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campusMain Glossary of IRB Regulatory Terms

 

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ADVERSE EFFECT An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy). {as OHRP}

ANONYMITY A research condition in which no one, including the researcher, knows the identities of research participants.

A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved

ASSENT Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research. {as OHRP}

ASSURANCE A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved [Federal Policy 45 CFR 46.103]. {as OHRP}

binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved

AUTHORIZED INSTITUTIONAL OFFICIAL An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human subjects in biomedical and behavioral research. {as OHRP} The Alverno President has assumed this designation.

to adherence to the requirements of the federal regulations regarding the involvement of human subjects in biomedical and behavioral research.

AUTONOMY Personal capacity to consider alternatives, make choices, and act without undue influence or interference of others. {as OHRP}

BELMONT REPORT A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978. {as OHRP}

BENEFICENCE An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm. {as OHRP}

principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.

BENEFIT A valued or desired outcome; an advantage. {as OHRP}

 

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