This manual outlines the research protocols for human subject research at American Public University System

Criteria for Approval of Research Not Exempt from Committee Review

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Criteria for Approval of Research Not Exempt from Committee Review

The IRB reviews proposals for research in accordance with federal regulations governing research with human subjects. It is the policy of APUS that in order for any research proposal to be approved, the IRB must determine that all of the following requirements are satisfied:

1. Risks to subjects are minimized and are reasonable in relation to anticipated benefits of

the research;
2. Selection of subjects is equitable given the purposes and the setting of the research;
3. Appropriate informed consent will be sought from each subject or the subject's legally

authorized representative, and such consent will be appropriately documented (for

sample consent forms, see Appendix C);
4. The research plan makes appropriate provision for monitoring the data (see Appendix D:

Data Collections, Storage and Destruction Agreement, collected to insure the safety of

subjects;
5. Appropriate provisions are made to protect the privacy of subjects and to maintain the

confidentiality of data;

6. Where some or all of the subjects are likely to be vulnerable to coercion or undue

influence, appropriate additional safeguards have been included to protect the rights

and welfare of these subjects; and
7. All investigators named in the protocol, including students, must have completed

approved training on the use of human subjects in research.

IRB Decisions are Final and Binding

It is the policy of APUS that the final decision regarding approval or disapproval of all research proposals subject to the IRB review are final and binding. Any investigator who has a proposal rejected by the IRB must make appropriate modifications and submit a new proposal for review.

PREPARING AND SUBMITTING IRB PROPOSALS

Prior to proposing or engaging in research, all faculty, staff or student researchers must successfully complete Human Subjects Training from CITI: www.citiprogram.org
Please request your official IRB proposal form via the Request an Application link at http://www.apus.edu/community-scholars/institutional-review-board/apply.htm. Once you complete the Request an Application form, Classroom Support will contact you to generate an IRB dropbox in Sakai, where you will upload your application with all supporting materials. Student researchers shall complete proposal forms in conjunction with a participating faculty member.
IRB Applications are due the 15th of each month in order to be considered at that month's meeting. Applications received after the 15th of the month will be considered the following month. Incomplete applications will be returned to the applicant and their review may be deferred to the next month.
The IRB will notify the investigator(s) as to whether or not a proposal has been accepted via APUS email. In the event that a proposal is not accepted, the IRB will provide a reason for denial and a list of steps (if any) that would be acquired for the approval of the proposed research.
All APUS students who submit an IRB application must first secure the approval their instructor prior to submitting the application. When you request an application via the IRB website, Classroom Support will send you the Student IRB Application.

INVESTIGATOR RESPONSIBILITIES

Once the IRB has approved the research, the investigator will need to interact with the IRB if there are changes in the study protocol, adverse events (should any occur), and/or project renewals.

Study Changes

If a study changes in such a way that subjects are treated differently than outlined or described in the original protocol, a form (Appendix E) describing such changes must be submitted to the IRB for approval. Once the change has been approved, you may proceed with your research.

A change in a protocol might require a change in the consent form(s). When consent forms are submitted for review with a change form, you must submit two different consent forms:

the original consent form and
the proposed new consent form(s) with all the changes noted (boldfaced, shaded, etc.).

Adverse Events

Unanticipated problems or serious adverse events involving risk to human subjects must be reported to the IRB immediately.

Federal regulations [45CFR46.103(b)(5) and 21CFR56.108(b)(1)] requires investigators promptly report “any unanticipated problems involving risk to subjects or others” (UPIRTSO). UPIRTSO is defined as any problem or event which was unanticipated, has created a new or increased risk to the subjects, and is related to the research procedures. All such events must be reported to the IRB using the UPIRTSO form, see Appendix F. The IRB will determine if the event meets the criteria as a UPIRTSO.

What to Report

The following events meet the IRB’s definition of UPIRTSO and should be reported within the 10 day time frame:

Any event that was unanticipated and involved new or increased risk to subjects or others, and is related to the research procedures.
Any accidental or unintentional change to the IRB-approved protocol that increases risk or has the potential to recur.
Any deviation from the protocol taken without prior IRB review to eliminate apparent immediate hazard to a research subject.

Any event that indicates an unexpected change to the risk/benefit ratio of the research.
Any breach in confidentiality that may involve risk to the subject or others.
Any complaint of a subject that cannot be resolved by the researcher.
Any other event which constitutes an unanticipated risk.

For more information on what constitutes “unanticipated problems” and “adverse events” please go to: http://www.hhs.gov/ohrp/policy/AdvEvntGuid.htm

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