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Clinical Research Support

Office for Human Research Studies (OHRS)

Consent Documents

CONSENT DOCUMENTS

 

You are responsible for using the most current version of our IRB forms posted on this website.   If you do not, and outdated forms are submitted to OHRS, it is possible that the submission will not be processed or reviewed by the SRC and/or IRB.  Please make sure to to ALWAYS download forms directly from this website.  Forms downloaded to your computer will not be the most recent version and will delay review.  Opening forms directly from the OHRS website before filling them out and submitting them to us will assure you have the most up-to-date form and will save both you and the OHRS time. 

SACHRP, Considerations and Recommendations Concerning Internet Research and Human Subjects Research Regulations, Final Document, approved at SACHRP meeting March 12-13, 2013, available at: http://www.hhs.gov/ohrp/sachrp/mtgings/2013%20March%20Mtg/internet_research.pdf 

Consent Templates

  • Biomedical Research  [Form] [Updates Log]
  • Social and Behavioral Research  [Form]  [Updates Log]
  • Continued Participation in a Research Study by a Young Adult Who Has Reached Age 18  [Form]  [Guidance]
  • Pregnant Partner Consent Form  [Form]
  • Screening Consent Form [Form]

Consent Form Language Resources


Consenting Non-English Speaking Subjects to Research Protocols

      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.