Thursday, October 22, 2015

Virginia Universities Take on Virginia Human Subjects Law

Virignia universities, including the University of Virginia, Virginia Tech, and Virginia Commonwealth University, want to reform Virginia’s human subjects laws, which in theory impose IRB requirements on all research in the state, even constitutionally protected speech like surveys conducted by news organizations and political polling firms.

[Derek Quizon, “New UVa Rector Discourages Post-Vote Dissent, Use of Email,” Richmond Times-Dispatch, August 17, 2015.]

The Richmond Times-Dispatch reported this in August. I had missed it, and I thank the IRBNet Newsletter for alerting me. Since the NPRM was released after the story came out, I don’t know how it affects the state-level initiative. Also, though not mentioned in the story, I am told that my home, George Mason University, is involved in the effort.

In any case, here’s the relevant portion of the Times-Dispatch report:

UVa joined institutions around the state, including Virginia Tech and Virginia Commonwealth University, in calling for simpler regulations for human research projects deemed “low-risk.”

The university follows a complex web of state and federal regulations for research involving human subjects, Sullivan said.

“The administrative burden is greater because we’re basically following two sets of rules,” Sullivan said.
Some of the regulations could be trimmed for research that do not put a subject’s health or well-being at risk — surveys, for example, or testing a new teaching model in a public school. The federal regulations can’t be changed, so this would only apply to research that receives no federal funding.

One suggested change to the language in state law would expand the types of research that require “written informed consent” from subjects to include research that “presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.”

Another expands the categories of projects that would be up for “expedited review” by each institution’s human-research review committee.
Sullivan said the changes will allow state and university regulators to focus on complex, high-risk projects involving human subjects.

“If you don’t want to complete a survey, you just discard it,” she said. “It’s not harming anybody.”

The Virginia law is mostly duplicative of federal efforts, and to the extent it is not, it may be unconstitutional. So I would prefer that the universities called for outright repeal.

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