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Clinicians Can Follow Recommendations to Better Serve Transgender Populations
Family planning clinicians and obstetrician/gynecologists likely will see transgender or gender-diverse patients seeking contraceptive care. Clinicians should learn more about transgender and gender-diverse patients to better inform their care of these populations.
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Guidance Helps Clinicians Counsel Transgender Patients on Contraception
One of the challenges facing family planning clinics and obstetricians/gynecologists when serving transgender and gender-diverse patients is the lack of research and evidence-based guidelines to inform their clinical decisions. More research is needed about contraceptive needs and health effects on transgender and gender-diverse people, experts say.
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Biometrics Expert Discusses Data Integrity for COVID-19 Clinical Trials
The first remdesivir double-blind, placebo-controlled clinical trial for treating COVID-19 was published recently in Lancet. A member of the trial’s data safety monitoring board is Weichung Shih, PhD. Shih discussed the role of biostatisticians in protecting data integrity for clinical trials and the challenges during the COVID-19 pandemic.
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Enhance Health Literacy Among Study Participants
IRBs can help improve health literacy among potential research participants using several tactics, including asking studies to use plain language in informed consent forms. IRBs can review informed consent and subject recruitment materials to ensure the study information is clear and adheres to regulatory requirements.
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IRB Highlights Standardized and Effective Metrics Model
As IRBs and research programs increasingly seek IRBs of record and form reliance agreements, they will need to know whom to trust. IRBs also need their own performance data to share with sponsors, researchers, and others. The challenge is developing metrics that work and can be used by other IRBs for benchmarking purposes.
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Small IRB Copes with COVID-19 Pandemic Under Limited Budget
Many IRBs have seen clinical trial submissions decline since the COVID-19 pandemic began. Clinical trials also were put on hold. But work at Great Bay Community College — a one-person IRB office — has increased.
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New FDA Guidance Explains COVID-19 Expanded Access Policy
The Food and Drug Administration published an eight-page guidance for IRBs handling expanded access to investigational products during the pandemic. The guidance, issued in June, explains how IRBs might review individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency.
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Actions for IRBs Reviewing Vaccine Challenge Trials
As the world looks for a safe and effective vaccine against SARS-CoV-2, IRBs should review the bioethical implications of this type of study design, including assessing risks and benefits.
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Vaccine Challenge Trials Present Ethical Issues to IRBs, HRPPs
Bioethicists and researchers say it may be possible to shorten the typical 15-year-plus vaccine timeline through a challenge trial. In this model, participants receive the study vaccine, the are deliberately exposed to SARS-CoV-2. Safety and efficacy are important, but the risk-benefit balance for study participants is weighed more heavily in favor of the greater public good.
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Failure to Diagnose and Treat Infection After Surgery Results in $2.75 Million Award
This case demonstrates the need to carefully monitor patients during the relevant times, particularly during and after surgery, and to investigate abnormal conditions. The primary basis for the medical malpractice liability in this case was the surgeon’s failure to diagnose and timely treat the infection, which escalated and caused severe, irreparable damage and pain to the patient.