Missions Impossible: Obtaining IRB Approval to Ask Children Sensitive Questions
Written by Ty Ridenour, Health & Human Development

MI_(RB) 1: Seeking Approval to Ask 8-13 year old Children Sensitive Questions

It was a damp and dreary night. The mission, should I choose to accept it, was to get an innovative computerized, children's self-report assessment that included sensitive questions approved by an Institutional Review Board (IRB) at a major research institution. We're talking really sensitive questions - such as questions about children's and their family members' use of drugs and criminal behavior. Not a mission for the fainthearted! There was a lot riding on this mission, too. The assessment had been two years in the making. It involved developing software; obtaining funding from the National Institute on Drug Abuse (NIDA) and PSU Children, Youth, and Families Consortium; creating and revising professionally cartooned illustrations (you think the wording of questions can be tedious); acquiring the assistance of world-renowned epidemiologists, psychiatrists, and preventionists; thoroughly combing two decades of research on problem behavior etiology; and continued publishing of research of other topics in the meantime. Moreover, the assessment held great promise for advancing the fields of child assessment, epidemiology, pediatric psychiatry, developmental psychopathology, and prevention. Not seeing any other options to IRB approval, I forged on.

As a good special agent, I took inventory of what gadgets I had to employ. Having served for 2 ½ years on a medical school IRB, I had some idea of what to expect. This experience was one of my secret weapons because it would help save time by avoiding common errors. Few researchers view service on their IRB as benefiting their careers; perhaps I could catch my local IRB off guard with the insights I gained during my own IRB tenure. However, this experience also taught me that the business of reviewing research to make certain that it is carried out ethically is imprecise, difficult, and stressful. Another tool at my disposal was Levine's (1986) Ethics and Regulation of Clinical Research, which provides many useful insights for conducting human research. Although a bit dated, Levine's book is helpful for anticipating the lay of the land of issues related to the IRB application. I had sequestered perhaps my best gadget during a recent stealth mission to gather intelligence about my local IRB, the Human Participant Program Investigator Manual, now online at www.research.psu.edu/orp/areas/humans/policies/index.asp.

My first strategy was to employ into my research design some key elements that are useful to almost any research conducted with people. First, the ubiquitous Certificate of Confidentiality would help protect my research participants' data. Second, the fact that data would be collected using computers also would help protect the confidentiality of the research participants' data. Third, I had designed sensitive questions about family members' behaviors to be generalized to any family member so that the data could not be traced back to a specific individual. I had heard horror stories from other special agents about an entire institution's research funding being frozen because one researcher was asking children sensitive questions about their fathers. By querying about family members in general, I could ask about risk factors in the child's environment (e.g., Do family members yell during arguments?) and still protect the children's family members' confidentiality. I also had experience speaking kiddish (speaking the tongue of children) which would help when designing the assent text and consent form.

However, I did not think that these tools were good enough. I decided to go undercover and communicate with people inside the local IRB! The disguised voice that I used on the telephone must have been a good one because the two persons I spoke with were kind and even offered good advice on preparing my IRB application. I couldn't help but think that HQ had planted the contacts with whom I spoke. It was as if these contacts were double agents trying to help me get my research passed through the review process. (psst. If you face a similar dilemma, try 865-1775 and ask for a double agent Human Participants coordinator.)

So, I prepared and submitted my application. My cover was blown! I was summoned to appear before a jury of my peers, I mean the IRB committee members. At the summons, I became suspicious immediately. They had thoroughly reviewed my application and assessment and actually had intelligent questions and suggestions. So, I took them by surprise and used the tact of working with the IRB committee members to protect my research participants; it seemed to go well. Then, one week later, my suspicions proved to be correct. The IRB sent to me an e-mail with 32 recommendations!! It turned out, however, that all except three or four of the recommendations were to request further documentation for the study. The few other recommendations were to include more information in consent forms. After making these revisions to my application and consent form, the study was approved. Mission accomplished.

MI_(RB) 2: Seeking Approval to ask the Children Sensitive Questions by Phone

Setting: Another damp and dreary night, approximately two years after MI_(RB)1.

This mission, should I choose to accept it, was to conduct follow-up telephone interviews of the child research participants from MI_(RB)1. By this time, the IRB had been successfully infiltrated and my contacts were helpful anytime that I contacted them. However, there were considerable challenges in this mission that pitted ingenuity against failing to protect participants' confidentiality. Few if any telephone interviews had been conducted with children this age and, again, the future of this research depended on the success of this mission.

Follow-up interviews had been funded by NIDA. However, to fit within the funding regulations, the interviews had to be conducted using telephone calls. Of course, sensitive questions were still to be asked as part of the study. There were clear vulnerabilities to protecting the confidentiality of my research participants. What if someone was in the same room as the children during phone interviews and overheard the conversation? What if someone had tapped the child's phone line or was listening in from a different receiver? A second challenge was a result of one of the findings from MI_(RB)1: computer interview results turned out so well that they provided convincing evidence that presenting questions to children in multiple modalities (text, audio, visual) can greatly improve the psychometrics of children's self-reports.

It turned out that both challenges could be solved by enhancing the telephone interviews by mailing response option cards to participants prior to the interviews. Each 8 ½" x 11" response option card presented response options that were accompanied by cartoon illustrations from the MI_(RB)1 computer interview. Some response options consisted of "yes" versus "no"; others were Likert type response options with different answers. At the top right corner of each response option card was a colored circle sticker. To make certain that respondents were using the correct set of response options, they were told to use the matching card (e.g., the one with an orange sticker on top). Each response option also had a number so that participants answered using the number rather than the answer. Using this system, someone who was listening in from a different receiver (the spy) would only hear "1" or "2" rather than participants' answers. But, what if the spy was writing down the color code and the response numbers to later find out confidential information about the child (e.g., "Is my child using marijuana?"). At the end of the interviews, research participants were instructed to take off the color stickers from the paper, thereby foiling any spy's attempt to connect a child's answers using the color coding.

All went as planned - I appeared before the IRB review committee to explain my strategy. IRB committee members provided helpful suggestions, especially for the consent process. Data were collected and the study completed. It was as if a treaty had been struck.

Epilogue: Data collection phases of both studies have been completed and at least seven manuscripts are at various stages of preparation, submission, and revision for peer-reviewed research journals. Missions accomplished. Bum bum bumba bum bum bumba bum. Dooda, dooo, dooda doo…

References
Levine, R.J. (1986). Ethics and regulation of clinical research (2nd ed.). New Haven, CN: Yale University Press.