[fullwidth background_color=”” background_image=”” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_repeat=”no-repeat” background_position=”left top” video_url=”” video_aspect_ratio=”16:9″ video_webm=”” video_mp4=”” video_ogv=”” video_preview_image=”” overlay_color=”” overlay_opacity=”0.5″ video_mute=”yes” video_loop=”yes” fade=”no” border_size=”0px” border_color=”” border_style=”” padding_top=”20″ padding_bottom=”20″ padding_left=”0″ padding_right=”0″ hundred_percent=”no” equal_height_columns=”no” hide_on_mobile=”no” menu_anchor=”” class=”” id=””][one_full last=”yes” spacing=”yes” center_content=”no” hide_on_mobile=”no” background_color=”” background_image=”” background_repeat=”no-repeat” background_position=”left top” border_size=”0px” border_color=”” border_style=”” padding=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”” animation_speed=”0.1″ class=”” id=””][fusion_text]For me and my husband, Matt, Wednesday night is film night. And on this particular Wednesday, Matt has found a film which he thinks will be right up my street. It’s called The Last Experiment, and it takes place in a Clinical Research Unit. Thanks, I think to myself, a film which will remind me of being at work!
Then I take a look at the plot synopsis. Two young and reckless students want to earn money to backpack around Europe, so they enrol in a Clinical Trial. A clinical trial with a twist! Anyone who takes the study drug becomes completely invincible, horribly vicious and utterly immoral – oh, so it’s a Zombie film! My husband just loves Zombie movies. He often has dreams about the zombie apocalypse. I’ll know he’s having these when he starts launching random kicks and punches during the night. They aren’t nightmares – he wakes up feeling like a total badass!
‘I would really like to watch this’ he tells me ‘just as long as you promise me you won’t spend the whole film pointing out how inaccurate it is’. I pinky-swear it, and clamp my teeth down firmly on my tongue.
The first challenge to my resolve comes when the two plucky students are seated in an office, being given the full lowdown on the study. ‘This must be their Informed Consent visit’ says my brain. But, true to my word, I say nothing. Very sensibly, one of the lads ventures the question ‘But is this really safe?’ . The woman who replies is a busty beauty (of course, not a patch on our Bridget, Ally and Rosy, mind you!). ‘It’s all here in the protocol’, she purrs, ‘read it for yourself’, handing them a pamphlet made from a single folded sheet of A4.
My nose erupts in a fountain of coke bubbles! I’m on the floor! I’m laughing uncontrollably! I’m… attracting some rather irritated looks from my darling husband. ‘Sorry’. I compose myself. I guess now isn’t a good time to tell him that I’ve never seen a study protocol with fewer than 30 pages. The document she’s waving around isn’t big enough to hold the glossary of a study protocol!
I am also very aware that a volunteer should never be left wondering about their safety. One of the purposes of a screening appointment is to guide volunteers through an Informed Consent document. A medical professional will take you through detailed information about the purpose of the study, everything that’s known about the drug we’re testing, and exactly what will happen during the study. Nobody gets on to a study until we’re happy that they have understood and considered all of this information. Once you have signed this, we cannot change any element of the study (like the number of samples we’ll be collecting or the amount of time you’ll be spending in the clinic) without re-writing the Informed Consent, re-issuing it to an independent Ethics committee and repeating your Informed Consent visit – in short, it’s a BIG deal!
Back in the movie, our unfortunate heroes haven’t been on their study very long before things turn sour. The test subjects who’ve been given the active drug start behaving erratically and soon start to attack the placebo group. But of course, the study Physician (the same busty beauty from earlier), believes that the drug may provide the key to eternal life, so is not too concerned about this. So much for Good Clinical Practice.
She has so much faith in the drug that she decides that she better extend the study and keep her volunteers in the clinic for another few days. Or weeks. Or whatever. I bet those boys wish they’d signed an Informed Consent now! I can’t supress a heavy sigh.
‘What is it now!?’ says Matt, not-too-happily.
‘Her extending the study like that. It wouldn’t happen. It just couldn’t.’
‘Well, who would know if they did?’
I think about my workplace… it’s in central Leeds, sandwiched between the University Campus, the General Infirmary and a busy Pub. That’s before you take into account the 187 members of staff who work around the clock in the clinic. No wonder the Clinic in our film is in an American wilderness, and appears to be staffed by a single woman and her two…sidekicks!
Did I completely ruin the film for Matt? I hope not. At times it did seem like he was suspending his disbelief, even if I couldn’t…
Like at the start of the experiment, when the volunteers are given a bag, a Bristol stool chart, and are asked questions about their movements.
‘Hahahahahahaa!’ roars Matt ‘This is all complete rubbish, right? Right?’
‘Right’ I concede.