During the coming months, aspects of the Scott Peterson murder trial will, of course, spark many a discussion about courtroom procedure at the UC Davis Law School. Perhaps less expected, though, is discussion the high-profile case has raised regarding human research protocols.
The importance of conducting human research according to federal policy was underscored in mid-January when a twist in the Peterson case made headlines. News stories said that CSU, Stanislaus, students admitted they had faked the results of a faculty-supervised survey performed for the case.
The survey -- conducted by 65 students as 20 percent of their course grade -- indicated a biased Stanislaus County juror-pool.
Defense attorneys had used the survey's findings to argue that Peterson -- who is accused of killing his wife and unborn son -- could not get a fair trial in Modesto. Superior Court Judge Al Girolami cited the survey when he rendered his decision to change the trial venue.
The next day eight students admitted to fabricating their results. They further claimed they were never told those results would be used outside the classroom.
In addition to alleged research misconduct, the professor also may have violated federal human subject research protocol by not submitting a proposal for his research to his campus's institutional review board.
It's the type of incident that could potentially jeopardize an institutions' federal funding, said Lynne Chronister, associate vice chancellor for research administration at UC Davis. "What they're facing is a potent reminder that even the perception that regulations might not have been followed can impact not just one individual or discipline, but a campus as a whole," she said. "Obviously, we do not want something like that to happen here."
From medical and nutritional studies, to political opinion polls and staff member surveys, human subject participation in university research is clearly essential, said Chronister, who helps oversee studies conducted both on campus and at the medical center.
And while the federal guidelines regarding human research haven't changed, per se, awareness of how to implement them has increased -- and, in a sense, tightened -- at institutions across the country, said Francene Steinberg, a nutrition professor and chair of UC Davis' institutional review board for social and behavioral studies.
Universities, including UC, are increasingly taking a broader view of what constitutes human research -- a view that encompasses more research in social and behavioral studies than ever before. Also, it's not just scientists who need to submit protocols to their institutional review boards prior to data collection. The policies apply to staff and students as well, as long as their research involves "intervention or interaction with a living individual," Chronister said.
"Harm to patients can come in many ways -- not just physically, but also mentally, financially or otherwise," Chronister said. "So we have to look at a broad spectrum." She remembers, years ago, reading about how a survey that triggered painful, buried memories ultimately was connected to a research subject's suicide.
During the past five years, Steinberg said she's seen an increase in the "proliferation of incidents where subjects have alleged harm from their participation in research or that they were not fully informed of the potential risks and their rights."
"These are very serious issues. They have become very high profile in the lay press as well as scientific press," Steinberg said.
One has to look no further than the Scott Peterson example or, Steinberg said, a case working its way through the New York court system. In the latter case, several New York City restaurants have filed suit against Columbia University and one of its business school professors. The suit stems from a 2001 study in which the professor was attempting to measure vendor responses to consumer complaints. In this case, it was a false complaint the professor sent to each operator of some 240 top city restaurants, claiming in each case that he had suffered food poisoning as a result of dining there.
In January 2002, acting together, six of the restaurant owners filed a $100 million suit against Columbia and the since-fired professor on the grounds of libel, misrepresentation and emotional distress. This January, an appeals court ruled that the owners could pursue their suit but not punitive damages.
The restaurants were never informed that they were part of a research project, Steinberg said. It's a situation the university might have avoided, she said, if the researcher had worked with an institutional review board to refine his study methods.
Subjects must be informed when they are part of a research protocol -- if not upfront, then through a debriefing process. And while behavioral research involving deception -- like the Columbia professor's - is not completely prohibited, it must be conducted under very strict guidelines, said Steinberg, who has experienced review boards not only as a board member but also as a researcher who has submitted protocols.
"It does afford the researcher a little bit of protection -- validity, if you want to call it that -- that their research has been reviewed and that it's a study that meets the guidelines for good scientific research," she said.
A main goal of review boards is to help foster better communication between researcher and subject, especially with regard to consent issues, Steinberg said. "As researchers, we tend to think about things in complex terms. But the lay public doesn't necessarily speak the same language and isn't used to dealing with the same terminology. So we have to make sure everything is very easily understood. They have to truly understand what the study is about, and what the potential risks and benefits are."
In addition to injuring the well-being of human subjects and the institution's reputation, a researcher's or review board's non-compliance can exact a high cost in dollars, Chronister said. In extreme situations, the federal government can halt an institution's human subject research, as they did for four days with Johns Hopkins University's clinical research programs in 2001.
There have been more than 25 such shutdowns during the last five years, Chronister said. And while those suspensions may be as brief as only a few days, the cost to the institution in lost resources can quickly run into the millions, she said.
During the 1990s, only a handful of suspensions were reported. But that tide seemed to turn in 1999 after Duke University's federal license to conduct human research was temporarily revoked. What followed was characterized by Jordan Cohen, president of the Association of American Medical Colleges, as "a veritable epidemic of federal orders to shut down research operations at some of our most highly respected institutions."
"These shutdowns … are likely to be just the beginning," Cohen wrote in 2000, noting that federal agencies had begun to view human research compliance issues as a problem nationwide. "If you find yourself thinking, 'It can't happen at my institution,' he said, "it's time to think again. It's also time to get better informed about what's required."
Most temporary suspensions have been related to clinical trial administration, but, in general, all human subject research is now being more closely scrutinized by the U.S. Department of Health and Human Services' Office for Human Research Protections, Chronister said.
