As a Drexel University investigator and research staff member working on a human subjects study, you are expected to follow the federal, state and university policies regarding the protection of human subjects.
The 2017 revisions to the Common Federal Rule (CFR) include important qualifications to the definitions of human subject research as well as categories of research that the require IRB oversight. Please note the following:
- If an investigation clearly meets the federal criteria for human research, then it must be submitted to the IRB for review. All applications are submitted in Coeus.
- If an investigation clearly does not meet these criteria, then it does not have to be submitted to the IRB. If an official letter about the IRB’s determination is needed or requested, then submit an application in Coeus. Choose “Letter of Determination” as the application type. It is possible that the IRB may determine a project to meet criteria as human research. The investigator will then have to change the application type to “Standard” and follow all requirements for an Initial Application.
- If it is not clear whether the investigation meets the criteria, then either contact the IRB/HRPP staff directly to discuss or submit an “Letter of Determination” in Coeus.
To assist researchers when making a human subject research determination and IRB submission it may be helpful to use tools provided below.
Human Subject Research Decision Tool
This is generally helpful for most research projects.
Human Subject Research Decision Tool [PDF]
Quality Improvement Decision Tool
This is specially designed to help with making decision whether quality improvement or quality assurance projects would require IRB review.
Quality Improvement Decision Tool [PDF]
CITI TRAINING
All key research personnel affiliated with Drexel must complete the online CITI program courses. Current certification is required for applications to be accepted by the IRB. Failure to have current certification may result in the rejection of an application or delay of its approval.
New Users: During CITI registration, be sure to use your Drexel abc123 username and email. Next, you will be prompted to add courses. Select the courses required for your research. The next screen will prompt you to select Basic or Refresher. Choose ‘Basic’ if this is your first time taking a course under Drexel. Choose Refresher if you have already been certified in a basic course under Drexel. On the next page, select the group that most closely reflects the main emphasis of your work (Medical or Social Behavioral).
If you have an existing CITI account, ensure that your profile is affiliated with Drexel University. Doing so will allow the IRB to access the courses you have completed. Please take the steps outlined in the ORI CITI Update Email SOP [PDF] to update your preferred address to your Drexel email.
| Modules |
Medical Research |
Social Behavioral Research |
| Human Subjects Research (HSR) |
Required |
Required |
| Conflicts of Interest (COI) |
Required |
Required |
| Health Information Privacy and Security (HIPS) |
Required if handling PHI |
Required if handling PHI |
| Good Clinical Practice (GCP) |
Required if sponsor specified |
Required if sponsor specified |
| Responsible Conduct of Research (RCR)(GCP) |
Required if receiving NSF funding |
Required if receiving NSF funding |
COEUS TRAINING
The Coeus Lite User Manual is located under the How to Submit section of this page. You may contact HRPP@drexel.edu or 267.359.2471 to request in-person training.
All IRB submissions are ONLY accepted via the Coeus Lite platform.
For detailed COEUS instructions, reference the Coeus User Manual [PDF].
To request access to create protocols in Coeus, please complete the Coeus Access Form.
INITIAL SUBMISSION
All new applications to the IRB for Full, Expedited and Exempt categories of review will use the same Standard IRB Application format, submitting directly to Coeus Lite.
Reference the Coeus Lite How to Submit Standard Submissions [PDF] document for a step-by-step guide with screenshots.
The minimum requirements for standard submissions include:
- HRP-504 – TEMPLATE Protocol [DOC]
- Completed CITI trainings for all study personnel (see Training section)
- Financial Conflict of Interest Disclosure for all study personnel
- Coeus eForm found at the bottom left corner of the page.
- Applications from St. Christopher’s Hospital for Children require a completed HRP-200 FORM - Initial Review [DOC] that has been signed by the PI, Department Chair, and the St. Christopher’s Office of Research Support.
- Note that while an item is submitted in Coeus, it is not received by the IRB office until the Principal Investigator and all others named in the approval route grant their approval. Once the approval route is complete, the Human Research Protection Office conducts an intake review to determine whether the above items are included. Submissions will be accepted and added to the queue for review when the minimum requirements are met.
All applicable Institutional and non-Institutional approvals must also be secured before study implementation. These approvals include, but are not limited to, Radiation Safety Committee (“RSC”); Institutional Biosafety Committee ("IBC”), Conflict of Interest (“COI”); individual departmental and external site approvals.
