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Informed Consent

 

Informed consent is a process and should always be obtained unless the IRB specifically approves a request to waive the requirement to obtain informed consent of research participants. For information on when a waiver of documentation or consent may be appropriate, visit the Waiver of Consent or Documentation page.

In certain instances, a Waiver of Consent may require participants to be debriefed at the conclusion of their participation in the research. Visit the Forms page for tips on writing a debrief and a sample debrief form.

For useful tips on writing consent forms, visit the Writing a Consent Form page.  Visit the Forms page for a sample consent form.

 

Basic Elements of Informed Consent

In seeking informed consent from a potential human subject or their representative, a researcher must provide the participants with the following basic elements of informed consent:

  1. A statement that the study involves research and an explanation of the nature and purpose of the research;
  2. A description of the procedures to be followed, and identification of any procedures which are experimental;
  3. The expected duration and time commitment of the subject's participation;
  4. A statement describing the extent, if any, to which confidentiality of records identifying the subjects will be maintained;
  5. A description of any foreseeable risks or discomforts to the subjects;
  6. A description of any benefits to the subject or to others which may be reasonably expected from the research;
  7. An offer to answer any questions concerning the study;
  8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss or benefits to which the subjects is otherwise entitled;
  9. An explanation of whom to contact for information about the research;
  10. An explanation of whom to contact for information about research subjects' rights.

Additional Elements of Informed Consent

Whenever appropriate, one or more of the following elements of information may also be required to be provided to the subjects:

  1. Any payment or reward for participation and how it will be prorated if the subject withdraws;
  2. If extra credit for a class is given, an explanation of the non-research alternative available to earn equivalent credit;
  3. Warning of UCSB’s mandatory child abuse reporting for studies through which the investigator might gain knowledge of child abuse;
  4. An instruction that either the investigator or subject may terminate the subject's participation at any time;
  5. For any study which may result in physical injury, include the following standard language: If you are injured as a direct result of research procedures, you will receive reasonably necessary medical treatment at no cost. The University of California does not provide any other form of compensation for injury;
  6. The disclosure of any alternative procedures, drugs or devices that might be advantageous to the subject; their relative risks & benefits;
  7. An explanation of any drug or device to be utilized, & any foreign substance to be administered;
  8. Identification of procedures, drugs, or devices that are experimental;
  9. For any study which may result monetary gain for the researcher, add the following statement: The study investigator has a financial interest in this research and may benefit monetarily from this study. You may ask your investigator for more information on his or her interest;
  10. If samples will be taken for research and development purposes not related to the subject’s treatment or condition, include the following standard language: Samples taken during this study may be used for research and development purposes not related to your treatment or condition. You will not have any property rights or ownership interest in products or data which may be derived from your samples;
  11. The approximate numbers of subjects involved in the study.
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