Stay Healthy
To participate in a clinical trial, you should make sure you or your child are doing all you can to maintain your health, including doing your treatments and following your CF care team's advice. Researchers may be reluctant to include you or your child in a study if they are concerned that you may not be able to follow the study's requirements. Take care of yourself, get your flu shot, and don't smoke.
Manage Your Time
Ask your research team members what the time commitment is for the clinical trial, so you know how many visits you will need to make, for example. Some studies will require a quick blood draw, while others may require hours of extensive testing. Don't forget to add in any travel time.
Most research teams are willing to coordinate with your CF care team so that you or your child can do the study tests and a regular appointment on the same day.
Consider Compensation and Reimbursements
You will not be charged a fee to participate in a clinical trial, but you may incur expenses -- such as meals, mileage, and parking -- as a result of participating. In some clinical trials, volunteers receive compensation for participating. This is a decision made by the trial sponsor, who is paying for the study. If you are considering participating in a clinical trial, you will receive information about compensation during the informed consent process before the study begins.
Compensation can vary and is usually given to pay for your time and to help offset the costs of participating. Some studies offer additional reimbursement for expenses. It is important to ask the research coordinator if these costs will be covered before the trial begins. Some expenses, such as child care, may not be covered.
“Jordan enjoys the studies that offer compensation because we allow her to keep the money. She loves to find the 'perks' of having CF.”
-- Rebeca Marquez, mother of Jordan, a child with CF, who has participated in five clinical trials
For trials within the Therapeutics Development Network, the most recent guidelines for compensation for a participant (or a parent who needs to take time off of work to bring a child in for a study visit) suggest a maximum of $30 an hour, up to a maximum of $250 for a single visit. These amounts may be adjusted in areas where the cost of living is higher than the rest of the country.
The Cystic Fibrosis Foundation spearheaded an effort to ensure that those with rare diseases such as CF can receive compensation for participating in clinical trials without losing critical benefits. The Ensuring Access to Clinical Trials Act allows participants in clinical trials for rare disease therapies to receive up to $2,000 a year without that compensation affecting their eligibility for Supplemental Security Income or Medicaid benefits.
Air Travel
In some instances, participants may need to fly to participate in a clinical trial. This is usually if the trial is more than 200 miles away. Normally the study sponsor will cover the cost. For minors, the study sponsor will pay for the participant and one parent or guardian. Consideration may be given to offsetting the travel costs of a travel companion for adults.
Additional expenses related to traveling long distances, such as housing, meals, and local transportation, also will usually be covered.
Taxes
The IRS requires research institutions to report compensation to clinical trial participants if the amount is $600 or more a year. Your study site will send you IRS Form 1099 as a record of this payment for you to include with your tax return. Reimbursement of expenses is not considered compensation.