MODIFICATIONS
Reference the COEUS Lite-How to Submit Amendments [PDF] document for a step-by-step guide with screenshots.
- Tracked and clean versions of all study documents affected by the proposed changes must be submitted.
- Please note that research must continue to be conducted without inclusion of the modification until IRB approval is received.
- Applications from St. Christopher’s Hospital for Children require a completed HRP-203 FORM – Modification [DOC] that has been signed by the PI and the St. Christopher’s Office of Research Support.
- Modifications to change study personnel:
- Submit this as a separate modification to expedite the process. In the memo accompanying the completion of the HRP-203 FORM – Modification [DOC] in COEUS Lite platform, include names of research personnel being added as well as removed.
- Modifications adding Drexel personnel:
- Add the individual to the Investigators/Study Personnel tab in Coeus. § If unable to find the individual in the Coeus search, contact coeus-help@drexel.edu with the individual’s name, department, email address, and unit number to have them added to Coeus
- Completed Financial Conflict of Interest Disclosure for each individual added.
- CITI training for all Drexel personnel must be current.
- If the modification is to change the PI, the HRP-207 FORM Change of Principal Investigator [DOC] must be attached.
- Modifications adding non-Drexel personnel:
CONTINUING REVIEW
Reference the COEUS Lite-How to Submit Continuing Reviews (Renewals) [PDF] document for a step-by-step guide with screenshots.
- Submit continuing review via the COEUS Lite platform 45 days prior to the expiration date. Attach all requested supplemental documentation
- Applications from St. Christopher’s Hospital for Children require a completed HRP-202 Continuing [DOC] that has been signed by the PI, Department Chair, and the St. Christopher’s Office of Research Support.
- Continuing reviews should not be submitted with proposed changes. Modifications are to be sent under a separate submission.
EMERGENCY USE, COMPASSIONATE USE AND HUMANITARIAN USE DEVICE
- Whenever possible, physicians are to notify the IRB in advance of a proposed Emergency Use.
- Physicians are to notify the IRB in advance of a proposed Compassionate Use
- Applications to use an unapproved drug, biologic, or device when there is no time for prior IRB review, contact the Director of Human Research Protection, HRP staff, or IRB chair immediately to discuss the situation.
- If there is no time to make this contact, reference the following documents:
- Use the HRP-502 - TEMPLATE Consent for Emergency Use [DOC] to prepare your consent document. You will need to submit the HRP-215 Report of Emergency Use of a Test Article [DOCX] to the IRB within five days of the use and for drugs and biologics, submit an IRB application for initial review within 30 days.
Reportable New Information
Reportable New Information must be submitted to the IRB within five days of awareness of the circumstances. Circumstances of an urgent matter must be communicated directly via email to the IRB.
Complete the HRP-214 Reportable New Information [DOCX] form, and within 5 business days alert the IRB by submitting to COEUS. In the COEUS protocol, select "Submit to IRB," and then select "Notify IRB." Attach the HRP-214 and relevant supporting documentation to COEUS, and after saving the submission details, send a notification email to HRPP@drexel.edu.
The criteria for reportable new information includes, but is not limited to, the following:
- Information that indicates a new or increased risk, or safety issue
- Any harm experienced by a subject or other individual, which in the opinion of the investigator are unexpected and probably related to the research procedures
- Non-compliance with the federal regulations governing human research or with the requirements or determinations of the IRB, or an allegation of such non-compliance
- Audit, inspection, or inquiry by a federal agency
- Written reports of study monitors
- Failure to follow the protocol due to the action or inaction of the investigator or research staff
- Breach of confidentiality
- Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a subject
- Incarceration of a subject in a study not approved by the IRB to involve prisoners
- Complaint of a subject that cannot be resolved by the research team
- Premature suspension or termination of the research by the sponsor, investigator, or institution
- Unanticipated adverse device effect
For more detailed information refer to HRP-071 POLICY – Prompt Reporting Requirements [DOC]
CLOSURE
The process for submitting a final report is the same as submitting for a continuing review. Reference the COEUS Lite-How to Submit Continuing Reviews (Renewals) [PDF] document for a step-by-step guide with screenshots.
