Medical research needs you so health care can make progress: Alex Rothbaum and Ellen Doernberg
CLEVELAND — In just months, over 150,000 people participated ‘ in COVID-19 vaccine trials to determine if the vaccines were safe and effective. Without their contribution to this vital research, we would not have the hope that many of us do now.
Pulling from our own work, it has taken four years to enroll 26 participants in a study aiming to predict post-traumatic stress disorder after trauma, and over two years to enroll 25 participants to evaluate an intervention for children with Autism Spectrum Disorder (ASD) — fairly standard rates. While these are specific examples, research recruitment is a common barrier to innovation.
In understanding diseases, developing treatments, and moving towards prevention, progress is participatory. Research studies are conducted worldwide with these aims. However, to be successful, studies need participants. Many of us forget that what we experience as standard of care was once experimental.
Representation in studies has been an ongoing issue — with women; those with nonwhite, non-European ancestries; and gender and sexual minorities especially underrepresented. While there has been some improvement, we can only come closer to representing everybody, if everybody participates.
We can’t create a call-to-action to participate in research without acknowledging that mistakes, misrepresentation, and maltreatment of participants have occurred throughout history, leading to deep-rooted and justified reluctance to participate. Every one of us is entitled to have trepidation, just as much as we have the right to decline participation.
No matter your background, participating in research can seem overwhelming, with lots of paperwork and jargon. As you weigh whether to participate in research, look for the following to ensure you’re participating in a legitimate and ethically monitored project:
1) Participation is optional. No one should pressure you to participate, and whether you participate should not impact your care, employment, etc. No one should promise you a miracle by participating.
2) In many cases, there will be informed consent where procedures, risks, and benefits should be presented. To mark that an institutional review board (IRB) has reviewed the study for safety and ethics, there should be a stamp with an expiration date that has not yet occurred. You should be encouraged to ask questions and offered a copy of the documents and time to review them.
3) You should be provided contact information for the person in charge of the study (the principal investigator, or PI) and the IRB, and everything should be in your preferred language if you participate.
4) Research for an experimental treatment should be registered on Clinicaltrials.gov.
5) If you’re the guardian of a participating child, researchers should explain the study to your child directly in language they can understand. Usually, at 7 or older, your child should be asked to give verbal or written approval to participate. A legal guardian will have access to collected study information.
6) Alternatives to participation should be discussed with you. For treatment studies, nonstudy treatments should be reviewed. For nontreatment studies, most often the alternative is to not participate. There are safe ways to stop participating at any point, which should be reviewed with you before you commit.
7) The consent form should indicate how your information will be protected, including local confidentiality laws. With advances in technology and analytics, it is common for study data to be shared across institutions. In many cases, only de-identified data will be shared.
8) It is standard to not receive the results of any study-related test you’re given.
9) Regardless of whether you participate, a list of resources should be available should you need it, such as referrals to providers or services.
10) You may not be eligible to participate in a particular study, even if you have a confirmed diagnosis that is being studied. Often, the researchers can’t tell you why you didn’t qualify. This should not discourage you from trying to participate in other studies.
Alex Rothbaum and Ellen Doernberg are doctoral candidates in clinical psychology at Case Western Reserve University.
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