This is a critical component of the HPRB application. Informed consent is necessary for all research studies (even exempt research).

The goal of informed consent is to make sure research participants are treated with dignity and respect and they understand:

  • what they will be asked to do
  • any risks and/or benefits involved
  • they can choose not to answer any questions
  • they always have the right to decline or withdraw from any study without consequence
  • how their data will be used and protected

Investigators must have every potential participant who is a physically and mentally able adult (at least 18 years old) provide consent prior to the initiation of the actual research. There are additional safeguards in place for populations who do not meet this description, whether due to age, disability, or other protected status.

The consent process is typically made up of two parts:

  1. a discussion between the the researcher and the potential participant, and
  2. a written document (either a “consent form” or “cover letter”) that captures the nature of the consent discussion.

Each participant must be given a complete copy of the consent form. The investigator should also keep one copy of the consent form. Investigators are required to keep consent forms on file for 3 years following the completion of the research.

Several types of research studies require extra attention and revision to the consent templates. Investigators should work closely with their Unit Designate and consider contacting the HPRB Chair prior to proposal submission in order to determine what, if any, additional restrictions may be imposed in order to assure the protection of participants in these situations.

If you answer, “yes,” to any of the following questions, it is likely that you will need to add additional or specialized language to your consent document.

Are you…?

+ Making audio or video recordings of participants

Investigators who plan to make audio or video recordings of participants must clearly state that in their consent form and they must explain:

  • how they will use the recordings
    (e.g., they will be transcribed and coded; individual participants will not be identifiable; individual participant’s comments will be included in presentations and publications but only using pseudonyms)
  • how long they will keep the recordings
    (e.g., until transcribed, coded, and analyzed)
  • how they will protect the recordings
    (e.g., on a password-protected laptop in a locked office)
  • who will see/hear the recordings
    (e.g., only members of the research team; research staff and professional transcription service)
  • where the recordings will be used
    (e.g., in a classroom, professional meeting)
  • what steps they will take to ensure confidentiality
    (e.g., if using third-party transcription)

If the recording will be viewed/heard by anyone other than the researchers and faculty supervisor (e.g., conference audience, people at the research site, transcribers, translators), or if it involves sensitive material, students must:

  • give participants an opportunity to view (or listen to) the recording after it is completed, and
  • obtain separate signed permission to use the audio or video recording.

+ Working with children (under age 18)

In order to work with children, investigators:

  • who are students must work closely with a Faculty Supervisor who has expertise in research with children
  • must complete a supplemental HPRB form (part of online application),
  • must obtain written parental (or guardian) consent using an HPRB approved Parent/Guardian Consent Form (please use our template), and
  • must obtain oral assent from the child using an HPRB-approved Child Oral Assent Script (see below).

Here’s what goes into a Child Oral Assent Script
Investigators must take into account the age, maturity, and psychological state of the participants when writing this script. Investigators need to ask children if they are willing to be a part of their study, but a signature is not required. Researchers should tell them—in a way they can understand:

  • what they will be asked to do;
  • how long it will take;
  • that nothing they say will be shared with anyone unless they they say it is okay (or, if appropriate, unless they mention that someone is hurting them or they are hurting themselves);
  • any risks or benefits;
  • that they can say at any time that they don’t want to answer any question, they need a break, or they want to stop doing the study.

A conversational and friendly tone is essential. With young children, there is a risk that investigators could interpret the fact that a child is not actively resisting as assent. Researchers must make sure to pay attention to the child’s body language and cues and use special care to discontinue participation with any child who appears to experience undue stress or fatigue from the research procedure.

Please feel free to adapt our Child Assent Script template.

Here’s how to Obtain Consent from Adolescents (under 18)
For adolescents involved in research where a signed consent form would have been used if the subjects were adults, it would generally be appropriate to use a similar form to document an adolescent’s assent.

+ Working with “special” or “vulnerable” populations

The situation of some research participants may be inherently coercive; their freedom of choice may be restricted by the nature of their employment, age, associations with others, place of residence (e.g., prisons or mental hospitals), mental or physical capacities, or the political/cultural in which they live and work.

Investigators must make a special effort to ensure that potential participants are given every opportunity to exercise free choice in consenting to participate in a research project.

Special Populations
Certain types of participants require special attention when obtaining informed consent. In all cases, the guiding principle is respect for the rights of the potential participant. Federal regulations consider children, prisoners, the mentally disabled, and pregnant women to be “special populations,” and as such, are entitled to extra protection under the law.

Vulnerable Populations
Other groups, such as racial minorities, the elderly, substance abusers, the economically disadvantaged, the very sick, and the institutionalized are described as “vulnerable populations” and are extended similar protection as research participants.

For more information on these groups, please consult with your Unit Designate or the HPRB chair.

+ Conducting a study in another country or in a language other than English

There is supplemental HPRB form for this type of research (part of online application).

Research done outside of the US, especially in non-western societies or places where the participants do not speak English poses some problems in obtaining written documentation of informed consent. In these situations, it is sometimes impossible, for a variety of reasons, to obtain written consent. If that is the case, students may request a Waiver of Documentation of Informed Consent and provide an acceptable alternative method of obtaining oral consent, which is appropriate to both the participants and their culture. This can be completed as part of the HPRB proposal.

If the participants may be economically or educationally disadvantaged, investigators should pay particular attention to these issues and ensure that appropriate safeguards have been implemented.

Please consult with your Unit Designate and consider contacting the HPRB Chair prior to proposal submission to discuss best practices.

+ Working with participants where there are barriers to consent, either language-related or physical

Please consult with your Unit Designate and consider contacting the HPRB Chair prior to proposal submission to discuss best practices.

+ Working with populations where the requirement for written consent could hinder or prevent your research

Consult with your Unit designate and consider contacting the HPRB Chair prior to proposal submission to discuss best practices.