IN ST IT UT IO N AL R E V I EW BO A RD
PROCESS AND PROCEDURES FOR REQUESTS TO WAIVE THE KAPLAN UNIVERSITY IRB
RESEARCH CONFIDENTIALITY AGREEMENT (RCA)i
In addition to generally applicable laws, regulations and Kaplan Higher Education policies and
procedures governing the conduct of research, investigators of protocols that are determined to
be research [45 CFR 46.102(d)]ii may, under certain conditions, request a waiver of the Kaplan
University IRB’s Research Confidentiality Agreement (RCA) (commonly referred to as the “legal
agreement”).
To raise awareness of this waiver option for certain research, this document, “Process and
Procedures for Requests to Waive the Kaplan University IRB Research Confidentiality
Agreement,” will be disseminated to the University community by means of the IRB Sharepoint
site, the Center for Teaching and Learning’s Sharepoint site, and Doc Sharing folders in research
courses.
As an additional step in raising awareness of the waiver option for certain research, when it’s
determined that an investigator is proposing to conduct research involving Kaplan populations,
effort will be made by IRB staff to have an initial telephone conversation with the investigator
for the purpose of providing an overview of the IRB process, including, but not limited to,
discussion of the RCA, existence of the waiver of the RCA, and addressing any questions the
investigator may have.
Following is the operating procedure for requesting, processing, and documenting requests to
waive the IRB’s RCA for research involving data on/from Kaplan populations.
KHE IRB
550 West Van Buren, Suite 700
Chicago, IL 60607
312.777.6406
1
7
sbelcarz@kaplan.edu:
doshana@kaplan.edu:
Associate Chair
Chair
IN ST IT UT IO N AL R E V I EW BO A RD
SECTION 1: REQUESTING A WAIVER OF LEGAL AGREEMENT
1. Who may request a waiver?
Only Kaplan University investigators who submit a research protocol to the IRB that involves
data on/from Kaplan populations may complete an application to request a waiver of the
RCA. To be clear, the waiver is only for Kaplan University employees (staff/faculty) and
students.
2. To whom should the waiver request be submitted for approval?
Requests to waive the IRB’s RCA should be submitted directly to the Kaplan University
President or an institutional official (IO) designated by the University President.
3. How will approval of a waiver be documented and reported back to the research
investigator so that he or she can include it in the submission to the IRB?
Approval of a waiver of the IRB’s RCA will be documented by the Kaplan University
President/IO, directly within the Waiver Form. The President/IO will return the approved
Waiver Form directly to the investigator.
It is the responsibility of the investigator to submit the completed Waiver Form (bearing the
signature of the Kaplan University President/IO) to the IRB.
For the IRB to honor any approval of a waiver of the RCA, the approved Waiver Form must
bear the original handwritten signature of the Kaplan University President/IO. To be clear,
an approval of waiver with a digital or scanned signature will not be accepted.
KHE IRB
550 West Van Buren, Suite 700
Chicago, IL 60607
312.777.6406
2
7
sbelcarz@kaplan.edu:
doshana@kaplan.edu:
Associate Chair
Chair
IN ST IT UT IO N AL R E V I EW BO A RD
SECTION 2:
AGREEMENT
PROCESSING REQUESTS FOR A WAIVER OF RESEARCH CONFIDENTIALITY
The following procedures will be implemented for any research protocol submitted to the
Kaplan University IRB that involves data on/from Kaplan populations:
1. When an investigator first contacts the IRB staff for information about getting started on the
IRB submission process, the IRB staff will inform the investigator about the stipulations of
the RCA and the option to waive the RCA.
a. Messaging to the investigator will make it clear that, although the waiver of the RCA
may be requested by any Kaplan University student or employee, priority is given to
granting waiver requests for institutional research projects that fit certain limited
and defined circumstances that are, typically, preceded by executive-level input.
2. The investigator informs the IRB staff of his/her choice for routing the proposed research
protocol; the investigator must choose 1 of 2 possible process paths, delineated below:
a. Process Path 1 – Comply with RCA
If the investigator opts to comply with the stipulations of the RCA, the
investigator’s protocol will be routed through the applicable IRB review mechanism
(i.e., exemptiii or full board reviewiv, depending on risk of harm to human subjects).
i. Contingent on the IRB’s determination to approve the proposed research,
the investigator will be asked to sign-off on the RCA.
ii. Upon the IRB’s receipt of the signed RCA, the investigator will be provided
with the final approval letter of the IRB.
b. Process Path 2 – Request a Waiver of RCA
If the investigator opts to request a waiver of the RCA, the investigator will be
instructed to complete the Waiver Form and submit it to the Kaplan University
President/IO.
i. If the Kaplan University President/IO approves the waiver request, the
investigator will be expected to submit the approved waiver to the IRB,
along with relevant protocol documentation, and proceed through the
regular IRB process (see Appendix A)
ii. The investigator’s protocol will be routed through the applicable IRB review
mechanism (i.e., exempt or full board review, depending on risk of harm to
human subjects).
iii. If the Kaplan University President/IO disapproves the waiver request, the
investigator may consider the option of signing-off on the RCA and
proceeding through the regular IRB process (see Appendix A).
