Authors: Ann Hardy, DrPH, CIP and Sherry Mills, MD, MPH, Learn eCORE Investigators who conduct human subjects research generally want to advance scientific knowledge that will improve people’s lives. However, there may be situations in which an investigator’s professional…
Adverse Events Update
Adverse events can be tricky to navigate! We have made additions to our Investigator Handbook that give more detail on adverse events to help. Please see the below information on adverse events that is included in the handbook you receive…
What is Human Subjects Research?
National and international ethics codes form a framework for the protection of rights and welfare of human participants in research. These codes have developed over time in response to research misconduct. Examples include horrific experiments conducted on prisoners by Nazi…
Who are Solutions IRB’s Clients?
Solutions IRB works with a number of clients involved in social-behavioral and clinical/biomedical research. We assist a wide variety of researchers such as those who are independent, sponsors, and clinical investigators. Our highly qualified administrative and reviewer team assists researchers…
What is a Private IRB?
Private IRBs have no affiliation with specific clinical or academic institutions. They typically provide oversight into research studies that are not tied to an academic or clinical research facility, serve as a single reviewing body for studies operating across multiple…
Defining Research for IRB Review
While clinical studies typically require IRB review, it might not be as clear for a social- behavioral study. The following checklist of questions can assist a researcher in deciding whether or not an IRB review might be appropriate. Is the…
Prisoner Research and Full Board Reviews
The IRB has been asked in the past whether all studies involving prisoners and/or prisoner research require a full board review. As defined in CFR 46 Subpart C, prisoners are considered a vulnerable population. Given the fact that prisoners are…
Coercion and Undue Influence Risk in Criminal Justice Research
Coercion and undue influence are risks that must be considered when recruiting study participants that are involved with the criminal justice system. Prisoners are considered a vulnerable population per CFR 46 Subpart C. Prisoners that are subjects in research are…
Waiver of Documentation of Consent
It may be surprising, but not all research requires subjects to sign a consent form. Many types of research can be reasonably conducted without written consent documentation. Depending on the level of risk, and if the consent form would be…
Alteration of Consent
An alteration of consent is when the [IRB [. . . approves] a consent procedure that omits some or alters some or all of the elements of informed consent]. The IRB may grant alterations to your informed consent form if…
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