CALL US

Blog

Upcoming Regulatory Deadlines: NIH Policy on sIRB Review, 21st Century Cures Act and Final Revisions to Common Rule

The past 12 months brought the research community some dramatic regulatory changes, including June’s NIH policy on the use of a single IRB for multi-site research, December’s passage of the 21st Century Cures Act, and most recently January’s final revisions to the Common Rule. With these new policies come compliance dates, and with so many […]

READ MORE

NIH Policy for sIRB Review of Multicenter Research: Research Community Perspectives

With the effective date for NIH’s single IRB (sIRB) policy coming in January, many institutions are still grappling with what this policy means for their research programs. To gain a better understanding of the research community’s response to this new policy, Schulman IRB conducted an online survey of 260 institutional research leaders and administrators in […]

READ MORE

Compliance Corner – News Round Up

We generally treasure our convenience tools – laptops, smart phones, baby monitors, home security systems – yet we are aware these tools can be hacked with deleterious effects. Now add to that list of hackable devices life-sustaining, health tools and medical devices, from pacemakers to insulin pumps. In FDA, Industry Fear Wave of Medical-Device Hacks, […]

READ MORE

Planning Gene Therapy Research? Plan for IBC Review

The completion of the human genome project and advances in genetic engineering have paved the way for clinical trials involving human gene transfer, colloquially known as gene therapy research, to enter the mainstream. Gene therapy research involves the deliberate transfer of engineered genetic material to humans, with the goal of compensating for genetic mutations, conferring […]

READ MORE

eConsent in Clinical Research: Trends and Questions

As everyone familiar with eConsent is aware, FDA and OHRP released a Q&A-style guidance on electronic consent in clinical research last December. Using that guidance as a springboard, some Schulman colleagues and I met with several dozen research professionals to discuss the topic in Boston this past February. We discussed key challenges of implementing eConsent […]

READ MORE

Compliance Corner – News Round Up

Considering Technology, Privacy and Its Impact on Health Technological advancements have made it possible for us to communicate and collaborate in incredible new ways. This same technology has also brought us new ethical challenges in what and how we share with each other. This month, we look at three recent developments in the realm of […]

READ MORE

Compliance Corner – News Round Up

Clinical Promise and Safety in First-in-Human Studies In our January wrap up of 2016 events, we speculated the ripple effects of the French Phase I trial gone wrong would endure as we continue to learn and seek ever better means to protect the rights, safety and welfare of research participants. In this month’s Nature, bioethicists […]

READ MORE

Component Analysis: Analyzing Benefits and Risks of Individual Interventions to Ensure Appropriate Research Participant Protections

A major element of any IRB review is the examination of potential benefits and risks to study participants. In studies involving multiple interventions and/or placebo, applying component analysis can help IRB members understand the different levels of risk associated with each intervention. Component analysis differs from an overall risk assessment, in which a study’s combined […]

READ MORE