Variability exists across IRBs and time and the information presented in this paper was collected from a limited set of researchers at one university who discussed experiences related to their psychosocial studies. There are likely critical regulatory issues relevant to the medical field and related disciplines that are not covered in this paper. However, the researchers who contributed to this paper are affiliated with a large substance abuse research center that probably has the largest portfolio of longitudinal studies in the world and, collectively, over the past 30 years these investigators have conducted numerous long-term follow-up studies on a wide and diverse range of drug-abusing populations. From these experiences, it is clear that ethical review of research is necessary and, in the current environment of heightened privacy concerns and widespread availability technological resources, PIs conducting longitudinal drug abuse research in particular are obligated to articulate not only their intent but also specific procedures for respecting participant rights.
Researchers and IRB members do not always agree, but they can often work together to resolve their differences. There are times when IRB members have not previously dealt with certain issues, and in other situations, researchers have not adequately addressed the risks associated with particular study features. When research needs and regulatory concerns collide, PIs and IRB members are often best served by raising awareness of one another’s issues by engaging in on-going dialogue. Greater understanding among IRB members of the oddities and idiosyncrasies common to longitudinal substance abuse research and more appreciation among PIs of the roles and responsibilities fulfilled by regulatory entities, will benefit both arenas and, more often than not, facilitate solutions that are satisfactory to both parties.
The value of anticipating necessary protocol changes and building in time to accommodate modifications to study activities cannot be emphasized enough. Longitudinal studies are likely to precipitate events that require particular attention and planning, for example, the desire to conduct further follow-up with research subjects, increases in incentive amounts, addition or modification of forms, and contacting incarcerated research subjects. Researchers benefit by anticipating how their study might evolve and how IRBs might react to the original protocol, as well as to the changes it may undergo. IRBs are as active and as invested as ever in reviewing research protocols, and interacting with IRB members can be a time-consuming and expensive process. However these are also good reasons for researchers to incorporate a sufficient amount of resources into their study plans to accommodate the time and funding needed to secure approval for longitudinal studies that involve human subjects. Also, individual investigators, particularly junior investigators, within research centers might find it useful to create a centralized mechanism for learning from one another’s IRB experiences, principally by utilizing a core set of staff who routinely prepare IRB applications and respond to related correspondence and thus have acquired the expertise, communication skills, and rapport needed to navigate the IRB process successfully. Researchers can learn from experiences like ours to provide appropriate and explicit justification for protocols, thereby minimizing the burden and cost associated with meeting regulatory requirements.
Balancing the interests of research participants with the needs of scientifically rigorous procedures requires compromises and plays out in at least three areas: (1) informed and voluntary consent, (2) participant payment, and (3) re-contact efforts. Comprehensive yet flexible research protocols are essential for securing IRB approval of longitudinal substance abuse studies, on the one hand, and enhancing the efficiency, quantity, and quality of research data collected, on the other.