Office of Research & Innovation
Human Research Protection

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

Please click on the links below for more detailed discussions of the obligations that Drexel researchers involved in human research must abide.

Activities Requiring Oversight

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 Novelution.
  • 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 Novelution. 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 Novelution.

To assist researchers when making a human subject research determination and IRB submission it may be helpful to use tools provided below.

This is generally helpful for most research projects.

Human Subject Research Decision Tool [PDF]

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]

Training

All research personnel affiliated with Drexel satisfy training requirements via the online CITI program courses website. Failure to complete or maintain as current the required trainings will delay the approval of personnel to begin work on human subjects research.

External individuals who are not performing research activities on behalf of another organization but require oversight from the Drexel IRB will also be expected to meet the Drexel CITI training requirements. Some collaborators from external organizations may need to complete the Drexel CITI trainings, but most will be required to complete only the trainings required of their home institution (collaborators from FWA-holding organizations will not need to complete the Drexel CITI trainings).

CITI trainings are not required or evaluated for personnel listed on submissions to the IRB requesting a determination of Not Human Subjects Research (NHSR) or Just-In-Time (JIT) requests. The JIT approval is a temporary approval in concept, and research activities with human subjects or their data must not begin until the FULL IRB approval has been released. Personnel CITI training requirements for those listed on a JIT will be evaluated during the FULL IRB review.

All personnel listed in the Research Team panel on a Human Subjects Research submission to the IRB (Exempt, Expedited and Convened Board levels of review) will have training requirements. All personnel listed will need to complete the Human Subjects Research (HSR) Basic training. This training requires users to choose either the Medical track or the Social Behavioral track. Users should only choose the IRB/Administration track if they will be serving as IRB Board members or IRB Staff. The basic HSR training expires after 3 years at which time a Refresher course is required in order to be considered current on training. Refresher courses will be required every 3 years thereafter.

All personnel listed will need to complete a Conflicts of Interest (COI) training. The Medical and Social Behavioral tracks both include COI training. The COI training expires after 4 years at which time a Refresher course is required in order to be considered current on training.

Conditional Trainings:

The Good Clinical Practice (GCP) training should be completed by personnel listed in the Research Team panel on submissions identified as a clinical trial. Clinical Trials are identified in the IRB submission’s Clinical Trial panel via a ‘yes’ response to the first three questions in the panel. The GCP training requirement will then appear for those listed in the Research Team panel. The GCP training expires after 3 years and must be completed again to renew. Please note that users selecting the Social and Behavioral GCP course will have separate required electives in order for the training to reflect as complete. The Biomedical GCP course does not have separate required electives.

The Health Information Privacy and Security (HIPS) training should be completed by personnel listed in the Research Team panel when the research protocol requires access to protected health information (PHI). IRB submissions indicate if protected health information (PHI) will be collected or obtained in the Privacy & Confidentiality panel. The HIPS training expires after 3 years and must be completed again to renew.

IRB protocol submissions in Novelution include a Research Team panel where personnel requiring oversight are listed. CITI training requirements for each protocol are viewable for the listed individuals by expanding their entry (+) at their name. The CITI-Novelution feed synchs between systems overnight, and CITI trainings completed will not show as completed until the next synch. A copy of the CITI certificate of completion for a training may also be uploaded as an Attachment in the Research Team panel if needed. As trainings expire, their status will change for that individual on all of the protocols on which they are listed in the Research Team panel. The CITI training information is viewable for anyone with access to the protocol in Novelution.

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.

 

Novelution IRB training materials, including step-by-step guides and video resources, are available on the Novelution Hub.

For Novelution technical support, system questions, or training assistance, please submit a Novelution Support Ticket or email novelution_info@drexel.edu.

For questions related to a specific IRB protocol or IRB requirements and processes, contact HRPP@drexel.edu or 267.359.2471.

Tools and Templates

Many templates that were previously provided here have been replaced by the new Novelution system’s eForm. Information previously collected by many of the standalone templates is entered directly into the system rather than completing a separate attachment.

Many templates that were previously provided here have been replaced by the new Novelution system’s eForm. Information previously collected by many of the standalone templates is entered directly into the system rather than completing a separate attachment.

Checklists are provided for informational purposes. Investigators are not expected to complete or submit them as part of their research review.

Worksheets are provided for informational purposes. Investigators are not expected to complete or submit them as part of their research review.

Consent templates provided here will continue to be used in the new system, Novelution. Investigators should utilize these templates as appropriate and attach to the Novelution submission for IRB review and approval.

How to Submit

All IRB submissions are ONLY accepted via the Novelution platform.

For detailed Novelution instructions, reference the Novelution Hub.

All new applications to the IRB for Full, Expedited, and Exempt categories of review should be submitted directly via Novelution.

The minimum requirements for standard submissions include:

  • Completed CITI trainings for all study personnel (see Training section)
  • Financial Conflict of Interest Disclosure for all study personnel
  • Novelution eForm submission
  • Note that while an item is submitted in Novelution, 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.

Reportable New Information must be submitted to the IRB via Novelution within 7 working days of awareness of the circumstances. Circumstances of an urgent matter must be communicated directly via email to the IRB. 

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].

Closing completed studies is an important regulatory step to formally document study completion and document that the study no longer requires IRB oversight. Study closures must be submitted to the IRB via Novelution when the following criteria are met: 

  • The research is permanently closed to enrollment
  • The research no longer involves obtaining, using, studying, analyzing, or generating identifiable private information or identifiable biospecimens
  • If identifiable biospecimens or information are being stored for future use, as previously approved by the IRB, a new study will be submitted and approved by the IRB prior to use
  • All research-related procedures, intervention, and/or interactions with participants have been completed, including analysis of data or samples described under this protocol
  • For multi-center studies, there are no further activities required of Drexel or its agents, and the sponsor or coordinating center has confirmed that the study can be closed

Detailed guidance for study closures can be found on the Novelution Hub IRB Training Materials page under "Closing an IRB Study in Novelution".

Investigator-initiated Research

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.

Reliance Agreements

Guidance under construction, please check back later.

Putting the Belmont Report into Practice

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).

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.

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.

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.

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.

MacKay D. Fair subject selection in clinical research: formal equality of opportunity
Journal of Medical Ethics 2016;42:672-677

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

More Racial Diversity Among Physicians Would Lead to Better Health Among Black Men, Research Shows

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

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.

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