Under the pre-2018 Common Rule regulation (45 CFR 46), unless the research qualified for specific exemptions, prospective consent from the potential subject for recording of their identifiable private information being obtained for recruitment was required, unless waived by the IRB.   For protocols subject to the revised (2018) Common Rule only, an IRB may approve certain screening or recruitment activities, or activities to determine eligibility, prior to obtaining informed consent.  These include:

• Obtaining information through oral or written communication with the prospective subject, OR
• Obtaining identifiable private information of identifiable biospecimens by accessing records or stored identifiable biospecimens.

In this event, the PI does not need to request a waiver of consent, but these activities that will occur prior to obtaining informed consent must be clearly described in the IRB approved protocol.  The solicited information should be limited to the minimum necessary for screening, or to determine study eligibility.

For minimal risk research being conducted remotely, the IRB may approve a web-based consent form or approve waiver of documentation of consent with no requirement for oral consent.  When a research study is subject to the Privacy Act, (i.e., will collect identifiable private information about a subject), the prospective subject must be provided with written Privacy Act notification. If an investigator wishes to conduct an oral consent process and receive a waiver of documentation of consent, they must still at least offer to provide the Privacy Act notification in writing. A description of the plan should be included in the consent section of the protocol. When the subject will not be registered as a patient at Clinical Center, please refer to the section labeled Privacy Language for Studies Conducted Outside ofthe Clinical Center in the  Consent Library. The Consent Library can be accessed on the OHSRP webpage titled Consent Templates and Guidance.

If the protocol will include use of a remote consent procedure (e.g., by phone or videoconferencing), the process must be described in the protocol, and IRB approval must be obtained. Otherwise, if the plan to use the remote consent process is only temporary and for a few subjects (e.g., due to the pandemic), a single patient planned deviation request form may be submitted rather than a protocol amendment. If the investigator will be conducting such a process via telehealth, use only an approved synchronous video platform that meets required NIH security and privacy standards. For additional information, please refer to Policy 303 Intramural Program Telehealth Requirements which can be found here. 

The subject should be provided with the consent form in advance of the consent conversation.  After the consent process has been conducted and the investigator has responded to the subject’s questions, the subject signs the consent form noting the current date. The investigator documents the process in CRIS/medical record (or the research record if there is no medical record) in real time on the day of the consent conversation. When the signed/dated consent form is returned to the investigator who conducted the consent discussion, the investigator signs and dates the consent form with the date s/he received the signed the consent from the subject.  The investigator should then record another note in CRIS/research record indicating the updated status and send a copy to medical records (or research record if there is no medical record) and provide a copy of the completed consent form to the subject. The date that the subject signs the consent form is considered their “date on study.” If, after the subject has signed the consent form, specimens and/or data are collected locally for research purposes, no analyses of these specimens and/or data may occur until the investigator has verified that the subject has returned a signed and dated informed consent document, unless the IRB has granted a waiver of documentation of consent.  

NIH investigators should document the consent process in the subject’s record, and describe the method used for communication with the subject and the specific means by which the subject communicated agreement to participate in the study (e.g., their verbal response and signing of the informed consent document).  Additional FAQs related to documentation of consent in CRIS are available at this internal  link.

The short form consent process is used when the subject is unable to read the long form version of the consent due to a language barrier. An interpreter is utilized for subjects who are unable to understand the language in which the long form consent is written.

Whenever possible, a professional interpreter, who is in-person, should be used or, alternatively, a professional interpreter can be utilized via a telephone interpretation service. Use of a family member for interpretation is not permitted unless a professional medical interpreter cannot be located.  The reasons for using a family member and the attempts made to locate a professional interpreter must be documented in the research record. Family members may not have adequate medical knowledge and are not trained as professional medical interpreters.  Additionally, family members may not be impartial or may try to speak for the subject which can limit the subject’s decision-making process. (Also see Question 20 for more information about when an investigator may server as the interpreter.)

