Researchers

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.

At a high level, investigators and research staff are responsible for:

Minimizing risk to subjects and protecting subject rights and welfare;
Securing IRB and other departmental or institutional regulatory approvals in advance of the research;
Obtaining and documenting informed consent;
Disclosing conflicts of interest;
Complying with sponsor-specific requirements as applicable; and
Completing required training for the protection of human research subjects when applicable.

Investigator Obligations

Overview

Activities Requiring Oversight

Overview

Human Subject Research Decision Tool

Quality Improvement Decision Tool

Training

CITI Training

Required Modules for Medical Research and Social Behavioral Research:
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

Tools and Templates

Policies

Forms

Checklists

Worksheets

Templates

Investigator Guidance

How to Submit

Overview

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.

For information about conflicts of interest in research, visit Drexel University's Conflict of Interest page.
If the protocol will involve radiation and human subjects, visit Drexel University Radiation Safety for more information about radiation safety policies, procedures, and Radiation Safety Committee Review.
If the protocol may involve biological hazards, visit Drexel University Biosafety for more information about biosafety policies, procedures, and Institutional Biosafety Committee Review.

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:
  - Upload an HRP-201 Contact Information Form [DOC].
  - Upload current Human Subjects Research training certificates for each individual added.

Continuing Review

Emergency Use, Compassionate Use, and Humanitarian Use Device

Reportable New Information

Closure

Reliance Agreements

Overview

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
1. 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:
1. 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)
2. 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:
1. HRP-205 FORM - Request for Drexel as the Single IRB [DOC]
2. 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)”
3. 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

SMART IRB

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

Overview

Putting the Belmont Report into Practice

A Focus on Justice and Community

Explore the concepts and the definitions

Stay informed about current scholarship and discussions about justice in research

Seek and utilize resources offered by Drexel

The University has many resources related to addressing issues of justice in research, including:

Drexel University College of Medicine Office of Diversity, Equity & Inclusion
Drexel University Office for Institutional Equity and Inclusive Culture
ResearchMatch - Drexel now participates in this secure, easy-to-use volunteer registry funded by the National Institutes of Health.
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.
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.
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:
- Establishing your eligibility criteria and subject selection processes according to scientific merit rather than mere convenience or familiarity.
- 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.
- 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.