Multisite research involves many challenges associated with managing and coordinating issues related to the protection of human participants and the necessary institutional review board (IRB) oversight.46
Federal regulations govern research involving human participants. Institutions engaged in human-participant research that is subject to the Department of HHS regulations must have an Office for Human Research Protections-approved assurance of compliance and certify that the research has been approved by an IRB before any research commences.47
These requirements apply to all research involving human participants. Further, most peer-reviewed journals and many conferences require an avowal that research has been approved by a human-participant committee.
A number of authors, most writing from the family practice physician perspective, have discussed complexities inherent in human-participant research in a PBRN setting.46,48–53
Many of these issues translate, and some are magnified, in research on the student-athletes that athletic trainers frequently provide care for in the secondary and postsecondary settings. Foremost among these is the necessity of ensuring compliance with federal regulations governing human-participant research across multiple sites. Athletic trainers in clinical practice may not be familiar with regulatory research requirements and may not have access to an IRB for purposes of protocol review. Local IRBs, if available, vary substantially in submission requirements and procedures, application formats, application questions, and review procedures.39
Obtaining consent from research participants in a school setting can be challenging because potential participants who are not of legal age (typically 18 years) cannot provide consent. Parents must consent to their child's participation, and the underage athlete usually provides assent. The successful transport of a consent form by the adolescent athlete home to the parents, where it is signed and then returned to the school requires sophisticated logistics, reminders, and multiple attempts. Further, underage athletes belong to a class of “vulnerable” participants and are afforded special consideration under the Code of Federal Regulations governing human-participant research (45 CFR 46)
Student-athletes' medical records may be protected from disclosure by 2 federal privacy laws. Medical data collected by secondary schools are typically classified as part of the education record and thus are protected by the US Department of Education and the Family Educational Rights and Privacy Act (FERPA).55
Medical data collected in a postsecondary school setting may, in some circumstances, be subject to the US Health Insurance Portability and Accountability Act (HIPAA).56
One way of ensuring the confidentiality of protected health information under HIPAA is by removing 18 explicitly named direct and indirect unique identifiers (eg, date of birth, Social Security number, phone number) from the record. Release of deidentified information is allowed by FERPA; however, the act does not list all of the information that must be removed in order to satisfy deidentification requirements.
If all personal identifying information collected as part of a medical record is removed from participant data in a manner such that an individual cannot be identified based on his or her record set and provided that the data may not be relinked to a participant, an IRB may waive the requirement for consent and assent. A safe harbor certificate—an agreement between the researcher and the entity storing the data—is developed to guarantee complete anonymity of the data. Yet PBRNs may wish to incorporate data from athletic trainers who are subject to local IRBs. In this case, the local IRB must have the final say on the specific elements required for approval of a research project. Some may require consent and assent, whereas others may waive this requirement due to deidentification of the data.
Graham et al,46
of the American Academy of Family Physicians National Research Network, have suggested the adoption of a centralized IRB review model to address the challenges associated with multisite studies conducted through a PBRN. Briefly, the American Academy of Family Physicians National Research Network has developed procedures for members who do not report to a local IRB. Those sites without a local IRB are required to sign an Unaffiliated Investigator Agreement, developed by a central IRB, stating that they will complete the appropriate human-participant protection training and comply with the procedural standards of the US Department of HHS regulations for the protection of human participants.54
The central IRB then becomes the IRB of record for these members. For members who report to a local IRB, a centralized tracking process is recommended for submitting and tracking the various local IRB applications. As a result, the study may be monitored by multiple IRBs.