GUIDELINES FOR SUBMITTING A HUMA

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					                   GUIDELINES FOR SUBMITTING A HUMAN SUBJECTS
                               CLEARANCE REQUEST

A clearance request form which outlines six requirements for institutional board review must be completed
and submitted to the Associate Provost's office in Warner Hall 405. A sample of the form is attached
(attachment A). Please answer questions as completely as possible, and attach the information for the six
requirements to the request form. Please submit one copy.

•   The first requirement on this form is for a draft of the proposal or an abstract. This should
    comprise the bulk of the submitted material. It is important that this document be complete, while at
    the same time remaining a concise and manageable read for reviewers. Pertinent excerpts from
    articles published by the PI about the research may be included with the draft or abstract written
    expressly for the CMU review board, but it is not advisable to submit lengthy articles for review. In
    short, details included in a draft or abstract are to be complete, but not excessive.

•   The second requirement is a clear definition of how the subjects will be utilized or how the
    experimental treatment will be administered. Again, detail is important. If the research consists of
    subjects answering questions or solving problems, give examples of the problems or questions.
    Explain who will administer tests and in what environment. For research in which subjects physically
    participate it is paramount that great detail be given so that a conclusive medical evaluation can be
    made. In all cases, every effort must be made to consider the subject's well being.

•   The third requirement is a sample consent form. Since, this is a key component of the clearance
    request, please be thorough. If more than one consent form is prepared (for example, if hospital
    patients as well as CMU students will serve as subjects, different consent forms would be used for
    each group), all versions that will be used must be submitted for review. A Consent Form Checklist is
    attached to provide you with details of the basic elements of informed consent. A sample of a
    standard consent form is attached (attachment B). This form may serve as a model for the
    preparation of your own form. Please revise it to include a contact person within your department and
    specific details about the proposed experiment. Note that the IRB Chair name, address, and
    telephone number as well as instructions for subjects to address concerns or questions to him/her
    appear on this sample form. Such a clause should appear in all forms. It is important that subjects
    have a contact outside of the department conducting research to whom they may address concerns.

•   The fourth requirement is an indication of how confidentiality of subjects will be protected. The
    Department of Health and Human Services stipulates that information taken from educational tests be
    recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to
    the subjects. Explain how this will be done. Will the subjects be given code names or numbers, for
    instance?

•   The fifth requirement (when applicable) is a list of the names and addresses of officials
    authorizing access to any subjects in cooperating institutions not under indirect control of
    CMU. Please provide this list if it applies to your research. In cases of human subjects research
    involving subcontracts, institutions having their own Institutional Review Boards should provide CMU
    with a copy of their Letter of Certification or other evidence of completed review. It is the responsibility
    of the PI to request and ascertain the receipt of this documents(s) from the subcontracting
    institution(s). A copy of the document(s) is to be sent to Sue Shingle, Compliance Officer, Associate
    Provost's Office, Warner Hall 405.




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                           GUIDELINES FOR SUBMITTING A HUMAN SUBJECTS
                                       CLEARANCE REQUEST
                                            (Continued)

    If a subcontracting institution does not have an Institutional Review Board, they will be contacted by
    (NIH) PHS OPRR, who will request a Single Project Assurance from those institutions, be they foreign
    or domestic. The PI is to be the CMU representative responsible for providing a contact at the
    subcontracting institution(s).

•   The sixth requirement for the review is a risk/benefit analysis. This can be a short explanation of
    two factors: how society and a particular field of study will benefit from this research, and how the
    subject will personally benefit from participation. Monetary compensation for a subject's participation
    is NOT considered a benefit. Their key concern will be seeing how the research will benefit society
    and a specific area of learning.

•   The seventh requirement for the review is to provide a statement describing how participants will be
    recruited. Include any advertisement brochures or flyers, invitation letters or invitation emails.

•   The eighth and final requirement for the review is to complete the on-line training course entitled
    “Human Participant Protections Education for Research Teams” (located at
    http://cme.nci.nih.gov/). Researchers/experimenters are required to complete the course, print the
    Completion Certificate and forward a copy to Warner Hall, Room 405. The IRB will not issue final
    human subjects clearance until the training certificate is on file.


The above items are required by the board that reviews human subjects clearance requests at CMU. If
you do not include all of the above information, your request may be held until it is complete. You will be
asked to provide additional information if necessary. Please keep in mind that it takes about three weeks
to complete a review. If a reviewer has questions for you to answer, this process may be slowed down.
This time-frame may be an important consideration if you are seeking support from an outside agency.

An agency to which you might apply for sponsorship will stipulate its own requirements. A frequently used
form, the HHS 596, is attached (attachment C). (If you have received this packet electronically, please
contact the Associate Provost’s Office at 8 4727 for a copy of form HHS 596.) Consult your sponsoring
agency to learn if they require a completed copy of this form.

Do not forget to submit one copy of all of the above to the Associate Provost's Office, Warner Hall 405.
Should you need additional information or assistance, please contact Sue Shingle at ext. 8 4727 or via
email at: sshingle@andrew.cmu.edu




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