Volunteering For Clinical Research In A Nutshell

How to use this site:

This site provides information about how to volunteer for clinical research.  This site is a tool for locating research clinics around the US, phone numbers and websites.  When you have obtained enough information to determine that you would like to volunteer for a research study, you will need to call any clinic you are interested in doing a study at directly to sign up. 

 

Introduction to clinical research

A quick run through from beginning to end of a study

What it's like to do a study

Okay, you ready?  This is the very least you need to know about the clinical research process!  I tried to keep this as simple as possible.  If you need additional information about the process, check out the full guide. 

Who is eligible for volunteering for a Healthy Phase I research study?

The majority of studies require people between the ages of 18 to 55 but there are studies for younger and older people. 

You must be in generally good health with no major health concerns. 

You cannot be taking any prescription or over-the-counter medications for at least 30 days prior to participating in a study. 

Most studies require non-smoking people for a period ranging from a few weeks to 6 months or longer. 

You should be willing and able to stay at a clinic for a period of 1 night to 30 nights or more without leaving unless the study has multiple stays. 

Finding a study near you

For starters, you can use this site to locate a healthy clinic near you. 

There may not be one in your home town so you must be willing to travel if necessary.

Another great resource is your local papers, job guides and college papers. 

Most clinics advertise on a weekly basis. 

Once you have located a clinic and acquired a list of studies available, you need to call the clinic to set up a screening. 

Phone Screening

When you call a clinic, ask to speak to a recruiter. 

Inform the recruiter of the study you are interested in . 

The recruiter will gather various information about your health and medical history. 

The recruiter will give you some basic information about the study such as the name of the drug, intended use, how the medication will be taken and known side-effects. 

If you meet the initial requirements, the recruiter will set up an appointment for you to visit the clinic. 

The Clinic Screening

When you arrive at the clinic, you should be fasting (nothing to eat) for at least 4 hours or however long the recruiter told you to. 

You should also be prepared to give a urine sample. 

Depending on the clinic, you may screen as a group or as you arrive. 

Check in with whoever is in charge of the screening area. 

The first thing you will typically do is verify you id and ss card.  They will copy it. 

Next, you will read the informed consent which will outline the study. 

You will find out what the drug is, who is sponsoring the study and any known side-effects. 

If you have any questions, this is the time to ask. 

The staff will do the best to answer your questions regarding the study. 

You will have your height and weight collected which will determine your Body Mass Index. 

You will have to give a urine sample which is to test for street drugs, alcohol and other values as required by the study sponsor. 

Your vital signs (blood pressure, body temperature and respirations) will be taken. 

An Electrocardiogram (ECG/EKG) will be performed. 

Several tubes of blood will be collected to determine your body functions and to also test for HIV and hepatitis. 

Depending on the clinic, you will have a brief physical exam by the study doctor.  Nothing serious.  Some clinics will do this on a separate visit to the clinic. 

Once you finish the screening, you will be given a copy of the informed consent and clinic rules.

The Phone Call

Within a few days you should receive a  phone call from the study recruiter. 

They will typically inform you of one of the following:

     Your lab results have passed and you should plan on checking in as scheduled

     One or more of your lab values were out of range the you need to return to the clinic to repeat the test (blood collection most likely)

     One or more of your lab values or your BMI or vitals signs were out of range and the study doctor has chosen to exclude you from the study.

     Your labs tested positive for drugs, alcohol, HIV or Hepatitis and you have been banned from participating in any studies at the clinic. 

If you do not make it into a study because your labs were out of range, you will be able to screen for another study. 

If you failed the drug or alcohol screen, you will more than likely be banned forever, depending on the clinic. 

If you test positive for HIV or hepatitis, they will typically do a repeat test to confirm and they you will be banned and told about counseling options. 

Checking In

If you cleared all the screening tests, you will be scheduled to check into the clinic. 

Make sure you arrive early as the clinic has a other studies to administer and cannot hold up a study for late people. 

Be sure to pack enough clothes for the study if they don't provide scrubs and shirts. 

Bring enough stuff to do. 

Make sure you check the clinic rules as it will have a list of stuff you can and can't bring to the clinic. 

All clinics ban food, beverages, drugs, weapons, medications and medicated lotions and shampoos. 

Don't bring valuables as there won't be a place to lock them up. 

If you bring a laptop, make sure you don't leave it lying around on public places for long periods of time. 

Make sure your suitcase does not have any contraband from previous trips. 

If you bring in something like medications, they can exclude you from the study because they don't know if you have taken them recently.   

Most clinics do not allow cameras of any type (cell, laptop or otherwise).

Once you check in, everyone in the study is considered a backup until the first dosing of the study drug. 

Most times, you will have to give blood and urine samples just like at screening.

The clinic needs to verify that you still meet all the study requirements before they can dose you. 

The coordinator will go over the rules of the clinic and give you more details about the study and the procedures involved. 

The Dosing

Typically, you will check in the day before the first dose. 

Before you take the first dose and any dose, the person administering the drug will verify you as the subject and read to you the drug information. 

Once you take the first dose, you are considered in the study.  

During the Study

While you are in the study, you will have several procedures on various days or every day. 

Most times the procedures will be the same stuff you did during the screening. 

Certain studies will have additional procedures. 

Usually you will have one or more PK (pharmakinetic) days where your blood will be collected multiple times to measure the drug levels in your system. 

You will typically have a clipboard or packet that outlines everything from procedures to meal time and everything else you will have to do during the study.

When your not doing a procedure, you can pretty much do what you like. 

Most clinics have computers with internet, TV's, dvd players, pool table and games for you to play with. 

Finishing Up

Once the your in-house stay is complete, you may or may not have one or more follow-up visits.  The staff will inform you if you do. 

Depending on the clinic, you may receive a check as you leave or you may not.  This varies widely.  But the general rule is that on long studies, you will usually get one when you leave and the rest in the mail. 

Once the study is complete you must not do another study for at least 30 days.  Some studies have longer washout periods. 

You should drink the standard daily allowance of water and eat foods high in iron to help replenish your RBC and hemoglobin. 

Well, that's it in a nutshell. 

If you need further information, please visit the guide on the menu bar to the left.  Guide sections have green bullets.   

Otherwise, click here to visit the main page to find clinic near you.