Reliance Agreements, or IRB Authorization Agreements, are useful and may be required by the Federal Revised Common Rule for projects where more than one institution is engaged in the same research protocol. These agreements may be study-specific, or institutions may have master agreements in place. Reliance agreements document respective roles, responsibilities, and communication between the institution that is providing the ethical review of human subjects, and the institution that is relying on their review. All projects involving a Reliance Agreement must also be submitted to the Drexel IRB's electronic system. For specific guidance about the single IRB requirement please refer to https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-requirement/index.html.
Initiating the Reliance
Drexel as the Relying Site
Create a COEUS protocol submission and specify the Type as “Letter of Reliance” on the General Info page. Add all Drexel study personnel to the Investigators/Study Personnel tab. Upload the following to COEUS on the Attachments page:
- HRP-204 FORM - Request for Drexel to Cede Review [DOC]
- The external IRB’s approval letter with the most recent approval date. This may be an initial approval letter or a continuing review approval letter. The letter must show that the protocol has an up-to-date approval period.
- The approved study-wide protocol
- If Drexel investigators will be enrolling and consenting subjects, the IRB-approved consent form
- The lead study team or reviewing IRB may provide a consent template to insert Drexel-specific language. If so, upload the template with tracked changes and a clean version.
- If Drexel investigators will be involved in recruitment, the approved recruitment materials
- If Drexel investigators will be involved with interactions or interventions, the approved data collection tools
- Financial Conflict of Interest Disclosure forms for Drexel personnel
If you need a letter from Drexel IRB stating that we will be willing to cede review to a single IRB for a grant application, fill out the HRP-204 FORM - Request for Drexel to Cede Review [DOC]. Send the completed form, including any available study documents, via email to hrpp@drexel.edu to request Drexel IRB support for the grant application.
When all criteria are met, the IRB Authorization Agreement will be signed by both parties’ Institutional Officials. Drexel IRB will need to be provided with the approval document, approving Drexel as a study site, from the reviewing IRB. The Drexel IRB will then provide an acknowledgement letter to the Drexel PI, acknowledging that Drexel has been approved as a study site by the reviewing IRB, and the COEUS record will be updated to reflect the reviewing IRB’s approval.
Drexel as the Reviewing IRB
Requests will be assessed on a study-by-study basis to determine if Drexel IRB has the resources necessary to serve as the reviewing IRB.
The Drexel IRB will need to provide initial approval of a research project prior to commencing the reliance process. Reliance requests when Drexel is the reviewing IRB should be submitted as an amendment.
For new protocols that will require reliance agreements with external sites:
- Create a new standard submission in COEUS
- The Drexel IRB will provide initial approval prior to starting the reliance process
- When Drexel IRB provides initial approval, the Drexel study team will send to the external sites:
- The approved version of the protocol and applicable study materials (e.g., consent form, recruitment materials, data collection tools, etc. according to the role of the external site)
- HRP-206 FORM - Local Context Survey [DOC]
Submitting the reliance request:
- Create an amendment in COEUS. Complete the Amendment Summary page, the HRP-213 Modification COEUS eForm, and upload the following to COEUS on the Attachments page:
- HRP-205 FORM - Request for Drexel as the Single IRB [DOC]
- Tracked and clean versions of the protocol to include the new setting of the research, the data management plan for maintaining the confidentiality across study sites, describe the role of the new site (additional information may be needed depending on the site’s role)”
- If the new site will need a site-specific consent form, submit a tracked and clean version of the consent form with the site’s required language
- Completed HRP-206 FORM - Local Context Survey [DOC] signed by a representative of the external IRB.
Note: The Drexel study team is not responsible for submitting CITI training documentation, contact information forms, or conflict of interest forms for the relying site study team with the reliance request submission. The relying site will maintain the responsibility for reviewing the education, training, qualifications, and conflict of interest information of the relying site study team.
More than one site may be added at a time but be aware that this may affect the time it takes for the amendment to be approved.
If you need a letter of support from Drexel IRB for a grant application, fill out the HRP-205 FORM - Request for Drexel as the Single IRB [DOC]. Send the completed form, including any available study documents, via email to hrpp@drexel.edu to request Drexel IRB support for the grant application. Requests will be assessed on a study-by-study basis to determine if Drexel IRB has the resources necessary to serve as the reviewing IRB.
When all criteria are met, the IRB Authorization Agreement will be signed by both parties’ Institutional Officials. Drexel IRB will send the approval determination, approving the external site, to the Drexel PI.
