Informed Consent

Federal regulations require that researchers obtain legally effective, documented, voluntary informed consent from prospective subjects (or subjects' legally authorized representatives) before subjects may be included in research.

The primary purpose of informed consent is to protect the prospective human subjects. Informed consent provides the individual with the pertinent information regarding the research in which s/he is being asked to participate, and the opportunity to make an informed decision regarding whether or not to participate in the research. 

Keep in mind that obtaining informed consent is a continuous process throughout the research, not simply a one-time event when a subject signs a form.

To ensure informed consent, researchers should:

  • Work to communicate clearly and effectively with their participants and to build trust and cooperation.

  • Openly and willingly explain their research, answer questions, and be sensitive to the needs and concerns of their prospective research participants.

When using an informed consent form, a final version, as it will appear to your subjects (e.g., on letterhead), must be included in the application. 

If no informed consent form will be used, a waiver for documented informed consent must be requested and an information sheet and/or informed consent script may be required.

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The informed consent form

Obtaining informed consent is most often accomplished through an informed consent form, which documents the information regarding the research the subject is being given to help him/her make the decision to participate or not in the research. 

While each informed consent form is specific to its research project, the federal regulations dictate the elements of informed consent that must be included. For guidelines and a template for creating an informed consent form, see Elements of Informed Consent and Informed Consent Form Template

Note that, for complicated and/or lengthy (>3 pages, generally speaking) informed consent forms such as those often used for clinical research, the forms must begin with an organized, concise, and focused presentation of the key information contained in the consent documents. 

Note, as well, that all subjects must be provided with a physical copy of the informed consent form. (If electronic informed consent is being obtained, an electronic version of the informed consent form is adequate.)

Waiver of documented informed consent

When the use of an informed consent form would be impractical or detrimental to the study, a waiver may be requested. Federal regulations allow an IRB to waive the requirement to obtain written documentation of informed consent for some or all subjects under any of the following circumstances:

  1. When the consent document would provide the only link to the subject and the principal risk of the research would be a breach of confidentiality. Note that each subject (or LAR) must be asked whether they would prefer to sign a consent form, linking them with the research - the subject's wishes must govern. 

  2. When the risk to the subjects is minimal and consent would not be required outside the research context.

  3. When the subjects or LARs are members of a distinct cultural group or community in which signing forms is not the norm, the research presents no more than minimal risk of harm to subjects, and there is an appropriate alternative mechanism for documenting that informed consent was obtained.

If you would like to request a waiver of documented informed consent, explain in your protocol how any of the above circumstances apply to your research. Be sure to clearly explain why you believe your research qualifies for the waiver.

Where the IRB waives the requirement for documented informed consent, investigators must understand that they are still required to communicate all the required elements of informed consent to their subjects and that the subject's active consent must be obtained before proceeding with the research.

Examples of projects that might qualify for a waiver of documented informed consent include online anonymous surveys, telephone surveys, and interviews with a vulnerable population (e.g., domestic violence survivors or undocumented immigrants).

Note that if documented informed consent is being waived, the IRB may require an information sheet be given to the subjects and/or an informed consent script be included in your application. 

Note, as well, that if feasible, the fact that informed consent was obtained should be documented (e.g., a checkmark on a master list). 

Information sheets in lieu of documented informed consent

In cases where documentation of consent is waived, the IRB may require investigators to provide subjects with a written statement regarding the research called an Information Sheet.

The information sheet generally includes all the elements of informed consent and looks similar to an informed consent form, without requiring the subject's signature.

An Informed consent script

Keeping in mind that informed consent is more than a form, an informed consent script may be required.

An informed consent script outlines how the investigator will conduct the informed consent process and what s/he will say to the subjects to explain this process. 

An informed consent script may be necessary when a waiver of documented informed consent is being requested and an information sheet is not feasible. 

Waiver or alteration of informed consent

In rare instances the IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirements to obtain informed consent entirely provided it finds:

  1. The research could not practicably be carried out without the waiver.

  2. The research involves no more than minimal risk to the subjects.

  3. The waiver will not adversely affect the rights and welfare of the subjects.

  4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

  5. If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format.
E-signatures on informed consent form

E-signatures are permissible provided the subject’s identity is verifiable. If the subject’s identity is not verifiable, a request for a waiver of documented informed consent must be requested.

Note that the Massachusetts Uniform Electronic Transactions Act (MUETA) requires four elements to create a valid electronic signature and fulfills both OHRP and FDA requirements:

  1. Authentication

  2. Capturing the user’s intent

  3. Binding of the signature to the document

  4. Maintaining the integrity of the document

In addition, the electronic signature must also capture and record the date that the subject provides consent. 

