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Do I Need A Full Board Review?


If you have determined  that your proposed study is greater than "minimal risk", or is minimal risk, but does not fit into one of the Expedited Categories mentioned in Step 3, you must submit your study for Full Board review. We have 5 Full Board Panels that each review different types of research:

  • ​Panel A - Adult Biomedical Study Full Board Submissions
  • Panel B - Adult Biomedical Study Full Board Submissions (with specific specialties)
  • Panel C - Pediatric Biomedical Study Full Board Submissions
  • Panel D - Adult Oncology and High Risk Biomedical Full Board Submissions
  • Panel S - Social and Behavioral Study Full Board Submissions (Of a non-biomedical nature)

It can often be ​difficult to determine which Panel is appropriate for your study because their overlapping areas of review. If you have any questions, please call COMIRB at 303-724-1055.

Certain Full Board, industry sponsored studies may be submitted to the Western Institutional Review Board (WIRB) for review if the Principal Investigator "opts-in". Click the "Submissions For Special Cases" link in the grey column on the left of the screen for more information.

The accordion folders at the bottom of this page will contain submission instructions for each of our Full Board Panels. Before you review the accordion folders, please review the following bullet points which may contain information relevant to your study:


Please first review the requirements for Full Board submissions in the accordion folders below:
 
Does my study include "vulnerable populations" that have additional regulatory requirements?

"Vulnerable populations" include those individuals whose status may create additional risk for study participation or undue coercion, such as: children, prisoners, pregnant women, neonates, mentally disabled persons, adults who lack the ability to consent, or economically or educationally disadvantaged persons.

COMIRB will determine if appropriate additional safeguards are in place to protect the rights and welfare of subjects if they are likely to be members of a vulnerable population.

If COMIRB reviews research that involves categories of participants vulnerable to coercion or undue influence, the review process will include one or more individuals who are knowledgeable about or experienced in working with these participants. For example, COMIRB will include one or more individuals who are knowledgeable about or experienced in working with children, prisoners, or adults with limited decision-making capacity, when reviewing research that involves individuals from these populations.

45 CFR 46 has additional subparts designed to provide extra protections for vulnerable populations which also have additional regulatory requirements:

Subpart B - Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research

Subpart C - Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

Subpart D - Additional Protections for Children Involved as Subjects in Research

If your study potentially includes any of vulnerable populations, please review the following links for guidance from COMIRB:

Submission instructions for Full Board review

Click here for an Initial Submission Checklist and Submission Instructions.

Full board applications are reviewed at a convened panel meeting. New protocols are assigned to the next available meeting in the order they are received, based on reviewer availability and current workload. Research may not begin until the investigator has received documentation of COMIRB approval. If the research involves the VA, the project may not begin until it is approved by COMIRB and then the VA R&D Committee. For a list of upcoming meeting dates for each panel, please click here.

Investigator's continuing responsibilities

We strongly recommend you review the following COMIRB documents which highlight the continuing responsibilities of investigators for approved studies:

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