Help files for the IRBWise Online Application (read them here, or access them as you fill out the application)
WHY THIS INFORMATION IS IMPORTANT TO THE IRB:
The Department of Health requests information about the department or location of research to assess research activity throughout the Department.
WHY THIS INFORMATION IS IMPORTANT TO THE IRB:
Funding information may indicate additional information that needs to be reviewed along with the IRB application (e.g., sponsor protocols, grants, contracts) and assists the DOH IRB in understanding the level of responsibility of the Principal Investigator in the management of the study.
Electronic copies of contracts, grants and all other funding information must be uploaded in their entirety (see Application Section IV Attach Documents, below)
WHY THIS INFORMATION IS IMPORTANT TO THE IRB:
This information is important for the DOH IRB to determine and document that the research is reviewed per the terms of the DOH Assurance. If the research is conducted at multiple locations (for example, multiple county health departments), it is important for the DOH IRB to make sure that the investigator has authorization from each institution (for example, prior permission from each county health department director or administrator), and to make sure that if multiple IRBs oversee the same research that the investigator has received approval from other IRBs.
WHY THIS INFORMATION IS IMPORTANT TO THE IRB:
Assessing the amount of funding helps the Office of Public Health Research track research at the Department of Health. Research is one of the ten essential services of public health. Tracking funding helps the Office of Public Health Research document how much research at DOH is not funded externally, but is pursued because of the interest and dedication of the investigators at DOH.
WHY THIS INFORMATION IS IMPORTANT TO THE IRB:
This information describes the specific objectives of the proposed research in plain language understandable to all DOH IRB Committee members. Please note that the committees are comprised of scientists with varied backgrounds, non-scientists, as well as members from the local community.
WHY THIS INFORMATION IS IMPORTANT TO THE IRB:
This information is important to determine whether the DOH IRB has jurisdiction over the activity. The DOH IRB is responsible for reviewing research involving human subjects. Some public health activities such as surveillance may resemble research, but do not require IRB review because they are specifically or broadly authorized by state law. The Ethics and Human Research Protection Program encourages investigators, contractors, and program directors to contact the office for assistance determining whether a particular activity involves research as defined in DOH policy and federal regulation, or whether DOH is directed to perform an activity under state law and not under the jurisdiction of the DOH IRB.
WHY THIS INFORMATION IS IMPORTANT TO THE IRB:
The DOH IRB follows additional guidance and regulations for certain populations considered to be vulnerable.
WHY THIS INFORMATION IS IMPORTANT TO THE IRB:
It is important to include persons of all ages in research to determine whether the intervention or therapy being studied affects various age groups differently. There are additional protections in the Federal regulations and/or guidance governing research involving certain age groups (e.g., children, elderly) often considered to be vulnerable.
WHY THIS INFORMATION IS IMPORTANT TO THE IRB:
In assessing the risk/benefit to potential participants the DOH IRB must be informed as to the total number of participants to be enrolled.
WHY THIS INFORMATION IS IMPORTANT TO THE IRB:
It is the responsibility of the DOH IRB to review and approve all forms of advertising for recruitment purposes. IRB review is necessary to ensure the information is not misleading or coercive to potential participants.