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Protocol, Modification & Reporting Requirements

Types of IRB Submissions

  • Addenda or modifications. Changes cannot be made to approved studies, including the informed consent document, without prior IRB review and approval. The review may be full or expedited, depending on the magnitude of the change and the effect of the change on the risks/benefit ratio.
    • All addenda and modifications to a study need IRB approval before they are implemented. If the investigator wants to change anything in the research that would impact the subjects, such as recruitment procedures, key personnel, inclusion/exclusion criteria, research procedures, the informed consent document/process, or data elements collected; the investigator must obtain IRB review and approval prior to implementation of the changes. The only exceptions are changes necessary to immediately protect subjects' safety.
  • Reports regarding adverse events or anticipated problems involving risks to subjects or others, incident of noncompliance, deviations from an approved study protocol or terms of approval, and data safety and monitoring report summaries.
    • Federal reporting requirements for IRBs, investigators, and funding sponsors are confusing and contradictory. Consequently, IRBs tend to develop their own idiosyncratic reporting requirements, based upon their interpretation of both FDA and OHRP guidance. This poses some difficulty for investigators because if the project is funded, the sponsor may have reporting requirements that differ from the IRB policy and procedures.

At minimum, to ensure compliance, the investigator is responsible for:

  1. Determining the IRB requirements for reporting with respect to what needs to be reported, when it should be reported, and the procedure for submitting the report.
  2. Setting up systems to ensure that reportable events are identified and submitted to the IRB in a timely manner.

Please contact the IRB Chairperson to discuss such reports.

  • Additional reporting requirements: Besides the IRB, the Principal Investigator (PI) has a variety of entities to which he/she is responsible for reporting. Minimum reporting requirements for each are:

Entities & Requirements

Entities & Requirements Entity PI Reporting Requirements
Research Subject The informed consent process is a report to the potential subject about the research, both before the research begins and on an ongoing basis throughout the study.
Also, if new information becomes available during the research that might impact the subject's willingness to participate, then the investigator is obligated to provide the subject with that information. This information will also need to be reported to the IRB. The IRB office can provide guidance on how additional information should be reported.
Institution Review Iona College's reporting policy. The Investigator must report to the IRB and it falls upon the IRB to keep the institution informed. However, check the IRB to make sure that the investigator does not have direct responsibility for reporting incidents.
Sponsor Adverse events should be reported immediately to the sponsor. Investigators should also check with the sponsor about proposed changes that might be made to the study, based on the adverse event that has occurred or preliminary findings. The sponsor also should be told about serious or ongoing noncompliance in a study.
DSMB If the project has a Data Safety and Monitoring Board, review the reporting requirements.

Externally Funded Research

What other regulations and regulatory groups require compliance based on the type of research being conducted?

Depending upon the nature of the research and agency that funds the research, there are a number of other regulations, policies, and procedures that may need to be considered. Below is a brief description of selected regulations, regulatory bodies, and funding agencies that may oversee your research. Funding agencies and/or our local IRB office can also provide guidance on whether any additional requirements apply to a research activity.

Funding Agencies & Regulations
Funding Agencies & Regulations Funding Agency/Regulatory Agencies General Regulations
The Department of Health and Human Services DHHS)-is responsible for one group of human subjects' federal regulation
  • The DHHS 45 Code of Federal Regulations (CFR) Part 46 applies to all human subjects submitted to or funded by DHHS and is applied to all research by most large institutions. Subparts include:Subpart A: Basic Federal Policy for the Protection of Human Subjects
  • Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates involved in research
  • Subpart C: Additional Protections for Children
The National Institutes of Health (NIH)-include funding agencies that provide federal funding for biomedical research. NIH requires grantees conducting certain types of clinical research studies to have either data safety monitoring plans and/or data safety and monitoring boards. In general NIH policy requires that a Data and Safety Monitoring Board be established for all phase III randomized clinical trials.
  1. NIH Policy for Data and Safety Monitoring.
  2. Policy for the National Cancer Institute for Data and Safety Monitoring of Clinical Trials.
  3. Essential Elements of a Data and Safety Monitoring Plan for Clinical Trials funded by the National Cancer Institute.
  4. Further Guidance on Data and Safety Monitoring for Phase I and Phase II Trials.
The Office for Human Research Protections (OHRP)-is the DHHS oversight body that provides guidance to IRBs and investigators conducting human subject research. OHRP Policy and Assurances guidelines, regulations, ethical principles, IRB Guide Book, OHRP/OPRR Reports, FAQs, and other materials relevant to the protection of human research subjects are available from the OHRP website.
The Food and Drug Administration (FDA)-oversees the use of all drugs, devices, biologics, etc. including their use in research with human subjects. The FDA has numerous regulations directly impacting informed consent and regulations indirectly impacting IRBs and investigators.
International Conference on Harmonization/Good Clinical Practices Human subject research that is conducted in international settings may have additional requirements that must be met such as International Conference on Harmonization/Good Clinical Practices.
Department of Education Research that is funded by the Federal Department of Education may have additional requirements that must be met.
Department of Veterans Affairs Research involving human subjects recruited from or conducted in a Veterans Affairs facility must also meet the requirements as set forth in the VA Manual 1200.5
Other Federal Agencies Each federal agency may have additional policies, procedures, requirements, etc. that must be applied to research involving human subjects. Examples are the Dept. of Defense, Dept. of Energy, and National Science Foundation.

Assurance Requirements

If DHHS regulations apply to research being conducted at an institution, the institution must have an "Assurance" on file with the DHHS Office for Human Research Protections (OHRP). The Assurance outlines the institution's responsibilities for meeting the requirements for 45 CFR 46.103 and documents how the institution will protect the welfare and rights of research subjects based on federal regulations. The Assurance encompasses:

  • A statement of principles
  • Designation of IRBs
  • A list of members of the IRB
  • Written operating procedures for the human subject protection program
  • Training in human subject protections

Everyone on the research team has a responsibility to understand the written policies and procedures.

Contact the IRB Office to:

  • Ensure registration with OHRP if federal dollars are funding the research.
  • Obtain the Federal Wide Assurance (FWA) or Multiple Project Assurance (MPA) number. Alternatively, this information can be found on the OHRP website.
  • Determine FWA requirements for multi-site research activities.