In Over Its Head?

The government arm that oversees most can we say "most"? dl federally funded research involving human subjects -- encompassing methodologies from surveys and oral histories to psychology experiments and medical trials -- last month informed Bluefield State College that it must suspend its relevant projects after an investigation revealed a series of alleged compliance failures.

The small historically black commuter college in southeastern West Virginia, which offers associate and bachelor's degrees, ran into trouble when the Office for Human Research Protections sent a letter in August 2006 alleging that the campus institutional review board had approved three faculty research projects in 2004 without considering key pieces of information -- such as the purpose of the studies, details on participants' informed consent and ways to protect their privacy -- and questioning whether a legitimate campus board even existed at the time.

With the cooperation of institutional review boards, or IRBs, the federal office enforces guidelines intended to safeguard the rights of study participants and applies to projects funded by agencies under the Department of Health and Human Services -- which disburses most biomedical research dollars and includes the National Institutes of Health -- as well as other agencies that have adopted the so-called Common Rule added -ag on human subjects. Guidelines on human-subjects research have come under fire recently for overreaching, especially in the humanities, and for necessitating significant overhead at colleges and universities, which dedicate resources to ensure compliance and that paperwork is in order.

At Bluefield State College, it appears that none of that institutional framework was in place when the OHRP started its investigation. Although the projects were ostensibly approved by the college's IRB in 2004, a July 9 letter alleged that the college "did not have a duly constituted, functioning IRB until Fall 2006 at the earliest, and that a BSC IRB did not conduct initial or continuing review" of the research before then. Referencing an April 25 letter from the college as well as a subsequent videoconference between faculty and staff and OHRP officials on June 15, the letter notes that several supposed members of the IRB (as reported to the agency in November 2004) said they were never on the board and that one did not exist until 2006.

There are a number of investigations into human-subjects research practices each year, sometimes as many as 50, and often at large and high-profile institutions such as the University of California at Berkeley and Arizona State University. The complexity of the regulations and sheer volume of research grants at such universities arguably increases the likelihood of the occasional misstep. But a whole-scale suspension of all federally funded research within a single college is rare: Patricia El-Hinnawy, a spokeswoman for OHRP, said that in the past four years she only knew of two other instances in which a college or university had had its research suspended -- in part or in full.

But the case at Bluefield, she said, was more wide-ranging. It seems likely from the evidence that the college was simply not prepared for (or even aware of) the need to comply with OHRP guidelines when it embarked on the research projects. In a statement, James A. Nelson Jr., the college's director of media relations, said, "Bluefield State College is very concerned about the findings of OHRP. As an institution that has been involved in human subject research for only a short period of time, we believe that our lack of expertise and lack [of] institutional oversight are significant contributing factors in the issues OHRP has identified. We are cooperating with the investigation to the fullest extent that our abilities/experience will permit, and we earnestly want to initiate appropriate steps to guard against these or similar concerns from arising again."

Still, the office emphasizes its collaborative approach, and the July 9 letter ended with several pages offering suggestions on how the college could form a "corrective action plan." Among the other regulatory violations noted in that as well as an earlier letter on March 20 include lapses in documentation and a failure to report assurances to Health and Human Services. Some highlights:

• In the April 25 letter, the college apparently said that the initial approval for the research projects was given -- verbally -- by the IRB chair at the time, "who has since left the institution."
• The office alleged that the college did not send a written assurance, per the regulations, that it would abide by the applicable rules. It further said that the college at least twice cited an invalid assurance number to the department. Federalwide Assurances (FWA) bind institutions to show compliance with human subjects regulations.
• The college allegedly did not maintain minutes of IRB meetings or give any written notification of IRB approval to the researchers.
• The July 9 letter said that during the videoconference with OHRP officials, "the IRB Chairperson" -- not identified -- "was unable to provide OHRP with the criteria that the BSC IRB considers when reviewing non-exempt human subjects research."
• Informed consent documents apparently didn't include necessary disclosures, such as a reassurance that subjects could quit at any time without penalty.

The July 9 letter noted that the college had begun to remedy some of the problems, but that most of the fixes "were inadequate" and didn't address the majority of the findings. The letter also mandated that the college send, by July 16, a list of all projects that would be suspended.

The three studies that triggered the investigation involved research into African-American health issues, specifically breast cancer prevention, HIV subtypes and screening for Type 2 diabetes.