KHE IRB
550 West Van Buren, Suite 700
Chicago, IL 60607
312.777.6406
3
7
sbelcarz@kaplan.edu:
doshana@kaplan.edu:
Associate Chair
Chair
IN ST IT UT IO N AL R E V I EW BO A RD
SECTION 3: DOCUMENTING REQUESTS FOR A WAIVER OF RESEARCH CONFIDENTIALITY
AGREEEMENT
The following procedures will be implemented for any research protocol submitted to the
Kaplan University IRB that (1) involves data on/from Kaplan populations; and (2) includes an
approved Waiver Form.
1. When assigning such research protocols for IRB review, the IRB staff will include an
investigator’s approved Waiver Form among the investigator’s protocol submission
materials.
2. In the assignment of the research protocol to IRB review, the IRB staff will include a
written statement that calls the attention of the IRB to the existence of a Waiver Form.
The statement will read:
Note: This submission includes a completed and approved “Request for Waiver of
Research Confidentiality Agreement” form.
3. Following the IRB’s determination on such research protocols, the IRB staff will maintain
both print and digital copies of the protocol submission materials, including the Waiver
Form, and the IRB’s review documentation (i.e., completed reviewer guides) and letter
of determination(s).
KHE IRB
550 West Van Buren, Suite 700
Chicago, IL 60607
312.777.6406
7
4
sbelcarz@kaplan.edu:
doshana@kaplan.edu:
Associate Chair
Chair
IN ST IT UT IO N AL R E V I EW BO A RD
The following procedures will be implemented for any research protocol that involves a
disapproved Waiver Form or one with modifications requested by the Kaplan University
President/IO.
1. It is the responsibility of the investigator to acquire approval of the waiver request from
the Kaplan University President/IO. The IRB will not be responsible, in any way, for
facilitating or supporting disapproved waivers or waivers involving modifications
requested by the University President/IO.
2. It is the responsibility of the investigator and the Kaplan University President/IO to
retain a record of any disapproved Waiver Form or one requiring modifications. The
IRB will not maintain a record of disapproved waivers or waivers involving modifications.
3. It is the responsibility of the investigator to contact the IRB staff when an approved
waiver is acquired and, subsequently, the investigator is prepared to initiate the IRB
process.
4. In cases where an investigator’s waiver request is disapproved, it is the responsibility of
the investigator to inform the IRB staff about the disapproval and his/her decision to
submit his/her protocol to the IRB to comply with the terms of the RCA.
5. If the investigator informs the IRB staff that (a) the waiver request was disapproved by
the Kaplan University President/IO; and (b) the investigator opts to submit his/her
protocol to the IRB to comply with the terms of the RCA, then:
a. The IRB staff will provide an email statement to the investigator to (a) acknowledge
receipt of the investigator’s submission materials; and (b) confirm with the
investigator that the submission is subject to the stipulations of the RCA (contingent
on IRB approval).
b. In the assignment of the research protocol to IRB review, the IRB staff will not
reference any history tied to the investigator’s initial waiver request. Instead, the
IRB staff will include a written statement that calls the attention of the IRB to the
applicability of the RCA.
Consistent with current practice, the statement will read:
As a reminder, if data is to be collected from Kaplan students, administrators, faculty
or staff, the protocol must also comply with the stipulations of our legal agreement.
c. Following the IRB’s determination on such research protocols, the IRB staff will
maintain both print and digital copies of the protocol submission materials, the IRB’s
review documentation (i.e., completed reviewer guides), and letter of
determination(s).
KHE IRB
550 West Van Buren, Suite 700
Chicago, IL 60607
312.777.6406
5
7
sbelcarz@kaplan.edu:
doshana@kaplan.edu:
Associate Chair
Chair
IN ST IT UT IO N AL R E V I EW BO A RD
Appendix A
Kaplan University IRB Process
At a very high-level, there are 6 sequential steps or stages involved in the Kaplan University IRB process. In short, these steps
summarize the IRB process from an administrative standpoint.
Step 1.
