INSTITUTIONAL REVIEW BOARD &
HUMAN SUBJECTS CONSIDERATIONS for CBMP PROJECTS
NOTE:
Every 2nd Year Student is required to complete an IRB protocol and submit it to the Office of Research.
When you receive your final approval letter, please submit a copy to the Director of Community Projects.
BACKGROUND
Protection of humans and animals is critical in all public health activities whether at the programmatic, research,
or policy level. “Protection” does not only refer to ensuring that individuals or animals are not directly exposed
to harm. “Protection” means commitment to and maintenance of an individual’s human rights, dignity, and
safety, his or her privacy and confidentiality of personal information, his or her right to informed consent and
freedom to agree or refuse to participate in an activity. Many public health related activities, especially those
that involve any type of research or service delivery, require both the approval of a designated Institutional
Review Board (IRB) and the informed consent of the individual. As a consequence, all CBMP projects will
require review by a Drexel University Institutional Review Committee.
The Drexel University IRB Committees are comprised of faculty, staff and community representatives who
have volunteered their time to review and provide oversight to investigators and clinicians regarding activities
involving humans and animals. General regulations regarding the protection of human subjects in clinical
practice and research have been developed by individuals from many different backgrounds and professions
(e.g. academicians, ethical leaders, judges, clergy, concerned citizens). Some specific regulations are mandated
by Federal and Local governments. The role of the IRB is to ensure that individuals are “protected from harm”
as consensually defined by ethicists, humanitarians, philosophers, and other individuals and as mandated by
governmental and regulatory groups.
DREXEL UNIVERSITY IRB OFFICE
The Office that handles the Drexel University Institutional Review activities is located within the combined
Drexel University/Drexel University Office of Research Administration. This office is located at 1601 Cherry
Street, 3 Parkway Building. Our main contact person there is Jack Medendorp, jcm29@drexel.edu, (215)
255-7859.
The IRB Office website includes information regarding the IRB and copies of the forms needed when
submitting a protocol for IRB review. You should become familiar with the information related to the NonMedical IRB on this website: www.research.drexel.edu.
DREXEL UNIVERSITY IRB PROCEDURES
As required by the Federal Government regulatory bodies, all IRB review offices must develop procedures that
govern the submission and review of research projects and that provide for the research projects to be monitored
over time. Several important policies developed by the IRB Office are summarized below.

Exempt and Expedited research projects conducted by students in the School of Public Health will
be reviewed by the Ad Hoc Committee for Student Research.

Student research projects that require Full Review will be submitted to the Drexel University IRB
Committee for review. A Drexel University IRB Committee meeting is held about every 2 weeks.
1. Before a proposal can be submitted to the IRB, the following are required:

All the IRB forms must be correctly completed. Strict adherence to the guidelines for
completing the forms is essential. Protocols may be placed on hold if each section has not been
accurately completed. If a section listed on the IRB form is not applicable to your project, do not
skip it, specify “Not Applicable”.

The IRB forms require signatures from several individuals before they can be submitted. These
must be obtained or the protocol will not be reviewed by the IRB Committee. Required signatures
include: the CBMP Chair, Department Chair, SPH Dean, and the designated individual within the
Tenet Hospital System if the project is to be completed within a Tenet facility.

The research or project proposal has to be fully developed before it can be submitted to the IRB. In
preparing the IRB application, it is important to keep in mind that the application is going to be the
only source of information on the project the IRB committee members have. The project summary,
therefore, must be comprehensive, yet brief, and very clearly written.

Consent forms to be signed by the study participants, if applicable, must be submitted with the IRB
application in their final form. Drexel guidelines for consent forms MUST be followed to the letter.
Exceptions should be reviewed with Dr. Sree Murthy or a member of the Ad Hoc Committee for
Student Research.

If data are to be collected, the final copy of the data collection forms (surveys, interview schedules,
record abstract forms) must be included. The IRB committee will review the surveys, interview
schedules, or other data collection forms. If these are poorly written, the committee may ask that
they be redone before the project can be approved.

If data are to be obtained from an agency or person outside of Drexel University, (e.g. the
Philadelphia Department of Public Health, investigators at another university) a letter must be
attached to the IRB submission indicating that the agency or individual will release the data to the
person submitting the project (see attached example).

If data are to be obtained from an outside agency, the student may be asked to sign a
“confidentiality statement.” This statement is usually written by the agency and simply affirms the
students’ commitment to keeping all information and data confidential.

If the project is being conducted at an outside location such as the Philadelphia Department of Public
Health or a community center or agency the project will also have to be approved by the IRB of the
outside agency or group if that agency has its own IRB. It is recommended that external IRBs be
completed prior to submitting the Drexel University IRB. Final sign off on the project by the
IRB will not occur until the Drexel University IRB has received a letter from the outside agency
indicating its IRB has approved the project. All projects approved by the city’s IRB can go
through expedited review with Drexel’s IRB when you fill out papers for expedited review and
present a copy of the city’s IRB approval. You can choose to use the city’s IRB for approval and
then submit that approval for expedited review at Drexel.