Personnel Changes
When Drexel is the relying site: The Drexel IRB will maintain the responsibility to review our site’s personnel changes. Follow the standard procedures for submitting personnel changes when Drexel study personnel changes occur. If the information about Drexel’s site PI changes during the time the study is open, the reviewing IRB must be informed of the change.
When Drexel is the reviewing IRB: The relying site will maintain the responsibility to review their site’s personnel changes. Changes to the relying site study team do not need to be submitted to Drexel IRB, with the exception of relying site PI changes. If the information about a relying site PI changes during the time the study is open, the Drexel IRB must be informed of the change.
SMART IRB
The Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Reliance Platform was developed to assist institutions in implementing the NIH Single IRB Policy. SMART IRB developed a Master Common Reciprocal IRB Authorization Agreement, which many institutions are participating in, including Drexel University.
Drexel IRB will use the SMART IRB Master Common Reciprocal IRB Authorization Agreement as a means of reliance with other SMART IRB participating institutions.
If the reliance request involves an institution that is not signed onto the master agreement, Drexel IRB will need to execute an individual IRB Authorization Agreement with the other institution(s). For additional information about SMART IRB, visit https://smartirb.org/.
MASTER IRB AGREEMENTS
Drexel IRB has Master IRB Authorization Agreements in place with the following:
- Advarra
- Western IRB
- National Cancer Institute CIRB
- Children’s Hospital of Pennsylvania
Advarra
- Create a COEUS protocol submission and specify the Type as “Letter of Reliance” on the General Info page.
- Add all Drexel study personnel to the Investigators/Study Personnel tab.
- Upload the following to COEUS on the Attachments page:
- The approved study-wide protocol
- HRP-505 FORM Permission to Use Private Identifiable Health Information for Research
- If the research involves the use and release of subjects’ private identifiable health information, the HRP-505 FORM should be completed by the study coordinator and included with the Coeus submission. Confirm that the HRP-505 FORM includes the appropriate information.
- For industry-sponsored research, Advarra may have an approved consent template on file with the sponsor. Use the Advarra-approved sponsor consent template to insert Drexel’s required language [DOC]. The template “Costs” language, “Research Related Injury” language, and HIPAA Authorization language should be removed.
- Financial Conflict of Interest Disclosure forms for Drexel personnel
- Seek out Drexel University Radiation Safety approval and/or Drexel University Biosafety approval as applicable
In addition to submitting to COEUS Lite, a separate CIRBI submission must be created: Advarra CIRBI Platform.
Advarra places a hold on the CIRBI submission until Drexel HRP provides authorization to conduct their review. The purpose of the HRP Authorization Letter is to document that Drexel HRP has reviewed the submission to assess the PI’s credentials, completion of required trainings, review the consent document and ensure the required institutional language is included, and any additional local/institutional requirements as applicable. The HRP Authorization Letter will be provided when the local/institutional requirements are met.
Amendments and Continuing Review submissions should be submitted directly to Advarra through CIRBI.
Changes to study personnel should be submitted to Drexel IRB as an Amendment through Coeus.
Reportable New Information should be submitted to Advarra. Advarra’s determination may need to be reported to Drexel through Coeus, as applicable.
Contact cirbi@advarra.com for any questions related to CIRBI submissions.
WIRB
- Create a COEUS protocol submission and specify the Type as “WIRB” on the General Info page.
- Add all Drexel study personnel to the Investigators/Study Personnel tab.
- Upload the following to COEUS on the Attachments page:
- The approved study-wide protocol
- HRP-505 FORM Permission to Use Private Identifiable Health Information for Research
- If the research involves the use and release of subjects’ private identifiable health information, the HRP-505 FORM should be completed by the study coordinator and included with the Coeus submission. Confirm that the HRP-505 FORM includes the appropriate information.
- For industry-sponsored research, WIRB should have an approved consent template on file with the sponsor. Use the WIRB-approved sponsor consent template to insert Drexel’s required language [DOC]. The template “Costs” language, “Research Related Injury” language, and HIPAA Authorization language should be removed.
- Financial Conflict of Interest Disclosure forms for Drexel personnel
- Seek out Drexel University Radiation Safety approval and/or Drexel University Biosafety approval as applicable
In addition to submitting to COEUS Lite, a separate Connexus submission must be created: WCG How to Submit.