Get Investigators Started on the IRB Process. This involves IRB support staff providing investigators with the appropriate
application form and guidance on preparing a submission, including how-to information on complying with the IRB’s educational
training standard.
Step 2.
Pre-Screen Protocol Submissions, involves IRB support staff, minimally, checking for completion of training, human
subjects’ protections assurances, assessing the quality of the proposed research design, and providing feedback to and working with
an investigator to ensure all possible elements the IRB would need to conduct its review are included in a submission.
Step 3.
Assign to Reviewers or Schedule a Meeting of the IRB, involves a number of sub-tasks that IRB support staff facilitate,
but that may vary depending on the type of submission: exempt (proposals posing minimal risk of harm to human subjects) or
full/expedited (proposals posing greater than minimal risk of harm to human subjects). Typically, in this step of the process, IRB
support staff compile submission materials for IRB members' review, and update the summary of submissions tracking matrix on the
IRB Share Point site accordingly. Depending on the content of the submission and availability of reviewers with content expertise,
IRB support staff may need to onboard new IRB members on what is expected of them in reviewing a protocol.
Step 4.
Monitor Review, also involves a number of sub-tasks that IRB support staff facilitate, but that may slightly vary,
depending on the type of submission. Typically, for exempt submissions sub-tasks include sending "as needed" reminders to IRB
members to complete the review; providing "as needed" updates to investigators on the status of review; and troubleshooting any
questions or issues from investigators and reviewers).
Step 5.
Documenting & Communicating a Determination. Here, IRB support staff draft a letter to the investigator to document
the IRB’s determination. If the determination calls for modifications to the protocol, then steps are taken to work with the
investigator to bring the protocol up to the IRB's standard; this may involve initiating the review process again or administratively
approving the modifications. If there are discrepancies between reviewer determinations, IRB support staff work with the reviewers
to resolve these. If compliance with Legal stipulations is required, IRB support staff work with the investigator to ensure this
happens. Here as well, and as a way to communicate the status of submissions to the University community, the IRB support staff
update the submissions tracking matrix on the IRB SP site accordingly. If the submission went through a full board review, then IRB
support staff draft the minutes of the full board meeting, request review and approval of the minutes by the Board, post the
minutes to the Share Point site, and communicate a determination to the investigator via a formal letter.
Step 6.
Archive, here, the IRB’s Determination and investigator’s Submission Materials are archived. This means that IRB support
staff create both a hard copy and electronic folder in which all submission materials are compiled, along with the IRB determination,
any key correspondence from the IRB review, and other relevant documentation for future reference.
KHE IRB
550 West Van Buren, Suite 700
Chicago, IL 60607
312.777.6406
sbelcarz@kaplan.edu:
doshana@kaplan.edu:
76
Associate Chair
Chair
IN ST IT UT IO N AL R E V I EW BO A RD
ii
Approved for use September 1, 2010.
ii
The Kaplan University Institutional Review Board (IRB) reviews activities that meet the Federal definitions of research with human
subjects. Per 45 CFR 46.102(d), “research” means a systematic investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research
for purposes of the policy, whether or not they are conducted or supported under a program which is considered research for other
purposes. For example, some demonstration and service programs include research activities. Per 45 CFR 46.102(f), “human subject”
means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data
through intervention or interaction with the individual, or (2) identifiable private information.
iii
Claim of exemption submissions from KU administrators, faculty, or students are channeled through an expedited process. Under
this process, two IRB members are assigned to review the submission. The two IRB members review the submission and make a
determination within five business days of receipt. Investigators can expect to hear from the OIE/IRB staff with updates on the
status of their submission during the review period. Upon receipt of the IRB members’ determination, individual letters are drafted
and sent via e-mail to investigators, so it may take another 2-5 business days for feedback to reach investigators.
iv
Research investigators submitting a proposal requiring full IRB review (i.e., research involving more than minimal risk of harm to
subjects) must be prepared to present their proposal during a regular meeting of the IRB, which occurs via teleconference on the
second Wednesday of each month at 1:00pm CST. An ad hoc meeting of the IRB may also be requested by the investigator, but the
IRB would need to receive and review the investigator’s submission at least two weeks before the meeting. If a protocol is
submitted for full/expedited review (i.e., protocols that do not qualify for a claim of exemption), it takes at least 5-7 business days
past the IRB meeting to compile the minutes of that meeting and draft individual letters to investigators. Typically, letters are sent
via e-mail, ensuring prompt feedback to investigators.
KHE IRB
550 West Van Buren, Suite 700
Chicago, IL 60607
312.777.6406
sbelcarz@kaplan.edu:
doshana@kaplan.edu:
7
Associate Chair
Chair