This is a critical component of the 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

Students 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.

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. When in doubt, consider checking with your Unit Designate or 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 students answer, “yes,” to any of the following questions, it is likely that they will need to add additional or specialized language to your consent document.

Does the study involve…?

+ Making audio or video recordings of participants

If students plan to make audio or video recordings of participants, they must clearly state that in the consent form and they must explain:

  • how recordings will be used
    (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 recordings will be kept
    (e.g., until transcribed, coded, and analyzed)
  • how recordings will be protected
    (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 you will take to ensure confidentiality
    (e.g., if using third-party transcription)

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

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

+ Working with children (under age 18)

In order to work with children, investigators must:

How to Obtain Oral Assent from Children
Researchers must take into account the age, maturity, and psychological state of the participants when writing this script. Children must be asked if they are willing to be a part of the 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 say it is okay (or, if appropriate, unless they say that someone is hurting them or they are hurting themselves);
  • any risks or benefits;
  • that they can say at any time they don’t want to answer a question, they need a break, or they want to stop doing the study.

Please feel free to use or adapt our Child Assent Script template.

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.

Researchers 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.

+ Conducting the 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, investigators may request a Waiver of Documentation of Informed Consent in Mentor and provide an acceptable alternative method of obtaining oral consent, which is appropriate to both the participants and their culture.

Students should work closely with you and their Unit Designate or 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

Investigators should prepare both English-language and translated consent forms for proposals involving non-English speaking participants. An explanation of the translations and the expertise of the translator should be provided for HPRB review. Any translators who will translate identifiable data obtained from participants used must sign a confidentiality agreement in order to protect the information disclosed by participants.

In the event that a participant has a physical limitation that could affect the consent process the investigator should provide alternate means to obtain consent and should consider asking the HPRB to waive or alter some of the elements of consent.

+ Populations where the requirement for written consent could hinder or prevent the research?

In situations where the requirement for written consent would prevent the participation of specific classes of people whose viewpoints need to be represented, researchers may obtain a Waiver of Documentation of Informed Consent or a Waiver of Informed Consent as part of the HPRB application in Mentor.

>>Waiver of Documentation of Informed Consent (no signed consent)

The HPRB may waive part/all of the normal consent requirements if:

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

This category of waiver includes those cases in which the researcher desires to withhold from the participant some information about the project that, if known by the participant, would bias the results of the study. Ordinarily, the researcher would plan a debriefing session after completion of the individual’s participation in order to provide the individual with the missing information, and provide the participant the option of including his/her data in the study or having it destroyed. In no case should a researcher seek to withhold information about the research or the participant’s role in the research solely to reduce the chance that the individual will refuse to participate.

The HPRB may waive the requirement for written consent if it finds that:

  • the only record linking the participant and the research would be the consent document and the principal risk would be the potential harm resulting from 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 the research context.

This type of waiver applies especially to anonymous interviews (including face-to-face and telephone interviews) where the researcher’s sole knowledge of the identity of the participant would come from the consent document. Waiver of written consent procedures does not imply waiver of the researcher’s responsibility to obtain consent from the participant.

In all cases, the researcher must provide the participant with a statement describing the research that includes all relevant elements of informed consent. The HPRB requires that when the use of written informed consent is waived, a cover letter be given to the participants outlining the purpose and procedures of the project and containing a statement, such as “Completion and return of the survey (questionnaire, interview, etc.) indicates consent to participate in the study.”

Obtaining Oral Consent
If oral consent is necessary (e.g., due to limited literacy), the participant or his/her legal representative will be asked to sign a short form stating that the basic consent form elements have been orally presented. Both the short consent form and the oral presentation must be approved by the HPRB. The HPRB might require that a witness also be present for this presentation and must sign both the short form and a written summary of the oral presentation. The participant or his/her legal representative must receive a copy of both signed documents.

>>Waiver of Informed Consent (no written or oral consent)

Some research that qualifies for Exempt review status does not require the use of an informed consent document. If students are submitting a proposal which they believe meets the criteria for Exempt status, they may request an exemption from the consent requirement in the appropriate section in the proposal form.