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How to Form A Clinical Research Team

by Karen Appold •

Try to provide an incentive, whether it is a gift card or a free assessment that comes from the research. If additional hospital or clinic visits are needed, consider reimbursing travel or parking expenses.

Enrolling Patients

Ask your research assistant to meet with patients who agree to enroll. This professional should be friendly and good at explaining things and answering patients’ questions. You can also have the research assistant obtain informed consent from patients.

The IRB for each institution will have specific guidance regarding informed consent, which includes these steps:

  • Participant is briefed on what the study involves in language that is easy for a patient to understand;
  • Participant is informed of the possible risks and benefits of the treatment;
  • Participant is told about the risks and benefits of other options, including not undergoing treatment;
  • Participant has the chance to ask questions and get them answered to his or her satisfaction; and
  • Participant has time to discuss the plan with family members or advisors.

If the patient is a minor, has a serious mental disability, or cannot give consent, then the parent, legal guardian, or a person authorized by the court must give consent before treatment can start, Dr. Nguyen said. This is usually a close family member who has reason to know what the patient would want.

Follow the rules for research explicitly. “It’s better for patients to know up front what they are agreeing to do, rather than to be surprised when they are asked to sign the form,” said Dr. Lieu.

Conducting a clinical trial is a huge undertaking. Make sure you have a team of dedicated assistants in place to ensure a smooth process and that you follow all of the requirements when enrolling patients to ensure a successful research experience.

Karen Appold is a freelance medical writer based in Pennsylvania.

Hot Topics for Research

Research topics are truly endless. As you ponder a topic, consider the big problems facing otolaryngologists and how your proposal could help resolve some of these problems, said Gerald S. Berke, MD, research liaison for the Triological Society and professor and chair of the department of head and neck surgery at the David Geffen School of Medicine at the University of California, Los Angeles.

For example, scarring is a big problem for surgeons practicing otolaryngology. What novel types of treatments might they use to improve outcomes?

Some other topics to explore include:

  • Studying patient quality of life following certain procedures;
  • Determining whether some surgeries are truly necessary;
  • Exploring whether patients are getting the best bang for their buck from certain medications;
  • Examining novel ways to treat common problems; or
  • Investigating novel therapeutics or drug delivery for patients with advanced cancers.

—KA