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Is This the Right Study for Your Research Site? Five Questions You Should Ask Before Agreeing to be an Investigator

Clinical investigators often have multiple opportunities to participate in sponsored clinical trials. In addition to the professional satisfaction of being at the forefront of therapeutic development, clinical trials present an ability for physicians to offer patients alternatives to treatments they may otherwise be unable to access. While study sites may receive compensation for time and […]

Four Essentials for Clinical Trial Enrollment

Clinical trial enrollment continues to be one of the most vexing challenges for research institutions and sponsors. Despite one quarter of sponsors’ clinical trial budgets being allocated to enrolling participants, half of research sites enroll only one or no patients in studies. Recruiting a diverse patient population is an even bigger challenge, with ethnic minorities, […]

Reconciling Your Clinical Trial Protocol Start-Up Costs and Budget

As clinical trials protocols have grown more complex and more disparate teams are working on different elements of executing them, there is a potential for incongruency between the protocol requirements and the budget. It is critical to engage the stakeholders that will have a part in carrying out the research in the budgeting process. All […]

Burnout Among Research Coordinators — Warning Signs and How to Avoid Them

Let’s face it. Every job has its challenges. However, burnout seems to be at an all-time epidemic level. A recent report from Harvard University highlighted physician burnout as a public health crisis. A keyword search for “preventing burnout” yields 15 million results in Google. In the United States, problems associated with burnout are estimated to […]

Aligning Timelines for Better Coordination

Increased complexity of launching and running research protocols means different teams are contributing their expertise to ensure human subject protection, accurate budgets and successful patient recruitment. It also means that, with so many disparate groups involved, the risk of delays increases. One significant contributor to delays in study start-up is the lack of a common […]

Are Staffing Challenges Affecting Your Institution’s Research Profile?

Many institutions still struggle to recruit and retain the best talent for these challenging positions. A changing regulatory landscape, increasingly complex protocols and a litany of deadlines all contribute to a stressful environment for these employees. Additionally, salaries have remained largely stagnant, creating a general sense of disengagement. Staff turnover can lead to interruption in […]

The Revised Common Rule and Informed Consent: Public Posting

Public Posting An important provision in the Revised Common Rule is the requirement to post, to a publicly-available federal Web site, a copy of an IRB-approved version of the consent form that was used for enrollment purposes for each clinical trial conducted or supported by a federal department or agency. The Office for Human Research […]

The Revised Common Rule Compliance Dates and Transition Provision Draft Guidance

The Department of Health & Human Services (HHS) has released The Revised Common Rule Compliance Dates and Transition Provision Draft Guidance. In it, you will find information about transitioning studies to the Revised Common Rule, and answers to frequently asked questions. Our team at BRANY has been closely monitoring the guidance from regulatory agencies and is […]

The Revised Common Rule and Informed Consent: Consent Waivers

The Revised Common Rule has a few important changes regarding consent waivers. Under the revised Common Rule, broad consent is provided as an alternative to the informed consent requirements for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. If an individual was asked and refused to provide broad consent, […]

The Revised Common Rule and Informed Consent: Broad Consent

While the industry waits for additional guidance on the Revised Common Rule, there are some aspects that are worth taking note now. This is a series of blog posts that address various important changes for research professionals to keep in mind as they implement the Revised Common Rule. BLOG POST #2 — Broad Consent One […]