Non-English Speaking Persons

Obtaining the informed consent for participation in research is perhaps the most fundamental ethical obligation in conducting human subjects research. It is one of the most important means by which individuals are able express their choice as to what will and will not happen to them and act in a manner consistent with their own, personal goals and values.

The Belmont Report identifies 3 key components to the consent process.

• Information: The prospective participant must be provided with sufficient information to allow them to make a considered choice whether, or not, they wish to participate in the research. The revised Common Rule specifies that the prospective participant “must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.” (45 CFR 46.116(a)(4))
• Comprehension: The information provided to the individual must be able to be understood by that person. There are many potential barriers to adequate comprehension. One important one, and the focus of this guidance, is the language in which the information is provided to the individual. Delivering information about research in a language that the individual is not able to understand does not meet the ethical obligation of respect for persons nor the regulatory requirement that “The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative. (45 CFR 46 (a)(3). (21 CFR 50.20)
• Voluntariness: Valid informed consent requires that the decision to participate be made voluntarily. Situations that present the possibility of coercion or undue influence may lead individuals to make decisions that are not truly consistent with their goals and values, and that might differ if they were presented with the choice in the absence of such pressures.

The need for individuals participating in research to have a full understanding of the trial is also important to ensure safety. The safety of the participant requires them to have an awareness and understanding of the potential adverse events they may experience so that they may take appropriate actions and report them to the investigator. The written informed consent document serves as an important reference document, providing study participants with information as to what to expect, and what do and whom to contact in certain situations. Many participants refer to this document throughout the trial as a source of important information.

When participants have limited English proficiency, their rights, welfare and safety may be compromised if the full consent form is not provided in their native language.

Both HHS and FDA regulations allow for consent to be documented using a process referred to as the “short form” process. (45 CFR 46.117(b)(2)) (21 CFR 50.27)(b)(2)). Typically, the short form has only generic headers that correspond to each of the required elements of consent, with no information about the actual study in which the person is enrolling. Given the ethical and regulatory requirements for obtaining valid informed consent and ensuring the safety of subjects, in many if not most cases, the short form process falls short.

The short form process is intended only for the unanticipated or unexpected enrollment of non-English speaking individuals when there is no IRB approved translated full consent document, and when it is clearly in the participant’s best interest to enroll prior to obtaining a translated consent. Given the known inadequacies of the short form process, the expectation has always been that use of the short form would be infrequent.

When the short form process must be used, the limitations of this process can be mitigated in part by translating the consent promptly after enrollment and providing it to the individual that was consented using the short form. Recent FDA guidance on informed consent indicates that this is an expectation of the FDA any time a short form consent process is used.

Unanticipated enrollment means that the study team could not have reasonably known that they might enroll a person that doesn’t speak English. The Washington DC metropolitan area is home to a substantial population of non-English speaking persons, with Spanish being a common first (and only) language for many. At NIH, we frequently enroll persons from all over the world that speak a diverse array of languages. Study teams should prospectively consider whether it is likely that they will encounter persons who are not native English speakers and consider prospectively translating consent documents.

This does not mean that study teams are obligated at the initiation of any study to translate the consent document into every possible language that might be encountered. Typically, at the time a clinic appointment is made, the study team will be aware that a potential participant does not speak English and that an interpreter is needed. At this time, the study team should have the informed consent translated into the language of that person. The prospective participant’s appointment may need to be delayed to obtain the translated document, unless it is clearly in the prospective participant’s best interest to not delay and proceed with enrollment using the short form process.

If there are modifications to the consent document that might affect the willingness of a participant to remain in the study, and the IRB has determined that reconsent is required, non-English speaking persons must be provided this information in their own language. In some cases, this may be accomplished by creating a translated consent addendum that addresses the changes, and providing this addendum to the non-English speaking participant, rather than incurring the expense of translating the entire document. However, if the changes are extensive, it may be that the full modified consent document must be translated. Consult with the IRB Office for guidance.

Policy 301 applies to all research conducted by NIH investigators, whether or not the NIH IRB is the reviewing IRB. In other words, NIH researchers must follow this policy even if the reviewing IRBs is an external (non-NIH) IRB and that IRBs policies do not require translation. NIH investigators must report short form use to the NIH IRB, even if the reviewing IRBs policies do not require reporting.

This guideline does not apply to non-NIH sites for which the NIH IRB is the reviewing IRB. The non-NIH sites should follow their institutional policies for translation.

If you need a short form in a language that is not available on this website, you must get a translation of the appropriate English short form version. You can use the NIH Library as a resource for obtaining this translation. After you receive the translation, submit the translated short form and the certificate of accuracy to the IRB via PROTECT using the Modification form. Once approved, we will post the newly translated version(s) on this website for future use by the NIH Intramural Research Program (IRP) research community.