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
You 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.
You must obtain written consent from participants using a Signed Consent Form, unless they request, and the HPRB approves, a Waiver of Documentation of Informed Consent. This waiver can be requested as part of your HPRB proposal on Mentor; there is no separate form required.
In rare circumstances, you may request a Waiver of Informed Consent. Consult with your Unit Designate and/or the HPRB Chair if you think this might be appropriate and necessary. Again, you may request this kind of waiver as part of your HPRB proposal on Mentor.
The HPRB has created templates to assist in preparing these documents. The type of consent document required depends on whether the investigator can assure Anonymity or Confidentiality to your participants.
Anonymity means that the individual participant cannot be identified from the data themselves, and no identifying information is linked to the data. Video and voice recordings are not anonymous. Interview or survey data in which recorded demographic characteristics or descriptions of specific incidents could easily lead to the recognition of the individual respondent are not anonymous.
Confidentiality means that the investigator knows the identity of the participant but will not share this information. Names and identifying information are protected (i.e., stored separately from the data). Any exceptions must be explained in the consent document.
Current Consent Templates
- Signed Consent Form (for research assuring Confidentiality, NOT Anonymity)
- Cover Letter (for use with low-risk, anonymous, surveys in hard copy format)
- Online Cover Letter (for use with low-risk, anonymous, online surveys)
- Parent/Guardian Consent Form (for research involving participants under age 18)
- Child Assent (for use with children, in conjunction with parent/guardian consent)
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 you 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.
+ Making audio or video recordings of participants
If you plan to make audio or video recordings of participants, you must clearly state that in the consent form and you 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 the research staff (e.g., conference audience, people at the research site, transcribers, translators), or if it involves sensitive material, you 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, you must:
- complete a supplemental HPRB form (part of online application),
- obtain written parental (or guardian) consent using an HPRB approved Parent/Guardian Consent Form (please use our template), and
- 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
You must take into account the age, maturity, and psychological state of the participants when writing this script. You need to ask if they are willing to be a part of the study, but a signature is not required. You should tell them—in a way they can understand:
- what they will be asked to do;
- how long it will take;
- that you won’t share anything they tell you with anyone unless they say it is okay (or, if appropriate, unless they tell you that someone is hurting them or they are hurting themselves);
- any risks or benefits;
- that they can tell you if they don’t want to answer any question, if they need a break, or if they want to stop doing your study at any time.
Please feel free to 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.
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.
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, click here.
+ 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 within Mentor and provide an acceptable alternative method of obtaining oral consent, which is appropriate to both the participants and their culture.
+ 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.
+ Working with populations where the requirement for written consent could hinder or prevent your 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.
Certificate of Confidentiality
Certificates of Confidentiality are provided by the federal Department of Health and Human Services. A certificate of confidentially protects the participant’s confidentiality by protecting research records from subpoena, going beyond the consent form in ensuring confidentiality and anonymity. Without the certificate, researchers can be required by a court-ordered subpoena to disclose research results (usually as part of a criminal investigation of the participants).
Certificates of Confidentiality generally take 4-6 weeks to obtain after application to the Department of Health and Human Services. For more information on Certificates of Confidentiality, their limitations, and HHS contacts, see the Guidance on Certificates of Confidentiality page.
The following language is typical of Certificate of Confidentiality requirements. Either this or other similar language must be present in the consent form.
To help protect your privacy, the researchers have obtained a Certificate of Confidentiality from the National Institutes of Health. With this certificate, the researchers cannot be forced to disclose the information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below. The Certificate cannot be used to resist a demand for information from personnel of the United States Government that is used for auditing or evaluation of federally funded projects or for information that must be disclosed in order to meet the requirements of the Federal Food and Drug Administration (FDA).
You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself and your involvement in the research. If an insurer, employer or other person obtains your written consent to receive research information, then the researcher may not use the Certificate to withhold that information.
The Certificate of Confidentiality does not prevent the researchers from disclosing voluntarily, without your consent, information that would identify you as a participant of the research project under the following circumstances the present danger of child abuse, suicide, and/or homicide.