"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:
Complete the following 4 steps to submit your study to COMIRB for Full Board review:
1. Before you may submit to COMIRB, you must complete the required education courses, gain access to the eRA(InfoEd) system, and complete several other tasks.
Click here for instructions on how to complete these tasks. These tasks can take several days to complete, so we suggest you factor that into your planning. When these tasks
are completed, you will be ready to continue with the submission process.
2. Complete the Application Form, which can be downloaded by clicking here. *To prevent problems, make sure to use Adobe Reader to open and edit the "Smart PDF" Application Form. Click here to download a free copy of the newest version of Adobe Reader.
3. Compile supporting documents printed with the PI's name and page numbers:
- A. A cover letter listing what documents are included in the submission.
- B. Grant application (if funded by a federal grant)
- C. Data collection tools.
- D. Surveys, diaries, questionnaires, interview guides, scripts used with subjects (if applicable).
- E. Recruitment materials, advertisements, invitations to participate, informational materials subjects (if applicable).
- F. VA or Denver Health clearance letter (if research is conducted at or involves employees of these sites).
- G. Consent forms, assent forms, verbal consent scripts (Standard consent and assent language templates can be found in an accordion folder on the COMIRB Forms page by clicking
here).
- H. Protocol (A standard protocol template can be found by clicking here).
- I. HIPAA Authorization A Form which allows a potential research subject to authorize their health care provider, who is uninvolved in a study, to release PHI to a study
investigator for the purpose of recruitment (if applicable).
- J. HIPAA Authorization B Form allows a potential research subject to authorize the use of their PHI for the purposes of a study. (if applicable, Note: the authorization
language included on this form is usually incorporated into the consent form, unless the study involves the VA).
- K. Other committee approvals (if applicable).
- L. Documentation of Investigational Device Exemption (if applicable).
- M. Conflict of interest management plan (if a potential conflict of interest has been identified).
- N. Investigator drug brochure or package inserts (if applicable)
- O. Documentation of Investigational New Drug number or exempt (if applicable)
- P. FDA 1572 Form (if applicable)
- Q. Background information for food supplements (if applicable)
- R. Device manual (if applicable)
- S. Documentation of Investigational Device Exemption (IDE) number, Non-significant risk device determination or IDE exemption (if applicable)
- T. Complete the billing information on the final page of the Application. Current fees are posted here. Requests for a fee waiver or reduction must be
accompanied by the Fee Waiver Form that is built into the Application Form.
4. Submit the materials to COMIRB.
Currently, how you can submit your study for Full Board review depends on which Panel you are submitting to. Please select the appropriate Panel to submit to below. If you are
unsure which Panel is appropriate, click here for help deciding. If you have any questions, please contact the COMIRB Help Line at 303-724-1055.
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
We strongly recommend you review the following COMIRB documents which highlight the continuing responsibilities of investigators for approved studies:
Please select the appropriate Panel to submit to below. If you are unsure which Panel is appropriate, click here for help deciding.
As of 2/25/2013, all submissions for Full Board review to Panels A or B can only be submitted in paper. They cannot be submitted using ePaper
through the eRA(InfoEd) system.
The number of collated submission packets required to submit in paper for Panels A or B is as follows:
- Initial Submissions: 3 single-sided, collated submission packets.
- Please submit the necessary number of paper submission packets for each submission to:
Anschutz Medical Campus
MS F490 (Building 500)
13001 E. 17th Place, Room N3214
Aurora, CO 80045
As of 2/25/2013, all submissions for Full Board review to Panel C can be submitted in paper or electronically using ePaper through the
eRA(InfoEd) system.
- Click here for instructions on how to submit using ePaper through the eRA(InfoEd) system. We strongly suggest that you attend our weekly training course before attempting to
make a submission electronically. Click here to sign up for the course.
If you are submitting in paper to Panel C, the number of complete, collated submission packets required is as follows:
- Initial Submissions: 3 collated submission packets, single-sided.
- Please submit the necessary number of submission packets for each submission to:
Anschutz Medical Campus
MS F490 (Building 500)
13001 E. 17th Place, Room N3214
Aurora, CO 80045
As of 2/25/2013, all submissions for Full Board review to Panel D can be submitted in paper or electronically using ePaper through the
eRA(InfoEd) system.
- Click here for instructions on how to submit using ePaper through the eRA(InfoEd) system. We strongly suggest that you attend our weekly training course before attempting to
make a submission electronically. Click here to sign up for the course.
If you are submitting in paper to Panel D, the number of complete, collated submission packets required is as follows:
- Initial Submissions: 3 collated submission packets, single-sided.
- Please submit the necessary number of submission packets for each submission to:
Anschutz Medical Campus
MS F490 (Building 500)
13001 E. 17th Place, Room N3214
Aurora, CO 80045
As of 2/25/2013, all protocols submitted for Panel S Full Board initial review can be submitted in paper or electronically through the eRA(InfoEd) system using ePaper.
- Click here for instructions on how to submit using ePaper through the eRA(InfoEd) system. We strongly suggest that you attend our weekly training course before attempting to
make a submission electronically. Click here to sign up for the course.
If you are submitting in paper for Panel S Full Board initial review, the number of complete, collated submission packets required is as follows:
- Initial Submissions: 1 submission packet, single-sided.
- Submit the submission packet to COMIRB. Please submit to the Anschutz Campus unless you are located on the Downtown Campus:
Anschutz Medical Campus
MS F490 (Building 500)
13001 E. 17th Place, Room N3214
Aurora, CO 80045
or
Downtown Campus
1380 Lawrence Street Building [LSC], Room 300
Campus Box 120
Denver, CO 80204
Phone: 303-315-2732
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