One of the many ways the Virginia Department of Health (VDH) serves the public and fulfills its mission is through research. VDH frequently conducts research that involves human subjects, and the protection of human subjects is as important as the methodology, research findings, or any other component of the research project.
VDH has developed policies and procedures to ensure that the rights and welfare of human subjects involved in research are protected and consistent with both
State (12 VAC 5-20-10) and
Federal (45 CFR Part 46) regulations. The Office for Human Research Protections (OHRP), under the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Health, is responsible for ensuring the safety and welfare of people who participate in HHS-sponsored research. Policies, guidelines, regulations and ethical principles from OHRP provided the framework for the development of the Virginia regulations, and provide the structure for VDH review and approval of human subjects research.
A major component of the process for ensuring the protection of the rights and welfare of human subjects involved in VDH research is the Institutional Review Board (IRB), also known as the Research Review Committee. Research protocols must be either approved or granted an exemption by the IRB before human subjects can begin participation. The IRB also conducts continuing review of each approved protocol at least annually. The IRB may modify, suspend or terminate approval of research that has been associated with serious harm to subjects or is not being conducted in accord with the IRB's decisions, stipulations, and requirements.
Below is a link to a presentation that will provide the answers to the most frequently asked questions, including why we have IRBs, what needs to be reviewed, what type of review is needed, the review process and criteria, and investigator responsibilities:
Determination of the Need for IRB Review and Types of Review
In general, any human subjects research that is conducted by VDH, by outside investigators in collaboration with VDH, or by outside investigators using VDH data, is subject to review and approval by the VDH Institutional Review Board. However, not all studies require IRB review. In brief, the decision-making process is divided into five key decision steps:
Step 1: Is the project considered research? Step 2: Does the project involve human subjects? Step 3: Does the project qualify for exemption review? Step 4: Does the project qualify for expedited review? Step 5: May informed consent and/or its documentation be waived or altered?
The following is a link to the Office for Human Research Protections (OHRP) decision charts developed to provide guidance for institutional review boards (IRBs), investigators and others on whether an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46:
There is frequently a gray area between public health practice and research. Although consensus has not yet been reached on this issue, the following report on public health practice vs. research by the Council of State and Territorial Epidemiologists (CSTE) is a good source for guidance:
The following is a link to a document that will provide you with guidance regarding obtaining VDH IRB Review:
VDH IRB Procedures coming soon
The following is a link to a document with checklists to provide you guidance regarding informed consent, documentation of informed consent, waivers and/or alterations of informed consent and special requirements for children:
Ongoing Responsibilities After VDH IRB Expedited or Full Board Approval
Reporting Adverse Events
Expected adverse events (those noted on the consent form) need not be reported to the VDH IRB on an individual basis.
At the time of continuation review the principal investigator should report the incidence of these adverse events.
If, in the course of conducting the study, the principal investigator finds that the expected adverse events are
occurring with a greater frequency or at a higher level of severity than expected, or if there is an occurrence of an
unanticipated adverse event, he/she should report this to the VDH IRB within 10 business days of when this finding is noted.
Also, the death of any study subject should be reported immediately to the VDH IRB. The only exception is when the study is
conducted among subjects who are expected to have a high rate of mortality from their underlying condition, and the investigator has
absolutely ruled out any connection between any study procedure and the subject's death. Adverse events should be reported emailing the completed
Adverse Event Form to firstname.lastname@example.org.
Reporting Modifications to the Approved Protocol
All modifications to currently approved research must have IRB review and approval prior to implementation. Minor modifications should be described to the Chair of the VDH IRB either via email or snail mail. Please reference both the Study # and Title of Protocol and where applicable, attach revised consent form, recruitment materials, etc. with changes or additions either highlighted or in bold font. A minor modification is defined as a change that (1) would not materially affect an assessment of the risks and benefits of the study or (2) does not substantially change the specific aims or design of the study. Examples of minor modifications include:
An increase or decrease in proposed human research subject enrollment
Changes to improve the clarity of statements or to correct typographical errors, provided that such changes do not alter the content or intent of the statement
A change in principal investigator or the addition or deletion of qualified investigators
The addition or the deletion of study sites
Reporting Modifications to the Approved Protocol
A major modification is defined as a change that materially affects an assessment of the risks and benefits of the study or substantially changes the specific aims or design of the study. Major modifications should be submitted to the Chair of the VDH IRB for review as if it were a new study.
The VDH IRB must conduct continuing review of protocols at intervals appropriate to the degree of risk, but not less than once per year. It is the investigator’s responsibility to ensure that the research is reviewed on or before expiration of the current approval period, even if the research activity did not begin until some time after the IRB gave its initial approval. As a courtesy, investigators will be sent a reminder by the VDH IRB approximately six weeks prior to the review due date. The Continuation Review Form must be received on/before the due date.
Reporting of Completion or Termination of Study
To close a study in the VDH IRB files, researchers must complete and submit Section I of the Continuation Review form and attach a brief (1–2 paragraph) study summary report. Materials should be received within 90 days of the conclusion of the research project.
The Collaborative IRB Training Initiative (CITI) offers online courses in human subjects protection for individuals conducting and reviewing research involving human subjects. These courses are available to all VDH investigators, key research personnel, IRB members, and IRB staff.
Accessing the CITI Courses
To access the CITI Courses in the Protection of Human Research Subjects, visit the site at: www.citiprogram.org. You will be asked to choose the course and enroll in a "Learner Group" that is compatible with your interests and training requirements. The program will automatically select the modules you are required to complete. Follow the instructions and links on the Learner's Menu to begin the course you selected. Use the "Add a Course or Update your Learner Group" link on the Learner's Menu to select or change groups.
PlainLanguage.gov – a website with tools and resources on Plain Language (also called Plain English) which is communication your audience can understand the first time they read or hear it – useful for both writing informed consent forms and for writing your protocols for IRB submissions!