 When the subject speaks and understands English but is illiterate or blind, the English long form should be used to obtain consent from the subject. The short form consent document should not be used. The subject may use assistive technology (such as screen readers for sight-impaired individuals) to read the consent, or the consent form should be read to the subject. There must be a witness to the entire oral presentation of the consent. The witness then signs the witness line on the English long form consent. See the screenshot below. Subjects who are unable to sign their name can make their mark on the signature line. (e.g., They may make an “X,” or provide a fingerprint.) The consent notes in Clinical Records Information System (CRIS) or the research record should document the process and include a statement that there was a witness to the entire consent process and any special circumstances regarding documentation of consent.

When conducting the consent process with a subject for whom no written language exists, the process is similar to that used with a blind or illiterate subject.  There should be an oral presentation of the English long-form consent by the interpreter.  There must be a witness (who can be the interpreter if they are willing to act as the witness) at the location of the investigator, who is present during the entire oral presentation.  The subject must sign or make their mark on the consent, and the investigator and witness both sign the consent. The administrative block for interpreters must be completed, and there must be a note in CRIS or the research record documenting the consent process used in this circumstance.

Even though the subject is illiterate or blind, written documentation of consent is still required, unless waived by the IRB.  This is a requirement of the regulations and in addition, it is respectful of the participant.  They may want to share the consent form with family members or health care providers who can read the consent form written in the subject’s language. Alternatively, they may have access to assistive technology (e.g., screen reader) that can “read” the consent form to them in the language they understand.  When conducting the consent process in this situation, there must be a witness who is present during the entire oral presentation. The witness can be the interpreter if they are willing to act as the witness. Interpreters scheduled by the CC Language Interpreter Program (LIP) must sign as the witness(See FAQ #12 below.) 

The English long form consent is used as the basis for discussion, whether or not there is a translated long form. The investigator obtaining consent reads the consent in English and the interpreter orally interprets the English words of the investigator and will facilitate the question-and-answer phase of the informed consent process between the non-English speaking potential subject and the investigator.  The interpreter’s role is to facilitate verbal discussions between parties that do not speak the same language.  Having the subject know what is in the translated long form, even if they are illiterate or blind, is optimal because the required information about the study is contained in the consent form.

If there is a translated long form consent in the subject’s language, the subject, the investigator obtaining consent, and the witness sign the translated long form consent.  Subjects who are unable to sign their name can make their mark on the signature line. (e.g., They may make an “X,” or provide a fingerprint.  The administrative block for interpreters must be completed.  The subject is provided with a copy of the signed translated long form that is in their language.

If there is no translated long form in the language of the subject, the English long form consent is used as the basis for discussion, and the short form process is used.  In this case, the subject and witness sign the short form consent that is written in the subject’s language (or, if applicable, the subject makes their mark as noted above), and the investigator obtaining consent and the witness sign the English long form consent. The administrative block for interpreters must be completed. The subject is provided with copies of both the signed English long form and  translated short form consents.

If there is no translated long form or short form in the language of the subject, the subject cannot be enrolled until the consent form (preferably the long form consent, but at the least, the short form consent document) is translated into the language of the subject and submitted to the IRB along with the certificate of translation and is approved by the IRB prior to use.

In all cases, the consent note in Clinical Records Information System (CRIS), or the research record should document the process and include a statement that there was a witness to the entire consent process and any special circumstances regarding documentation of consent.

While the above scenarios provide an acceptable path to document informed consent, OHSRP expects investigators to carefully consider whether it is appropriate to enroll an individual in the study in the situations described above.  In particular, enrolling an illiterate non-English speaking person when the only document we can provide is the translated short form, which they cannot read without assistance, provides that person with no study specific information to use for future reference.  The challenges with effective and meaningful communication to assure there is adequate understanding of the risks of the study and the requirements of study participation will continue to be present throughout the study.  In such circumstances, investigators must be able to justify that the potential benefits outweigh the risks for that individual participant.

For the English long form consent: the investigator obtaining consent and the witness sign the English long form consent document. The interpreter may also act as the witness.

Alt Text: Image title is English long form consent.  Image shows the signature page of the English long form consent.  There is an arrow pointing to the Signature of Investigator line.  The arrow text indicates that the Investigator obtaining consent needs to sign on this line.  Image then shows the signature page of the English long form consent.  There is an arrow pointing to the Signature of Witness line.  The arrow text indicates that the Interpreter or separate witness to the entire consent process needs to sign on this line.

For the short form consent that is in the language that can be read by the subject:  The subject and the witness sign the short form consent document.  

