IRB Members


October 14, 2021

Brazilian Zika research stirs debate about study result return to participants

Brazilian families who enrolled their children in research about Zika later had concerns about not having the research results returned to them, according to this article in the online magazine Undark. Although this article is specific to research done in Brazil, the challenge of returning study results to research participants will look familiar to researchers…


September 22, 2021

An argument about possible overprotection

Federal regulations include additional protection for certain so-called vulnerable populations, including pregnant women and fetuses. These restrictions run the risk of being unethical by discouraging, or disallowing, people who might benefit from research to participate in it, according to the author of a recent Washington Post opinion column. Sarah N. Cross writes that pregnant women…


September 16, 2021

What’s a protocol addendum, and how does it help?

Is your study team participating in a multi-site study in which each site will undergo separate IRB review? If so, take advantage of the option to submit a “local protocol addendum” to add detail about the main protocol the main site sends you. The IRB knows that asking for a correction or an addition to…


September 9, 2021

A new approach to flexible review

Ever wondered how to make a grown IRB office staffer cry? Easy — send them a protocol submission that almost but not quite meets the criteria for expedited review. An example — protocols that involve multiple teeny tiny blood draws done over a short period of time. Expedited category 2a allows a reasonable amount of blood to…


ORC wants to hear from you about education programs!

ORC, which has worked wonders over the past 18 months to keep the education offerings coming during a pandemic, is asking for feedback about the Certified Research Specialist (CRS) and Advanced Certified Research Specialist (ACRS) programs! Please click this link to take a short (10-minutes-max or so) anonymous survey about these two educational programs. ORC…


September 2, 2021

Updated IRB policies

Although  it wasn’t easy — some behind-the-scenes server switching caused the IRB’s web page to go a little kablooie — we finally were able to get some updated IRB policies posted. All of the current policies can be found on the IRB’s webpage. Retired policies are archived on the policy archive webpage. The most notable…


August 27, 2021

Considerations for eConsent

A recent blog entry on the Public Responsibility In Medicine & Research (PRIM&R) is a good reminder of some of the considerations associated with obtaining consent for research remotely. eConsent is becoming more common, both because of the growth of telemedicine in general, and also because of its ability to make research available across a…


Penn Medicine apologizes for prisoner research

A recent Philadelphia Inquirer article indicates the dean of Penn Medicine has apologized for the work of a longtime faculty member (now deceased) for conducting medical research on inmates at a Philadelphia prison. The research led by dermatologist Dr. Albert Kligman was done at Philadelphia’s Holmesburg Prison, where most of the inmates were Black. The…


August 25, 2021

Exempt research consent templates now available

We’ve been noticing, as we review studies that qualify for exempt status review, that sometimes it seems like the consent process is the longest and most daunting-to-subjects part of participation. We realized that we didn’t have any consent material templates geared for exempt status research readily available. At least that’s a problem we can solve…


August 18, 2021

Vitamin D study in children with asthma raises ethical concerns

The use of a placebo in a study assessing whether vitamin D supplements reduced the number of asthma attacks in kids with asthma raised some eyebrows in research ethics circles, according to a recent online publication in Science. Per the article, children with asthma and known to have low vitamin D levels were to receive either…



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