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Research at ChristianaCare
Human Research Protection Office
The HRPO provides a forum for integrated decision making.
Building a Self-Sustaining Research Capability
The Board of Directors of ChristianaCare has designated the ChristianaCare Human Research Protection Office which is composed of qualified individuals to oversee the development of the process to review all research protocols in relation to the relative risks and benefits to the subjects and the mechanism for obtaining the subject’s consent. The Human Research Protection Office reviews all protocols for scientific merit and may be assigned other responsibilities to assure the protection of the rights and welfare of human subjects as determined by the Board of Directors.
The Human Research Protection Office provides a forum for integrated decision making and a body for assessing multidisciplinary accountability. The Human Research Protection Office oversees and assures ChristianaCare’s compliance with the Department of Health and Human Services (DHHS) regulations for the Protection of Human Research Subjects, found in the current Code of Federal Refgulations, Title 45, Part 46, 21 CFR 50, 21 CFR 56 and all state and local regulations.
In order to carry out the Human Research Protection Office’s charge, the co-chairpersons or corporate director may request other committee and departmental reports as deemed appropriate. The Human Research Protection Office’s minutes and recommendations for action are forwarded to the Board of Directors Performance Improvement Committee and Staff Council for informational purposes.
The Human Research Protection Office reviews and takes action on all investigative projects to be conducted within ChristianaCare by affiliated members and any other participating hospitals as required by contractual agreements unless otherwise exempted by the federal government (see Centerwide Policy 5033). All reviews and actions follow the guidelines on human research protocols established by the federal government and the Nuremberg, Helsinki and Belmont reports. Other studies done outside ChristianaCare by members of the staff in which the staff member wishes to include notice of his affiliation with ChristianaCare may be reviewed by the Human Research Protection Office at the discretion of the co-chairperson or corporate director.
The Human Research Protection Office oversees the activity of ChristianaCare regarding research and investigative studies and requires adherence to ChristianaCare policies on these subjects as outlined in the Human Research Protection Office Assurance of Compliance to DHHS. The Human Research Protection Office also oversees the responsibilities of the research investigators as described in the Assurance of Compliance to DHHS document as well as oversees the responsibilities of the Human Research Protection Office secretary as described in the Assurance of Compliance to DHHS document.
The Human Research Protection Office has the responsibility to review and the authority to approve or disapprove all activities or proposed changes in previously approved activities covered by the Assurance document. The Human Research Protection Office approves research protocols when it has determined that the following requirements are satisfied:
The Human Research Protection Office requires documentation of informed consent by use of a written consent form in accordance with 45 CFR 46.ll7 (b)(1). The Human Research Protection Office determines in its review of research protocols, which projects will require Human Research Protection Office review more often than the annual standard and shall conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year. The Human Research Protection Office reports to DHHS all information concerning serious injuries to subjects or continuing noncompliance by investigators with requirements of the committee.
The Human Research Protection Office has the authority to suspend or terminate approval of research that is not being conducted in accordance with the Human Research Protection Office’s decisions, conditions and requirements or that has been associated with unexpected serious harm to subjects. The Human Research Protection Office determines which projects need verification from sources other than the research investigators that no material changes have occurred since the previous Human Research Protection Office review.
The Human Research Protection Office follows all required reporting guidelines as outlined in the Assurance of Compliance to DHHS document, which includes reporting of at least the following:
The Human Research Protection Office prepares and maintains adequate records and documentation of Human Research Protection Office activities as outlined in the Assurance of Compliance to DHHS document.
The Human Research Protection Office follows established protocols for expedited reviews as outlined in the Assurance of Compliance to the DHHS document and shall follow established Full Committee Review of protocols as outlined in the Assurance of Compliance to the DHHS document.
The Human Research Protection Office follows all additional protection policies developed pertaining to research, development and related activities involving fetuses, pregnant women and human in vitro fertilization, children and prisoners as described in the Assurance of Compliance to DHHS document.
Membership information
By federal law, we must have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted at ChristianaCare. We must be sufficiently qualified through the experience and expertise of our members and the diversity of members backgrounds (including consideration of racial and cultural backgrounds) and sensitivity to issues such as community attitudes to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
The membership of the IRB is composed of individuals from diverse backgrounds to promote complete and adequate review of research activities covered by the assurance of compliance to the DHHS document, and has the professional competence necessary to review the specific research activities which will be assigned to it.
A quorum of members is necessary, and majority vote is required for approval of actions.
The IRB members are sufficiently qualified through the experience and expertise of its members, and the diversity of the members’ background including consideration of the racial and cultural backgrounds of members and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. Whenever research involves a category of vulnerable subjects, i.e. children, prisoners, etc., the IRB includes as part of its reviewing body one or more individuals who have a primary concern for the welfare of the selected group of subjects.
The IRB includes both male and female members from a variety of professions and shall have at least one member whose primary expertise is in a non-scientific area. The IRB also includes at least one member who is not otherwise affiliated with the institution.
The IRB meets twice every month or more frequently as deemed necessary by the co-chairpersons or corporate director.
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