WIRB places a hold on the Connexus submission until Drexel HRP provides authorization to conduct their review. The purpose of the HRP Authorization Letter is to document that Drexel HRP has reviewed the submission to assess the PI’s credentials, completion of required trainings, review the consent document and ensure the required institutional language is included, and any additional local/institutional requirements as applicable. The HRP Authorization Letter will be provided when the local/institutional requirements are met.
Amendments and Continuing Review submissions should be submitted directly to WIRB through Connexus.
Changes to study personnel should be submitted to Drexel IRB as an Amendment through Coeus.
Reportable New Information should be submitted to WIRB. WIRB’s determination may need to be reported to Drexel through Coeus, as applicable.
Contact clientservices@wcgirb.com for any questions related to Connexus submissions.
NCI CIRB
NCI CIRB Local Submission Guidance [DOC]
Children’s Hospital of Philadelphia
The Drexel-CHOP Determination Form [PDF] should be completed by the CHOP or Drexel investigator requesting that their home institution’s IRB serve as the IRB of Record. The signed and completed determination form should be included with the IRB application to whichever institution (CHOP or Drexel) that is being proposed to serve as the Reviewing IRB. If that IRB agrees to serve as the Reviewing IRB, a copy of the signed determination form will be forwarded to both the PI and to the Relying IRB.
Refer to the Initiating the Reliance section above for further guidance on how to submit the request. See either “Drexel as the Relying Site” or “Drexel as the Reviewing IRB” as applicable.
Investigator-initiated research involving interventional treatment on human subjects is a valuable component to the academic and research initiatives of Drexel University. This research is unique in that the investigator serves not only as the principal investigator, but also as the sponsor. Thus, the researcher can expect a higher level of preparation, consideration and responsibilities. Drexel University must also assume a higher level of responsibility and risk as the institution housing such research. Researchers should expect to meet additional institutional requirements based on the nature of the research.
In support of investigators and their protocols of this design, Drexel has formed the Investigator Initiated Study Advisory (IISA) committee to assist and guide investigators through a review process in advance and support of IRB application. The IISA Committee of members from various administrative departments (i.e. Clinical Research Group, Human Research Protection, Office of General Counsel).
The IISA Committee was established to provide researchers with an early assessment of their research to identify additional regulatory and institutional requirements imposed on such research. The early assessment will allow researchers to plan for these additional requirements. The early assessment will also allow Drexel, as the research institution, to conduct a risk and cost analysis. Such early assessment is aimed to reduce the delays in initiating such research.
If you would like to arrange an IISA review or speak with the team please contact the IISA at 215-762-4889 or email Dr. Noreen Robertson at nmr26@drexel.edu.
Putting the Belmont Report into Practice: A Focus on Justice and Community
The ethical principles of the Belmont Report (autonomy, beneficence, and justice) are built into the federal regulations and guidance concerned with human research protections. The Belmont Report is also the foundation for Drexel’s Institutional Review Board (IRB) and its Human Research Protection Program (HRPP). Collectively, we all help to ensure that the spirit and the letter of these principles are incorporated into the design and conduct of human research in Drexel’s purview.
While all three principles hold equal importance, this section of our webpage will focus on ways in which justice can be addressed. The Belmont Report frames justice in terms of concern for subject selection. The Common Federal Rule further clarifies that the IRB’s criteria for approval of human research must include equitable selection of subjects. In doing so, it must consider the purposes of the research, the setting in which it would be conducted, whether subjects will be vulnerable to coercion or undue influence, the selection (inclusion/exclusion) criteria, subject recruitment and enrollment procedures and the influence of payments to subjects. (Please refer to HRP-400 WORKSHEET: Criteria for Approval [PDF] and Footnote 6 for more details about these criteria).
