{"id":11092,"date":"2018-07-18T11:00:54","date_gmt":"2018-07-18T15:00:54","guid":{"rendered":"http:\/\/lifeinsurance-orleans.ca\/Life-Insurance-Blog\/integrated-consent-ethics\/"},"modified":"2019-04-25T06:36:06","modified_gmt":"2019-04-25T10:36:06","slug":"is-it-ethical-for-doctors-to-ask-their-own-patients-for-research-consent","status":"publish","type":"post","link":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/2018\/07\/18\/is-it-ethical-for-doctors-to-ask-their-own-patients-for-research-consent\/","title":{"rendered":"Is it ethical for doctors to ask their own patients for research consent?"},"content":{"rendered":"
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What is purpose of the integrated consent model?<\/strong><\/h2>\n

The model was developed largely in an effort to simplify what some consider<\/a> an unnecessarily cumbersome process that often impedes enrollment into clinical trials. With traditional informed consent, though a patient\u2019s own doctor or nurse is usually the one to broach the idea of participating, someone other than the clinician\u2014usually a research coordinator or assistant from the study\u2014must do the actual enrolling. \u201cAnd they\u2019re not always handy,\u201d says Dean Fergusson, epidemiologist at OHRI and lead scientist for its Rethinking Clinical Trials<\/a> (REaCT) program, which is currently using informed consent in some 11 studies. \u201cThey\u2019re off in different parts of the hospital, or they\u2019re busy, or it\u2019s after hours, or they\u2019re on vacation, and that patient may never even meet up with the coordinator. That happens a fair amount.\u201d<\/p>\n

In many studies, patients are given at least 24 hours to consider the request; most never follow up, says Fergusson. Patients are frequently asked to come in for further baseline testing\u2014a pregnancy test, for example\u2014and these can be a challenge to schedule. Fergusson describes enrollment in cancer trials as \u201cdismal\u201d\u2014less than five percent<\/a> across Canada, and less than three percent for breast cancer trials. This is one of the big \u201cknocks\u201d against clinical trials, says Fergusson\u2014a lack of generalizability. \u201cIf you find results in the five percent who participated, can you generalize them to the other 95 percent?\u201d<\/p>\n

Enrollment in REaCT trials can happen at the initial step, when the clinician first speaks to the patient. Care providers are expected to read a script explaining the purpose of the study, the process of randomization, and the fact that the patient can withdraw at any time. The patient is given an information sheet covering much of the same ground which they can take home. They can also sign up right there and then, in which case the care provider documents the patient\u2019s consent in their clinical notes, signs off electronically in the REaCT app, and randomizes the patient to one of the two treatments\u2014all in one visit.<\/p>\n

The REaCT trials have been running for about three years and have enrolled about 1,700 patients\u2014well over 80 percent of those approached. In part, this difference reflects the fact that the REaCT trials are low-risk, whereas most cancer trials are of novel therapies (for which the informed consent process typically has several more steps). Fergusson estimates that the integrated model allows a five-fold reduction in costs, due to the ease of data collection and management, and to the efficiency of enrollment.<\/p>\n

Is the integrated consent model ethical?<\/strong><\/h2>\n

When Ray Saginur, chair of the Ottawa Health Science Network Research Ethics Board, which is responsible for vetting all research at the Ottawa Hospital, first considered the integrated consent model, the hardest thing to wrap his head around was the absence of a signature. \u201cWe\u2019re very used to having things written,\u201d he says. \u201cIn part because we know what was said, and [in part because] we know that that the person was there.\u201d At the same time, he welcomed the \u201cdiscomfiture\u201d caused by the departure from convention. \u201cBecause I have concerns about our conventional practice,\u201d he says.<\/p>\n

Saginur explains that consent documents have become increasing long, complex and jargon-ridden. \u201cThey start looking inadvertently more like contracts,\u201d he says, speculating that they\u2019re primarily designed to try and protect the sponsors of research from liability. \u201cOftentimes people who are asked to sign these forms either can\u2019t or won\u2019t read a whole document. They just sign them. So the consent process may be subverted.\u201d The integrated model\u2019s script, the information sheet provided to participants, and the fact that participants can withdraw at any time (which is true about any trial), sufficiently mitigate Saginur\u2019s concern around the absence of written consent.<\/p>\n

But these aspects of the model may not be enough to assuage some ethics boards when it comes to consent being obtained directly by clinicians. \u201cHow do we ensure that there\u2019s no coercion involved?\u201d says Sharon Freitag, director of research ethics at St. Michael\u2019s Hospital in Toronto. \u201cHow do we ensure that the patient or participant is really understanding and not just agreeing because of the trust they put in the relationship with their physician or treating surgeon?\u201d Freitag also wonders if some people might feel unable to decline. \u201cIf this is the person who\u2019s going to be operating on me, who\u2019s going to be treating me going forward, how do I say no?\u201d<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

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The traditional way of obtaining informed consent can be cumbersome and hinder enrollment. A new model is simpler—and some even say more ethical. <\/p>\n

The post Is it ethical for doctors to ask their own patients for research consent?<\/a> appeared first on Healthy Debate<\/a>.<\/p>\n<\/div>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[],"tags":[],"jetpack_featured_media_url":"","_links":{"self":[{"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/posts\/11092"}],"collection":[{"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/comments?post=11092"}],"version-history":[{"count":4,"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/posts\/11092\/revisions"}],"predecessor-version":[{"id":14741,"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/posts\/11092\/revisions\/14741"}],"wp:attachment":[{"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/media?parent=11092"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/categories?post=11092"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/tags?post=11092"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}