With very few exceptions research protocols must include a consent procedure. That is, the opportunity for subjects to make a fully informed decision whether or not to participate in the research. Describe the consent procedures to be followed, involving how and where informed consent will be obtained. Informed consent is an on-going process, not just the securing of a signature. Subjects should always have the opportunity to ask questions and express concerns to investigators about their participation in the research. Also, a statement of significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation should be provided to the subject. All subjects should be given a copy of their signed consent form when possible. Include the appropriate number of copies of your consent form with this application. (See Table 4, p.18 of UCRIHS Instructions).
Written consent forms are usually required. However, under certain circumstances, (e.g., when using questionnaires to collect data), investigators may incorporate the elements of consent into a letter or instruction sheet accompanying a data-collection instrument. (See Table 3, item 9, p. 15 of UCRIHS Instructions)
Occasionally, informed consent may be obtained orally in situations where written consent is deemed inappropriate or culturally disrespectful. In all cases the IRB must review, in advance, the language that will be used to obtain oral informed consent. Researchers proposing to obtain informed consent orally must include a script of the oral consent language with their UCRIHS application. Oral informed consent should include all the elements of informed consent. (see Table 3 pp. 15-17 of UCRIHS Instructions) including contact information for the investigator and the IRB. Unless it increases risk, that contact information should be given to the subjects in writing. Investigators should keep a log documenting the oral consent process throughout the duration of the study.
"Passive" or "negative" consent language is not permissible under University and federal policies protecting human subjects of research. Passive consent is a practice of informing potential subjects that they will be included unless they explicitly object to their inclusion.
The practice of "passive" consent may be widely used and may be legally appropriate for some purposes. However, it is impermissible under the regulations protecting human subjects for the following reason.
With few exceptions "Informed consent" is required by the regulations protecting human subjects. Informed consent means that the subjects or their legal guardians must have sufficient information to understand the nature of the research to knowledgeably and voluntarily decide whether or not to participate. They may need to ask questions of the researchers to gain this information. It is the investigator’s responsibility to assure that the subjects or their parents/guardians have provided informed consent. Therefore, affirmative consent is required, usually as a signature on the consent form, although under certain circumstances UCRIHS does permit oral consent.
Subject’s Withdrawal of Consent
A request by any subject to withdraw his/her consent and to discontinue participation in the investigation shall be honored promptly and unconditionally. Investigators may not withhold benefits to subjects that they would be otherwise entitled to (e.g., other extra credit opportunities for students, or medical/psychological care for patients that would be normally available). Ordinarily, subjects may not prohibit researchers from using the data provided while they were participating voluntarily in the project.
If enrolled subjects are not fluent in English, translations of the consent form into the subject’s primary language(s) must be reviewed and approved by UCRIHS before these subjects can be enrolled. It is solely the responsibility of the Investigator to ensure that any translation is error free. An English version of the consent should also be submitted with the translated consent.
Under the following conditions (per 45 CFR 46.116 (d)), an IRB may waive the requirements for consent:
(1) the research involves no more than minimal risk to the subjects; and
(2) the waiver or alteration will not adversely affect the rights and welfare of the subjects: and
(3) the research could not practicably be carried out without the waiver or alteration; and
(4) whenever appropriate, the subjects will be provided with additional pertinent information after
participation.
These conditions may apply, for example, to the use of existing data but all the conditions have to be met for the IRB to grant a waiver.