The Office for Human Research Protections (OHRP) states that “informed consent is one of the primary requirements underpinning research with human subjects; it reflects the basic principle of respect for persons." Informed consent is the knowing consent of an individual or his/her legally authorized representative, which is obtained without undue inducement or element of force or coercion. Obtaining informed consent does not end with a signature on a piece of paper. It is a process in which the subject receives enough information about a study to make a decision about participation in the research. The subject should have up-to-date information about the requirements of the study during all phases of participation. The process involves reading, understanding and signing an informed consent document as well as discussing the details of study participation with a knowledgeable member of the research team.
The following procedures should occur during the informed consent process (45 CFR 46.116):
The following information must be included in informed consent documentation unless an alteration of basic informed consent is requested and approved:
AND for research involving more than minimal risk:
AND when appropriate:
The CPHS may approve a consent procedure which alters or eliminates any or all elements of basic consent. 46.117 (c) may apply when only the subject's signature and identifying information is eliminated from informed consent and the researcher documents:
OR
46.116 (c) or (d) may apply when other or additional alterations or eliminations to informed consent are requested and the researcher documents:
OR
The following points must be followed to ensure that the subject understands the nature and purpose of the research in which they are being asked to participate:
Parental permission is required when recruiting children or minors as subjects in research. In California, a minor is identified as a person under the age of 18 years. Parental permission must be obtained in advance of enrolling a minor subject into a study.
The Informed Consent format is used when developing a Parental Permission form. Text should reflect the activities that the child (and the parent, if they are also considered a subject) will be asked to participate in as a research subject. If the consent form is being developed to obtain parental permission only, the signature line is labeled "Parent or Guardian of Minor Child." The child subject's name is also printed to indicate the child for whom they are giving permission.
Assent is demonstrated by a child's agreement to participate in research. In California, a child is a person who is under the age of 18 years (unless legally emancipated). It is required that the researcher makes adequate provisions to solicit assent from children unless the CPHS waives this requirement.
To determine whether the child is able to assent really depends on the child's age, maturity and psychological state of the children involved. The CPHS has the discretion to judge children’s capacity to assent for all of the children involved in a proposed research activity or on an individual basis.
For research activities involving adolescents whose capacity to understand is similar to that of adults, the assent procedure should reflect information similar to what would be provided for informed consent by adults or for parental permission. For children whose age and maturity level limits their ability to fully comprehend the nature of the research activity but who are still capable of being consulted about participation in research, it is more appropriate to focus on conveying an accurate picture of what the actual experience of participation in research is likely to be (for example, what the experience will be, how long it will take, whether it might involve any pain or discomfort). The assent procedure should reflect a reasonable effort to enable the child to understand, to the degree they are capable, what their participation in research would involve.
If the child is considered to be capable of providing assent, whether or not assent is documented is also determined by the CPHS. If the parent gives permission for the child to participate and the child assents to participate, then he/she may be enrolled in the study.
It is generally recognized that a research researcher has an ethical responsibility to disclose a possible conflict of interest to potential research subjects as part of the consent process. The CPHS asks researchers to provide information within the protocol to indicate whether they or any other person responsible for the design, conduct, or reporting of this research has an economic interest in, or acts as an officer or a director of any outside entity whose financial interests would reasonably appear to be affected by, the research. If the researcher reports a financial interest with the study sponsor and the conflict can be managed, it is expected that the consent form will adequately inform subjects of the relationship as well as procedures used to minimize the effect the relationship may have on the study. (http://aspe.hhs.gov/sp/coi/refs.htm).
In most cases, informed consent is documented by the use of a written consent form approved by the CPHS and signed by the subject or the subject's legally authorized representative.
Unless the CPHS has authorized revisions to the consent procedure, the consent form must include all elements identified within the CPHS-approved consent template. The CPHS-approved consent form may be read to the subject or to the subject's legally authorized representative in addition to allowing the potential subject an opportunity to review the consent document and ask questions before signing the consent document.
The CPHS may waive the requirement for the researcher to obtain a signed consent form for some or all subjects if it finds either:
If the CPHS approves waiving the requirement for documenting consent, the researcher may be required to provide the subject with a written statement regarding the research.
The project representative (lead researcher, study coordinator or designated project representative) also signs the consent to verify that the consent process is complete. When obtaining consent, the setting and timing of explaining the research must be conducive to good decision-making. The project representative should see that everything is done to enhance the prospective subjects’ comprehension of the information and their ability to make a choice. The person signing as the project representative should be knowledgeable about the study, able to present information using easily understood terminology, and one who can identify and resolve any remaining questions.
