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HSRC - Frequently Asked Questions

The Human Subjects Review Committee consists of qualified members from across the service areas of the Health Care Agency, as well as member(s) outside the agency, in accordance with 45 CFR 46.107.

HSRC/IRB Roster

All research, sponsored either directly or indirectly by the Health Care Agency, in which human subjects are utilized must be reviewed by the Human Subjects Review Committee. Furthermore, any protocol for such an activity must be reviewed and approved by the committee before it can be undertaken, and annually until completion.

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Some studies may not need full IRB Committee Review. To help determine if your study qualifies for an exemption, expedited (limited) review, or requires full committee review, consider the following questions:

  • Does your study present no more than minimal risk (45 CFR 46.102(j))?
  • Does your study qualify for exemption under 45 CFR 46.104(d)? 
  • Are minors (under 18 years old), prisoners or institutionalized persons a target population of this project?   (These populations typically do not qualify for exempt or expedited review. See guidance and FAQs from OHRP regarding prisoners and institutionalized persons, and children.)
  • Is your project legally mandated reporting or surveillance, or data collected or charted as part of routine clinical care?
  • Does your study fall into any of the following categories?
    • Standard Quality Assurance/Quality Improvement
    • Program evaluation for internal use only
    • Needs assessment intended only for program planning, monitoring and/or improvement
    • Non-legally mandated public health surveillance

 

Further information on exempt and expedited research can be found on the OHRP website, specifically:

If your protocol includes the use/storage of HCA PHI/PII on non-county IT systems (including equipment and internet), you will need to fill in IT’s Questionnaire for Security Requirements worksheet.  Please email irb@ochca.com for the IT Questionnaire for Security Requirements worksheet, which will need to be completed in order for IT to complete their review.

An official approval form signed by the Chair of the HSRC will be sent to the principal investigator or designee. 

If the protocol receives approvals from the relevant Health Care Agency departments at least one week before the upcoming HSRC committee meeting, it will be included on the agenda for that meeting.  Otherwise, the protocol would be reviewed at the following meeting.

Please note that the approval within HCA departments can take on average 4 weeks, and sometimes longer depending on the completeness of the materials submitted to these departments and the number of departments involved. Please plan your research project accordingly and allow ample time for HCA departments to review and approve a protocol in advance of the HSRC Committee meetings.

Once the protocol is reviewed at an HSRC Committee meeting, a response will be prepared for the principal investigator within five (5) business days.

Annually, until the project is completed (unless otherwise specified by the HSRC).

1. Complete the HSRC Status Report form. Download form  If another form is used the same information must be included:

  • Name of principal investigator, title of research, project start and anticipated end date, number of subjects accrued to date and expected total number of subjects.
  • Brief project summary
  • Progress of the project
  • Adverse events (if any) encountered in the course of the research
  • Recent literature (if any) associated with research project
  • Current copy of consent form and any changes made to consent form after initial approval by HSRC.
  • Signature of principal investigator, (and typed name), date of signature and telephone number where investigator may be reached.

2. Provide copy of updated IRB approval if study is affiliated with a university or other external institution.

Complete the HSRC Final Report form . If another form is used the same information must be included:

  • Name of principal investigator and title of research. project start and end date, and number of subjects.
  • Summary of project.
  • Findings/conclusions.
  • Benefits derived from the study (for the subjects and in general).
  • Any adverse events encountered during the course of the study. Signature of principal investigator, (and typed name), date of signature and telephone number where investigator may be reached.