Alt Text: Image title is Required signatures on the short form consent.  Image shows the Spanish short form consent.  There is an arrow pointing to the participant line.  The arrow text indicates that the participant needs to sign on this line.  Image then shows an arrow pointing to the Signature of Witness line.  The arrow text indicates that the Interpreter or separate witness to the entire consent process needs to sign on this line.

Confirm that the witness has signed both the short form in the language of the subject and the English long form used as the summary of what is to be said to the subject.

Alt Text: Image title is Required signatures when using the short form process.  Image shows the Spanish short form consent as an example.  There is an arrow pointing to the participant line.  The arrow text indicates that the participant needs to sign on this line.  Image then shows an arrow pointing to the Signature of Witness line.  The arrow text indicates that the Interpreter or separate witness to the entire consent process needs to sign on this line.

Yes. Interpreters in the CC scheduled by the CC Language Interpreter Program (LIP) are either NIH staff members who are federal employees or contract employees whose job is to provide medical interpretation. Interpreters scheduled by the CC LIP must sign the short and long form consent as the witness when facilitating the short form consent process, because they speak both languages. In all cases, the identity of the interpreter will be noted as indicated in Questions 14 and 17 below. The witness must be present for the entire oral presentation.

Before starting the consent process, confirm with the interpreter if they are willing to witness the consent. If the interpreter declines to act as the witness, please contact the CC LIP immediately at 301-496-2792 and they will assist.

A telephone service interpreter cannot act as a witness since they are not physically present to observe the consent process. Another individual, fluent in the language of the subject and in English, must observe the entire consent process at the site of the investigator and sign as the witness. Information regarding the interpreter should be included in the administrative sections of the long form and short form consent documents as described in Question 14.

In the vary rare instance that a witness who is fluent in both English and the language of the subject cannot be located, then the witness should verify with the interpreter that the subject understands the information presented, that all questions have been satisfactorily addressed, and that the subject agrees to participate. The witness, or investigator, obtaining informed consent should document this as a note in the record documenting the short form consent procedure.

Both the English long form and the translated short form includes a section titled NIH ADMINISTRATIVE SECTION TO BE COMPLETED REGARDING THE USE OF AN INTERPRETER which must to be completed when the short form consent process is used. (Note: On the translated short form, this section will be in the subjects preferred language.) This section allows NIH staff to attest that an individual speaking both English and the subject’s preferred language facilitated the consent process and also indicates whether the individual acting as the interpreter also served as the witness to the short form consent process.

If the individual providing interpretation services did not serve as a witness, the interpreter’s name (for on-site interpreters), or ID number (for telephone-based interpreters), should be entered in the designated 2^nd field below.

English long form administrative block

Examples of scenarios

• Interpreters in the CC scheduled by the CC Language Interpreter Program (LIP) who are either NIH staff members who are federal employees or contract employees whose job is to provide medical interpretation:  The first option is checked, and these interpreters sign as the witness.

• A telephone translation service (trans-telephonic interpreter service, e.g. “blue phone” service) is used and the consent is obtained in person (person obtaining consent and the subject are co-located):  Since the interpreter is not physically present and cannot serve as witness, the second option is selected, and the name or ID of the interpreter is entered.  In such cases there must be a separate individual present with the investigator to observe the entire consent process and who signs as the witness.

The difference from the earlier examples relates to the location of the individual who will serve  as the witness, and timing of the investigator and witness signatures.

• The subject should be provided with both the short form consent and the long-form English consent prior to the phone discussion.
• The investigator who is obtaining consent is in the same place as the witness (this may/may not   be the interpreter).
• The investigator, interpreter, and witness (if the interpreter will not/cannot serve as the witness) must all be involved for the duration of the consent process conducted via phone.
• After completion of the consent process, the following should be completed in real time:
  • The subject signs and dates the short form consent and returns it to the investigator.
  • At the time of the consent process, the investigator and the witness sign and date the long form English consent that was used as the basis of translation.
  • The administrative section on the last page of the long form English consent is completed.
  • The investigator documents the process in a consent note in the subject’s medical chart or research record (in real time after the consent discussion).
• Upon receipt of the signed and dated short form consent from the subject, the investigator completes the administrative section of the short form, and the same witness signs and dates the short form consent using the current date. (It is not backdated to the date that the consent process was conducted by phone.)
• The subject is provided with copies of the signed short and long form consent
• The investigator adds a note to the medical/research record regarding the date the signed short form was received and signed by the witness and indicates when the copies were returned to the subject.

