Guidelines Regarding Protocol Specificity
The IRB receives protocols for review that differ substantially in specificity of the description of the research. The purpose of these guidelines is to clarify our existing policy regarding the amount of methodological detail that must be included in protocols submitted to the IRB, with a special focus on protocols that describe multiple studies.
The general guideline is that all studies must be described in sufficient detail that the IRB can make an informed judgment regarding the potential risks to research participants. Thus, for every study to be conducted, full information is needed regarding subject recruitment, informed consent, research procedures (including experimental manipulations), measures and/or questions to be administered, debriefing, confidentiality, and all features of the study that might raise concerns regarding the rights and welfare of the participants.
Protocols Containing Multiple Studies
Providing sufficient detail is of special concern when multiple studies are described within a single protocol. The IRB permits researchers to submit multiple studies within a single protocol when all of the studies are designed to answer the same, or highly related, specific research question(s).
Protocols may describe potential variations that might be used in subsequent studies as the program of research unfolds. Researchers may describe multiple studies in one of two ways:
- Each study is described separately and in full detail, just as if the studies were being submitted in separate protocols.
- The first study in a series of highly similar studies is described in full detail, with possible variations then described for potential subsequent studies. When this approach is used, (a) the essential features of the method must be the same for all studies and (b) any variations must be explicitly described. All essential features of every conducted study (subject recruitment, informed consent, research procedure, measures, and debriefing) must appear in the protocol covering that study. Using participants, manipulations, measures, or procedures that are not described in the approved protocol is a violation of IRB policy.
- For example, after describing in detail a study about how people estimate probability with and without seeing other subjects’ probability estimates, a protocol might state that the researchers might later ask subjects to estimate the number of heads or tails in a coin toss, estimate the probability that numbered balls will be drawn from a bowl, and estimate the number of smiling faces in a large array of faces. However, such a protocol would not cover variations that were not stated (such as estimating the number of dead bodies in a picture of a massacre) or new experimental manipulations (such as varying the time that people have to make their estimates). Such possible variations must be explicitly mentioned in in the original protocol or added later via amendment.
Amending Protocols to Include New Studies
New studies may be added to an approved protocol through the amendment process when they are designed to answer the same, or highly related, research question(s) and employ the same general procedure as the studies in the approved protocol. Amendment requests must include the revised protocol with the changes incorporated in Track Changes.
Studies posing new research questions or using substantially different methods should be submitted as new protocols.