Consent Procedures

Consent Purpose

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.

Consent Process and Procedures

The following procedures should occur during the informed consent process (45 CFR 46.116):

The prospective subject is given adequate information to make an informed decision about participating in the proposed study.
The nature and expectations of the research including risks and benefits are explained to the subject.
The study is presented in a language that is clear and understandable.
The subject receives answers to questions that they may have about the study.
The study is explained in an appropriate setting and with enough time conducive to good decision-making.
The prospective subject comprehends the information and can make a choice about whether they want to participate.
The prospective subject understands that he/she retains the right to refuse or withdraw from the study at any time without penalty.
The prospective subject and/or the parent or guardian is given copies of the approved consent form(s).
The subject (or the parent/guardian when relevant) is provided with a copy of the Research Participant’s Bill of Rights to sign when the research involves medical experimentation.
Additionally, the researcher must retain the signed copies of the consent document and the Research Participant’s Bill of Rights (when applicable) for three years.

Components of Basic Informed Consent

The following information must be included in informed consent documentation unless an alteration of basic informed consent is requested and approved:

Title of the research project.
The name, status (faculty or staff) and department of all researchers involved in the study.
A statement that the study is research.
An explanation of the purpose of the research.
An explanation of the expected duration of the subject's participation.
The approximate number of subjects involved in the study.
A description of any reasonably foreseeable risks or discomforts to the subject.
A description of any benefits to the subject or to others which may reasonably be expected from the research.
A statement describing the extent to which confidentiality of records identifying the subject will be secured during the research and destroyed or maintained after the research is over.
A description of experimental procedures, or a statement that no experimental procedures are involved.
A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
An explanation of whom to contact (study personnel and CPHS) for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
A signature line, printed name line, and date line for the subject and researcher obtaining consent.

AND for research involving more than minimal risk:

An explanation as to whether compensation is available if injury occurs, or a statement that no compensation is available if injury occurs.
1. If compensation is available when injury occurs, an explanation as to what it consists of or where further information may be obtained.
An explanation as to whether any medical or mental health treatments are available if injury occurs, or a statement that no medical or mental health treatments are available if injury occurs.
1. If medical or mental health treatments are available when injury occurs, an explanation as to what it consists of or where further information may be obtained.

AND when appropriate:

A statement that notes the possibility that the FDA may inspect the records.
A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
Any additional costs to the subject that may result from participation in the research.
Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
The 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.

Alternative Consent Procedures

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:

The research presents less than Minimal Risk of harm to subjects; AND
Involves no procedures for which written consent is normally required outside of the research context.

The only record linking the subject and the research would be the consent document; AND
The principal risk would be potential harm resulting from a breach of confidentiality; AND
Each subject will be asked whether they want documentation linking them with the research, and the subject's wishes will govern.

46.116 (c) or (d) may apply when other or additional alterations or eliminations to informed consent are requested and the researcher documents:

The research presents less than Minimal Risk the subjects; AND
The waiver or alteration will not adversely affect the rights and welfare of the subjects; AND
The research could not practicably be carried out without the waiver or alteration; AND
Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; AND
The research could not practicably be carried out without the waiver or alteration.

Structure of a Consent Form

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:

The consent should be written in 6th to 8th grade reading level avoiding technical jargon.
The consent document should be written in the second person (using the "you" pronoun).
Legible font size is used based on population targeted (12 point minimum). Note: Protocols requiring HIPAA authorization must use 14 point.
Use of clear paragraph/section headings to allow the potential subject ease of access to specific study information.
Double spacing is used between paragraphs.
Additional information about accessibility can be found at Accessibility at CSUMB (https://csumb.edu/ati).

Obtaining Parental Permission (45 CFR 46.408)

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.

Obtaining Assent/Dissent from Minors (45 CFR 46.408)

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.

Disclosing a Financial Interest to Subjects

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).

Documentation of Informed Consent (45 CFR 46.117)

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.

Waiving Requirement to Document Consent (45 CFR 46.117(c))

The CPHS may waive the requirement for the researcher to obtain a signed consent form for some or all subjects if it finds either:

That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. If this is the case, the researcher will ask the subject whether he/she wants to sign the document that links him/her to the research. The subject's wishes for documentation will dictate whether or not a signed consent form is needed; or,
That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

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.

Signature of Project Representative

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.

Short Form Written Consent (46.117(b)(2))

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."

Consent Translation

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.

Special Considerations

Obtaining Consent of Non-English Speaking Persons

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.

Obtaining Consent from Visually Impaired Persons

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.

Obtaining Consent from Cognitively Impaired Persons

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.

Deception or Incomplete Disclosure

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.

Debriefing

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.

Sample Consent Forms

Consent and assent sample documents are located on the CPHS main website.

Obtaining Consent in Exempt (Level I) Research

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:

Identify who is conducting the study including institutional affiliation and academic status.
Describe why the study is being conducted.
State who is being recruited and why they have been chosen.
Explain what each participant will be asked to do and estimate how long it will take to complete the task.
Emphasize that participation is voluntary.
Clarify whether participant's information will be anonymous (no identifiers) or confidential. If confidential, indicate whether any information linked to the individual's identity will be used.
Describe incentives/compensation offered or costs that may be incurred.
Provide a department number and point of contact for telephone inquiries. Include the CPHS telephone number for questions related to their rights as a participant in research.

Consent Forms with Collaborating Institutions

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.