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Single IRB NIH guidance may leave more questions than answers

In December 2014, the National Institutes of Health (NIH) released draft guidance detailing its support and expectations for the use of a single IRB for multisite NIH-funded studies. But for many in the IRB community, the guidance raised more questions than answers.

Guest column: Is “Right to Try” the right fit for better access to investigational drugs?

There is a constant struggle between giving people, particularly the terminally ill, access to new treatments quickly, while also ensuring that those treatments are as safe and effective as possible. The debate continues with the proposal and passage of state “Right to Try” laws, which would give terminally ill people access to investigational drugs that have completed Phase I studies.

When creating a resource guide, hyperlinks can be useful

The main goal of creating an IRB resource guide is for it to be used and useful. If it’s too large and difficult to search, such as a 50-page paper document, or if it’s too cumbersome, such as a spreadsheet, staff might avoid it.

New SACHRP member brings legal and bioethical perspective to board

IRB Advisor asked Holly Fernandez Lynch, JD, MBioethics, executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, Cambridge, MA, to discuss her role in joining the Secretary’s Advisory Committee on Human Research Protections (SACHRP). Before joining the Petrie-Flom Center, Lynch was a senior policy and research analyst for the Presidential Commission for the Study of Bioethical Issues’ report on the Guatemala STD inoculation study.

NIH issues guidance promoting central IRB use

The National Institutes of Health (NIH) is officially promoting the use of a single IRB for large, multisite clinical trials.

SUPPORT study that started controversy was complicated

A study called SUPPORT, short for Surfactant, Positive Pressure, and Oxygenation Randomized Trial, was a major reason behind recent draft guidance published by the Office for Human Research Protections (OHRP).

Standard of Care Draft Guidance Praised, Criticized

Weighing in on a recent standard of care guidance published by the Office for Human Research Protections.

Compliance Corner: IRB has CR sites correct errors with action plans

IRBs and research offices need a variety of procedures and tools to ensure compliance. One tool that sometimes is overlooked is requiring research sites to develop corrective action plans (CAPs) when they have problems.

Lean process QI plan can work well for IRBs

Most major corporations and business sectors have adopted business quality improvement (QI) measures like Six Sigma, Lean Process, and others. But in human subjects research, this type of QI approach is fairly new, an expert says.

AAHRPP says regulators need more information

In assessing the recent revisions to the Common Rule proposed by the Department of Health and Human Services (HHS), the accrediting agency for human subjects protection programs suggests that HHS may lack the necessary information to move forward with a final rule.