The IRB regulations indicate that a faculty member must be the principal investigator on all
proposals that are submitted to the IRB. The CBMP committee chair will be the principal
investigator. As the Principal Investigator of a project, a faculty member assumes ethical and
legal liability. To minimize the number of drafts and rewrites, IRB proposals need to be developed
in close consultation with the faculty chairperson. If your community preceptor is also a Drexel
faculty member, the CBMP Committee must determine together who will serve as principal
investigator.

All individuals who conduct research projects must take the certifying IRB and HIPPA
training courses and pass the certifying exams. The Drexel University training courses and exams
are on the Web. They have been approved by the Federal Government who has set up this
requirement. The Web site is: https://apps.research.drexel.edu/train/login.asp. Once completed,
submit your certification numbers by email to the Director of Community Projects.
2. The IRB Office has identified four types of project submissions, Release Letter, Exempt, Expedited, and
Full. Those students conducting non-human subjects research may be eligible for a Release Letter:

Release Letter: Project qualifies as “non-human subject research” and therefore does not require a
submission to the Drexel IRB. To obtain this letter, the student should draft a one or two page
description of the research to be conducted (titled a “Student Study for Human Subject Research
Determination”) and send it to Jack Medendorp at the Drexel Office of Research (jcm29@drexel.edu,
please cc: danyelle.s.greene@drexel.edu). If Jack determines that no submission is necessary based on
this description, he will issue the Release Letter. For guidelines to help you determine if your project
qualifies as “non-human subject research,” please see section IX of the Non-Medical IRB page of
research.drexel.edu, called “Research Involving Private Information or Biological Samples Policy.”
 Exempt: Project, by virtue of the limited and superficial involvement of human subjects, is exempt from
full review by the IRB.
 Expedited: Project involves human subjects but at a level that exposes the individual to minimal danger
and/or hazards and do not involve “high risk” or “vulnerable” populations. These projects may be eligible
for expedited review. “Vulnerable or high risk populations” include children, pregnant women, disabled
individuals, individuals with cognitive impairments, individuals with HIV/AIDS, prisoners, etc.
 Full: Those that involve “vulnerable populations” and/or involve some degree of risk and invasion of
privacy and where the data regarding an individual study subject can be traced back to him or her. These
projects require full committee review.
Consult with your CBMP Advisor and the Director of Community Projects to determine the type of review your
CBMP requires. Once you have determined the type of review required for your CBMP, you can access the
appropriate forms at http://www.research.drexel.edu/compliance/IRB/non_medical_irb.aspx. (or just
Google “Drexel non-medical IRB.” Exempt submissions have several subcategories, while Expedited and Full
submissions use identical forms. Your CBMP Advisor is the Principal Investigator on the IRB paperwork. Most
projects will have no Sponsor. If your CBMP Advisor is also your Department Chair, then you will also need
the Dean’s signature on your IRB submission. The Office of Research requests that students read IRB
submission instructions carefully on the Office of Research website, and use fonts no smaller than 9 point on
their submission paperwork.
3. Brief guidelines to preparing an IRB application:

Determine in consultation with your Advisor, Director of Community Projects, and Jack Medendorp
whether you project is eligible for a Release Letter, Exempt, Expedited or Full review.

Assemble the materials needed for the required IRB application from the IRB website.

Complete all sections of the IRB application in language that is concise and clear. With few
exceptions, use full sentences. Check that spelling and grammar are correct, that all the necessary
content is included, and that the application is not redundant. It is important to remember that the
IRB Committee members are dedicated but busy individuals. A clear, concise, thorough but not
lengthy application will be much easier for them to review than one that is confusing,
redundant, or does not include important information. Maintain close contact with your CBMP
faculty chairperson while preparing the IRB application. Remember it is he or she who must submit
this. Your final product, therefore, must meet his or her standards.

The IRB requires that any risks or hazards to the individual associated with the project must be
specified and that all steps to minimize the risks or hazards must be outlined. These sections must
be completed even if you do not think that there are significant risks. It is not satisfactory to dismiss
the issue by stating “not applicable.”

Follow the guidelines for the consent forms developed by the IRB office. There are sections within
a consent form that may appear cumbersome or unnecessary for your project. These are typically
required for legal reasons and need to be kept in the consent form.

Complete the IRB application with sufficient time to obtain the required sign-off signatures.
“Sufficient time” means that those who are to sign-off will be able to review the proposal before
signing it.

Submit the completed, signed IRB package to the Office of Research. Be sure to include the number
of copies specified on the “Submission Checklist” for the type of review submitted. Give the
Director of Community Projects a copy of your final approval letter when you receive it (you should
receive this regardless of submission type.)
Note: The information presented above may not address all the issues that you will encounter. For
example, additional work will be required when the project involves patients or space at one of the
Tenet Hospitals. In such cases, you should work closely with your Advisor, IRB Staff, and the
Director of Community Projects.