Human Research Protection Program

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. A waiver of informed consent must be requested of the Institutional Review Board 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 misdescribed. 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.

Research involving minors (defined in Massachusetts as nonemancipated subjects under 18 years old) involves special considerations; federal regulations require certain additional protections for children involved as subjects in research.

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 Institutional Review Board 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.

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: For each language into which documents are translated, a translation certification must be submitted with the translated documents. Consider submitting the translated documents and certification as a modification after your English versions have been approved, as revisions are often required and would necessitate an updated certification to be submitted with the revised documents. 

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. 

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