Partnering with BHN Community Health Centers to Support Research Engagement

February 2022 Issue

Author(s):

• Allyson Richmond, Manager, Operations & Network Strategy, Boston HealthNet, Boston Medical Center
• Dema Hakim, MPH, Program Manager, Community Engagement, Boston University Clinical Translational Science Institute
• Roz Schomer, IRB Reliance Specialist, Boston Medical Center and Boston University Institutional Review Board
• Matthew Ogrodnik, MS, CIP, Director, Office of Human Research Affairs

 

• Introduction
• The Community Health Centers
• Steps for Partnering with CHCs in Research Projects
• Navigating the IRB Process for Partnering with CHCs
• Conclusion

Introduction

Boston HealthNet (BHN) is an integrated health care system consisting of Boston Medical Center and 11 Community Health Centers (CHCs) dedicated to improving the health of Boston’s low-income and minority populations. Each BHN CHC is an independent FWA-assured institution and can be added to INSPIR studies with Boston Medical Center (BMC) or Boston University (BU) Medical Campus Principal Investigators. This month’s Feature Article will describe the new process for partnering with the BHN CHCs for research.

The Community Health Centers

The following CHCs are part of Boston HealthNet:

• Boston Health Care for the Homeless Program
• Codman Square Health Center
• DotHouse Health
• East Boston Neighborhood Health Center
• Greater Roslindale Medical & Dental*
• Harbor Health Services, Inc.**
• Manet Community Health Center
• Mattapan Community Health Center**
• South Boston Community Health Center
• Upham’s Corner Health Center
• Whittier Street Health Center**

*Component of BMC FWA

** Not accepting new projects at this time as of January 2022

The BU Clinical & Translational Science Institute (CTSI) Boston HealthNet website contains detailed Bios for each BHN CHC. These Bios include contact information, clinic information, patient demographics, research priority topics, and best practices for research methodology. The information contained in these Bios is critical for determining which CHC(s) you will seek to collaborate with.

Steps for Partnering with CHCs in Research Projects

Step 1: Review the CHC Bios to identify potential partners:

As discussed earlier, the CHC Bios include information crucial to determining which CHC(s) is an appropriate collaborator for your research project. Please carefully review the information provided to determine who you will reach out to for a discussion about your study. Please note that your collaboration with the CHC(s) will be most fruitful and productive for all involved if the CHC(s) is involved *as early as possible* in the project development process. Remember that the CHC(s) are your partners in the research enterprise, and will offer valuable insight into how best to frame your research hypothesis and design your study.

Step 2: Complete the Qualtrics BHN Project Request Form:

This form must be completed by those who are interested in engaging BHN CHCs in research activities. The intent is to provide relevant information to help your selected CHCs determine if the project aligns with their priorities and if partnership is feasible. Please refer to the Guide for Partnering with BHN CHCs in Research with the full instructions, prior to submitting this form. You should also be sure to review the Guiding Principles & Rules of Engagement. These are utilized by CHCs in decision-making for research participation, and fall into four main categories:

Research Priorities: Research is aligned with Health Center priorities

Regular Communication: Communication is transparent and regular throughout the research process

Equitable Partners: Health Centers are adequately supported and treated as equitable partners

Potential Benefits: Potential benefits to all participants are prioritized and workflow impact is considered

Please review the full Guiding Principles and Rules of Engagement when engaged in this process.

Again, when possible, you should submit this form to describe your proposal as soon as you have a project in mind, before your grant submission (if applicable). This way, the CHC(s) will be able to act as a partner in the study design. That said, you are permitted to request collaboration with the CHCs at a later point in your study. The timing of your form submission along with the types of research activities you seek to conduct will determine which sections of the form you need to complete. The activity categories are:

• Planning for grant submission and would like to partner with a BHN CHC
• Funding awarded, but project has not started and would like to partner with a BHN CHC
• Active research project in which you would like to add an addendum to include a BHN CHC
• Data only: Request for CHC data use in an active research study (to be abstracted from the CDW)*
• Data only: Request for CHC data use in feasibility analysis (to be abstracted from the CDW)**

* Requests for data from the Clinical Data Warehouse (CDW) must first be submitted and approved by the CDW

**Aggregate count requests are approved by the BHN Research Data Review Committee and will have a 2-business day turnaround time.

Once you submit this form, the system will automatically transmit the form to the Research Liaison for each CHC checked in the survey. As a reminder, the Research Liaisons for each CHC are provided in the Bios.

Step 3: Collaborate with CHC Research Liaisons and CHC Leadership

The Research Liaison will coordinate your communication with the CHC during the proposal phase when needed, and will provide a written decision on research participation within 2 weeks of receiving requests.

Step 4: Receive your BHN Letter of Approval

Once the partnership has been established and both parties are in agreement on the proposed study activities, the CHC(s) Leadership will need to approve participation in the project.  The Research Liaison will provide a Letter of Approval template for you to document the finalized study activities that you agreed upon with the CHC. You will then provide the completed Letter of Approval template to the Research Liaison, who will obtain the required CHC signature. Once the Research Liaison provides you with the signed Letter of Approval, you may begin the IRB process to submit your study for initial review or to amend your study to add CHC participation, which includes attaching the signed CHC Letter of Approval to your INSPIR submission.