The regulations also allow for consent to be documented by signing a "short form" that states only that the required elements of informed consent have been presented orally to the subject or the subject's legally authorized representative. When this method is used, the CPHS will approve a written description of the consent statement that is orally presented to the prospective subject. In addition, a witness to the oral presentation is required. Following the oral presentation, the prospective subject/legal representative will sign the "short form" if he/she decides to participate in the research. The witness verifies the consent process by also signing the "short form" and the consent statement that is presented orally to the subject. A copy of the consent statement is then given to the subject or the representative, in addition to a copy of the signed "short form."
Both DHHS regulations (45 CFR 46.116) and FDA regulations (21 CFR 50.20) require that informed consent be obtained in language understandable to the subject (or the subject's legally authorized representative), and documented in writing (46.117 and 50.27, respectively). Non-English speaking subjects must be presented with and sign a consent form that is written in their primary language. The researcher must provide the CPHS with a language appropriate translated consent document for review and approval prior to recruiting subjects. It is recommended that the researcher secure CPHS-approval of the English consent document prior to translating the consent form. The CPHS does not require that a certified translator perform the document translation. However, the CPHS does not verify the accuracy of the translated consent document and the researcher must provide assurance to the CPHS that the consent or assent form has been adequately translated. The CPHS recommends that the researcher either hire a certified translator or verify the translation using a back-translation procedure. Translation of a document to Spanish using the back-translation method involves translation of the English document to a Spanish version. The Spanish version of the document is then translated back to English by another bilingual individual. The original English version is then compared to the English version of the Spanish-translated document for accuracy. If the two documents are comparable, the translation would be considered adequate.
The consent document must be written in a language that is understandable to the subject and presented to the potential subject by a person who is fluent in the individual’s language. The researcher must document proficiency (fluency in the appropriate language(s)) by the individual obtaining consent from subjects and the research personnel responsible for informing subjects on an ongoing basis throughout the course of the research. See preceding section for more detail.
The consent document must be written in a font size that is legible to the subject and presented to the potential subject by a person who is capable of interpreting the content if the subject has visual impairment. See preceding section for more detail.
If participants are identified as being cognitively impaired, it may be necessary to include additional procedures during the consent process to ensure that the prospective subject understands the information presented about the study. Consider including questions at the end of each section of the consent document to use in assessing participant comprehension of the consent content. This mechanism allows for the researcher to clarify the participant's understanding of specific aspects of the study as the consent process occurs (e.g., After the Description of the Study section, include the following questions: Do you understand what will happen during the testing phase? The training phase?).
Internet Research
For the purposes of the CPHS, internet research is categorized as either: Research about the internet and users of the internet, or, research using the internet as a tool to conduct otherwise routine research. Internet research, in either category, may be subject to increased scrutiny for potential harm resulting from a breach of subject’s confidentiality (whether by accident or unauthorized). The CPHS must carefully examine the probability of occurrence and determine if the magnitude of impact should a breach occur in order to assess Minimal Risk. Informed consent information should explain added risks associated with privacy violations and strategies developed to reduce the risk of privacy loss or breech of confidentiality.
In studies involving deception or incomplete disclosure, information about the details of the study hypothesis or research question to subjects may be abbreviated or withheld during the consent process. However, subjects should be provided with enough general information about the study or experiment to understand and make an informed decision about whether or not they want to complete the study tasks or expose themselves to potential risks involved in study participation. Subjects should be debriefed about the true nature and purpose of the study after their participation has ended.
In behavioral research involving deception, the CPHS requires that subjects be debriefed after their participation. The debriefing statement should be presented both orally and in writing. Debriefing procedures should include a written statement that will be summarized and then given to subjects to take home to read in more detail if they choose. Along with a description of the deception involved and an explanation about the true purpose of the research, include a statement to inform subjects of their right to withdraw their data from the study and still receive course credit if they feel upset or uncomfortable with the deception involved. Referral information should also be provided to the subject should participation in this study raise personal concerns that he/she would like to discuss with a clinical professional.
Consent and assent sample documents are located on the CPHS main website.
A signed consent is generally not required for Exempt (Level I) research. The researcher will provide adequate information about the research to potential subjects so that an informed decision can be made. The researcher can deliver this information verbally or both verbally and in writing. The appropriate mode of delivery will depend on administration procedures. The consent statement will include the information needed for a participant to make a decision regarding participation. The statement will be written in a language easily understood by the target audience.
When applying for CPHS review, submit the text to be used to obtain informed consent. Include the following information:
Researchers who have a joint appointment (e.g., joint doctoral students) may be required to obtain CPHS approval from all institutions with which they are affiliated. The CPHS encourages researchers to work with each institution's CPHS toward developing a consent document that meets with requirements of both institutions. This is preferred to having two or more approved consent documents that are used to document informed consent from each subject.