IRBWise Online Application Help

WHY THIS INFORMATION IS IMPORTANT TO THE IRB:

If the study plans to enroll research participants who do not understand the English language, then it is imperative that all subjects have an opportunity to understand enough about the study and the elements of consent in order to make an informed decision about participating in a research study. This means the consent must be translated and presented to the prospective participant in the language the non-English speaking participant understands. If you anticipate enrolling non-English speaking participants, the written consent form should be translated to the appropriate language. Alternatively, if approved by the IRB, an oral consent procedure using a short form presented in the relevant language by a person who is fluent in both English and the relevant language may be used.

If the population involves non-English-speaking participants, a translated version of the consent is required, unless the DOH IRB has approved an alteration or waiver of consent. The DOH IRB does not provide translation services. However, investigators may wait to have the consent translated until the English version is approved by the IRB.

WHY THIS INFORMATION IS IMPORTANT TO THE IRB:

The DOH IRB must ensure that Federal regulations and guidelines are met when a waiver or alteration of the consent process or consent documentation is requested by a Principal Investigator. The Federal regulations allow for a process other than a written document for obtaining informed consent. However, the conditions in which a waiver may be granted are specifically stated in the regulations.

WHY THIS INFORMATION IS IMPORTANT TO THE IRB:

Research conducted under the jurisdiction of the DOH IRB may need to be reviewed by a Privacy Board for Research that is responsible for assuring proper use and disclosures of Protected Health Information (PHI) for research purposes as specified in the Health Insurance Portability and Accountability Act (HIPAA), unless the activity is exempt from requirements of HIPAA. Guidance documents specify the conditions in which a "covered entity" may use PHI for screening or recruitment for research. However, a entity may have stricter rules regarding screening of PHI for research.

WHY THIS INFORMATION IS IMPORTANT TO THE IRB:

This information is important to the DOH IRB in assessing the risk/benefit ratio of the study. The IRB is responsible for ensuring that adequate plans have been established to protect the safety and welfare of participants, which is a requirement of the Federal regulations for approval of the research study.

WHY THIS INFORMATION IS IMPORTANT TO THE IRB:

This information assists the DOH IRB in determining the appropriate level of review. Per Federal regulation, unless the research meets the specified criteria for Expedited Review or Exemption, studies are reviewed at a convened meeting of the full IRB Committee. The Investigator should be aware of the criteria for review and indicate which level of review the study may require. The IRB makes the final determination regarding appropriate committee review.

WHY THIS INFORMATION IS IMPORTANT TO THE IRB:

Evaluating the risks and benefits of drug trials require the DOH IRB to consider many aspects of study design, paying special attention to the study population, the trial phase, and mechanisms for safety surveillance and data analysis. The DOH IRB must ensure that the participant is made aware of the purpose, methods, and possible hazards of the research and that the Principal Investigator has adequately minimized the risks to the participants. The IRB must also ensure the informed consent document contains all the information necessary for potential participants to adequately assess those risks to make an informed decision to participate.

WHY THIS INFORMATION IS IMPORTANT TO THE IRB:

Information about investigational devices is important to the DOH IRB in assessing the risk/benefit ratio of the study.

WHY THIS INFORMATION IS IMPORTANT TO THE IRB:

Radiological procedures used in human subjects research that the participant would not receive as standard medical care, including standard of care procedures that are being altered for research purposes, are required by Federal regulations to receive an additional review of the procedures. In addition, research protocols involving certain radioactive drug(s) must also be reviewed and approved by the IRB.

WHY THIS INFORMATION IS IMPORTANT TO THE IRB:

This information is important to the IRB because if the Principal Investigator is a student, resident or fellow, the DOH IRB requires a Faculty Advisor be appointed to oversee the conduct of human research. The Faculty Advisor is considered the responsible party for the legal and ethical performance of the student Principal Investigator’s project.