INSTITUTIONAL REVIEW BOARD GUIDE FOR THE 2012-13 NCAA NATIONAL STUDY OF SUBSTANCE USE HABITS OF COLLEGE STUDENT-ATHLETES ______________________________________________________________________________ Dear Faculty Athletics Representative (FAR): The purpose of an institutional review board (IRB) is to ensure that the rights and welfare of human participants involved in the proposed research are adequately protected. IRBs have the right to approve, disapprove or require modification of all research involving students on their campus. While the NCAA has received approval from its own Research Review Board (RRB), a national external board consisting of faculty and community representatives, it is important that you check with your IRB to determine whether additional approval is required to carry out this research on your campus. In order to assist you with your campus IRB, we have included information that may be of use in answering questions posed to you by an IRB. Please contact Michael Miranda, NCAA associate director of research, at mmiranda@ncaa.org if you would like an electronic copy of this document, have any questions or would like assistance in completing your IRB application. Note that it is possible your local IRB will require changes to the standard study administration procedures as a condition for conducting the study on your campus. If this is the case, please contact Michael at mmiranda@ncaa.org to work with you in modifying those procedures. Project Information Project Title: 2012-13 NCAA National Study of Substance Use Habits of College Student-Athletes Project Dates: Start Date: October 1, 2012 End Date: October 1, 2013 Number of Participants: The 2008-09 study included data from more than 20,000 student-athletes. We anticipate a similar number of respondents in the 2012-13 study. Project Description/Purpose: The goal of the 2012-13 NCAA National Study of Substance Use Habits of College StudentAthletes is to determine the scope and extent of drug and alcohol use by student-athletes, and how those levels have changed over time. In this study, student-athletes will be asked to complete a paper-and-pencil survey relating to their substance use. As a result of strict protocols that have been developed over seven national administrations of this survey to ensure participant 1 anonymity, it is expected that the self-reported data obtained will be valid for assessing national substance use trends. The NCAA will use the results of this study to formulate effective strategies to combat the problem of substance use on college campuses through educational intervention and prevention programs. Project History: This study is the eighth in a series conducted for or by the NCAA to measure the substance use patterns of NCAA college student-athletes. The initial National Study of the Substance Use and Abuse Habits of College Student-Athletes was published in 1985. That study and two subsequent replications were conducted for the NCAA by researchers at Michigan State University. The studies were again replicated in 1997 and 2001 by the NCAA research staff with the assistance of Dr. Percy Bates from the University of Michigan. The 2005 and 2009 replications were conducted by the NCAA research staff. The current 2013 study will also be administered by the NCAA research staff. Prior IRB Approval: The study commenced in October 2012 after it was approved by the NCAA RRB. The NCAA RRB is an external body composed of five non-staff members who represent the membership or the community. The NCAA RRB is assisted by a research compliance coordinator who facilitates operation of the NCAA RRB by providing information to investigators, receiving requests for NCAA RRB review, relaying information to the NCAA RRB and conducting other tasks as necessary to make the review process quick and efficient. At the same time the study is being proposed and undertaken on this campus, it will be undergoing a similar review and initiation on hundreds of other college campuses nationally. Scientific or Academic Merit of Current Study: Considerable care has gone into designing a study, survey and sampling protocol that will lead to unbiased, generalizable results. From a sampling perspective, we attempt to minimize bias via strict stratified random sampling of teams, comparison of obtained demographic profiles of the sample versus known demographics of the student-athlete population and subsequent (as necessary) weighting of individual responses to create aggregated estimates that are likely to best represent the behavior of the national student-athlete population. Instruments: The only instrument in this study will be a survey. In all, there are five sections to this survey. The first section is an overview of demographic questions. The second section is an overview of substance use. The following section asks about attitudes toward drug testing. The fourth section asks detailed information on where student-athletes obtain these substances and receive information on how to use the substances. The final section inquires about prescription drug use and the use of other supplements. No information that could be used to identify a particular student-athlete or institution is collected by this survey. 2 The five sections asked for responses related to the following issues: 1. Information about sport participation, academic performance and other general demographic information; 2. Information about the use of and experience with various substances; 3. Specific questions related to drug testing and attitudes toward drug testing; 4. Specific questions related to substance use and sources of information; and 5. Specific questions related to prescription drugs and supplements. Describe the setting in which the research will be conducted. It is suggested that the research take place in a classroom setting. The FAR on each campus is asked to administer the survey to the student-athletes. All staff from the athletics department (e.g., coaches) will leave the room before the survey is distributed. The FAR will read the attached scripted statement to the student-athletes detailing the purpose of the study and the directions for completion of the survey. Any student-athletes who are not