Is it Human Subjects Research?
This map is a guide to help investigators determine if an activity is research involving human subjects that must be submitted to the IRB for review. It is based on the Human Subject Decision Charts developed by the Office for Human Research Protections.

The map does not address requirements that may be imposed by other organizations, such as the Food and Drug Administration, National Institutes of Health, other sponsors, or state or local governments.

Note: The map provides generalized guidance and may not be specific enough for particular situations. When in doubt, call the Office of the IRB at 516-719-3100.

Further information is available at: OHRP Policy Guidance by Topic.

Pre-submission Quality Assurance Checklist
The Pre-submission Quality Assurance Checklist has been developed to assist investigators and coordinators in preparing their IRB submissions.As you develop your submission packet use this to assure that you have all the required documentation. Accuracy in preparing you packet will expedite the process of IRB approval. Submit a copy of your QA assessment with your packet.

Serious Adverse Event (SAE) Decision Maps
The necessity to report serious adverse events (SAEs) to the IRB is frequently a confusing issue. The following decision maps will help you determine the category of the SAE and the appropriate action to take. The maps are divided based upon the location of the event: external SAEs, those occurring outside of your site, and internal SAEs, those occurring at your site.

Research Database Guidance/Decision Map
Databases containing protected health information (PHI) used for research purposes are affected by the HIPAA Privacy Rule. The Privacy Rule affects all research uses of PHI, even if the research is designated as exempt under the Common Rule. The Privacy Rule regulations cover the use of databases containing PHI just as they apply to any other research using PHI.

The purpose of the Research Database Map is to guide researchers in applying the requirements of the HIPAA Privacy Rule to any research database containing PHI.
 

Glossary of Lay Terminology
Informed consent documents must be written at a reading level that is understandable to someone with an eighth-grade level of education. The Glossary of Lay Terminology is designed to help investigators achieve that goal.

Investigator Response Template
The Investigator Response Template is available to help investigators organize and develop their responses to IRB decision letters.