Policy Handbook

Affinity:

Institutional Review Board - Protection of Human Subjects

Provost Office

Purpose:

Juniata is committed to promote, encourage and facilitate academic and clinical research in broad areas of human development. The purpose of this policy then is to protect the rights and well-being of human subjects of that research.

Policy:

Juniata has established an Institutional Review Board (IRB) for Human Subjects, commensurate with the with Title 45 of the Code of Federal Regulations regarding public welfare, Part 46 (45 CFR 46) and promulgated by the federal Office for Human Research Protections, National Institutes of Health. The Juniata IRB is certified by that agency of the United State Government and the Juniata IRB is in all actions, to remain well within the compliance of all applicable federal laws and regulations. A copy of those regulations is found as an attachment to this policy or at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm.

Applicability:

This policy shall apply to all research, conducted under the auspices of Juniata College and involving human subjects. Projects that have been approved and reviewed by IRB’s under other institutions are to be additionally submitted and reviewed by the Juniata IRB if those projects involve Juniata faculty, personnel or resources. Juniata approval for the use of human subjects in research must be obtained from the Juniata IRB before such research is conducted.

Administration of the IRB:

The Office of the Provost at Juniata College shall be administratively responsible for the Juniata IRB and applications for review can be obtained through that office. In an administratively related but subordinate role, the Juniata College office of Development shall also serve in an administrative and reporting role for the IRB and also maintain applications for IRB review. (The application shall also be available on the public drive of the Juniata EagleNet, found under p:\ Grants).

Submission Procedures:

The principal investigator shall obtain the forms for the review entitled “Initial Approval Request for Studies Involving Human Subjects” from the public drive of EagleNet, the Office of the Provost, or the development office of Juniata College.

The completed application shall be submitted to the office of the Provost (including any completed “Informed Consent” forms completed by the human subjects.

The Provost shall determine if the proposed activity is exempt from the 45 CFR 46 regulations and shall further determine if an expedited review or full review by the IRB is required.

Exemptions are usually determined with a week of the submission, expedited reviews within two weeks. If a full review by the IRB is required, the IRB will be convened as soon as possible, but as Juniata expects limited activity of this body in the foreseeable future, not predetermined and regular meeting dates are established by this policy.

Guidelines:

Services provided to the benefit of the subject do not require IRB approval unless the service places the subject in any risk. For example, normal instruction is a service, but does not place the subject at risk.

Signed parental approval is required for any subject that is a minor (under the age of 18). The minor must also provide additional consent.

Research surveys and questionnaires do constitute the use of human subjects in research. Such surveys and questionnaires are therefore subject to this policy, with the following exceptions:

· the survey/questionnaire is not supported by any direct federal or state funding, or

· the survey/questionnaire is purely for administrative purposes, or

· the results will not be included in an scholarly publications, or

· the results will not be disseminated outside of Juniata College.

However, if the data gathered in the survey/questionnaire in any way precludes the respondent’s ability to remain anonymous, an “informed consent” form must accompany the IRB application or the principal investigator must formally indicate that the “informed consent” form will accompany the survey vehicle.

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