Hello Nicholas, from what you describe, those patients cannot give informed consent. The consent form you will be using, has it been IRB approved? Did the IRB raise ethical concern or provide guidance about this group of subject? Those patients must be under administrative supervision/tutelage, aren't they? Then, it's up to the responsible supervisor to sign the consent.

Hi Nicholas,

Informed Consent is absolutely necessary in research involving humans unless the institutional review board finds allows the otherwise on basis of very careful decision. The only reason for not taking informed consent before an intervention or a research is an emergency. In case of patients with serious cognitive disabilities where they might not be able to give consent, a consent from the 'custodian' (a person or an institution) is necessary. Additionally, assent is necessary is children below 18 years who have developed acceptable cognitive abilities.

In your case, I find no reason why the patient may not be able to understand and give consent. Further, the patient has the freedom to opt out of the study whenever he feels like. The consent is never a 'binding agreement'. If your patient, therefore, feels that he does not want to continue, he is free to leave (regardless of his consent or dementia).

I am attaching links of some literature that will be useful to you.

http://www.ncbi.nlm.nih.gov/pubmed/20509807

http://www.ncbi.nlm.nih.gov/pubmed/9670887

http://www.ncbi.nlm.nih.gov/pubmed/3367937

http://www.alzheimer-europe.org/Ethics/Ethical-issues-in-practice/Ethics-of-dementia-research/Informed-consent-to-dementia-research?#fragment-1

Ah thank you both for your input, although I have been given approval (from the legal guardian), something within myself feels ethically conflicted.  On the one hand, we have a fascinating human who has led a fascinating life more than worthy of documentation.  The subject, is more than overjoyed to have life stories recorded, as has been expressed to me personally.  Also, if these stories are not recorded, they will surely disappear.  Yet, on the other hand, as I mentioned, the ability to remember the short term is beyond help.  Hence, the subject can only recall events that happened during adolesence and early 20's.  It is as if speaking to a 'time capsule' of a human.  That the person who agrees to the interviews is a self who lived 40+ years ago, versus the person today who has great difficulty recognizing the present.

I think the relevant issues in obtaining informed consent from cognitively impaired or underdeveloped indificuals was covered well by the previous respondents. However, I would suggest you also take a look at the attached article.  You might find it informative.

Alzheimer's disease is a brain disorder that usually affects older people. People with Alzheimer’s slowly lose their ability to think, to remember, and to perform daily tasks. Over time, they become totally dependent on others. 4.5 million Americans have Alzheimer’s and there is no known cure. 

http://hrsonline.isr.umich.edu/modules/meta/2006/core/qnaire/online/Module8_InformedConsent.pdf

I completely agree with Patrick. It is necessary to take written consent from the patient as governed by guidelines of ICH GCP. 

Several protocols and corresponding consent forms gave the impression that investigators may have inappropriately used their positions in order to obtain subjects. Though the consent forms contained language intended to inform subjects that their right to treatment would be unaffected by a refusal to participate in research, persons with mental disorders that may affect decisionmaking capacity who are seeking treatment may nevertheless feel indebted to the provider, or suspect that they are confronted with a quid pro quo—research participation for treatment.

The developing ways to promote the congruence between surrogates' decisions and patients' values.

https://bioethicsarchive.georgetown.edu/nbac/capacity/Informed.htm

I thank you all for all of your contributions to my understanding!

I concur with Lawrence.  Especially as the problem I continually confront is that the patient regularly 'agrees'. However, the subject never remembers having 'agreed to'.  I could ask a million times, with the subject agreeing every time, yet it is as if every meeting is a new one.

I agree with previous coments in relación to the need of getting an informed consent, well from the patient- if he/she preserves his/her mental capacity well enough-, well from a legal guardian. Do you know the MacCAT instrument? After the appropiete assessment, you will be able to decide if only the consent from the patient is needed or you will need the consent from the legal guardian, if there is available.

http://www.ncbi.nlm.nih.gov/pubmed/9355168

Great resources in prior responses.  You mention a series of interviews.  The guardian or proxy signing the consent is responsible for making the informed determination of whether participation is in the subject's best interests or at least not counter to his or her best interests.  I would say the the requirement for assent in older minors is a good rule of thumb here as well.  While a single informed consent may be adequate from the proxy, assent of the subject should be re-established with each subsequent interview with particular attention to any indication that the subject feels uncomfortable, threatened or intimidated by the request. 

I used process consent throughout, having established capacity to consent at the outset of my study when recruiting participants for my PhD. I followed the protocols of the Mental Capacity Act (2007) and read about process consent McKeown (2010). However in my study I did not consult anyone other than the Gatekeeper who informed the families,at the start. In addition, I checked for capacity  at  the outset of each of the eight interviews, gaining consent to continue and consent to use the cassette recorder. Section 34 of the Mental Capacity Act (2007) has a special protocol for researchers should the participant have a fluctuating or loss of capacity and also information regarding proxy consent. Killick and Allan have carried out a lot of work with people with dementia at the end stages of life. 

Looking not through the lens of knowledge of law and legal requirements, what I would have done morally as a human being is that I would have introduced myself and the process we are going through before each session and told the patient that we can stop it if he/she doesn't feel comfortable. If this conversation comes as a recording would it serve the 'legal purpose of consent' as well?

Ankur asks if the recording would serve the legal purpose of consent, and I would say yes with the proviso that in this particular context we are talking about assent since the subjects do not have full decisional capacity.  The recorded conversation is, if anything, a better indicator of assent than any legal form, which loses the true context of the conversation.  As I mentioned in my other post, it is important to be able to observe the subject's total response to the conversation to assess whether the subject's willingness is truly voluntary and/or is not causing distress. 

Thanks for the answer Deb.

I am reminded of the song "I've a hole in my bucket".  If you are going to record someone, you need consent!  Also check the local regs re consent and capacity.  In Britain, if an adult lacks capacity for a particular decision, no-one else can consent for them - you have to go down a different route of establishing best interests.  Its not clear to me whether you're desired intervention is for research or clinical purposes and that makes a difference too.  Our research ethics committees would only agree to research with someone who did not have the capacity to consent if it were not possible to gather the same information from someone who did have capacity.  But the criteria for judging capacity also relate to the serousness and risk incurred in the decision to be taken.  Talking to someone isn't a very risky intervention and I agree that moment to moment consent may well be possible - if you say each time that you want to discuss their life and record the discussion for whatever the purpose is and the person agrees on the day, that's certainly sufficient for a clinical intervention where the information discussed will remain confidential.  From a research perspective, you have to consider whether there is a risk to the person or their family's dignity or well-being related to wat you are going to do with your data.

My research did not focus on clinical aspects of AD but I did read widely and I felt that Auguste D was not really investigated deeply enough and of course was certainly observed from a biomedical perspective. When I come across the paper I have I will cite it here.

 A nominated person can hold power of attorney for Health and Welfare but not everyone with AD has capacity loss at the outset. They may of course have fluctuating capacity.