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Guidelines :: Section III
Part A: Institutional Compliance
Part B: Investigator Compliance
Part A: Institutional Compliance
As stated in the introduction to this manual, most federal agencies have adopted a common law that requires that all universities and other organizations that receive federal funding to support research involving human participants establish procedures that will ensure compliance with the Federal Policy for the Protection of Human Subjects. Compliance with this law, known as the Common Rule, are described in the Code of Federal Regulations at 45 CFR 46, is monitored by the Office for Human Research Protections (OHRP), of the Department of Health and Human Services (DHHS).
These regulations, at 45CFR46.103, specify that each institution engaged in human subjects research supported by DHHS obtain an assurance of compliance approved by OHRP. In the past, institutions were required to obtain either a Multiple Project Assurance (MPA), Single Project Assurance (SPA), or a Cooperative Project Assurance (CPA) for federally supported research. These assurances have now been replaced by a single FederalWide Assurance (FWA), which NDSU obtained on May 1, 2002. The terms of this assurance specify the responsibilities and procedures that will be used to protect human research participants. NDSU has also elected to apply 45CFR46, and all Subparts, to all such research, regardless of source of support.
U. S. Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP)
FEDERALWIDE ASSURANCE OF PROTECTION FOR HUMAN SUBJECTS
A. TERMS OF THE FEDERALWIDE ASSURANCE FOR INSTITUTIONS WITHIN THE UNITED STATES
1. Human Subject Research Must be Guided by Ethical Principles
All of the Institution's human subject activities and all activities of the Institutional Review Boards (IRBs) designated under the Assurance, regardless of funding source, will be guided by the ethical principles in: (a) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, or (b) other appropriate ethical standards recognized by Federal Departments and Agencies that have adopted the Federal Policy for the Protection of Human Subjects.
2. Applicability
These terms apply whenever the Institution becomes engaged in federally-supported* (i.e., conducted or supported) human subject research, which is not otherwise exempt from the Federal Policy for the Protection of Human Subjects**. The Institution becomes so engaged whenever (a) the Institution's employees or agents intervene or interact with human subjects for purposes of federally-supported research**; (b) the Institution's employees or agents obtain individually identifiable private information about human subjects for purposes of federally-supported** research; or (c) the Institution receives a direct federal** award to conduct human subject research, even where all activities involving human subjects are carried out by a subcontractor or collaborator.
[*Federally-supported is defined throughout the FWA and the Terms of Assurance as the U.S. Government providing any funding or other support (including, but not limited to, providing supplies, products, drugs, and identifiable private information collected for research purposes) and/or the conduct of the research involves U.S. Government employees.]
(**NDSU has elected to apply 45 CFR 46 to ALL human subject research, regardless of source of support)
3. Compliance with the Federal Policy for the Protection of Human Subjects
Institutions conducting federally-supported human subject research and the IRB(s) designated under the Institution's Assurance will comply with the Federal Policy for the Protection of Human Subjects, known as the Common Rule. All federally-supported** human subject research will also comply with any additional human subject regulations and policies of the supporting Department or Agency. All human subject research conducted or supported by the Department of Health and Human Services (DHHS) will comply with all Subparts of DHHS regulations at Title 45 Code of Federal Regulations Part 46 (45 CFR 46 and its Subparts A, B, C, and D).
The reference in the Code of Federal Regulations is shown below for each Agency which has adopted the Common Rule:
| 7CFR 1c | Department of Agriculture |
| 10 CFR 745 | Department of Energy |
| 14 CFR 123 | National Aeronautics and Space Administration |
| 15 CFR 27 | Department of Commerce |
| 16 CFR 1028 | Consumer Product Safety Commission |
| 22 CFR 225 | Agency for International Development |
| 24 CFR 60 | Department of Housing and Urban Development |
| 28 CFR 46 | Department of Justice |
| 32 CFR 219 | Department of Defense |
| 34 CFR 97 | Department of Education |
| 38 CFR 16 | Department of Veterans Affairs |
| 40 CFR 26 | Environmental Protection Agency |
| 45 CFR 46 | Department of Health & Human Services |
| 45 CFR 690 | National Science Foundation |
| 49 CFR 11 | Department of Energy |
| By Executive Order | Central Intelligence Agency |
| By Statue | Social Security Administration |
4. Written Procedures
(a) The Institution should establish, and should provide a copy to OHRP upon request, written procedures for:
(1) ensuring prompt reporting to the IRB, appropriate institutional officials, the relevant Department or Agency Head, any applicable regulatory body, and OHRP of any: (i) unanticipated problems involving risks to subjects or others, (ii) serious or continuing noncompliance with the Federal Regulations or IRB requirements, and (iii) suspension or termination of IRB approval.
