HRPP policies & procedures manual
700: Informed consent
This policy describes the general requirements for obtaining informed consent and documentation of consent.
Informed consent must be legally effective and prospectively obtained. Except as described in Section 701, no investigator may involve a human being as a research subject unless he or she has obtained legally effective informed consent of the subject or the subject’s legally authorized representative. Consent shall be sought only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.
The informed consent of a subject is a privilege freely granted by a subject. He or she is under no obligation to participate no matter how worthy the research objectives. Furthermore, while obtaining the signature of a subject is an event, obtaining consent is a process that leads to the signature and that is to be continued throughout the project as may be required by respect for persons.
The IRB requires documentation of informed consent by use of a written informed consent form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative. In studies involving children, the legally authorized representative is the parent or court-appointed guardian.
2.1 Legally authorized representative (LAR)
In studies involving cognitively impaired adults, the legally authorized representative is a designated proxy (such as a durable power of attorney for health care), court-appointed guardian, or next-of-kin, in that order. For a more detailed explanation on LAR see section 502 of this manual.
3. Specific policies
3.1 Informed consent document
A written consent document is one that embodies the elements of informed consent described in 21 CFR 50.25 and 45 CFR 46.116(a). This form may be read to the subject or the subject’s legally authorized representative; but, in any event, the investigator shall give either the subject or the representative adequate opportunity to read and reflect upon it before it is signed.
The subject or the subject’s legally authorized representative signs and dates the consent document. The subject must be given a copy of the signed form.
3.2 Required and additional elements of informed consent
The IRB reviewers will use the informed consent checklist when reviewing informed documents to ensure that the consent contains the required elements and additional elements, if appropriate.
General guidance for informed consent
Information must be presented to enable persons to voluntarily decide whether to participate as a research subject. The language and process used in obtaining informed consent should be culturally appropriate and use language the subjects can understand. Informed consent language and its documentation must be written in “lay language”, (i.e. understandable to the people being asked to participate). Generally, a 6th-8th grade reading level is appropriate for average adults.
Consent documents are more understandable if they are written just as the investigator would give an oral explanation to the subject, that is, the subject is addressed as “you” and the investigator as “I/we.” This second person writing style also helps to communicate that there is a choice to be made by the prospective subject. Use of the first person may be interpreted as presumption of subject consent, i.e., the subject has no choice. Also, the tone of the first person “I understand” style seems to misplace emphasis on legal statements rather than on explanatory wording enhancing the subject’s comprehension. In this manual, the word “subject” is used to refer to the people who will take part in the study. Depending on the nature of the research, the word “participant” may be more applicable. Generally, one term or the other is used consistently throughout the consent according to the investigator’s preference and the research purposes.
Required elements for informed consent
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, the number of subjects and identification of any procedures which are experimental;
- 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 disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
- For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
- An explanation of whom to contact 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; and
- 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.
Additional informed consent requirements for FDA-regulated clinical investigations
- The informed consent must include notice that FDA personnel may review any and all documents related to the research, including subject medical records, in either a directed or routine audit of the investigator, the institution, or the IRB.
- Under new 21 CFR 50.25(c), the following statement must be reproduced word-for-word in informed consent documents for applicable clinical trials:
“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”
- 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.
- Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent.
- Any additional costs to the subject that may result from participation in the research.
- 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.
WSU elements on the informed consent form (ICF)
- Study title and name(s) of researcher(s) at the beginning of the consent form.
- A statement that the study has been approved for human subject participation by the Washington State University Institutional Review Board.
- Consent document written at a reading and comprehension level appropriate for the age and/or background of the subject (6th-8th grade for most).
- The language and its documentation (especially explanation of purpose, duration, experimental procedures, alternatives, risks, and benefits) written in “lay language,” (i.e. understandable to the people being asked to participate).
- Signature block including subject, researcher(s), witness if appropriate, and date of signature.
- When appropriate, check box or signature provided to indicate agreement to audio or videotape is included.
- A statement that the subject will receive a copy of the consent form, if appropriate.
- Consent form free of exculpatory language through which the subject is made to waive, or appear to waive, any of the subject’s legal rights.
- Payment or compensation to research subjects should not be considered a benefit, but a recruitment incentive. The compensation should not be such that it would be considered coercive or unduly influence subjects to enroll into a study or stay in a study. All information concerning the compensation, including the amount and schedule of payments, should be included in the consent document. The compensation should not be contingent upon completion of the study, but should be prorated.
- If compensation is class extra-credit, an alternative means of obtaining extra credit must be made available to the students who wish not to volunteer as research subjects. The alternative means of obtaining extra credit needs to be comparable in time and effort.
- The WSU controller’s office requires that a gift card log should be kept.
3.4 Translations of consent documents into a foreign language
Translations of consent documents will also be submitted for IRB approval. There are two options available to obtain approval of translated consent forms.
Option #1: The IRB-approved consent form is translated by the sponsor or site and submitted to the IRB. The IRB will have a member or consultant fluent in the language of the consent review the translated document for accuracy. In his/her opinion it must match the English version. If the IRB does not have a consultant available, the investigator will need to obtain and pay for translation services.
Option #2: The investigator (or sponsor) may submit the IRB-approved version of the consent to an IRB-approved, certified translator. A second translator may then back translate the consent to the original English. Both original and back-translated consent must be submitted.
3.5 Observation of the informed consent process
The IRB may observe the informed consent process in ongoing research, when appropriate. As part of the IRB oversight options, an IRB may require that a staff member, IRB member, post-approval reviewer, or outside third party observe the consenting of research subjects to determine whether the informed consent process has been appropriately completed and documented.
An IRB may require that selected protocols have one or more informed consent process situations be observed. IRB considerations used to choose such protocols include:
- High risk studies.
- Studies that involve particularly complicated procedures or interventions.
- Studies involving vulnerable populations.
- Studies involving study staff with minimal experience in administrating consent to potential study subjects.
- Other situations when the IRB has concerns that the consent process is not proceeding well.
3.6 Withdrawal from a clinical trial
The IRB considers the following issues regarding data retention when subjects withdraw from a clinical trial:
- When a subject withdraws from a study, the data collected on the subject to the point of withdrawal remains part of the study database and may not be removed. The consent document cannot give the subject the option of having data removed.
- A research may ask a subject who is withdrawing whether the subject wished to provide continued follow-up and further data collection subsequent to their withdrawal from the interventional portion of the study. Under this circumstance, the discussion with the subject would distinguish between study-related interventions and continued follow-up of associated clinical outcome information, such as medical course or laboratory results obtained through noninvasive chart review, and address the maintenance of privacy and confidentiality of the subject’s information.
- The researcher must obtain the subjects’ informed consent for this limited participation in the study (assuming such a situation was not described in the original informed consent form). The IRB must approve the consent document.
- If a subject withdraws from the interventional portion of a study and does not consent to continued follow-up of associated clinical outcome information, the researcher must not access, for purposes related to the study, the subject’s medical record or other confidential records requiring the subject’s consent. However, a researcher may review study data related to the subjects collected prior to the subject’s withdrawal from the study, and may consult public records, such as those establishing survival status.
4. Applicable regulations and guidelines
6. Procedures employed to implement this policy & assignment of responsibility
|Primary, secondary and tertiary reviewers||Review proposed informed consent forms and confirm that all required elements are present and the consent includes the six (6) additional elements, if appropriate.|
|IRB coordinator||If elements are missing, return consent document to investigator with request for revision and suggested language (where appropriate).|