, but is also slow and expensive.
The solution was to use option 3 but to develop an improved informed consent process, splitting the ‘informing’ from the ‘consenting’. Subjects were given a pamphlet which was used for the ‘informing’ part of the process, and explained what would be entailed by their participation. The pamphlet was validated prior to use, by using a simple understanding test. A one-page consent form was then given to the patient, containing several aspects: IRB approval (this is similar to REC approval for the US), the elements of their consent and what this will mean, HIPAA (a regulation specific to the US), the options that they have (e.g. withdrawing and so on), and then the record of their signature. Following their reading of the pamphlet, all subjects were given an assessment of understanding and the chance to discuss and have any misunderstandings explained. They were given the opportunity to withdraw and then, if they wanted to continue, were then shown the consent form. Around 99% of subjects consented to their samples being used in the biobank.
Professor Steneck noted that there are further ethical issues – the discussion about whether or not they wanted to donate the material would have to be gained during health visits, and therefore who should present it? A doctor presenting it could exert undue influence on patients simply because of their high status, and this could be seen as coercion. Possibly the nurse or another health care worker would be more appropriate, but careful consideration would have to be made for the point in the visit when the question was raised; it would be unfair to patients to ask them about this early on in the visit, since it could distract them from the reasons they came in.
The weaknesses of the above study were based around the fact that the current subject group were highly-literate people from the local university area, who had signed up to possibly being in future studies; however, the research group planned to branch out bit by bit into other groups, considering the ethics of each along the way: firstly they would work on looking at the ethics of using the same system for those of lower literacy, and also for working with children.
The presentation closed with further discussed on informed consent, which Professor Steneck asserted needed to take a number of variables into consideration: he suggested that informed consent is ‘authorised informed permission to conduct research on a subject’ – each element of the sentence should be further broken down into its parts, for example authorised means that there is an authority and an institution performing the process and there must be a method for authorisation and consideration for what it actually implies in the particular context; similarly ‘informed’ breaks down into the process of informing a subject, the elements that they are informed of, and validation of this process – and so on.
The lecture provided an informative and interesting insight into the issues surrounding informed consent and the ideas presented by Professor Steneck for improving the methods for attaining truly informed consent will be useful across a range of clinical settings.