The Institutional Review Board (IRB) and the Human Subjects Office (HSO) provide guidance and support for UI researchers involved in research collaborations or affiliations with non-UI organizations or independent individuals for translational research. 

Community Research Continuum

Community Research can best be envisioned on a continuum which runs from the traditional research approach to completely community driven, as noted below.

  • Traditional Research Approach: Research that is completely academic researcher-driven. The researcher identifies the research question(s), plans the study design, and conducts the research. The researcher analyzes and interprets the data and disseminates results to the academic community.
  • Community-Placed Research: Research is conducted IN the community setting but is still academic researcher driven. Community members may be study participants but are not engaged in designing or conducting the research.
  • Community-Based Research (CBR): Research is planned and conducted WITH community members are engaged in conducting the research study activities.
  • Community-Based Participatory Research (CBPR): Research is planned and conducted WITH community members as equal partners. CBPR is a collaborative approach to research involving community members, organizational representatives, and academic researchers in all aspects of the study design and procedures.
    Community partners provide the research questions, assists with study design and data collection/review, final outcomes, distribute results back to the community in a format they understand. Community partners share funding received for the research. 

References

  1. Israel BA, Schulz AJ, Parker, EA, Becker, AB. Review of community-based research: Assessing partnership approaches to improve public health. Annu Rev Public Health,1998; 19:173-202.
  2. Novel Organizational Approach: Development of the Harvard Catalyst CEnR Subcommittee-Working to Address Issues Across the Continuum. Jacob, CA. Accessed 11.4.2011.
  3. Practicing Community-engaged Research. McDonald, MA (2009). Accessed 11.4.2011. http://www.citiprogram.org/citidocuments/Duke%20Med/Practicing/comm-engaged-research-4.pdf

Non-UI Research Team Members

CBR is a specific type of research that by nature includes collaboration with individuals who are not affiliated with the University of Iowa. These collaborators typically are not affiliated with an institution or organization that has an IRB to oversee their research activities. However, everyone must have IRB oversight to conduct research activities, such as screening potential study participants for eligibility, conducting the informed consent process, interacting with enrolled subjects to collect data or to perform intervention activities.

The UI Principal Investigator may add non-UI team members in Section II of the HawkIRB application to initiate the process of asking the UI IRB to serve as the IRB of record for individuals or organizations involved in the conduct of the research.

Non-UI team members Responsibilities

  1. Complete the human subjects protection training in the CITI Program that is required for all UI faculty, staff and student researchers.
  2. Sign an Individual Investigator Agreement (IIA) or IRB Authorization Agreement (IAA) to request UI IRB oversight. When you add a non-UI research team member in Section II of the HawkIRB application, the IIA Template worksheet on the Attachment page. The External IRB Coordinator will prepare the agreement for signature by UI Institutional Official and by the individual or organization engaged in the research.
  3. Complete FERPA training if accessing educational records for research purposes.
  4. Complete a Conflict of Interest disclosure. Since non-UI team members cannot access the eCOI system, staff in the Conflict of Interest Office will obtain this disclosure on a separate form.

Principal Investigator Responsibilities

  1. Obtain a letter from the HIPAA Privacy Officer documenting approval to use protected health information from the non-UI location (if applicable).
  2. Obtain a Letter of Agreement if research activities will be conducted at an off-campus location that would need to provide permission (if applicable).
  3. Ensure that non-UI team members complete the required training (including human subjects protection training in the CITI Program and FERPA training for use of educational records).

Additional Assistance

To consult about community based research or non-UI team members, contact the Human Subjects Office (irb@uiowa.edu) or the External IRB Coordinator (uirb-external@uiowa.edu).