Behind a flyer or a post asking for research volunteers is a research team, and the study it is recruiting for runs on a written plan called a protocol, with a head researcher, the principal investigator, responsible for making sure the protocol is followed. Most clinical studies in the United States must also be approved by an institutional review board, IRB for short. Its members are doctors, scientists and members of the public, who check that the people taking part are not exposed to unnecessary risks and who keep reviewing the study and its results while it runs.
What a review board checks in a study's ad
For a study that tests a drug, a biologic such as a vaccine, or a medical device, the review board should review and approve the ad as part of its first review of the study. Advertising aimed at possible volunteers counts as the start of the informed consent process and of choosing who takes part, and it includes posters, flyers and bulletin boards, among other forms. A trial testing a change in behavior, rather than a drug or a medical device, is not regulated by FDA, although most clinical studies in the United States still need a board's approval. For a study of that kind, ask the research team whether the board that approved the study also read its ad.
A board can approve research, require changes before it approves, or disapprove it, and on the papers you are handed it may go by a name other than IRB, since each institution may use whatever name it chooses. When it reviews an ad, it is expected to check that the wording is not unduly coercive and does not promise a certainty of cure beyond what the consent form and the protocol say, and it should read the final printed copy, including the size of the type and other visual effects. When appropriately worded, an ad may carry the items in the first column, though not every item is required, and the second column lists what an ad should not do:
| An ad may include | An ad should not |
|---|---|
| the name and address of the investigator or the research facility | claim or imply that what is being tested is safe or effective for the purpose under study |
| the condition under study or the purpose of the research | claim it is known to be equivalent or superior to any other drug, biologic or device |
| the eligibility criteria, in summary | use "new treatment", "new medication" or "new drug" without explaining that it is investigational |
| a brief list of benefits, if any, such as a no-cost health examination | promise "free medical treatment" when it means only that you will not be charged for taking part |
| the time or other commitment required | emphasize the payment or its amount, such as with larger or bold type |
| the location, and the person or office to contact for more information | state or imply a certainty of a favorable outcome or other benefits beyond what the consent form and protocol describe |
A study's entry in an online trial registry may never have gone before a board at all. Board approval of an internet listing is not required when the listing site limits it to basic trial information, such as the title, the purpose, a protocol summary, basic eligibility criteria, the site locations and how to contact the site. ClinicalTrials.gov lists open studies on overweight or obesity, and a listing there is not a safety check: the National Institutes of Health does not review the studies from industry, universities and individuals, and cannot ensure they are safe.
What you hand over to the person who answers the study's number
The person who answers is often a receptionist following a script to determine basic eligibility for the specific study, and in some cases you will be asked for personal and sensitive information. A simple promise that confidentiality will be maintained does not say how that information will be handled, so before you answer anything sensitive, you can ask questions like these:
- What happens to my personal information if I end the interview or simply hang up?
- Is the information gathered by a marketing company, and if so, are names sold to others?
- Are the names of people who do not qualify kept in case they qualify for another study?
- Are paper records shredded, or are readable copies put out as trash?
To be eligible, you may need certain characteristics, called inclusion criteria, and other characteristics, called exclusion criteria, can keep you out of some trials; they include specific health conditions or medications that could interfere with the treatment being tested. Different trials have different criteria, so being excluded from one trial does not necessarily mean you will be excluded from another.
More screening follows once you consent: the research staff ask more questions and perform tests to see if you are eligible, which may include blood and other laboratory tests, thinking and memory tests, and a physical examination. Once you are in a study, people other than the researchers, such as the study sponsors or experts who monitor safety, may be able to access medical information related to the study. Researchers are expected to tell you what could be shared, and how your privacy will be protected, before you consent; if they have not, ask the research team before you sign.
What signing the consent form commits you to
Your signature on the consent form provides documentation of agreement to participate in a study, but is only one part of the consent process, and the informed consent form is not a contract: you may leave the study at any time and for any reason. The whole process involves giving you adequate information about the study, enough opportunity to consider all your options, answers to your questions and a check that you have understood, then your voluntary agreement, and further information as you or the situation require. The consent document the research team gives you includes the study's purpose, how long it will last, the required procedures and who to contact, and it explains the risks and potential benefits.
In a study of a drug, a biologic or a medical device, which FDA regulates, the form has to name contacts for three things: questions about the research, the research subject's rights and a research-related injury. The same person may be listed for all three. It is better, though, for your rights contact to be a knowledgeable person other than the clinical investigator, because having the investigator as the only contact may inhibit people from reporting concerns or possible abuses. If the investigator is the only name on yours, ask the research team whether someone else can take questions about your rights.
In such a study you are given a copy of the board-approved consent document, so that you can go over it with others while you decide and afterwards, including your own physician or your family, and keep it as a reference for the schedule of procedures and the emergency contacts.
If something that could be life threatening happens to you during a study, such as a heart attack or a severe allergic reaction, phone 911, or the emergency number where you are, first, then tell the research team, using the contacts on your consent form.
In the usual order, you sign and are then screened to make sure you qualify, so a signature does not mean you have been accepted into the study. In some trials you are assigned by chance to a group that gets the intervention being tested or a control group that does not, which in some studies receives a placebo, and you will be told if placebos are used before you enter a trial.
What a study may pay you and what it may cost you
Paying volunteers is a common and, in general, acceptable practice, and payment for participation in research should be just and fair. The board should review both the amount and how and when it is paid, so that neither is coercive or an undue influence.
Credit for payment should build up as the study goes on and should not depend on your completing the whole study. If you leave early, the payment you have earned may be held until the date you would have finished the study, or that phase of it, unless waiting would be an undue inconvenience or would pressure you to stay in the study. A small part may be paid as a bonus for finishing, if it is not so large that it keeps people in a study they would otherwise leave, and all information about payment, including the amount and schedule, should be set out in the consent document. A sponsor's compensation may not include a coupon for a discount on the product once it is approved, because it presumes a favorable outcome and prompt approval for marketing, and because it could financially pressure you to insist on that product even when it may not be the most appropriate medically.
Ask the research team, before you sign, whether taking part will cost you anything, whether you will be reimbursed for travel, parking, lodging or meals, whether your insurance will pay for costs the research does not cover, and whether you can still take part if you have no insurance.
If a study harms you, institutional policy, not FDA regulation, determines whether compensation and medical treatment will be offered, and on what conditions. In a study FDA regulates that involves more than minimal risk, you must be told whether any compensation and any medical treatment are available if an injury occurs and, if so, what they are, or where further information may be obtained.
If the price of a medicine you were prescribed is part of what has you reading study ads, a cheap offer of it from a seller outside a pharmacy carries risks of its own, counterfeits among them (see Is a cheap injection from a private seller safe to buy?).
When to tell your own doctor about joining a study
Tell your own doctor about a study as soon as you are thinking of joining it, and before you decide. Always talk with your health care provider before you participate in a clinical study, because your provider may want to talk to the research team to make sure the study is safe for you and to help coordinate your care. During a typical trial you continue to see your regular physicians for usual health care. Questions about your care worth putting to the research team include:
- Can I take my regular medicines while participating?
- Who will be in charge of my care while I am in the study, and will I be able to see my own doctors?
- If I withdraw from the study, will this affect my normal care?
A study's exclusion criteria can include medicines you already take, and a study testing a drug may add one. Before you sign, also send the study's name and the research team's contact details to the NicoCares care team, if you have one, in the Spruce messaging app, because new medications and changes in your health are things to tell your care team promptly.