The short form consent process requires that the witness attest, by signature, to the validity of the consent process and the subject’s agreement to participate.  If the witness is unable to sign the required documents, it is not acceptable for the PI to make a notation in the research record on behalf of the witness.

In such scenarios, the acceptable options for obtaining informed consent are to either: 1) translate the full consent into the language of the subject, or 2) if it is urgent to enroll the subject, the short and long form consents could be provided electronically to the witness, who will then sign and return the documents electronically.  Note, that such signatures must be “wet” signatures using a pen, mouse or stylus and not electronic signatures.

If these options are not feasible, then it may not be possible to enroll the subject.

The CRIS documentation of the Informed Consent Progress Note has been updated to include the required fields related to use of interpreters and witnessing the consent process. Whenever an interpreter facilitates the informed consent process, the PI or investigator who is obtaining consent should complete the check box fields in the progress note and include the name or ID number of the interpreter in the designated field.

If investigators anticipate enrolling subjects who speak a specific language other than English, the English long form consent should be fully translated into that language and submitted to the IRB for approval.  In this case, an interpreter is also used to facilitate the discussion and answer the subject’s questions, and the investigator obtaining consent and the subject both sign the fully translated long form consent (as they would if the long form was in English).

In this case, since an interpreter is used but a witness is not required on the long form consent, the second box in the administrative section should be checked to indicate that the interpreter facilitated the consent process but did not serve as the witness.

Check “yes” to the question, “Interpreter used during the consent process?” Fill in the name or ID code of the person providing interpretive support. Under additional notes, include a statement that a translated consent long form was used.  See below.

If the investigator is truly fluent in English and the language of the subject, consent may be obtained using the IRB approved translated long form if it exists, and no witness is needed. When the short form process is used because the long form has not been translated into the subject’s language, the bilingual investigator conducts the consent process in the language of the subject and explains all applicable elements of consent using the English long form as the summary of what is said to the subject.  The investigator obtaining consent cannot act as the witness, so the second option in the administrative block noted in FAQ question 9 above is checked, and the investigator’s name is noted on the provided line.  In such cases, there must be a separate individual present to observe the entire consent process who signs as the witness.

If the long form has not been translated into the language of the proposed subject, the subject should not be enrolled until a short form in their language is available. If you need a short form that is in a language which is not available on the IRB website, then you must obtain a translation of the appropriate English short form version.  A resource for obtaining a translation is the NIH Library.   Once you receive the translation, submit the translated short form and the certificate of accuracy to the IRB via PROTECT using a modification form.

The interpreter should ask the subject the embedded question and convey their response to the investigator obtaining consent. The investigator indicates the subject’s response on the long form ICF. Neither the interpreter nor the subject should record the response. This process should also be described in the consent note in CRIS or the research record.

Verbal assent should be obtained from the minor, and the process should be documented in the consent note. NIH does not have translated short form assent documents.

When obtaining assent from a non-English speaking older minor, if there is a translated long form and the IRB has   approved a process that allows older minors to provide their assent on the long form, then the older minor may read and indicate their assent on the translated long form. Otherwise, verbal assent should be  obtained and documented as above.

Submit the updated long form English consent document for translation. (A resource for obtaining a translation is the the NIH Library.) Upon receipt, submit the newly translated long form, along with the certificate of translation, to the IRB for approval. If the IRB requires reconsent prior to translation and IRB approval of the updated consent in the subject’s language , the short form process should be used with the approved English long form (that has the updated information) as the basis for consent.  When the updated translated long form has received IRB approval, provide it to the subject.  Document each of these activities in the subject’s medical or research record.(for example an important new risk needs to be communicated before the IRB approved English consent form can be translated and approved by the IRB), then using a qualified medical interpreter, the study team should verbally inform the participant of the changes and document this in the research and/or medical record. Once the translated consent is available, those participants should be formally reconsented with the revised translated consent document.  The participant’s signature and that of the person obtaining consent should be entered on the revised translated consent document.  This process should also be documented in the subject’s medical or research record.

Exempt research is not subject to the Common Rule requirements for consent nor is there an equivalent short form process for exempt research.  However, the NIH policy requires that there be a consent information sheet provided for most exempt research (see https://policymanual.nih.gov/3014-301#E.1). 

Given that much of this type of research is survey research, and/or participants are performing a task online, the scientific validity of the data would likely require that the research be in a language that can be read by the participant.  In addition, if the expectation is that the person has read the consent paragraph at the front end of the survey or task, and that by proceeding they are agreeing, then it would have to be provided to the person in a language they can understand to be meaningful and valid.

While our policy does not specifically address exempt research, we would expect investigators to use good judgement and best practices to determine when translation is needed, for both ethical and scientific validity reasons.

NIH HRPP Policy 301, Informed Consent

Guideline for Enrolling Non-English Speaking Subjects

Except as described below, VFs, IRTAs, and CRTAs serving as Associate Investigators may observe or participate in the informed consent process only if they are under the direct and constant supervision by a qualified NIH federal employee investigator. These trainees may not sign the informed consent document.

Post-doctoral IRTAs/CRTAs and post-doctoral VFs who are Associate Investigators may obtain the informed consent of a prospective subject without the presence of a qualified NIH federal employee investigator only if they have completed the expanded training requirements listed in MC 3014-301 Informed Consent that include the following:

• They must have received sufficient training by the PI about the protocol. The post-doctoral IRTA/CRTA or post-doctoral VF must be knowledgeable and be able to explain the protocol and all the information contained the informed consent document and be capable of addressing all subject questions.
• They must have also completed Elements of a Successful Informed Consent course and the validated Objective Structured Clinical Examination (OSCE) for the Informed Consent Process offered by the NIMH Human Subjects Protection Unit (HSPU).

The policy permitting post-doctoral IRTAs/CRTAs and Visiting Fellows (VFs) to obtain informed consent so long as they meet expanded training and policy requirements is specific to these trainees. IC staff should NOT confuse IRTAs/CRTAs and VFs with Clinical  Fellows and Research Fellows who are federal employee investigators who can independently obtain informed consent. For more information, you can look up various types of fellows including helpful information about fellow hiring authorities here: https://oir.nih.gov/sourcebook/personnel/ipds-appointment-mechanisms/official-list-approved-intramural-professional-designations-ipds

If the IRB has determined that signature of both parents is required, permission must be obtained from both parents unless one is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.  However, for research taking place at an NIH site when the IRB has approved the study as needing permission from only one parent, in cases where parents share joint legal custody for medical decision-making of a child (e.g., by a custody agreement or court order), both parents must give their permission regardless of the risk level of the research. Exceptions may include if one parent has since died, become incompetent, or is not reasonably available. However, in such cases, if one of the parents wants to give the decision-making responsibility to the other parent, they can do so.  In this situation, the parent who wants to give up such responsibility must write and sign a letter to the study PI stating they want the other parent to make decisions about the child as they relate to their study participation at NIH. It can indicate the parent’s willingness to give up this responsibility for a specific duration of time, or they can indicate that they are doing so indefinitely or until they decide otherwise.  This letter does not need to be notarized.

Even if both parents are required to sign the consent form, only one parent needs to initial the embedded questions. This is true whether documentation of consent is collected on a paper form or on an electronic consent form, e.g., using iMed.  Please note however that both parents must agree on the responses to the embedded questions to allow the research to move forward.

If the potential subject is able to speak, verbal consent may be obtained.  If the individual is unable to speak, they can be entered into a study if they are competent and able to indicate approval by other means. However, if the protocol states that written documentation of consent is required, the alternative procedure that will be used to indicate the subject’s consent (including verbal consent) must be prospectively reviewed and approved by the IRB.  This should be done by submitting a Single Patient Modification Request in the electronic IRB system.

When a method of obtaining consent other than written documentation is utilized (for example, verbal consent for a subject who does not have the ability to provide written consent), investigators must document the method used for communication with the subject and the specific means by which the subject communicated agreement to participate in the study in the documentation of consent note in the subject’s medical or research record.  When feasible, it is advisable to have a witness present.