[D115.0000] Community-Engaged Research (CEnR) and Community-Based Participatory Research (CBPR)

• Pam Stafford, Director, Associate, Sr.
• Belinda Smith, Education Specialist

• Helene Lake-Bullock, Director/Research Compliance Officer
• Jenny Smith, IRB Reliance Manager
• IRB Reliance Team

• Jenny Smith, Research Privacy Specialist (HIPAA)
• Emily Matuszak, Research Privacy Concerns

The Medical IRBs review research originating from the Colleges of Dentistry, Health Sciences, Medicine, Nursing, Pharmacy and Health Sciences, and Public Health. The Nonmedical IRB reviews research originating from the Colleges of Agriculture, Arts & Sciences, Business & Economics, Communications & Information Studies, Design, Education, Engineering, Fine Arts, Law, and Social Work.

Note: The Nonmedical IRB does not review studies that involve the administration of drugs or studies that involve invasive medical procedures. (e.g., blood stick). Studies including those types of procedures should be submitted to the Medical IRB.

Before submitting to the IRB, if you have specific design issues that the IRB may not be familiar with, consult with ORI staff. 

There are several IRB members with experience in CBPR and CEnR.

Yes. Use the Informed Consent template that is most appropriate for your subject population and your research. The templates include suggested language for providing various kinds of information. If the suggested language does not appear to be appropriate to your project or study population, replace it with language that expresses the information in a more appropriate manner.

See informed consent templates and resources on the Informed Consent Website.

When submitting your initial application, one of the attributes is “community-based participatory research." 

Also, the Study Design section of the Research Description asks for the following additional information: If you are conducting community-based participatory research (CBPR), describe strategies for involvement of community members in the design and implementation of the study, and dissemination of results from the study.

The Office for Human Research Protections has stated that any change from the current approved IRB application must receive prior IRB review and approval. 

In preparing your initial application, include appropriate details to allow the IRB to apply the federal criteria for approval. However, when describing your operational procedures, your descriptions should be general enough to allow flexibility. Describe a range of procedures that may be employed. For example, when describing a meeting place for an interview, state a “mutually convenient place” instead of “Room 413 in Kinkead."

Note: The IRB will make the final determination as to whether your research procedures meet the requirements for approval or may require revisions.

Yes. You can submit an application without a final instrument, but in the research description, you must describe the nature of the survey, the procedures for developing the data collection instrument, and assurances that once the survey instrument is developed, it will be submitted to the IRB for approval prior to implementation. Failure to do so is considered noncompliance.

It depends on how the original application was written and what was initially approved by the IRB. If the research protocol was written to include flexibility in the questions for subjects or as a semi-structured interview, then changes that do not alter the risk to subjects and stay within the approved parameters are permitted. The IRB understands there may be follow-up questions resulting from the answers provided by the subjects; in these situations, IRB approval is not needed as long as the questions stay within the key areas of the research. If a structured survey or instrument was approved at initial review, then any changes must be submitted to the IRB as a proposed modification to the research protocol.

If you need a quick response, notify ORI staff when you submit the modification request. Although ORI attempts to facilitate urgent modification requests as quickly as possible, there is no guarantee when the modification will be reviewed and approved. For example, if a request does not meet federal criteria for approval, revisions may be needed.

At UK, there are two steps in defining engagement in research for individuals on a protocol. The first step is for the Principal Investigator, in consultation with ORI, to determine whether the individuals meet the UK definition for study personnel. 

UK definition for study personnel: A person listed as study personnel, in the IRB application, is an individual who is interacting and/or intervening with human subjects or handling personally identifiable data of a human subject. 

The second step is to determine whether the activities that the individuals participate in constitute “engagement in the research.” In order to make the preliminary determination whether the person is “engaged,” the Principal Investigator, in consultation with ORI, uses the federal guidance. 

Federal HHS Guidance on Engagement: In general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.

Non-UK study personnel may need to sign an Individual Investigator Agreement (IIA).  The Principal Investigator should contact the ORI IRB Reliance Team early for guidance.

The following human subject training options were developed to meet the needs of community-engaged partners or field workers. Curriculum materials may be used and tailored to fit the needs of the specific community population and protocol.

Publicly Available Non-UK Study Personnel HSP Training Options

• University of Kentucky (UK) Office of Research Integrity (ORI) Non-UK Human Subject Protection (HSP) Course: You MUST have a Coggno account to receive a certificate.
• Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) Human Research Protection Training
• The Association of Clinical Research Professionals (ACRP) online Ethics and Human Subject Protection training without Contact Hours is available to the public at no cost.

In addition, HSP Training courses are available for non-research individuals from the community who assist with or partner with researchers to provide input to community needs or engage participants via their role in the community.

Community-Based Non-UK Study Personnel HSP Training Options

• CIRTification: Community Involvement in Research (CIRT), Developed by the University of Illinois at Chicago
• K-12 Teacher & Support Staff Human Subject Protection (HSP) Training: For non-UK teachers and support staff helping with research in a K-12 classroom.
• Research Ethics for All (RE4ALL): Research ethics training for Community Research Partners with developmental disabilities.
• Johns Hopkins University Human Subjects Research Ethics Field Training Guide: Training document available in multiple language translations; useful for international research study personnel.
• Research Ethics Training Curriculum for Community Representatives (RETC-CR): designed for international research.
• Building Research Integrity and Capacity (BRIC): Program created by Research Optimal Digital Ethics Health (ReCODE), designed for community partners with emphasis on research design and research ethics.