Special Topics Involving Informed Consent

Research involving deception or incomplete disclosure

The use of deception or incomplete disclosure limits the subject's ability to make a fully informed decision of whether to participate in the research -- one of the essential ethical concerns in human subjects research -- and a waiver of informed consent must be requested of the IRB whenever deception or incomplete disclosure is planned.

Because subjects cannot be formally consented prior to the research, subjects must agree to participate in the research through the use of a consent to participate in lieu of formal informed consent. This agreement will include all of the elements of informed consent aside from a description of the actual purpose of the study. 

To mitigate the concern regarding the lack of informed consent, subjects should ideally be informed prospectively, via the consent to participate, of the use of deception/incomplete disclosure in the research in which they are being asked to participate, and consent to its use. 

Sample Consent Language:

Research sometimes requires that information regarding its purpose not be shared with the research participants because its knowledge could impact the results of the research. While the tasks you will be asked to perform for this research have been explained, certain details have been left out of the description of the study, or intentionally mis-described. At the completion of the study you will have the opportunity to ask questions, including about the purpose of the study and the procedures used, and withdraw your data if you so choose. Note that none of the aspects of the research being withheld are reasonably expected to affect your willingness to participate.

*Note that, in order for research to be exempt, the consent form must include such a statement of prospective agreement.

Once the subject’s participation in the research is complete, s/he must be debriefed regarding the true nature of the research. A debriefing and informed consent form giving the investigator permission to retain and use his/her data must be signed by the subject and attached to the consent to participate.

For additional important information regarding debriefing and the use of deception in human subjects research, see the HRPP's Deception webpage.

Research involving children

Research involving minors (in MA, non-emancipated subjects < 18 of age) involves special considerations and federal regulations require certain additional protections for children involved as subjects in research.

For more information, see the HRPP's Research with Children and Students webpage.

Research Involving third parties

When an investigator conducting research obtains identifiable private information about a living individual, that individual becomes a research subject, regardless of whether that person is the individual with whom the investigator is having an interaction.  For example, if the research involves asking the primary subject to provide identifiable private information about a third party, that third party then becomes a subject in the research. As such, all of the regulatory requirements for protecting that individual apply.

The IRB can determine whether informed consent needs to be sought from third party subjects, or whether it can be waived. In making this determination, the IRB relies on both the requirements for a waiver (noted earlier in this section) and the importance of the information to the research.  Investigators whose research may involve so-called “secondary subjects” are encouraged to contact the IRB Administrator to discuss how to best protect the rights and welfare of these subjects in a given project.

Research involving a language other than English

Informed consent must always be obtained in a language in which the subject is comfortably fluent. In those instances where the subjects do not speak English, the informed consent form should be translated into the primary language spoken and understood by the subjects and, if the investigator is not fluent in this language, an interpreter hired to translate throughout the informed consent process.

It is important that the investigator not rely on family members or friends of the subjects. Instead, a professional should be hired with whom the investigator can discuss the study in detail. It is important that the interpreter fully understands the research or s/he may not communicate the information accurately. In addition, it is important that the subjects feel comfortable answering and/or asking questions freely.

In those instances where a subject has some competency in English, the investigator may be tempted to forgo the use of an interpreter. The investigator must be careful, however, to be sure the subject is truly proficient in English. There are often times when a subject believes s/he is proficient “enough” and so does not inform the investigator – or even realize – that both s/he and the investigator would be better served by the use of an interpreter.

Note that for each language into which documents are translated, a Translation Certification must be submitted with the translated documents. 

Research Involving focus groups

When working with focus groups, confidentiality is always a special concern as it is not simply the researchers who must keep a participant's data confidential, but all the participants involved in the focus group, as well. 

In addition to discussing this problem in your protocol (in the risks section), the fact that the researchers cannot guarantee confidentiality should be addressed in the informed consent form. In addition, it is helpful to remind all participants of the need to keep all information discussed in the focus group confidential.

Sample consent language:

Please be advised that although the researchers will take every precaution to maintain the confidentiality of what is discussed, the nature of focus groups prevents the researchers from being able to guarantee confidentiality. The researchers would like to remind participants to respect the privacy of your fellow participants and not repeat what is said in the focus group to others.

___ I agree to maintain the confidentiality of the information discussed by all participants and researchers during the focus group. 

Research involving audio or video recordings

When audio- or video-recording your participants while conducting research, you must specifically ask your participants' consent to be recorded prior to having them sign the consent form. 

Sample consent language:

I have read (or had read to me) the contents of this consent form and have been encouraged to ask questions. I have received satisfactory answers to my questions. I understand that my participation is voluntary and that I may withdraw my participation at any time without penalty. I voluntarily agree to participate in this study.

___ I do   ___ I do not   give you permission to make audio/video recordings of me during this study.

Signatures of subject and investigator