Protocol materials are submitted through email to email@example.com
Materials to Submit
The following is a general list of items required by CARAS to begin the review process for a research study. These include:
New Research Application Form - Download here
Supporting documents, such as data collection instruments used, including survey and interview questions
All information intended to be seen or heard by subjects, including:
Consent documents (in Microsoft Word compatible format)
Information sheets (in Microsoft Word compatible format)
Advertisements and recruitment scripts and materials
Current curriculum vitae for the Principal Investigator and study staff that interact with subjects or have access to human subjects data
Research ethics training certificate of completion for each researcher who will be involved in the collection, storage, or analysis of human subjects data (must be completed within the past 12 months).
If applicable, professional license(s), for the study investigators showing the expiration date, if a current one is not already on file with CARAS HRPP
HRPP Review and Regulatory Determinations
Upon receipt of the application packet, a staff member from the CARAS HRPP will review the submission for completion. We will coordinate with the principal investigator to address any questions or missing information. Once complete, the HRPP Director, or designated CARAS person, will evaluate the regulatory status and appropriate review pathway. As detailed below, these can be: Not-Research, Not Human Subjects Research, Exempt, Expedited, Limited IRB, or Full IRB. Only the IRB is legally authorized to review and approve non-exempt human subjects research. Expedited review is performed by the IRB Chair or an IRB member designated by the Chair, and the results are reported to the full IRB.
Not-Research and Not-Human Subjects Research Determination (or not subject to IRB requirements)
Many activities that involve collection and analysis of information are not classified as human subjects research under the regulations and do not require IRB review. In some cases, an activity may technically meet regulatory criteria for human subjects research but not require IRB review because the activity is not under federal legal jurisdiction. It may be helpful for a researcher to have a formal determination made by an independent authority that their research or scholarship does not require review by an IRB. CARAS can assess the activity and, if appropriate, can provide a determination letter documenting such regulatory status. If the project does require IRB review, CARAS can clarify the regulatory status for the investigator and assist with obtaining necessary review and approvals.
If you have questions about the regulatory status of your research, please contact the CARAS HRPP at firstname.lastname@example.org.
Types of Review
There are four types of human subject research review: exempt, expedited, limited IRB, and full IRB review. These categories are discussed below. For non-exempt human subjects research, the IRB has the authority to approve, require modifications in (to secure approval), or disapprove research activities.
There are eight categories of research activities involving human subjects that may be exempt from regulatory requirements applicable to human subjects research; these are defined in regulation at 45 CFR 46.104. With the exception of research involving “limited IRB review” (see below), exempt status is an administrative determination that does not involve the IRB. Continuing review is not required for exempt research.
Attributes of research that may be Exempt include:
Comparison of instructional techniques in established educational settings
Interviews with adults about non-sensitive topics
Analysis of identifiable private information that is publicly available
Data collection in which Information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects
Surveys that obtain private identifiable information in which the IRB conducts a limited IRB review to determine that there are adequate provisions to protect the privacy of subjects and maintain confidentiality of data
A determination that human subjects research is exempt does not release the investigator(s) from the ethical obligation to ensure that the welfare of research subjects is protected.
Full IRB Review
Review by the convened or “full” IRB is conducted for all human subject research that presents more than minimal risk to the subject, and any other project that is not covered under other review categories.
Non-exempt human subjects research that fits one of nine specific categories may be reviewed administratively through the expedited review process by a designated IRB member. Expedited review can also be performed for minor changes in approved research, and research for which limited IRB review is a condition of exemption. Continuing review is generally not required for research initially approved using the expedited review process.
The expedited reviewer may refer the protocol to Full Board for review, if there are specific issues that may require consideration by the convened IRB. In such an instance the IRB Chairperson will notify the PI that the application requires full board review and that it will be added to the agenda for a forthcoming IRB meeting.
Limited IRB Review
Limited IRB review, a new process available under the 2018 regulations, provides increased oversight by the IRB for certain exempt categories. This includes verification that identifiable private information or biospecimens have appropriate data security and privacy protections in place to reduce the chance of inappropriate disclosure. This also includes ensuring that broad consent was obtained for the future use of identifiable data or biospecimens. The limited IRB review process is generally completed via the expedited review process.
Possible Approval Determinations
(New Research and Continuing Review).
Approve as Submitted: The research study meets regulatory criteria and is approved.
Approve with Conditions: Research study is approved pending completion of specific changes or provision of information that will confirm compliance with regulatory criteria for approval. The Investigator may not begin the study before these changes are reviewed and confirmed by a designated reviewer, and the principal investigator is formally notified by the HRPP.
Deferred: IRB action on the research study is postponed to a later board review pending resolution of substantive issues that the IRB believes can be addressed in a future re-review of the protocol, and that would allow approval under the regulations. These issues will be specified in IRB correspondence with the investigator.
Disapprove (Full IRB only): The IRB cannot approve a proposed study that does not meet regulatory criteria for approval defined at 45 CFR 46. The IRB will notify the investigator of the reason(s) for disapproval. If disapproved, the Investigator may respond to the disapproval in writing. Studies modified by the Investigator to address the concerns leading to disapproval may be resubmitted as a new project at a later date.
When required, continuing review of research must be conducted at intervals appropriate to the degree of risk, but not less than once per year. The following factors are among those considered as the study progresses:
Safety and effectiveness data that inform the question of whether the study should be continued
Changes in key personnel
Changes in research regulations and guidance
Serious adverse events and unanticipated problems associated with the study.
New, pertinent information that should be incorporated into the protocol
Unless an IRB determines otherwise, continuing review will not be required in the following circumstances:
research that is eligible for expedited review in accordance with 45 CFR 46.110
research that is reviewed by an IRB in accordance with the limited IRB review
research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
data analysis, including analysis of identifiable private information or identifiable biospecimens
accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
The IRB Executive Secretary will contact investigators approximately 60 days prior to the current expiration of a research protocol. Investigators may elect to close the protocol or apply for continuation. In the event of closure, a form documenting the closure of the protocol must be submitted to the HRPP office.