Michelle Onofrio and Dr. Erin Maughan, College of Nursing
In 2006, the FDA approved a vaccine that prevents cervical cancer by guarding against the sexually transmitted human papillomavirus (HPV), which is responsible for 99% of cases of cervical cancer. The vaccine, called Gardasil, is currently routinely recommended for girls age 11-12 years. Because routine vaccination is recommended for such a young age group, parents will largely determine the success of Gardasil. Although research has indicated acceptance of the vaccine among parents has been high, a number of parental concerns have been raised which may still alter nationwide vaccine support. Due to Utah’s low childhood immunization rates and largely conservative culture, there is concern there will be particular parental resistance here to the vaccine.
In order to assess the concerns of parents in Utah and their level of acceptance of the vaccine, it was decided that Dr. Maughan and I would do a quantitative study based around results from a survey that we would develop and distribute to parents in the state. In fall 2006, Dr. Maughan and I contacted Intermountain Health Care (IHC) in hopes that they would be interested in our study and would be willing to let us use their patient database to reach our target population for survey, which is parents living in Utah with daughter(s) between the ages of 8 and 18. IHC expressed interest, and in January, 2007, after it was announced I was an ORCA grant recipient, Dr. Maughan and I attended a meeting with IHC research directors to further discuss the study. However, when the directors saw the rough draft of the survey we planned to distribute, they decided that some of the questions (which were sensitive in nature due to the fact HPV is sexually transmitted) might be offensive to their patients and they therefore declined to assist with our research or allow us access to their patient database.
After loosing the support of IHC, Dr. Maughan and I decided to search out health care providers that might assist with survey distribution. In February, 2007, we were referred to Dr. Paul Summers from the University of Utah Department of Obstetrics & Gynecology and School of Medicine. Dr. Summers agreed to act as faculty sponsor so that we could distribute the survey using the University Health Care patient population. He suggested that rather than distribute the surveys via mail, we distribute them at clinics as patients arrive for appointments. We spent the following few months working on the logistics of getting the survey out in the clinics and refining the survey, which now consists of 42 questions regarding parent concerns about the HPV vaccine, attitudes toward vaccines in general, parent willingness to get the vaccine for their children, demographics, and related questions. We also had the refined survey translated in Spanish so that our survey population could include the Hispanic Spanish-speaking population. During this time period we also worked on completing IRB applications for both BYU and the University of Utah. Our project received approval from both IRBs in September.
In June, 2007, it was determined that that in order to distribute the surveys at clinics we would have to go through the Utah Health Research Network (UHRN), which is a research network associated with the University of Utah that is designed to facilitate researchers’ access to patients and data, and which also regulates the research done at the University Health Care community clinics. All projects carried out through UHRN must be reviewed and approved by an internal UHRN committee in addition to the IRB. This review process was begun during July, and ended in September. The UHRN committee concluded that distributing the survey in clinics would be disruptive to clinic flow and therefore was not an option, but they suggested that we instead return to our original idea of distributing the survey via mail. They informed us it was possible to use the clinics’ electronic patient database called EPIC to search for and acquire the addressed of individuals that fall into our target survey population. With this new information, I worked to update our protocol and budget and resubmitted the changes to UHRN. The UHRN committee reviewed the updates, and invited me present the protocol before the committee the last week of November so that they could ask questions before giving final approval.
Dr. Maughan and I presented as planned, and during the last week of December, 2007, we were informed that UHRN approved the study and was ready to help us start gathering data. Also during December, Dr. Maughan applied for an additional grant for our project from the BYU College of Nursing. The grant was applied for after being informed by UHRN that their assistance with the research would require significantly more funding than the ORCA grant would cover.
Receiving IRB approval of our changes is the last obstacle we are waiting to overcome beginning research. Although our study received IRB approval in September, because of the changes that were made to the project, an amendment to the protocol had to be completed and submitted to the IRB of both the University of Utah and the BYU. We have received approval of our amendment from BYU, and the University of Utah IRB is scheduled to review our amendment on January 23. Once approval has been received we will immediately begin survey distribution through UHRN as planned. All surveys will be mailed at approximately the same time, and UHRN staff will collect the returned surveys for a period of one month following mailing. At the end of that month, UHRN staff will remove any identifying information from the surveys and mail them to Dr. Maughan and I for statistical analysis. Our results will then be compiled and prepared for publication and presentation.