Institutional Review Board (IRB)
Frequently Asked Questions
A case report is an activity that does not meet the DHHS definition of “research” and therefore does not require IRB review. However, all case reports prepared for publication must be prepared in accordance with the requirements of the HIPAA privacy regulations. Any use or disclosure of PHI must be authorized by the patient, or, or if the patient is deceased, the patient’s family. Publication of PHI is disclosure of PHI.
This is the IRB reviewer’s checklist and includes the elements that the IRB will be evaluating during the review process.
42 CFR, Chapter 1, Chapter 11, Subchapter A: This part applies to the responsible party for an applicable clinical trial that is required to be registered under § 11.22, a clinical trial for which clinical trial registration information or clinical trial results information is submitted voluntarily in accordance with § 11.60, or an applicable clinical trial that is required by the Director to have clinical trial information submitted to protect the public health under § 11.62.
OHRP has published a variety of guidance documents to assist the research community in conducting ethical research that is in compliance with the HHS regulations. On this page, OHRP guidance documents are organized in categories that should be intuitive for members of the research community. In addition, all guidance documents can be accessed through an alphabetical list.
The FDA also has a resource page for clinical trials and human subject protection.
Investigators are expected to be knowledgeable about the requirements of the HHS regulations, applicable state law, their institution’s Assurance, and institutional policies and procedures for the protection of human subjects.
Investigators are responsible for:
- Conducting their research according to the IRB-approved protocol and complying with all IRB determinations at each site;
- Obtaining and documenting the informed consent of each subject or each subject’s legally authorized representative, unless the IRB has waived these requirements;
- Ensuring that each potential subject understands the nature of the research and participation;
- Ensuring that each person involved in the research follows all protocols;
- Providing a copy of the IRB-approved informed consent document to each subject or the subject’s legally authorized representative at the time of consent, unless the IRB has specifically waived this requirement (all signed consent documents are to be retained for at least 3 years after the completion of the research and according to institutional policy);
- Promptly reporting proposed changes in previously approved human subject research activities to the IRB (the proposed changes may not be initiated without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subjects);
- Reporting progress of approved research to the IRB as often as, and in the manner, prescribed by the IRB; and
- Promptly reporting to the IRB any unanticipated problems involving risks to subjects or others or any serious or continuing non-compliance with the HHS regulations or determination of the IRB.
- Promptly providing the final closure report to the IRB at the conclusion of the project.
Common Rule: Common Rule (45 CFR Part 46 of the Code of Federal Regulations)
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.
Federal Food and Drug Administration: Federal Food and Drug Administration
Regulates clinical investigations involving food, drugs, medical devices, and biological products for human use. (21 CFR Parts 50 & 56)
Good Clinical Practices (GCP)
Good Clinical Practices (GCP) refers to the regulations and requirements that must be complied with while conducting a clinical study. These regulations apply to the manufacturers, sponsors, clinical investigators, institutional review boards, and the medical device. The primary regulations that govern the conduct of clinical studies are included in the Code of Federal Regulations, Title 21 (21 CFR):
- 21 CFR 812, Investigational Device Exemptions, covers the procedures for the conduct of clinical studies with medical devices including application, responsibilities of sponsors and investigators, labeling, records, and reports.
- 21 CFR 50, Protection of Human Subjects, provides the requirements and general elements of informed consent;
- 21 CFR 56, Institutional Review Boards, covers the procedures and responsibilities for institutional review boards (IRBs) that approve clinical investigations protocols;
- 21 CFR 54, Financial Disclosure by Clinical Investigators, covers the disclosure of financial compensation to clinical investigators which is part of FDA’s assessment of the reliability of the clinical data.
- 21 CFR 820 Subpart C, Design Controls of the Quality System Regulation, provides the requirement for procedures to control the design of the device in order to ensure that the specified design requirements are met.
HIPAA Privacy Rule: Privacy Rule of the Health Insurance Portability and Accountability Act (45 CFR Part 160)
Provides protections for personal health information by designating that it may not be released for research purposes unless the patient has signed an authorization or an IRB has approved a waiver of a signed patient authorization.
California Civil Code: California Information Practices Act, Civil Code, Section 1798.24 (SB-13)
Requires review and approval before personal information (linkable to any individual) that is held by any state agency or department can be released for research purposes.
Protection of Human Subjects in Medical Experimentation Act: Sections 24170-24179.5
State law regarding the rights of human subjects participating in medical experiments. This includes: the “Experimental Subject’s Bill of Rights,” required elements of informed consent, and consent by surrogate decision makers.
Research Involving Prisoners:
Section 3500 provides definitions of biomedical and behavioral research.
Sections 3501-3509.5 delineate general provisions and prohibitions for conducting research with prisoners.
Sections 3515-3520 delineate administrative requirements with regard to research with prisoners.
Sections 3521-3523 delineate prisoners’ rights when participating in research, including informed consent.
Section 3524 addresses prisoners’ legal remedies for injuries incurred while participating in research.