(2) Verifying, by a qualified person or persons other than the investigator or research team, whether proposed human subject research activities qualify for exemption from the requirements of the Common Rule;
(b) The designated IRB(s) has established, and will provide a copy to OHRP upon request, written procedures for:
(1) Conducting IRB initial and continuing review (not less than once per year), approving research, and reporting IRB findings to the investigator and the Institution;
(2) Determining which projects require review more often than annually and which projects need verification from sources other than the investigator that no material changes have occurred since the previous IRB review;
(3) Ensuring that changes in approved research protocols are reported promptly and are not initiated without IRB review and approval, except when necessary to eliminate apparent immediate hazards to the subject.
5. Responsibilities and Scope of IRB(s)
Except for research exempted or waived in accordance with Sections 101(b) or 101(i) of the Common Rule, all human subject research will be reviewed, prospectively approved, and subject to continuing oversight and review at least annually by the designated IRB(s). The IRB(s) will have authority to approve, require modifications in, or disapprove the covered human subject research.
6. Informed Consent Requirements
Except for research exempted or waived in accordance with Sections 101(b) or 101(i) of the Common Rule, informed consent will be:
(a) sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by Section 116 of the Common Rule;
(b) appropriately documented, in accordance with, and to the extent required by Section 117 of the Common Rule.
7. Requirement for Assurances for Collaborating Institutions/Investigators
The Institution is responsible for ensuring that all institutions and investigators engaged in its U.S. federally-supported** human subject research operate under an appropriate OHRP or other federally-approved Assurance for the protection of human subjects. In some cases, one institution may operate under an Assurance issued to another institution with the approval of the supporting Department or Agency and the institution holding the Assurance.
8. Written Agreements with Non-Affiliated Investigators
The engagement in human research activities of each independent investigator who is not an employee or agent of the Institution may be covered under the FWA only in accordance with a formal, written agreement of commitment to relevant human subject protection policies and IRB oversight. OHRP's sample Unaffiliated Investigator Agreement may be used or adapted for this purpose, or the Institution may develop its own commitment agreement. Institutions must maintain commitment agreements on file and provide copies to OHRP upon request.
9. Institutional Support for the IRB(s)
The Institution will provide the IRB(s) that it operates with resources and professional and support staff sufficient to carry out their responsibilities under the Assurance effectively.
10. Compliance with the Terms of Assurance
The Institution accepts and will follow items 1-9 above and is responsible for ensuring that (a) the IRB(s) designated under the Assurance agree to comply with these terms; and (b) the IRB(s) possesses appropriate knowledge of the local research context for all research covered under the Assurance (please refer to the OHRP guidance on IRB Knowledge of Local Research Context on the OHRP website).
Any designation under this Assurance of another Institution's IRB or an independent IRB must be documented by a written agreement between the Institution and the IRB organization outlining their relationship and include a commitment that the designated IRB will adhere to the requirements of this Assurance. OHRP's sample IRB Authorization Agreement may be used for such purpose or the two organizations may develop their own agreement. This agreement should be kept on file at both organizations and made available to OHRP upon request.
11. Assurance Training
The OHRP Assurance Training Modules describe the major responsibilities of the Institutional Signatory Official, the Human Protection Administrator, and the IRB Chair(s) that must be fulfilled under the Assurance. OHRP strongly recommends that the Institutional Signatory Official, the Human Protections Administrator (e.g., Human Subjects Administrator or Human Subjects Contact Person), and the IRB Chair(s) personally complete the relevant OHRP Assurance Training Modules, or comparable training that includes the content of these modules, prior to submitting the Assurance.
12. Educational Training
OHRP strongly recommends that the Institution and the designated IRB(s) establish educational training and oversight mechanisms (appropriate to the nature and volume of its research) to ensure that research investigators, IRB members and staff, and other appropriate personnel maintain continuing knowledge of, and comply with, relevant ethical principles, relevant Federal Regulations, OHRP guidance, other applicable guidance, state and local laws, and institutional policies for the protection of human subjects. Furthermore, OHRP recommends that a) IRB members and staff complete relevant educational training before reviewing human subject research; and b) research investigators complete appropriate institutional educational training before conducting human subject research.
13. Renewal of Assurance
All information provided under this Assurance must be updated at least every 36 months (3 years), even if no changes have occurred, in order to maintain an active Assurance. Failure to update this information may result in restriction, suspension, or termination of the Institution's FWA for the protection of human subjects.
Part B: Investigator Compliance
NDSU IRB policy includes the minimum guidelines described in 45 CFR 46 (Appendix B). In addition, NDSU IRB policy requires that ALL research involving human participants, without regard to funding status, must comply with NDSU and federal regulations.
