Clinical Research Support
Office for Human Research Studies (OHRS)
Consent Forms
Forms and Instructions | Quick Links |
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3) Consent Forms
Templates:
- Required Consent Form Template for Biomedical Research *REVISED*
- Required Consent Form Template for Social and Behavioral Research
- Consent Form for Continued Participation in a Research Study by a Young Adult Who Has Reached Age 18
- Guidelines for Obtaining Informed Consent
- Lay Terminology References
- Consent Form Log - Updates Made to Consent Form Template
Consenting Non-English Speaking Subjects to Research Protocols
- Instructions
- Translated Short Forms
Informed consent is one of the primary ethical requirements underpinning research with human subjects; it reflects the basic principle of respect for persons. It is too often forgotten that informed consent is an ongoing process, not a piece of paper or a discrete moment in time. Informed consent assures that prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate.
Clinicians and investigators have an ethical and legal obligation to obtain informed consent from an individual (or the appropriate surrogate) before enrolling him/her in a research trial.
The process of obtaining informed consent, unless waived by the IRB, must comply with the requirements of 45 CFR 46.116 and 21 CFR 50.20. The documentation of informed consent must comply with 45 CFR 46.117 and 21 CFR 50.27.
The IRB Recommends using the following guidelines:
- Drug Information Sheets - IRB approved language for commonly -used investigational and non-investigational agents.
- www.medterms.com
- www.cancer.gov/dictionary
- Quality Assurance Office for Clinical Trials (QACT)
- Clinical Research Unit (CRU)
- Clinical Trials Education Office (CTEO)
- Protocol Review and Monitoring System (PRMS)