yet 18 years of age will be asked not to participate in the study and to leave the room. The FAR will explain the survey instrument and the purpose of the national study, and will note that responses will not be personally identifiable once the survey is turned in. The studentathletes must be informed that participation in the survey is entirely voluntary and that they are free to turn in their survey at any time during the testing procedure. Student-athletes who wish not to complete the survey in its entirety may answer only those questions they wish to (if any) and may return the survey to the pre-printed return package. The FAR will inform the student-athletes that when they have completed the survey, they should place the survey directly into the pre-printed return package that has been prepared for mailing of the surveys back to Scantron. Neither the FAR nor any member of the athletics department staff should handle any student’s survey. Is this a collaborative project? Yes. More than 1,000 member institutions were invited to participate. In studies conducted each year using similar methods, institutional response rates tend to be 60 to 70 percent. The NCAA takes the lead in IRB review, but each campus must submit to their IRB as required. Please explain how you intend to manage information obtained in multi-site research that could be relevant to the protection of research participants, such as reporting unanticipated problems involving risks to participants or others. In addition to reporting any unanticipated problems to their own campus IRBs, the survey administrators are instructed to also report any such incidents to the NCAA RRB. This will allow the NCAA RRB to track and correct unanticipated problems should they occur. 3 Sampling Explain your recruitment process and enrollment procedures. All active member institutions of the NCAA will be asked to participate and each institution will be sampled. This sampling plan was devised to achieve an appropriate representation of all NCAA student-athletes while minimizing burden to institutions by asking that all studentathletes on no more than three teams be surveyed on any campus. The teams surveyed will be determined by a stratified computer-generated random draw. Schools may opt to replace teams with the assistance of NCAA research staff. Approximately 15 percent of teams within each NCAA championship sport will be asked to participate under this plan. The FAR will contact the coach and/or athletics department to arrange a time and place to administer the survey to all student-athletes on the sampled teams. Participants Will the subject's identity remain anonymous, confidential or other? No questions that could identify the participant or his/her school are asked, thus the data are collected anonymously. Skip patterns on the survey have been eliminated to keep completion time constant regardless of drug use. Does your research involve an investigation into legal matters, illegal activities, admissions of guilt, breaches of duties or noncompliant matters? Yes. The "yes" answer here must be qualified because in society, taking some of the substances listed are legal activities (e.g., caffeine, nutritional supplements). However, the NCAA has its own rules that prohibit the use of particular substances in some forms and in some situations. Also, some of the behavior asked would be illegal. Nothing will or can be done to intervene, though, because data are collected completely anonymously. Describe the informed consent process in detail. The participants will be read instructions that will make clear they are giving their implied consent by filling out the survey. The instructions on the survey also state that participation implies consent. Do you intend to obtain a Certificate of Confidentiality? No. Please explain how you intend to protect the privacy interests of participants during the research. We have attempted to be sensitive to these issues in designing the suggested procedures for administering and collecting the survey forms as described previously. Only the participant will handle the completed survey form until it is deposited and sealed in the return envelope that goes to the third-party data entry vendor. Skip patterns on the survey have been eliminated to keep completion time constant regardless of drug use. 4 Please explain how you intend to protect the privacy interests of participants after their involvement in the research. Once the data are entered and checked, survey forms will be destroyed. There will be no way to identify the respondent or their school. Only aggregate data, based on a sufficient number of cases to protect against inadvertent highlighting of particular cases or responses, will be published. Describe the procedure(s) in place for research participants to ask questions and voice concerns or complaints to the research investigator(s). Participants can report to the survey administrator, to NCAA researchers (contact information on survey) or to the NCAA RRB administrator (contact information on survey). How do you intend to minimize the risks to the subjects? In the event that any questions asked are disturbing to the student-athlete, he or she may stop responding to the survey at any time. Student-athletes who experience discomfort are encouraged to contact a local service. The survey administrator is being instructed to provide a local resource at the beginning of the survey administration. In addition to the local resource information, a sheet with national information will be available for each student-athlete. Risk of identification is minimized through strict anonymity procedures described previously. What benefits to society may result from this research? The results of this study will provide NCAA policymakers with data related to current levels of drug and alcohol use by student-athletes, and how those levels have changed over time. These data will also provide information regarding why student-athletes do or do not use specific substances, where they obtain illegal drugs, when they started to use drugs and their attitudes regarding different drugs. In addition, the data will provide insight about student-athletes' attitudes regarding drug testing.