A test article means any drug including a biological product for human use , medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug and Cosmetic Act 21 CFR All rights reserved. Office of Research Ethics. Toggle menu Go to search page. Search Field. Contact iRIS Training. Research is:. Systematic Investigation Typically predetermined method for studying a specific topic, answering a specific question s , testing a specific hypothesis es , or developing theory.
Dissemination with the intent to influence behavior, practice, theory, future research designs, etc. FDA does not specify who this individual should be. Some sponsors and some IRBs require the clinical investigator to personally conduct the consent interview.
However, if someone other than the clinical investigator conducts the interview and obtains consent, this responsibility should be formally delegated by the clinical investigator and the person so delegated should have received appropriate training to perform this activity. How do you obtain informed consent from someone who speaks and understands English but cannot read? Illiterate persons who understand English may have the consent read to them and "make their mark," if appropriate under applicable state law.
The 21 CFR Clinical investigators should be cautious when enrolling subjects who may not truly understand what they have agreed to do. The IRB should consider illiterate persons as likely to be vulnerable to coercion and undue influence and should determine that appropriate additional safeguards are in place when enrollment of such persons is anticipated, see 21 CFR Must a witness observe the entire consent interview or only the signature of the subject?
FDA does not require the signature of a witness when the subject reads and is capable of understanding the consent document, as outlined in 21 CFR The intended purpose is to have the witness present during the entire consent interview and to attest to the accuracy of the presentation and the apparent understanding of the subject. If the intent of the regulation were only to attest to the validity of the subject's signature, witnessing would also be required when the subject reads the consent.
Although not required by the IND regulations, the sponsor provides a service to the clinical investigator and the IRB when it prepares suggested study-specific wording for the scientific and technical content of the consent document. However, the IRB has the responsibility and authority to determine the adequacy and appropriateness of all of the wording in the consent, see 21 CFR If an IRB insists on wording the sponsor cannot accept, the sponsor may decide not to conduct the study at that site.
For medical device studies that are conducted under an IDE, copies of all forms and informational materials to be provided to subjects to obtain informed consent must be submitted to FDA as part of the IDE, see 21 CFR For investigational devices, the informed consent is a required part of the IDE submission. When an IRB makes substantive changes in the document, FDA reapproval is required and the sponsor is necessarily involved in this process.
FDA regulations for other products do not specifically require the sponsor to review IRB approved consent documents. However, most sponsors do conduct such reviews to assure the wording is acceptable to the sponsor. The regulations generally require that the investigator obtain informed consent from subjects.
Investigators also may obtain informed consent from a legally authorized representative of the subject. FDA recognizes that a durable power of attorney might suffice as identifying a legally authorized representative under some state and local laws. For example, a subject might have designated an individual to provide consent with regard to health care decisions through a durable power of attorney and have specified that the individual also has the power to make decisions on entry into research.
FDA defers to state and local laws regarding who is a legally authorized representative. Therefore, the IRB should assure that the consent procedures comply with state and local laws, including assurance that the law applies to obtaining informed consent for subjects participating in research as well as for patients who require health care decisions. Alternatives 1 and 2 are provided for in the regulations and are appropriate.
Alternative 3 allows a designated individual to provide consent for a patient with regard to health care decisions and is appropriate when it specifically includes entry into research. FDA defers to state and local laws regarding substituted consent. Therefore, the IRB must assure itself that the substituted consent procedures comply with state and local law, including assurance the law applies to obtaining informed consent for subjects participating in research as well as for patients who require health care decisions.
Protocol amendments must receive IRB review and approval before they are implemented, unless an immediate change is necessary to eliminate an apparent hazard to the subjects 21 CFR Those subjects who are presently enrolled and actively participating in the study should be informed of the change if it might relate to the subjects' willingness to continue their participation in the study 21 CFR FDA does not require reconsenting of subjects that have completed their active participation in the study, or of subjects who are still actively participating when the change will not affect their participation, for example when the change will be implemented only for subsequently enrolled subjects.
The FDA requirements for informed consent are the minimum basic elements of informed consent that must be presented to a research subject [21 CFR An IRB may require inclusion of any additional information which it considers important to a subject's decision to participate in a research study [21 CFR Does FDA require the informed consent document to contain a space for assent by children?
No, however, many investigators and IRBs consider it standard practice to obtain the agreement of older children who can understand the circumstances before enrolling them in research. While the FDA regulations do not specifically address enrollment of children other than to include them as a class of vulnerable subjects , the basic requirement of 21 CFR Note: permission to enroll in research is not the same as permission to provide medical treatment.
IRBs generally require investigators to obtain the permission of one or both of the parents or guardian as appropriate and the assent of children who possess the intellectual and emotional ability to comprehend the concepts involved. Some IRBs require two documents, a fully detailed explanation for parents and older children to read and sign, and a shorter, simpler one for younger children.
The Subpart D regulations provide appropriate guidance for all other pediatric studies. Assent by children is addressed in subpart D. This interim final rule and its preamble are available at Additional Protections for Children.
As indicated above, researchers may seek assent of children of various ages. Signing a form to give their assent for research would not be perceived as unusual and would be reasonable. Younger children, however, may never have had the experience of signing a document. For these children requiring a signature may not be appropriate, and some other technique to verify assent could be used. For example, a third party may verify, by signature, that the assent of the child was obtained.
Informed consent of children who participate in clinical trials is addressed in subpart D. It does not specify whom to contact. The same person may be listed for all three. However, FDA and most IRBs believe it is better to name a knowledgeable person other than the clinical investigator as the contact for study subject rights. May the "compensation" for participation in a trial offered by a sponsor include a coupon good for a discount on the purchase price of the product once it has been approved for marketing?
This presumes, and inappropriately conveys to the subjects, a certainty of favorable outcome of the study and prompt approval for marketing. Also, if the product is approved, the coupon may financially coerce the subject to insist on that product, even though it may not be the most appropriate medically.
Must informed consent documents be translated into the written language native to study subjects who do not understand English? The signed informed consent document is the written record of the consent interview. Study subjects are given a copy of the consent to be used as a reference document to reinforce their understanding of the study and, if desired, to consult with their physician or family members about the study.
In order to meet the requirements of 21 CFR When the prospective subject is fluent in English, and the consent interview is conducted in English, the consent document should be in English. However, when the study subject population includes non-English speaking people so that the clinical investigator or the IRB anticipates that the consent interviews are likely to be conducted in a language other than English, the IRB should assure that a translated consent form is prepared and that the translation is accurate.
A consultant may be utilized to assure that the translation is correct. If the project does not meet the definition of research i. If the project meets the definitions of research i. Are Human Subjects Involved? A Human Subject is a living individual about whom an investigator conducting research obtains 1 data through intervention or interaction with the individual or 2 identifiable private information.
If the project does not meet the definition of research or the project does not include human subjects, as described above, then the project does not require IRB review.
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