Step-by-step instructions for adding non-UK study personnel to a protocol application are available on the IRB Study Personnel webpage. 

Voluntary faculty can be key personnel, but several factors must be taken into consideration on a case-by-case basis, including data ownership, HIPAA, and ownership of the results of the research, if applicable. An Individual Investigator Agreement may be required. Voluntary faculty and other faculty who are not UK-paid employees may not act as the PI in a research study. For assistance, contact the IRB Reliance Team.

Yes. Under federal regulations and consistent with UK policy, there are mechanisms available to establish protocol-specific inter-institutional agreements, which require approval by the UK Vice President for Research (VPR). UK may enter into an agreement with an individual or an institution. There are standard agreement templates for an Individual Investigator Agreement (IIA) and an IRB Authorization Agreement (IAA). 

For more information, see the IRB Reliance SOP [C1.0350]. Requests should be submitted to the IRB Reliance Team.

As a UK employee, begin by contacting the ORI IRB Reliance Team.

The next steps depend on a number of different variables, including the funding source, whether activities are FDA-regulated, the roles of the employees at each institution, and whether the institution is “engaged” under the federal guidance. 

Federal HHS Guidance on Engagement: In general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.

These factors will help determine what type of agreement (Individual Investigator Agreement (IIA) or IRB Authorization Agreement (IAA)), if any, is needed. 

For more information, see the IRB Reliance SOP [C1.0350]. 

There are several criteria used to determine which IRB covers research in the community, including the federal guidance on engagement, the primary grant recipient, whether the institutions have an IRB, and the policy and procedures of the institutions involved in research. 

For further clarification, contact the ORI IRB Reliance Team.

It depends on the agreement between institutions that outlines each IRB’s responsibilities. If UK is the IRB of record, then all modifications must be approved by the UK IRB.

For more information, see the IRB Reliance SOP [C1.0350].

Yes. UK may enter into an agreement with an institution that outlines each IRB’s responsibilities. The terms of the outlined agreement may include that each IRB reviews and approves the consent document for the local site. If UK is the IRB of record, then UK’s IRB typically reviews one consent form, and any changes to the consent document must be approved by the UK IRB.

For more information, see the IRB Reliance SOP [C1.0350].

Yes. UK may enter into an agreement with an institution that outlines each IRB’s responsibilities. The terms of the outlined agreement may include that each IRB may request changes for the local site.

For more information, see the IRB Reliance SOP [C1.0350].

The HIPAA Rules only apply to covered entities and business associates. If an entity does not meet the definition of a covered entity or business associate (45 CFR 160.103), it does not have to comply with the HIPAA Rules. The Privacy Rule protects all "individually identifiable health information" held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper, or oral. The Privacy Rule calls this information "protected health information (PHI)”. The data cannot contain any of the 18 HIPAA identifiers. Age, Race, and Gender, in addition to data, are permissible. If data from deceased individuals are used in research, then IRB review is not required. However, HIPAA may still apply. If there are any HIPAA-related questions about deceased individuals, contact the University of Kentucky Corporate Compliance.

You must contact the other facility to determine if it is a covered entity and abide by its HIPAA requirements. The forms/agreements for release of information will depend on the nature of the research and the institution’s interpretation of HIPAA. You can contact the facility’s Medical Record Department for assistance. The Medical Record Department will tell you which forms are necessary for the release of information. If the Medical Records Department cannot assist you, then contact the facility’s Privacy Officer for further assistance.    

Accessing medical records in another facility may or may not involve a Business Associate Agreement. Contact the University of Kentucky Corporate Compliance for questions regarding Business Associate Agreements.

Data transfer is permissible through a HIPAA Authorization or a HIPAA Waiver in some cases, but in other cases may require a business associate agreement (BAA). Contact the University of Kentucky Corporate Compliance for questions regarding Business Associate Agreements.

It could. If another facility transmits PHI to UK, it would be released by the other facility to UK according to that facility’s HIPAA regulations, if applicable. If it is then entered into medical records here at UK, UK HIPAA regulations would apply.

The University of Kentucky applies the same data ownership policy with CEnR/CBPR research as it would with any other research. 

The UK Data Retention and Ownership Policy: Research data are created at the University of Kentucky by faculty, staff, students, post-doctoral fellows, scholars, and visiting scientists in the course of their scholarly activities and in conducting sponsored activities funded by external agencies. The University of Kentucky owns data resulting from scholarly activities, sponsored activities, or works produced in certain University units whose specific mission includes the production of works for instructional, public service, or administrative use. The University may choose not to claim ownership rights if there is a specific condition to the contrary in the sponsored project's grant, contract, or cooperative agreement or if the activity is considered to be the unrestricted property of the author as defined in the University of Kentucky Administrative Regulations 7:6, IV.A, which defines traditional products of scholarly activity.

However, in many CBPR-focused projects, the data or study outcomes are generally viewed as “owned” by the communities in which they reside or originated. The investigator should work with university legal counsel and the community to clearly establish use and access rights as a part of the protocol prior to the initiation of the research.

• UK Center for Appalachian Research in Environmental Sciences (UK-CARES) is a National Institute of Environmental Health Sciences (NIEHS) Core Center to enhance research capacity focused on major environmental health impacts to air and water quality that have been implicated in environmentally induced disease.
• UK CARES Community Engaged Research: Initiating a Successful Community/Academic Partnership