Preparing for Success: Protocol Start-Up. Michelle Groy Johnson Quality Improvement Officer Research Integrity Office . Most Common Findings. Consent Form Issues Wrong versions used to consent Unstamped versions of form used to consent
Michelle Groy Johnson
Quality Improvement Officer
Research Integrity Office
Researchers must follow the protocol as approved and may not implement changes that have not been approved by the IRB. This includes but is not limited to:
If deviations or violations of the approved protocol occur, it must be promptly reported to the IRB.
Other considerations that must be promptly reported to the IRB include but are not limited to:
Professor Fit is conducting a study on the effect of exercise on literacy in grades 2 through 5 at a local school. The study will include physical activity and literacy testing on all participants (approximately 400) as well as an additional literacy test on a subset (75). All activities are described in the protocol as research and are not part of the regular curriculum at the school. The protocol indicates that only students with parental permission will be participants in the study. All data will be kept confidential.
Prior to data collection, the school principal tells the researchers she wants all of the kids at the school to participate in the physical activities and the general literacy testing. The researchers are happy about this because now their research is “part of the curriculum” and they only need consent from the parents of the kids in the subset. They have already sent out the consent forms and 400 consent forms have been returned, far more than the 75 they need.
Almost 800 kids participate in the physical activities and general literacy testing, and the results of the physical testing are given to the teachers to send home.
The protocol, data, code sheets, and consent forms are stored together in both paper and electronic formats. The PI is unsure if the code sheets are up to date and believes that the co-investigator may have some additional information relevant to the study.
Spanish versions of the consent form were used in the study but had not been submitted to the IRB. None of the consent forms were signed by the PI.
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