When an institution is engaged in non-exempt human subjects research that is conducted or supported by HHS, it must satisfy HHS regulatory requirements related to holding an assurance of compliance and certifying institutional review board (IRB) review and approval.
Before engaging in human subjects research that is not exempt, an institution must hold or obtain an OHRP-approved Federalwide Assurance and certify to the HHS agency conducting or supporting the research that the research has been reviewed and approved by an IRB.
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. An institution is defined in 45 CFR 46.102(b) as any public or private entity or agency (including federal, state, and other agencies).
In other words, institutions are considered engaged in an HHS-conducted or -supported non-exempt (EXPEDITED OR FULL BOARD) human subjects research project when the involvement of their employees or agents in that project falls into various examples including:
Institutions whose employees or agents intervene for research purposes with any human subjects of the research by performing invasive or noninvasive procedures
Examples of invasive or noninvasive procedures include drawing blood; collecting buccal mucosa cells using a cotton swab; administering individual or group counseling or psychotherapy; administering drugs or other treatments; surgically implanting medical devices; utilizing physical sensors; and utilizing other measurement procedures.
Institutions whose employees or agents intervene for research purposes with any human subject of the research by manipulating the environment
Examples of manipulating the environment include controlling environmental light, sound, or temperature; presenting sensory stimuli; and orchestrating environmental events or social interactions.
Institutions whose employees or agents interact for research purposes with any human subject of the research
Examples of interacting include engaging in protocol dictated communication or interpersonal contact; asking someone to provide a specimen by voiding or spitting into a specimen container; and conducting research interviews or administering questionnaires.
For more information and other examples, go to http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.html.
23 January 2009
IACUC review of federal grant funded animal research
PHS Policy regarding review and approval of animal studies state that "the IACUC shall conduct continuing review of activities covered by this policy at appropriate intervals as determined by the IACUC but not less than once every three (3) years". UMBC animal research protocols are approved for a three-year term. The investigator or instructor must resubmit a new application for Committee review in order to continue research activities.
What doe this mean if the proposed research, at the time of grant award, will not involve animal research until years 4 or 5 of an award?
The Office of Laboratory Animal Welfare (OLAW) recently issued guidance about this (http://grants.nih.gov/grants/olaw/faqs.htm#proto_20). If this occurs, the PHS awarding unit will not make an award unless the institution provides "..verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals".
IACUC review must be performed prior to the conduct of any PHS-supported animal activity; this usually means approval must be obtained before an award is made and well before any animal research activity can begin. But, an IACUC can review activities if they will occur later in the life cycle of a grant. OLAW says that during these rare cases, the grant application must clearly explain when these activities will occur and that the PHS awarding component will issue a Notice of Award with a special term and condition indicating that no funds may be drawn from the grant or contract until a valid IACUC approval date has been issued by the IACUC.
Be sure to discuss any and all components with your OSP contact during the UMBC routing process or with the Human and Animal Research Protections Office.
What doe this mean if the proposed research, at the time of grant award, will not involve animal research until years 4 or 5 of an award?
The Office of Laboratory Animal Welfare (OLAW) recently issued guidance about this (http://grants.nih.gov/grants/olaw/faqs.htm#proto_20). If this occurs, the PHS awarding unit will not make an award unless the institution provides "..verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals".
IACUC review must be performed prior to the conduct of any PHS-supported animal activity; this usually means approval must be obtained before an award is made and well before any animal research activity can begin. But, an IACUC can review activities if they will occur later in the life cycle of a grant. OLAW says that during these rare cases, the grant application must clearly explain when these activities will occur and that the PHS awarding component will issue a Notice of Award with a special term and condition indicating that no funds may be drawn from the grant or contract until a valid IACUC approval date has been issued by the IACUC.
Be sure to discuss any and all components with your OSP contact during the UMBC routing process or with the Human and Animal Research Protections Office.
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