20 - Specialty Areas: Avoiding the Pitfall of Jack of All Trades, Masters of None in a Human Research Protection Program

Background:  HRPP staff are often pressured to be experts in multiple fields within human subjects research, leading to stress, particularly for newcomers. This institution addressed this by introducing "specialty areas," which allow focus on specific expertise rather than requiring them to be knowledgeable across all domains, alleviating some of this burden.

Program

Description:  To help combat this, our institution has implemented a “specialty area” system. Each Protocol Coordinator (PC) is assigned 2-3 areas that are identified as needs for the program and university. Currently, some examples of these are: FERPA, deception, international research, education/training/outreach, metrics and process improvement, reliance agreements, and informed consent. These specialty areas do not mean that everyone else is not familiar with the basics of these realms. But, it does mean that each individual becomes familiar enough with their respective area and becomes a resource for the others in the HRPP, IRB, and university community. Within their specialty area, Protocol Coordinators: attend training in their areas, develop guidance for the research community, educate other members of the HRPP and IRB, and become a point of contact for their respective areas. This also gives staff leadership opportunities by developing resources and leading trainings in their respective specialty areas.

Program

Assessment:  In the past five years, protocol coordinators across all of the available specialty areas have been a part of developing seven standard operating procedures (SOPs) to provide to investigators at the university. The HRPP has also developed and released a parent permission form, as well as an additional child assent form. Guidance documents on FERPA, deception, and class projects vs. research have been provided to the research community. HRPP and IRB processes have been evaluated and improved for both internal and external use. Some of these improvements include submissions and reliance agreements, as well as providing clear and concise guidance for researchers. While it is difficult to quantify this type of program, the improvements can be seen in the day-to-day operations of the HRPP and IRB.

An issue that should be considered is: if members of the team leave and take their in-depth knowledge with them. While others on the team may have a base knowledge of those topics, additional training and learning will be required to recover and maintain more specific, in-depth knowledge.

Limitations: Quantifying the effectiveness of something like specialty areas can be difficult. For example, unless someone is actively tracking questions they get across all modes of communication (email, phone, office hours, etc.), it may not be obvious how much time they are devoting to this area or how effective they are. Measuring effectiveness is limited to what can be easily tracked or seen.

Discussion:  Specialty areas within the HRPP provides reviewers with the opportunity to become more knowledgeable and proficient in areas that they are needed by the institution. It allows for someone to develop expertise and be the lead for specific areas, which allows for consistency in information provided. Identifying and assigning specific, pertinent specialty areas allows for members of the team to focus on specific areas and not become a “jack-of-all-trades.” Specialty areas allow for reviewers to dive deeper into subjects, complete additional training, and be able to be a resource for the research community, the HRPP, and the IRB.