Human Subjects Review Committee (HSRC) / Institutional Review Board (IRB)

1.    Submit completed protocol by email to irb@ochca.com

2.    Review Steps*
 

2.a. IRB Office reviews the protocol/study for required items, then submits the protocol     to the Service Area Director for review and approval. 
•    If the protocol is approved, research will move forward to the next steps. 
•    If modifications are required, the protocol is sent back for revisions. 
•    If disapproved, a notification is sent to the principal investigator (PI).
 

2.b. Office of Compliance Review: Protocol must be approved by this office. This office also determines if the protocol would need to be forwarded to Contracts Division for Data Use Agreement (DUA). (Forwarding to Contracts would entail another administrative step subject to an additional 2 week response time.)   
 

2.c.  IT Review (if applicable, simultaneous with Compliance Review): If the protocol involves use/storage of HCA PHI/PII on non-county IT systems (including equipment and internet), the protocol requires IT review and approval. 
If you believe this applies to you, you may email irb@ochca.com to request the IT Questionnaire for Security Requirements worksheet in advance. This worksheet must be completed for IT to proceed with their review.   
 

2.d. HR Review (if applicable, simultaneous with Compliance Review): If the protocol involves County staff as subjects of the research, Agency HR must review, followed by:

i. County Counsel
ii. Labor Relations 
(Forwarding to each of these entities entails another administrative step subject to an additional 2 week response time.)
 

3.    Protocol Completeness (final IRB Office review)
•    IRB Office reviews protocol for final time before Chair review to ensure all Agency and regulatory components are present and protocol is ready for further evaluation.
 

4.    IRB Chair Review

• The IRB Chair (or designee) determines if the protocol qualifies for exemption, expedited review, or requires full committee review.
  • Exempt: If the Chair or designee determines the protocol meets the criteria for exemption, the PI will receive confirmation that the study can proceed.
  • Expedited Review: If the Chair or designee determines the protocol meets the criteria for expedited review, the PI will receive confirmation that the IRB approves the study and the study can proceed.
  • Full Committee Review: If a protocol does not meet the criteria for exempt or expedited review, the IRB Office will schedule the protocol for Committee Review – note that a protocol cannot be disapproved at this step. The protocol will be scheduled for the next closest meeting. If the submission is received 10 or more business days    before the next scheduled meeting, it will be reviewed at that meeting.  Otherwise, the protocol would be reviewed at the following meeting. (see Agency Approval Deadline table under “New Research Protocols”
     

5.    Decision Outcomes:
•    If the protocol is approved by the IRB, research can commence, and data may be released.
•    If modifications are required, the protocol is sent back for revisions. 
•    If disapproved, a notification is sent to the PI.
•    The committee has 5 days from the meeting to respond to the PI regarding protocol status.  

*Note: Response can take up to 10 business days     for each county office once protocol is referred to them, which may compound the timeline. A simple protocol not requiring IT and HR review may take an average of 4 weeks for review from both the Service Area Director and Office of Compliance. If, however, a protocol then needs to be reviewed by HR, and then County Counsel, it could take 6 to 8 weeks to get responses from all the required county offices. Furthermore, if additional information is requested from any of these offices, approval can be further delayed beyond the 10 business days response window from an office. 
 

When planning a research project, please keep these circumstances in mind and plan for at least 60 days before a protocol would be scheduled on the HRSC agenda. If you have questions about planning in this time frame, please contact the HSRC/IRB office:  irb@ochca.com
 

The following steps are required to gain approval to conduct research under the auspices of the HCA.

Step 1: Complete research protocol including the following:

