|IRB Policies and Procedures||Policies and procedures document|
|Human Subjects Policy||All PIs and associates for a research protocol must show evidence that they have had human subjects research training|
|Protocol Review Cover Sheet||Use as a cover sheet for the IRB application|
Initial application to IRB for review of the research protocol
and approval form to accompany request
|Continuing Protocol Review Request||Application for IRB review of a continuing research protocol|
|Request for Amendment/Modification to Protocol||Application to amend/modify a previously approved protocol.|
|HIPPA||Participant form for Health Insurance Portability and Accountability Act (HIPAA) compliance|
||Consent Form template for protocols and Instruction page for Consent Form.|
|Adverse Event Reporting Form||PIease use this form to report adverse events to the IRB and the RIO|
|Media-Release-Form||New Media Release Form|
|Sample Protocol||Sample Protocol for your review.|
Training for Human Subjects Researchers
All PIs and associates for a research protocol must show evidence that they have had human subjects research training. This training should be updated every 5 years. On-line training is available at http://phrp.nihtraining.com/users/login.php and also through CITI.
The U.S Department of Health and Human Services’ Office of Human Research Protections has a webpage dedicated to frequently asked questions and answers on consent. The page is designed to serve as a resource in the areas of Assurance Process, IRB Registration Process, 45 CFR 46, Research with Children, Investigator Responsibilities, Prisoner Research, and Consent. Users can find answers, ask questions, and provide feedback on a variety of human research issues. Visit the site at www.hhs.gov/ohrp
Review of some protocols may be expedited. The Board may expedite experiments that involve no more than minimal risk to the subjects and involve human subjects only in the following categories:
- Collection of: hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth if patient care indicates a need for extraction.
- Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed a delivery, and amniotic fluid at the time of rupture of membrane prior to or during delivery.
- Recording of data from subjects 18 years of age or older using non-invasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter of significant amount of energy into the subject or an invasion of the subject’s privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves).
- Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.
- Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.
- Voice recordings made for research purposes such as investigations of speech defects.
- Moderate exercise by health volunteers.
- The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
- Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the research investigator does not manipulate subjects’ behavior and the research will not involve stress to subjects.
- Research on drugs or devices which an investigational new drug exemption is not required.
- Any other category specifically added to this list by DHHS and published in the Federal Register.
Exemption from Board Review
Some protocols may be exempt from IRB review. All protocols (even those determined to be exempt) must be reviewed by the IRB Chair. While the decision to exempt is the discretion of the IRB Chair, these categories are provided as a guideline for PIs who may wish to request exemption. Note that these exemption categories do not apply to research involving prisoners, fetuses, or pregnant women.
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular or special education instructional strategies, or (b) research on the effectiveness or the comparison among instruction techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (b) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
- This exemption category for research involving survey or interview procedures or observation of public behavior does not apply to research with children, except for research involving observations of public behavior when the investigator does not participate in the activities being observed.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) if: (a) the human subjects are elected or appointed public officials or candidates for public office; or (b) the research is conducted for the Department of Justice under Federal statute 42 U.S.C. 3789g, or for the National Center for Education Statistics under Federal statue 20 U.S.C. 12213-1, which provide certain legal protections and requirements for confidentiality.
- Research involving the collection or study of existing data, documents, records, pathological or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies, if (a) wholesome foods without additives are consumed or (b) a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the U.S. Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.