The stricter environment has been a hard one to palate for some U.S. social science scholars. At Emory University, for instance, humanities researchers have argued in an online forum, The Academic Exchange, that a broader definition of what constitutes human research actually discourages research by making the process too cumbersome.
"Getting people's permission to take photographs or do videotaping has always been the norm in my field. What is new for us is getting people's permission to talk to them," wrote Sidney Kasfir, an associate professor of art history at Emory. Additionally, he said: "The whole idea is to protect the subject from abuse of power. But in the humanities, most of us research famous people who are much more powerful than we are."
It's a sentiment that's likely fairly common at U.S. universities, Steinberg said. "But (the IRB's) intention is not to be a barrier; it's to be a conduit for the research to attain approval and make sure ethical standards are met," she said. The goal is to advise investigators as the rules and definitions of compliance become increasingly complicated.
At Emory, as increased federal funding focused the university on what constituted compliance under U.S. guidelines, review boards began realizing how that responsibility also translated to non-federally-funded research and even unfunded research that posed no obvious risk, said Karen Hegtvedt, a sociologist and chair of Emory's social, humanist and behavioral IRB, in a spring 2002 issue of The Academic Exchange. Previously, her board's review work had focused on social science involving vulnerable populations, like children. Most other humanities work did not come to its attention.
At UC Davis, federal funding is, similarly, a key component of research funding. In November, Dateline reported UC Davis' record-setting $426.3 million brought in through research funding in 2002-03, more than half of which ($233 million or 54.6 percent) were research awards from the federal government. Of that, $124 million came from the Department of Health and Human Services, principally through the National Institutes of Health.
It marked an increase of $69 million (almost 20 percent) over the previous year, and the 10th consecutive year that totals had risen.
Steinberg and Chronister said to offset concerns about encumbered research, there has been increased emphasis on expediting UC Davis' institutional review board process. Approximately 1,500 human subject research protocols are reviewed per year, she said.
In response to this growth, Chronister said that in 1999 the Office of Research tripled its staff and increased the number of its review boards from one to three.
Steinberg's full 10-person board meets once a month. They review about 20 protocols per session, she said. The other two boards, both for clinical studies, are a few members larger, meet twice per month and generally have 20-25 protocols to review at each meeting.
About two-thirds of the board members are faculty members. But the other members come from the regional community -- people who "more nearly represent potential subjects who would be participating in trials," Steinberg said.
Protocols can be approved in two weeks or sooner if they require review only by the IRB director and are deemed exempt from a formal board review. A small percentage of the protocols the Office of Research receives annually fit into this category, Chronister said, noting an example might include a survey of attitudes among a general population of staff and faculty for internal campus use.
Meanwhile, protocols deemed to pose low risk to participants are expedited, usually within three to four weeks, through mid-level review by a partial board. This level might apply, for instance, to an opinion poll of a vulnerable population -- children, for example -- that could become widely published data.
Chronister said a full board must review research that poses moderate to high-level risk, for instance exercise stress tests on middle-aged populations or clinical trials that involve new drug therapies. If no revisions are needed, initial review of protocols and approvals can take approximately six weeks, she said.
The UC Davis Office of Research has created a Web site that provides links to several key resources for researchers -- including a National Institutes of Health online course for human subject research investigators. In 2000, the NIH began requiring investigators who wanted to submit a research protocol to take the course.
The Office of Research also is developing an electronic submission form to further streamline the process for researchers, Steinberg said. And orientation sessions for those planning to submit to an IRB for the first time are held throughout the year on campus and at the medical center.
Although surveys are generally exempt from more involved, full-board review, investigators still must submit a protocol to the Office of Human Research Protection, Chronister said.
Exempt research generally falls within one of six federally-defined categories -- categories deemed to present the lowest amount of risk to potential subjects, she said. They include anonymous surveys, taste sensory panels, retrospective chart reviews and analysis of discarded pathological specimens that do not have personal identifiers.
The best rule of practice is for an investigator to contact the Office of Human Research Protection. Staff members can answer questions or help with the process, Chronister said, noting, "It is vital that we recognize that conducting research with human subjects is a privilege that requires our complete adherence to rules and laws that act as safeguards for human subjects, researchers, and, ultimately, all of us."
-------------------------------------For more information about human research protocol issues…
- Education and training officer Connie Kogg provides seminars and educational programs at the request of departments. She can be reached at (916) 734- 6785 or connie.koog@ucdmc.ucdavis.edu.
- Contact the Office of Human Research Protection at (916) 734-6866. The office is located at the medical center at 4860 Y St., Suite 3870, in the Ambulatory Care Center/Ellison Building.
- See sections 210-25 of the campus Policy and Procedures manual, which deal with handling allegations of research misconduct.
- Contact the Office of Human Research Protection at UC Davis -- http://ovcr.ucdavis.edu/HumanSubjects/.
- Contact the U.S. Office for Human Research Protections -- http://ohrp.osophs.dhhs.gov/index.htm.
Want to learn how to submit to the IRB?
New submitter's orientations are set for the following dates in 2004:
On the medical center campus:
Thursday, March 25, 10 a.m. to noon, Ambulatory Care Center, Room 3030C
Thursday, June 24, 10 a.m. to noon, Ambulatory Care Center, Room 3030C
Thursday, Sept. 23, 10 a.m. to noon, Ambulatory Care Center, Room 3030C
On the Davis campus:
Thursday, April 8, 1- 3 p.m., Mrak Hall, Room 203
Thursday, Oct. 7, 10 a.m. to noon, Mrak Hall, Room 203
Debbie Gilad contributed to this story.