Persons conducting research involving human participants have an ethical, as well as professional, obligation to ensure the safety, protection, and rights of participants. It is the intent of NDSU, through the IRB and the Office of the Vice President for Research, Creative Activities and Technology Transfer, to assist investigators engaged in human subject research to conduct their research along ethical guidelines reflecting professional as well as community standards. In addition, the university has an obligation to ensure that ALL research involving human subjects meets the regulations established by the United States Code of Federal Regulations (CFR). It is not the intent of the university, the IRB, or the Office of the Vice President for Research, Creative Activities and Technology Transfer, to interfere in any way with the competent, ethical, and sound research involving human participants. However, there exists an obligation and a requirement for all parties involved to ensure that the University and its personnel are in compliance with the regulations governing human participant research. It is important for us all to observe the "spirit" as well as the "letter" of these regulations, since how we conduct research involving human participants reflects on our professional, personal, and community commitments to rigorous ethical and scientific standards of conduct.
Toward these ends, investigators must be in compliance with NDSU IRB policies and procedures regarding research involving human participants.
1. NON-COMPLIANCE/COMPLAINTS PROCEDURES
Federal regulations require the IRB to report instances of serious or continuing noncompliance, as well as for-cause suspensions or terminations of IRB approval to the appropriate institutional officials, and federal oversight agencies (ie, OHRP, FDA):
45CFR46.103(b)(5). Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of (i) any unanticipated problems involving risks to subjects or others or any serious or continuing non-compliance with this policy or the requirements or determinations of the IRB and (ii) any suspension or termination of IRB approval.
45CFR46.113. Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head.
21CFR56.113. Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the Food and Drug Administration.
Examples of complaints would include, but are not limited to: verbal or written complaints from subjects in research, or reports that the investigator is not following the protocol as approved by the IRB. Examples of non-compliance would include, but are not limited to: failure to follow IRB policies and procedures, failure of the investigator to report required or requested information to the IRB, human subjects research conducted by NDSU investigators without IRB approval, or certification of exempt status, failure to report adverse events or proposed protocol changes to the IRB, whistleblower information, or audit reports from federal agencies regarding an investigator or a study.
When an allegation or information regarding potential noncompliance or a complaint is received by the IRB, additional information may be requested from the investigator, or other study personnel. A determination will be made by the IRB Director, IRB Chair, IRB members, and/or the Institutional Official whether or not suspension of the study is warranted. This decision will be based on preliminary information and the seriousness of the situation. For non-compliance involving human subjects research conducted without IRB approval, the research must be terminated immediately, and any data generated will not be usable in a publication or presentation listing NDSU as an affiliation.
Suspension not merited: If the non-compliance or complaint is minor and did not result in unanticipated problems involving risk to subjects or others, suspension is not necessary, and the issue will be resolved between the investigator, IRB Chair, and IRB Director and appropriately documented and reported to the IRB members.
Suspension is merited: If the non-compliance or complaint results in suspension of the study, a notice of the suspension will be sent to the principle investigator, co-investigators, department chair, funding agency (as applicable), the Office of Sponsored Programs Administration, and the Vice President for Research, Creative Activities & Technology Transfer. The IRB will then meet with the investigator to determine if the non-compliance is serious or continuing. An audit of the study records may be required to gather additional information and make the determination. Grant funds allocated to the research project may be frozen.
Non-serious and Non-continuing: If the incident is isolated and appears to be a miscommunication or misunderstanding of a non-serious and non-continuing nature, the incident will remain internal. A letter to the investigator from the IRB office will describe a summary of the audit, and any corrective actions to be taken; the study suspension will be lifted.
Serious or Continuing: If the audit indicates noncompliance that is serious or continuing, the Office of Human Research Protections (OHRP) (and the Food and Drug Administration, as applicable) will be notified within 48 hours. The initial letter will describe the incident, preliminary steps, and an indication of the time frame for full audit and full report to follow, including corrective actions for the specific incident as well as for the research program in general to ensure incidents will not occur again.
In order to determine that all substantive and relevant changes in protocol and/or consent documents are being reported, and in order to verify compliance with IRB regulations, the IRB shall have the authority to physically inspect and/or audit any research premises or review non-confidential research documents relating to the protocol and procedures being used in human participant experimentation. Generally, the investigator will be asked to provide copies of relevant and necessary documents for IRB review. Such document requests are in addition to that generated in the project progress/completion report. In most cases, this will only occur when there is an indication that a substantive change is in effect which has not been reported, or that unforeseen risks to participants are present or alleged.
Failure to comply with such an IRB request for information may result in suspension or termination of IRB approval of research.
There are no formal appeal procedures associated with IRB review. The IRB is not a judicial body, but a review board embodied to consider and uphold the rights, welfare, and protection of human participants in research. IRB approval for research that has been suspended or terminated can be reinstated with a demonstration that the protocol/project complies with IRB and federal policies. Similarly, a disapproved project need only be altered such that it can secure approval. An appeal process assumes that the decision of an IRB can be overturned by another group. An IRB ruling is not subject to appeal nor can it be overturned by another group. Only the IRB can alter its previous determination.
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