Navigating the IRB Process for Partnering with CHCs

The electronic INSPIR application has been updated to reflect the changes in the BHN CHC research process in two main ways:

1) Linking to the IRB “Guidance for Adding Community Health Centers (CHCs) to INSPIR Studies”

2) Collecting information in the INSPIR application about the involved CHCs and the research activities that will occur at each site

Step 1:

First, you should determine if your initial submission is time-sensitive (for example, if you have any grant deadlines).  If it is, then you should consider having the initial application approved by the IRB first, and then submitting an amendment later to add the BHN CHCs.

Then, determine what research activities will take place at the BHN CHCs; and whether the BHN CHCs will be “engaged in research.”  The IRB CHC Guidance document provides all of the various options for research activities; you should check off each that apply. If your activities are not included, you may instead type a description of them in the document.  If you have any questions, send an email to medirb@bu.edu.

In the majority of instances, the CHC(s) will not be considered “engaged in research.” If, however, the CHC(s) are engaged (for example, CHC staff will administer the study intervention or consent subjects), then a reliance agreement will be needed between the CHCs and the BMC/BU Medical Campus IRB. This is described in more detail in Step 4.

Please note that if your study is ceded to an external IRB, then you *cannot* add CHCs that are engaged in research because the BMC/BU Medical Campus IRB is ceding review to another institution as the IRB of Record. The CHC(s) will need to cede review directly to the Reviewing IRB.

Step 2:

Collect your signed “Boston HealthNet Letter of Approval” from each CHC (as described earlier), then prepare your INSPIR initial submission or amendment to add the CHCs to the application.  If several BHN CHCs are involved, then amendments can be submitted for “batches” of signed “Boston HealthNet Letters of Approval” as they are received.

Please save the signed “Boston HealthNet Letters of Approval” to the INSPIR application under “Other Study Documents – Letter”; and then add them as attachments to the initial or amendment submission. 

Step 3:

Follow this step if you determined in Step 1 that the BHN CHCs are NOT engaged in research; otherwise, move on to Step 4.

In your INSPIR application, populate the applicable sections with the specific names of the BHN CHCs for which you have attached their signed “Boston HealthNet Letters of Approval.” Please note that the order of the sections, section numbers and section titles will vary depending on the type of INSPIR application you are submitting:

AMENDMENT DESCRIPTION:  Explain that you “have updated the INSPIR application to add the following BHN CHCs (list them); and have attached their signed ”Boston HealthNet Letters of Approval.”  OR, state that you “have submitted the BHN Qualtrics pre-screening form, and have added the BHN CHCs to the appropriate sections of the application.”

☐ STUDY SUMMARY

☐ EXPLANATION OF STUDY PROCEDURES / DESIGN AND PROCEDURE

☐ QUESTIONS SPECIFICALLY ASKING ABOUT BHN CHCS / RECRUITMENT PROCEDURES / CONSENT PROCEDURES:  Answer YES and list specific BHN CHCs where text box is provided.  Explain your CHC recruitment and/or consent process; and any recruitment/consent modifications specific to a CHC as documented in the signed ”Boston HealthNet Letter of Approval.”  The information you enter in the application must match the information in the signed ”Boston HealthNet Letter of Approval.”

☐ SAMPLE SIZE/SPECIMENS/DATA ANALYSIS:  Provide estimated numbers and explanation of sample size for all listed CHCs

☐ SUBJECT INCLUSION CRITERIA

☐ HIPAA COMPLIANCE and SELECTION CRITERIA:  Answer YES if obtaining medical record data from CHCs prior to obtaining signed consent/authorization from subjects; then list the specific CHCs in the Selection Criteria.

At this point, if none of the CHCs are engaged in research, move on to Step 5. If one or more CHCs are engaged in research, proceed to Step 4.

Step 4:

If the BHN CHCs WILL be engaged in research, then this will require a reliance agreement with each BHN CHC engaged in research, as described earlier. Reliance agreements must be pre-screened and pre-approved by the IRB before completing the reliance agreement sections of the INSPIR application.  BHN CHC External Investigators must also comply with Medical Campus CITI training; and, if the study is a clinical trial, Good Clinical Practice Training. In order to begin the reliance agreement pre-screening process, send an email to IRB Reliance Specialist Roz Schomer at roz@bu.edu for assistance and for further instructions to revise the application, if needed. 

Step 5:

You are now ready to submit your initial application or amendment in INSPIR. If you feel that your submission is particularly time-sensitive, send an email to medirb@bu.edu with your INSPIR study H-# and an explanation of your time-sensitive deadlines (for example, JIT grant deadlines). The IRB will review your justification and determine whether it merits priority review consideration.

Conclusion

The Boston HealthNet CHCs are valuable and willing partners in the research enterprise. This new process for working with the BHN CHCs has been designed to facilitate a community engagement-focused partnership that benefits all parties involved, including, most importantly, the patients served by the BHN CHCs. By following this new process and engaging with the BHN CHCs in research, you will be able to pursue conducting research that is focused on improving the health of Boston’s low-income and minority populations.