1. Provide the name of the study.
2. Provide information about the principal researcher and co-researchers:, as well as key personnel who will assist in carrying out the research protocol, including activities such as consultation, data collection, analysis, and manuscript preparation:
   Include a sheet containing the names (with phone numbers and addresses, credentials, job titles, divisions, and/or agency names) and signatures of the principal researcher, each co-researcher, and the appropriate program director).
3. Provide expected start and end dates for the project.
4. State the purpose of the research (e.g., its significance, expected impact). Include any relevant literature, findings, or other relevant information regarding the risks/benefits associated with the research. If applicable, include any public reports or publications that have been produced in previous iterations of this research project.
5. Describe the methodology of the project. Include the following elements, if applicable:
   - State the hypothesis or hypotheses that will be tested.
   - Describe procedures for subject recruitment, selection, and screening. Identify the number and characteristics (e.g., age, sex) of subjects to be included, and any exclusionary criteria including justifications for any exclusions.
   - Describe if any mono-lingual speakers of languages other than English will be recruited and how they will be accommodated.
   - Describe any sampling methods that will be utilized.
   - List any populations in your project that are considered vulnerable populations.
   - Detail where and when recruitment will occur as well as who will conduct the recruitment.
   - Describe all procedures to be performed (i.e., how data will be collected).
   - Describe criteria or procedures for assigning subjects to different "treatment" groups (e.g., control, experimental), and all program/research activities, including any experimental procedures to be employed. Include the duration and location of activities.
   - Describe the data collection and analysis methods (e.g., surveys, focus groups, interview/focus group scripts).
   - Describe the rationale for the data-collection methods to be used, including if PHI will be collected and why.
   - Describe any data sources that will be used or accessed, including how they will be accessed and by whom. Include a list of any software that will be used and how each software will be used, including any software that will be used to collect, store, transfer, or analyze any PHI or PII.
   - Describe the data analysis plan: How data will be organized and analyzed, including the variables and relationships that will be explored, as well as the statistical analyses that will be performed.
6. State any risks or benefits to subjects and any potential benefits for mankind. Include any steps that will be taken to minimize risk and any measures that will be taken as a result of a negative or adverse event.
7. Describe provisions for any medical care required as a result of participation in the research study.
8. Describe procedures for safeguarding confidentiality. Include information about who will have access to data, how data will be stored and/or transferred, how long data will be retained and what will be done with it after it is no longer needed.   
9. Describe (if applicable) manner by which subjects are to receive compensation (e.g., cash, special benefits or services, etc.)
10. Detail the process for obtaining informed consent or a justification for any alteration/waiver of informed consent requirements; include a description of steps you will take to ensure participant comprehension of the informed consent language. 
11. Describe how the community has been or will be involved in your project (e.g., project is informed by a community needs assessment, community involved in the development of the research plan, study materials, or recruitment)
12. Provide information on how your study/project results or findings will be disseminated, including any summary reports that will be developed and how they will be shared, and/or manuscripts that will be submitted for publication.
13. Develop and provide a consent form (not all projects require this). To determine if a consent form is necessary, view the DHHS website.
    ohrp.osophs.dhhs.gov - 46.116
    Consent forms must be in language easily understood by the subject, and must contain all pertinent information in sufficient detail to allow the subject to make an informed decision to participate or not to participate in the study.
14. Include copies of survey instruments or other forms to be used in data collection with protocol submission.
15. Include a copy of approval from other Human Subject Review Boards. This is required if study is done collaboratively with a university or other external institution.
    See sample Human Subjects Protocol.

Example Research Protocol tile

Step 2: Submit protocol to irb@ochca.com

Step 3: After completing these steps, the principal investigator (PI) will be contacted with an acknowledgement of having received your protocol. The IRB coordinator will contact the PI if there are any missing documents or for clarifying questions. 

Step 4: The protocol will be reviewed by the Service Area Director, then the Office of Compliance. Additional Agency approvals and Data Use Agreement (DUA) may also be required (IT, HR, Contracts, etc.) as described in the IRB Workflow. The review process can take up to 10 business days for each reviewer, and if further information is requested, this can delay a decision beyond the 10 business days. 

Step 5: Once approved by the required Agency offices, the protocol will be sent to the HSRC for Chair or full committee review.  Once  the protocol is reviewed by the HSRC, an official approval form signed by the Chair of the HSRC will be sent to the principal investigator or designee. The PI will receive notification of the HSRC’s decision within 5 business days after the HSRC meeting. Download form 

If the protocol receives approvals from the relevant agency departments at least 10 business days 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.

* Approvals from all necessary HCA departments (Service Area, Office of Compliance, etc.) are required before the HSRC deliberates a protocol.

If changes to a study are needed prior to renewal, the IRB must be notified and changes approved before taking action, exceptions only in cases regarding the safety of subjects, where the IRB must be informed as soon as possible after the changes take place.

When submitting an amended protocol, please complete and submit the “HSRC Status Report” form, summarizing the modifications under the “Other Updates” section. In addition to this form, submit your updated forms as applicable, including updated survey instruments, consent forms, personnel information, and/or updated protocol in its entirety.

If the study extends past one year, and for each subsequent year thereafter, a renewal will be required. The renewal steps are as follows:

1. Complete the HSRC Status Report 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. If applicable, include any public reports or publications regarding this study that you have produced during the progress of this 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.
 

After study is terminated or completed, complete the HSRC Final Status 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.