INFORMED CONSENT

Greetings, sicky! You’re invited to be in a new research study for a medical device and drug combo! This clinical trial is designed for people like you who know something is wrong “down there” but haven’t had any luck getting a diagnosis, or for that matter having anyone believe you.

You don’t have to participate if you don’t want (regulations make us say that), and we are not coercing you in any way. But we at MEGOPharma & MEGOMedDevice, Inc. sure hope you say yes. And, so does your doctor, who quite frankly is disgusted with your ongoing complaints and inability to diagnose yourself off WebMd.

STUDY NAME: A Multicenter Randomized Trial of a ­Varied Approach for General Urogenital or Endocrine Ailments (VAGUE)

STUDY SPONSOR: MEGOPharma & MEGOMedDevice, Inc

PURPOSE OF THE STUDY

Over at MEGOPharma, we had an overstock of acid reflux and bladder control drugs, while our sister company, MEGOMedDevice was up to its artificial eyeballs in pacemakers, knee replacements, and other implantable hardware. We thought, why not repurpose this stuff to make some money? You know, the hair growth drug Rogaine was originally a blood pressure medication. By letting us mix and match our surplus inventory on you, just to see what happens, you could be part of the next miracle cure.

WHAT HAPPENS IF YOU SAY YES?

This is a randomized study. Think of it like buying a grab bag from a high-end boutique, playing the slots in your favorite casino, or eating that leftover chicken and rice bowl from three weeks ago.

If you choose to be in our study (and we really, really, want you to!) you’ll be assigned to one of four groups:

GROUP 1: The Works

This is the jackpot. You’ll get the implant (parts of several devices jerry-rigged with an overstock fitness tracker). We’ll insert it in your lower abdomen, and you’ll also get the brand-new experimental drug.

GROUP 2: Experimental implant and placebo

We’ll give you the implant, but the medication you receive will be nothing but powdered rice crackers.

GROUP 3: Experimental drug and unnecessary procedure that does nothing other than make you think you had an operation

You get the real drug! We’ll also put you under, make a small incision above your pubic bone (approximately 7 inches), and poke some tubes and wires into your gut, so you’ll feel like you had something new and exciting going on in there.

GROUP 4: Control Group

You’ll have the same sham procedure as Group 3 and get the encapsulated rice crackers. This might seem like you’re not getting anything, but, hey, it’s no different than what you’re doing now, aside from the post-surgical recovery.

RISKS

You might experience any of the following: Indigestion, rapid heartbeat, slow heartbeat, night terrors, hemorrhoids, blindness, swollen tongue, nail fungus, constipation, drowsiness, dementia, death, and in some instances having cats mistake you for a scratching post.

BENEFITS

The pride of knowing you contributed to science and good old American capitalism. Also, the off chance that our experimental treatment could fix whatever is actually wrong with you.

WHO PAYS FOR THIS? ARE THERE ANY COSTS TO ME?

We bill insurance. You won’t pay a dime… Unless your insurance company doesn’t pay. In that case, you’ll be on the hook for the full amount of the surgical procedure and drugs. We can’t say exactly how much that will be, but depending on your group assignment somewhere between $450-$200,000.

WILL I BE PAID AND WHAT HAPPENS IF I’M INJURED?

Yes! You’ll have eight follow-up visits, and we’ll pay you $50 for each one! Research says that’s the lowest price point where people feel it’s worth their trouble. We’ll even sweeten the pot by putting your study medication in an imported faux gold embossed MEGOPharma tote bag—a $3.99 value!

If you’re injured, we will treat you and then send you the bill. We assume most injuries are because you didn’t follow directions. However, for severe cat scratches that are a documented side effect of the study medication, we provide you with a shot of penicillin, a tube of Neosporin, and a MEGOPharma squirt bottle.

CONFIDENTIALITY

We promise to do our best, but let’s face it. A lot of people will be looking at your medical records. We can’t control who might find them entertaining enough to share around the office. Where they go from there is anyone’s guess.

YOUR VOLUNTARY SIGNATURE

Your participation in this study is totally voluntary. You can quit at any time, but there’s no reason you would. Your doctor agrees, too, and will be even madder at you than he is right now if you don’t do this. So grab a pen and sign your life… Just sign. Please!


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