Working with Human/Animal Subjects - Tip Sheet




 

IRB

IACUC

OH&S

Who can serve as Principal Investigator (PI)?

PI may be the student, however, the faculty mentor must be listed as Co-PI and is equally responsible for the conduct of the study.

PI must have faculty status. List faculty mentor as PI on animal protocol and list student’s name in parentheses after title.

PI may be the student, however, the faculty mentor must be listed as Co-PI and is equally responsible for the conduct of the study.

How are students added to a protocol?

(1) Submit amendment/revision form noting addition of personnel to existing protocol,

(2) submit new protocol including student’s name as PI

(3) add student’s name to request for changes in Investigator’s Progress Report (renewal form) if involvement coincides with renewal due date.

(1) Submit modification request form noting addition of personnel to existing protocol,

(2) submit new protocol including student’s name in personnel section, or

(3) add student’s name to renewal form if involvement coincides with renewal due date.

(1) Send email to Glenda P. Moon (Glenda@uab.edu) or Donna S. Williamson (dsw@uab.edu) and indicate protocol name and funding agency (provide OH&S project #) and list students to be added. 

(2) Amend Project Registration form to include additional student names.  Make a note that the addition of students is the only amendment.

When is it a procedural vs personnel modification?

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If the student proposes to conduct animal procedures that are not already part of an approved protocol under their mentor then the mentor must either submit an amendment or a new protocol.

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Timeline for review and approval.

Amendment/Revisions are normally reviewed within a week – you may add RUSH to top of form with an explanation as to the nature of the RUSH request – some request may be returned in 2 – 3 working days.

Personnel modifications are reviewed within 1 -2 business days of receipt and can be approved when all required training documentation is on file. Procedural modifications and new protocols received by the 21st of the month (or next regular business day if 21st is holiday or weekend) are entered into the subsequent month for review. Voting for protocols called for Full Committee Review occurs on the last Wednesday of the assigned review month.

Personnel modifications are reviewed within 1 -2 business days of receipt.  PI and added personnel will be notified if additional information is needed.

Required training.

Initial and continuing Human Subjects Training which as applicable.  Available training options and instructions are available at

http://main.uab.edu/show.asp?durki=56078.  If students have completed training at another institution it may be submitted for review by the OIRB and may be accepted to meet UAB’s training requirements.   On-line training may be started before student arrives on campus. 

Students must complete the following training items, accessible through BlazerNet: (1) Basic training in rules, regulations, ethics and (2) species-specific training.  Items 1 and 2 are on-line training modules (ca. 3 hrs).

Depends on the nature of the research.  In addition to IACUC and IRB requirements, the use of material of human origin requires annual bloodborne pathogen training.

Occupational Health Requirements

 

The requirements for the UAB Occupational Health Program must be met before final approval to work with animals is granted.  All non UAB employees must receive clearance from their personal physician indicating that the physician has reviewed the proposed work and the medical history of the individual, that the individual is current for all required immunizations, and has been cleared to conduct the work proposed on the UAB Employee Occupational Health Enrollment Form.  The letter and the form must be submitted before the requirements are met and the student cleared.  Please note: this may take extra time.

The requirements for the UAB Occupational Health Program must be met before final approval to work with animals and certain other work (i.e., work with material requiring immunizations) is granted.  All non UAB employees must receive clearance from their personal physician indicating that the physician has reviewed the proposed work and the medical history of the individual, that the individual is current for all required immunizations, and has been cleared to conduct the work proposed on the UAB Employee Occupational Health Enrollment Form.  The letter and the form must be submitted before the requirements are met and the student cleared.  Please note: this may take extra time.

Student defined.

An individual enrolled in a UAB undergraduate or graduate program.

An individual enrolled in a UAB undergraduate or graduate program.

An individual enrolled in a UAB undergraduate or graduate program.

Non-UAB students.

An individual enrolled in an undergraduate or graduate program at another institution. Non-UAB students must complete training, however, training from their “home” institution may be accepted.  Please call OIRB for clarification.   Non-UAB students may need a “blazer ID”  to access on-line training.   Faculty mentors may contact Human Resources for more information about obtaining a blazer ID and appointment of the student.

An individual enrolled in an undergraduate or graduate program at another institution. Non-UAB students may complete training items 1 and 2 but are not eligible for enrollment in the UAB Occupational Health Program. They must submit documentation of an equivalent evaluation provided through their own personal physician. They may use the UAB form, which must be submitted with a physician clearance, as the basis for that evaluation.

An individual enrolled in an undergraduate or graduate program at another institution.  Non-UAB students may complete UAB on-line training (call to register) but are not eligible for enrollment in the UAB Occupational Health Program. They must submit documentation of an equivalent evaluation provided through their own personal physician. They may use the UAB form, which must be submitted with a physician clearance, as the basis for that evaluation.

Sponsored Projects

If the student is the Prime Awardee of their own sponsored research project they must submit a new protocol specifically detailing the protocol which must be concordant with the funding application. 

If the student is the Prime Awardee of their own sponsored research project (i.e., funds budgeted for direct support of animal purchases, per diems, supplies, etc.) they must submit a new protocol specifically detailing the animal procedures proposed in the corresponding grant, fellowship, contract, etc.

If the student is the Prime Awardee of a grant, fellowship, contract, etc with funds solely for salary support they must submit the IACUC form to register the project as a salary support project. Note: faculty mentor should be listed as PI on the IACUC form.

If the student is the Prime Awardee of their own sponsored research project, and that project either involves material that is potentially hazardous or requires some sort of approval from OH&S, they must submit a new protocol specifically detailing the protocol which must be concordant with the funding application. 

Forms and staff directory.

www.uab.edu/irb

www.uab.edu/iacuc

www.healthsafe.uab.edu