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It is the policy of the CSS IRB that all human research studies involving medical devices must be reviewed and conducted in compliance with Investigational Device Exemption (IDE) requirements (21 CFR 812) unless determined to be exempt via 21 CFR n812.2(c).

The purpose of this SOP is to describe the process for reviewing research that will be conducted by CSS researchers outside of the United States.  This SOP also applies to community based research where the participants are of an immigrant culture within the United States.

It is the policy of the CSS IRB that all research involving human research participants or the use of information about human research participants be planned and conducted in a manner that protects the privacy interests of the research participants and the confidentiality of any personal information about the research participants.

CSS IRB approved human subjects training is required for all individuals involved in the conduct of research involving human subjects, regardless of funding source.  The IRB will not release the approvals for new protocols until all individuals involved with human subjects on the project (i.e., direct contact with subjects or access to data) have completed the required training.

Federal regulations do not permit an IRB member to participate in the review of research in which he/she has a conflicting interest, except to provide information requested by the IRB. This requirement helps to ensure that financial or other interests do not compromise the rights and welfare of human research subjects. (45 CFR § 46.107 (d).)

The CSS IRB does not currently review research involving pregnant women. If a woman becomes pregnant while participating in a study that has not been approved for inclusion of pregnant women, the IRB must be notified immediately so that the IRB can determine whether the subject may continue in the research, whether additional safeguards are needed, and to make the determinations required by the regulations and these policies.

The CSS IRB does not currently review research involving prisoners. If this were to change, procedures consistent with the requirements of Subpart C of 45 CFR 46 will be developed.

If a subject were to become incarcerated while participating in a study that has not been approved for inclusion of prisoners, the IRB must be notified immediately so that the IRB can determine whether the subject may continue in the research, whether additional safeguards are needed, and other determinations.

The purpose of this SOP is to describe the special regulatory requirements that the researcher and the IRB must take into consideration when a proposed research study involves children, a vulnerable population, to provide additional protection for children involved in research.

When all research-related interventions or interactions with human subjects have been completed, and all data collection and/or utilization/analysis of identifiable private information, for any purpose, have been concluded, then the research may be considered as completed and the application may be closed. The Principal Investigator should not close an IRB application as long as the investigator is utilizing individually identifiable private information collected as part of the research.

Under 21 CFR 56.113 and 45 CFR 46.113, an IRB shall have the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. The conditions under which approval of previously approved research may be suspended or terminated, and the procedures to be followed for suspending or terminating research are described.

It is the policy of the CSS IRB  that all allegations of non-compliance with human subjects research must be reported promptly, each report will be investigated, and determinations made about these allegations.  Issues or events that are reported are considered possible non-compliance until a final determination is made by the convened IRB or the IRB Chair. Non-compliance that is determined to be serious or continuing must be promptly reported to the appropriate entities.