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.
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:
- A statement that the study involves research and an explanation of the nature and purpose of the research;
- A description of the procedures to be used and the expected duration of the subject's participation;
- The expected duration and time commitment of the subject's participation;
- A statement describing the extent, if any, to which confidentiality of records identifying the subjects will be maintained;
- A statement that identifiers might be removed from identifiable private information or identifiable biospecimens and after such removal, the information or biospecimens could be used in future research without additional informed consent. OR, a statement that information or biospecimens, collected as part of this research, even if identifiers are removed, will not be used for future research studies.
- A description of any attendant discomforts and risks reasonable to be expected or (rarely) that there are no foreseeable risks;
- An explanation of any benefits to the subject or to society which may be reasonably expected from the research (note payment/class credit is not considered a benefit);
- An offer to answer any questions concerning the study;
- 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;
- An explanation of whom to contact for information about the research. Include the investigator's name, phone number, and email address;
- An explanation of whom (i.e. HSC) 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:
- The approximate numbers of subjects involved in the study;
- Any payment, reward or cost for participation and how payments or rewards will be prorated if the subject withdraws;
- If extra credit for a class is given, an explanation of the non-research alternative available to earn equivalent credit;
- Warning of UCSB’s mandatory child abuse reporting for studies through which the investigator might gain knowledge of child abuse;
- An instruction that either the investigator or subject may terminate the subject's participation at any time;
- For any study involving more than minimal risk 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;
- The disclosure of any alternative procedures, drugs or devices that might be advantageous to the subject; their relative risks & benefits;
- An explanation of any drug or device to be utilized, & any foreign substance to be administered;
- Identification of procedures, drugs, or devices that are experimental;
- A statement that the particular treatement or procedure may involve risks to the subject (or embyro or fetus if the subject is or may be pregnant) which are currently unforeseeable;
- Consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
- A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject;
- 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;
- 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;
- A statement whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions;
- For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing.