Standard Operating Procedures - Chapter 12

INFORMED CONSENT AND DOCUMENTATION

Signed informed consent is required for all human participant research unless the activity meets regulatory findings stipulated for waiver or alteration of informed consent. Informed consent presumes two simultaneous concepts: informed decision-making and voluntary participation.

To assist individuals conducting research, the HRPO provides information on the website regarding the informed consent process. Templates and instructions are available, including guidelines for the consent form process and developing an informed consent document, suggested wording, and additional instructions for specific circumstances.

12.1	Required Elements
12.2	Limited English Speaking Participants
12.3	Signatures
12.4	Alterations to Informed Consent or Documentation
12.5	Passive Consent
12.6	Assent
12.7	Informed Consent for Vulnerable Populations
12.8	Witness to Consent

12.1 Required Elements

The Informed Consent form must include all of the following elements, when applicable, as required by 45 CFR 46.116(a):

Statement that the study involves research
Explanation of the purpose
Expected duration of participation
Description of procedures to be followed
Identification of any experimental procedures
Description of any reasonably foreseeable risks or discomforts to the participant
Description of benefits to the participant or others that may be reasonably expected from the research
Disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant
Statement describing the extent to which confidentiality of records identifying the participant will be maintained
For research involving more than minimal risk, an explanation as to whether any compensation and whether any medical treatments are available if injury occurs during study participation
Explanation of whom to contact for answers to questions related to research and rights of research participants
Explanation of whom to contact in the event of a research-related injury to participant
Statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.

12.2 Limited English Speaking Participants

Informed consent information must be presented in a language understandable to the prospective participant or the participant’s representative. Routine ad-hoc translations of the consent document may not be substituted for a written translation.

When recruitment for the research is anticipated for a particular non-English speaking population, a translation of the written informed consent document should be provided to the prospective participants in a language they understand. The written translations should be made by a reliable source and their accuracy verified through back-translation, whenever possible. The IRB must approve the translated consent form before use. A letter from an individual not associated with the research verifying the translation may be requested.

If a non-English speaking individual is unexpectedly encountered and a translated IRB-approved consent form is not available, the investigators may use an oral translation process to provide the information in a language understandable to the prospective participant (or participant’s representative). The oral translation must be made in the presence of an impartial witness who is fluent in both English and the language of the prospective participant (or representative). If a translator is used for the oral translation, this individual may serve as the witness if he or she is impartial to the research.

An IRB-approved short form consent document, written in a language understandable to the prospective participant (or representative), must be provided and include the following: the invitation to participate in research; the categories of information that will be explained orally; contact information in event of concerns about a research injury or questions about the research or the participant rights; the voluntary nature of participation and clarification that there will be no penalty or loss of benefits for refusal to participate; and an explanation that signing the form denotes agreement to participate. This short form must be signed by the participant (or representative) providing consent and the witness.

In addition, a written summary of the research, or the IRB-approved consent form in English, must be provided and signed by the investigator obtaining consent and the witness. The participant (or representative) will receive copies of both of these signed documents.

When used with participants who do not speak English, (1) the oral presentation and short form informed consent document should be in a language understandable to the participant (or representative); (2) the IRB-approved English language informed consent document may serve as the summary; and (3) the witness should be fluent in both English and the language of the participant. Regulations prohibit exculpatory language through which the participant is made to waive, or appear to waive, any of the participant’s legal rights.

12.3 Signatures

In cases of signed informed consent, UMASS policy requires the signature of a participant or the participant’s representative who may provide legally effective informed consent.

The signature of a witness is required when a participant or participant’s representative is unable to read or when the IRB authorizes the use of a short form written consent procedure for limited English speaking individuals. The witness observes the informed consent process and signs a statement attesting to the consenting process being done voluntarily on the part of the research participant, as well as being accurate.

12.4 Alterations to Informed Consent or Documentation

Waiver or Alteration of Informed Consent

The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent outlined above, or waives the requirement to obtain informed consent as outlined in 45 CFR 46.116(d) provided the IRB finds and documents:

The research involves no more than minimal risk to the participants; and
The waiver or alteration will not adversely affect the rights and welfare of the participants; and
The research could not practicably be carried out without the waiver or alteration; and
Whenever appropriate, the participants will be provided with additional pertinent information after participation.

Waiver of the Requirement for Documentation of Informed Consent

The IRB may waive the requirement to obtain a signed consent form, in accord with 45 CFR 46.117(c) when:

The only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality; or
The research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide the participants with a written summary of the research.

When the IRB approves a consent procedure that does not require, or which alters, some or all of the elements of informed consent outlined above, the IRB determines and documents that the specific findings are met as required by the regulations. If the request is reviewed at a full IRB meeting, the meeting minutes document the IRB’s findings regarding the decision to grant a waiver. Similarly, if the study meets the criteria for review under expedited procedures, the reviewer documents the findings and decision to grant the waiver.

12.5 Passive Consent

Passive consent, where the lack of an objection to research participation would be considered an agreement to participate, may be approved only if the investigator justifies this consent process and the IRB determines that the study meets the criteria to waive the requirement for informed consent.

12.6 Assent

The Human Research Protection Office (HRPO) provides assent form templates on the website. Assent is typically required for participants age 7-17. See Chapter 16.1 for more information.

12.7 Informed Consent for Vulnerable Populations

Individuals Who Are Unable to Read or Physically Unable to Sign the Form

When informed consent discussions are conducted for individuals who may provide legally effective informed consent but are not able to read the consent form, or for individuals who are capable of legally effective informed consent but are physically unable to sign the written form to document their informed consent decision, a witness must be present during the entire informed consent process. This applies to individuals who are capable of providing legally effective informed consent and understand English.

Following the presentation of the information, reading of the consent form if applicable, and the informed consent discussion, prospective participants (or representatives) who are capable of providing legally effective informed consent should sign and personally date the consent document (including making their mark), if able.

Individuals who are physically unable to sign the consent form may indicate their approval or disapproval by other means. The investigator conducting the informed consent process should then document on the consent form, the date and time, print the name of the individual providing consent and indicate by what means consent was communicated. An impartial witness must be present during the entire consent process to observe that the information in the consent form and other material presented about the research was explained accurately, and that the potential participant (or representative) understood and made the consent decision freely.

12.8 Witness to Consent

A witness to the informed consent process is required when an informed consent discussion will be conducted with a prospective participant, or participant’s representative, who is eligible and capable of providing legally effective informed consent, but the individual is:

Unable to read the consent form; OR
Physically unable to sign the consent form; OR
Non-English speaking and a Short Form Consent and Oral Translation Process will be used.

To qualify as a witness for the consent process, an individual must be an impartial third party who is not connected with the research such as, a non-research team employee, a relative of a participant, or person similarly unconnected with the research. The witness must be present during the entire informed consent discussion, while the consent form and any other written material and information for the participant is read, explained and discussed. The role of the witness is to observe that the information in the consent form and other material about the research is explained accurately, that the potential participant or participant’s representative understands, and that the decision to participate is made freely.

After witnessing the informed consent process, the witness signs a witness statement attesting to the consenting process being done voluntarily on the part of the research participant, as well as being accurate. The witness statement may be incorporated in the IRB-approved informed consent document, or a separate witness form may be signed and attached to the informed consent form, becoming a part of the consent documentation for the participant.