Presented by:

Bow Lee, Kerri Vanderbom, Carlos Algara Dwaine Plaza

Tuesday, June 12, 2012

Introduction• Purpose

• Literature Review

• Methods

• Results

• Suggestions

• Conclusions

Purpose• Gather preliminary information regarding the IRB at Oregon

State University (OSU)

• Explore the IRB experiences of OSU students, faculty, and independent researchers

The Challenge with IRB• Though the IRB is federally mandated, individual institutions

(universities, research hospitals, etc.) have their own policies to guide decisions about the research approval process in regards to human subjects

Literature ReviewMultiple Revisions (Green 2006, Stair 2000)

• IRB request revisions 90% of the time

IRB committee members should be experts (Edgar 1995, Moon 2009)

• Carefully select committee members

Literature Review cont.Variation in IRB practices/operationalization

(Green 2006; Moon 2009, Stair 2000, Kimberly 2005, Edgar 1995, Dziak 2005, Hirshon 2002)

• No standard protocols • Fragmented organization

A: 15 days for approvalB: 12 days for approvalC: 77 days for approval

Literature Review cont.Process Issues (Green 2006, Stair 2000, Moon 2009, Hirshon 2002, Edgar 1995, Bozeman 2009)

• Procedures are inconsistent • Do not respond in timely manner• Investigators are not fully aware of the amount of work needed

for IRB approval • Unclear or too many rules• The subject of “human protection” has become blurred • IRB deliberation should be transparent so that the

investigators are fully aware of revisions

Methods Process• Completed in three weeks• Phase 1: literature review• Phase 2: survey design lead by a small group• Phase 3: survey design by entire class• Phase 4: pre-test• Phase 5: finalized items in survey• Phase 6: administer• Phase 7: analysis

Methods cont.Items: 13 items total• Demographics• Experiences with the IRB at OSU and other campuses• Strengths and challenges of the IRB at OSU• Suggestions respondents made to improve the IRB at OSU

Methods cont.Sample (N=177)• Survey was sent out to various OSU list serves (i.e. ClAall, EXSS,

etc)• Convenience and snowballing• Faculty and graduate students were the majority of the

respondents

Results

SuggestionsConsistency across reviewers•Protocol/ manual for reviewers may help

•“They were also not consistent with their requests of other students meaning that my coordinator insisted that I had certain requirements that my peers did not have to provide.”

•“The consent form was questioned and areas suggested to be omitted. These, oddly, were cut and pasted from the template consent form on the website!”

•“Different reviewers have different review standards, such as the type of risk associated with participating in a survey or focus group or the acceptability of some words in a cover letter or consent form as pertains to reading level.”

•“the inconsistency of reviewers. Some reviewers seem to be very nit-picky while others are not.”

Suggestions cont.Maintain given scope of human protection

• “…They have moved beyond being mainly protection from medical invasiveness to being in charge of every conversation between a researcher and an informant.”

• “Overly complicated paperwork processes and overly detailed editing of protocols once they are submitted.”

• “I felt a sense of confusion...why were these changes requested? …Do these changes really make a difference with regard to protection of human subjects from abuse?”

Suggestions cont.Provide better instructions

• “I felt that the IRB office could have given me more specific instructions on what was needed, including items such as headers for PDF documents.”

• “I think the consent form process is the most difficult…Maybe there isn't enough information made available without having to ask multiple questions. More information could be made available on their website.”

• “Not much clear instruction BEFORE submission.”

Suggestions cont.Hire Additional Staff

• “Provide incentives; increase in FTE for IRB reviewers”

• “The length of time it takes to get through it. I believe this is because of a lack of resources (staff, etc.), not any fault of the staff that's available.”

• “They're overwhelmed by requests and under-staffed, so they are slow in spite of their efforts. Faculty reviewers I suspect slow this down a lot, with not enough volunteers on the IRB review panel and too many requests.”

• “It was easy to communicate with the IRB office through email but difficult to talk to someone in person as they only hosted office hours for 2 hours a week.”

Suggestions cont.Compare IRB processes at other Universities

• “IT TAKES TOO LONG!!!! At the U of O we can get approval in less than a week on an exempt protocol, ... 4-6 weeks for approval of an exempt protocol with no risk is absurd.”

• “At other universities graduate students can be primary investigator (PI) rather requiring a faculty to be the PI.”

• “…a survey I was doing with a researcher at XXXX and since it would be exempt, it did not require XXXX approval, but OSU did? The result was the OSU IRB held up this joint research project with XXXX and by the time it was approved,…the people we needed to include were too busy.”

Suggestions cont.Reducing paperwork for exempt/low risk studies and

continuing review process

• “TOO MUCH PAPERWORK for studies that are very low risk”

• “For Exempt: the process is too involved and causes people to avoid research…This impacts MS students”

• “Prioritize high and low risk studies- it is a little ridiculous how long the process takes even for researchers who are not engaging in any kind of work with experimentation or vulnerable populations.”

• “Honestly, I ended up having to add a year onto my graduate study to proceed with my research. It has been frustrating to say the least.”

Suggestions cont.Make a different process/application for qualitative

research• “Too strict, it doesn't give the needed flexibility for good qualitative

research.”

• “…It is overly complex and time-consuming for non-intrusive record interviews. Had I carried out the same interviews relying on my notes (highly inaccurate), I would need no IRB approval, but fore the more accurate method (audio recording), I needed approval.”

• “I don't know that it as effective in reviewing all the different kinds of research that are done at this university.”

• “IRB reviewers who are unfamiliar with the processes and methodologies they review.”

• IRB process is vital to operation and success of research at OSU

• Consistency of reviewers• Reduce paperwork• Need clear instructions• Increase FTE for IRB reviewers• Streamline process to expedite more research • Explore the need for a different application for qualitative

research• Need to create a different protocol for undergraduate

research because of time constraints

Conclusions

• Survey method:• Quick & inexpensive method• Preliminary data• Limitations: small sample size, limited time, sample of

convenience, lack of in-depth qualitative methods (i.e. focus groups, interviews, content analysis)

Conclusions cont.

Thank You.

Questions/Comments