The University of South Alabama IRB follows numerous regulations set by federal agencies to ensure the protection of participants in human subjects research. These include:
The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing
of human subjects involved in research conducted or supported by the U.S. Department
of Health and Human Services (HHS). OHRP is part of the Office of the Assistant Secretary
for Health in the Office of the Secretary of HHS.
OHRP provides clarification and guidance, develops educational programs and materials,
maintains regulatory oversight, and provides advice on ethical and regulatory issues
in biomedical and behavioral research. OHRP also supports the Secretary’s Advisory
Committee on Human Research Protections (SACHRP), which advises the HHS Secretary
on issues related to protecting human subjects in research.
Title 45 CFR 46: Protection of Human Subjects
Policy guidance and documents
Inclusion of Children - Policy Implementation (NIH)
Certificates of Confidentiality
OHRP Frequently Asked Questions
Informed Consent (guidance)
21 CFR Part 50 - Protection of Human Subjects
21 CFR Part 56 - Institutional Review Boards
21 CFR Part 312 - Investigational New Drug Applications (INDs)
21 CFR Part 812 - Investigational Device Exemptions (IDEs)
Significant Risk and Nonsignificant Risk Medical Device Studies
FDA Guidance FAQs on Form 1572
Summary of Investigator Responsibilities
IRB Frequently Asked Questions
Clinical Trials and Human Subject Protections - Guidance, resources, good clinical practices (GCPs)
Good Clinical Practice (GCP) - International Conference on Harmonisation (ICH)
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its regulations, including the Privacy Rule and the Security Rule, as well as the Health Information Technology for Economic and Clinical Health (HITECH) Act, govern the way certain health information is collected, maintained, used, and disclosed. The Privacy Rule establishes a set of safeguards on certain types of health information known as protected health information, or PHI. HIPAA is designed to protect individual’s privacy and to inform patients and research participants how their health information is used and disclosed. See list of 18 PHI identifiers.
HIPAA requires specified language in the informed consent for the collection, use and/or disclosure of PHI for research. The HIPAA Subject Authorization template below includes University specific language which must be included in the Confidentiality Section of the Informed Consent form in order to comply with HIPAA requirements.
Databases containing protected health information (PHI) used for research purpose are impacted by the HIPAA Privacy Rule. The Privacy Rule regulations cover the use of databases containing PHI just as they apply to any other research using PHI.
Faculty, fellows, staff, and students conducting human subjects research involving Protected Health Information (PHI) are required to complete the USA HIPAA Research tutorial. Training must be completed before participating in human subjects research involving PHI.
There are four ways to perform HIPAA compliant research. They are:
Reviews Preparatory to Research Certain activities involving the use/disclosure of PHI are permitted without Authorization. The “preparatory to research” provision allows researchers to use PHI for limited purposes, such as a feasibility assessment (e.g., whether a sufficient population exists to conduct research). However, the Privacy Rule does not permit the researcher to remove PHI. To comply with HIPAA Privacy Rule and human subjects regulations, researchers are permitted to review PHI, but identifiers may not be recorded. To conduct a review preparatory to research, a researcher must provide CERTIFY all of the following representations:
INVESTIGATOR’S ACCESS PREPARATORY TO RESEARCH
The Privacy Rule provides protections to living and deceased individuals. To use decedents’ PHI for research purposes, a researcher must CERTIFY all of the following:
Note: If the participant population contains both living and deceased individuals, the requirements for Authorization (or waiver or alteration) apply.
RESEARCH INVOLVING DECEASED INDIVIDUALS
HIPAA compliant research documents include:
Intentional releases of research data outside USA must be made clear in the research study documents submitted for IRB approval. Such releases should be described within the authorization portion of the informed consent. Upon IRB approval, then such releases are permitted. Disclosures for studies involving de-identified information of a limited data set are also permitted.
For additional information, please contact the Office of Research Compliance and Integrity at (251) 460-6625 or email dlayton@southalabama.edu
The Family Educational Rights and Privacy Act (FERPA) is a federal law that protects the privacy of student education records. The law applies to all schools that receive funds under an applicable program of the U.S. Department of Education.
The Protection of Pupil Rights Amendment (PPRA) is a federal law that sets forth additional requirements in elementary and/or secondary public schools when certain activities are conducted (e.g., survey, analysis, physical examinations) or if funded by the Department of Education (e.g., survey, analysis, or evaluation).
International Compilation of Human Research Protections (OHRP) - listing laws, regulations, and guidelines on human subjects research in over 100 countries and standards from international and regional organizations.
