Hello!
The federal Office for Human Research Protections, or OHRP, created these videos to help you
learn more about participating in research.
Deciding if you want to volunteer in research can be difficult, and that the decision can
have important consequences.
To help you think it through, this video provides information about different types of research,
specifically clinical trials.
You may have heard the term “clinical trial” or “clinical study.”
This is research that tests medical or health-related interventions.
“Intervention” is a general term for the treatment or procedure that the research is testing
Interventions are commonly tested in phases.
Phase 1 and 2 trials determine if an intervention is safe and effective in humans.
These are followed by larger phase 3 trials to find out whether the intervention works,
or is genuinely helpful to those who need it.
One common type of clinical trial is a randomized controlled trial or RCT.
To find out if a new intervention works, researchers compare it to something they already understand.
To do this, they put participants into groups.
The different groups in a study are called “arms.”
The “experimental arm” is the group assigned to the intervention being tested.
The “control arm” is the comparison or “usual care” group.
For example, suppose the researchers want to see if a new antibiotic can help people
fight off an infection better than a current one.
They can give one group of volunteers the new antibiotic and another group the current
one, and collect information comparing how they do and if they have any side effects.
When a new drug is tested, sometimes volunteers in the control arm receive what is called
a placebo.
A placebo looks like the new drug, and is taken the same way, but doesn’t actually
contain any medication.
For the comparison to make sense, researchers make sure there aren’t any major differences
between the two groups, apart from the new intervention.
One way to do this is to use “randomized assignment.”
“Randomized” means that the decision to assign a volunteer to the experimental or
control group is done completely by chance, like a coin flip.
This way, the group that the volunteer will be in is not decided by the researcher or
the volunteer, and no one can unintentionally influence the study results.
So a randomized controlled trial or RCT is a clinical trial with research volunteers
randomly assigned to groups in order to test an intervention.
RCTs are just one type of research.
There are many other types of research done for other reasons.
For example, researchers who want to understand people’s behavior may collect information
by interviewing them or asking them to complete a survey.
Other researchers may want to study blood samples and do so by using leftover samples
from medical tests.
The type of procedures done in a research study will influence the kind of risks, if
any, to which volunteers might be exposed.
Hopefully this video answered some of your basic questions about research and gave you
some things to think about.
Deciding whether to participate in research can be tough.
Don’t be afraid to ask the research team for more information and talk with them about
your concerns.
It’s their job to give you the information you need.
OHRP has created a printable list of questions to consider when deciding whether to participate
in research.
You can print this list and take it with you when you meet with the research team.
It can help remind you of some of the questions you may want to ask.
To print this list of questions and see other information about research participation,
check out the OHRP website at
www.hhs.gov/about-research-participation