Explore the concepts and the definitions
The Belmont Report begins its section on justice with a question: “Who ought to receive the benefits of research and bear its burdens?” Please explore the original text. While this document speaks about “equality” in research, it alludes to but does not specifically mention “equity,” which is a more impactful aspect of justice. For more discussion about “equity” please explore these resources:
Parekh, Jenita and Ramos, Manic F. Racial Equity Considerations and the Institutional Review Board Child Trends, March 11, 2020.(https://www.childtrends.org/publications/racial-equity-considerations-and-the-institutional-review-board)
Sheridan N, Kenealy T, Stewart L, Lampshire D, Robust TT, Parsons J, et al. When Equity is Central to Research: Implications for Researchers and Consumers in the Research Team. International Journal of Integrated Care. 2017;17(2):14. DOI: http://doi.org/10.5334/ijic.2512
Friesen P, Kearns L, Redman B, Caplan AL. Rethinking the Belmont Report? Am J Bioeth. 2017 Jul;17(7):15-21. doi: 10.1080/15265161.2017.1329482. PMID: 28661753.
Stay informed about current scholarship and discussions about justice in research
The nature of and ethical context for human research do change with time. While the Belmont Report remains an ethical standard, it is important to note that was written more than 40 years ago. In 2018 the Common Rule was revised for the first time since it was issued in 1991. Formal response to set ethical and regulatory standards is a historically slow and conservative endeavor even when social and scientific circumstances shift rapidly and in profound ways. This gap in response makes it imperative that all those involved in human research and its oversight remain committed to scholarship about research ethics. On the topic of justice this includes consideration of evidence-based research on subject selection, enrollment practices, and the impact of research findings. Please start exploring this area of study here:
Pratt B, Wild V, Barasa E, et al Justice: a key consideration in health policy and systems research ethics BMJ Global Health 2020;5: e001942. (https://gh.bmj.com/content/5/4/e001942)
MacKay D Fair subject selection in clinical research: formal equality of opportunity
Journal of Medical Ethics 2016;42:672-677 (https://jme.bmj.com/content/42/10/672)
Benfer, Emily and Mohapatra, Seema and Wiley, Lindsay Freeman and Yearby, Ruqaiijah, Health Justice Strategies to Combat the Pandemic: Eliminating Discrimination, Poverty, and Health Inequity During and After COVID-19 (June 1, 2020). Yale Journal of Health Policy, Law, and Ethics, Forthcoming, Available at SSRN: https://ssrn.com/abstract=3636975 or http://dx.doi.org/10.2139/ssrn.3636975
More Racial Diversity Among Physicians Would Lead to Better Health Among Black Men, Research Shows https://fsi.stanford.edu/news/more-african-american-doctors . . .
Fleck, L.M. (2020), Some Lives Matter: The Dirty Little Secret of the U.S. Health Care System. Hastings Center Report, 50: 3-4. doi:10.1002/hast.1176 (https://onlinelibrary.wiley.com/action/showCitFormats?doi=10.1002%2Fhast.1176)
Seek and utilize resources offered by Drexel
The University has many resources related to addressing issues of justice in research, including:
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Drexel University College of Medicine Office of Diversity, Equity & Inclusion. For more information, please visit https://drexel.edu/medicine/about/diversity/about-the-office/
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Drexel University Office for Institutional Equity and Inclusive Culture. For more information, please visit the EIC website.
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ResearchMatch- Drexel now participates in this secure, easy-to-use volunteer registry funded by the National Institutes of Health. For more information, please visit the ResearchMatch website https://www.researchmatch.org/
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Drexel University Office of University and Community Partnerships- This office features current information about centers and initiatives, academic engagement and other opportunities related to the University’s commitment to the Philadelphia community. For more information, please visit https://drexel.edu/civicengagement/centers-initiatives/overview/
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IRB Membership- In research, “community” applies not just to geographic neighbors, but also to groups of people associated according to shared backgrounds, interests, experiences. By contacting the IRB, researchers can be connected to experts on our Committees (and to those outside Drexel) who can offer valuable guidance on topics such as equitable subject selection, introduction to possible stakeholders, and building ethics into research design.
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Incorporate justice into your IRB application, study protocol, and its supporting documents. Complete the appropriate sections of the protocol and informed consent templates and other supporting documents in language which helps to demonstrate how justice will be implemented in the research. This may include:
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Establishing your eligibility criteria and subject selection processes according to scientific merit rather than mere convenience or familiarity.
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Ensuring that the consent document and consent process are culturally appropriate, readable, and otherwise acceptable to the population of prospective participants. It may be necessary to conduct focus groups with stakeholders in the early stages of research design or an ongoing basis.
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If appropriate, periodically evaluate the racial or ethnic demographic characteristics of enrolled participants to ensure that these reflect the demographics of the community involved in and/or impacted by the research.