In addition to the actions described above, an IRB-approved study may be voluntarily suspended upon request by the Principal Investigator of that study. The Associate Vice Provost for Human Subject Research may also temporarily withhold permission for a Principal Investigator to conduct a study at any time. Voluntary suspensions and temporary withholds shall be governed by the policies on suspensions defined in this SECTION 13 of the IRB Written Policies and Procedures with regard to enrollment, subject safety, the continuance of treatments, and the collection, evaluation and use of research data and information. These policies include that subject enrollment must cease and that study interventions or interactions with already enrolled subjects should continue only when these are in the best interest and safety of individual subjects as determined by those authorized to make such decisions.
Requests for voluntary study suspension should be directed to the HSRO in writing. Voluntary suspensions require approval by the Associate Vice Provost for Human Subject Research or his designee. Approval of a suspension volunteered by the Principal Investigator is subject to the stipulation that lifting of the voluntary suspension by Principal Investigators must be preceded by written notice to the HSRO at least one full working day prior to the resumption of study activities and/or enrollment. A voluntary suspension of enrollment and/or other study activities by the Principal Investigator without administrative suspension shall not be defined as a "suspension" as per definition in other policies in this section and shall not carry with it the reporting requirements of a suspension for cause.
If the Associate Vice Provost for Human Subject Research temporarily withholds study permission or subsequently reinstates such permission, he/she must inform the Principal Investigator and the HSRO promptly in writing. Such temporary withholds by the Institution shall also not carry the reporting requirements of a suspension for cause, since the withdrawal of permission is temporary and must be unrelated to compliance with human subject research-related federal regulations or UM IRB policies and determinations.
A voluntary suspension shall not be approved for a study that is already in suspension either by administrative action or by determination of the IRB. However, a study under voluntary suspension may be suspended either by administrative action or by IRB determination. If a suspension "for cause" is imposed administratively or by the IRB, this suspension shall override the voluntary suspension or temporary withhold of permission by the Institution and carry with it the reporting requirements defined in other policies in this section.