Function of the Consent Document
Consent Document Toolbox
» Consent and Assent from Minors
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» Video and Audio Recording
» Consent in Foreign Countries
» Barriers to Consent
» Waivers of Written Consent
» Certificate of Confidentiality
The goal of the Informed Consent process is to ensure that the research participant is treated with respect and human dignity. This is achieved by safeguarding and advocating for the participant's right to deliberate and make a knowing decision whether to cooperate with the investigator's research interest. Smith College requires that every researcher (whether student, faculty or staff) secure the informed consent of any human participant before involving that participant in the research project.
Every potential participant who is a physically and mentally able adult (at least 18 years old) must provide consent to participate in the research prior to the initiation of the actual research. The ideas of mental and physical normalcy revolve around the ability of the participant to provide truly informed and voluntary consent. Populations who do not meet this description, whether due to age or disability or other protected status, are afforded additional safeguards.
Researchers must ensure that the circumstances under which consent is sought will provide the participants (or their representatives) with sufficient opportunity to consider whether or not to participate in the proposed research. The circumstances must minimize the possibility that the participants will experience coercion or undue influence.
The informed consent document communicates to the prospective research participant the purpose, procedures, risks and benefits of the study; the participant's rights in participating in the research; and the freedom to decline to participate without penalty. The consent document also allows the participant to obtain further information and answers to questions related to the study. The consent form, therefore, serves as a written summary of the proposed research and provides a reference for both the participant and the researcher.
All research participants must give their express consent to participate in a research study. Consent is a necessary element for all research studies, even exempt research. Consent is only considered valid if the participants are given enough information to allow them to weigh the study's risks and benefits and if the information is told to them in terms that they can understand. participants always have the right to decline or even withdraw from any study.
The consent process is made up of two parts:
- the discussion that takes place between the researcher and the participant
- a written document (either a “consent form” or “information sheet”) that captures the nature of the consent discussion
The consent process should be specific to each participant population as well as the individual participant. There may be some participants who require special considerations, such as children, prisoners, cognitively impaired individuals, economically/educationally disadvantaged individuals and others. The IRB will always look to see that the study and consent process provide additional protections for these “vulnerable populations.”
Information Sheet vs. Consent Form: Documenting the Consent Process
The consent discussion that takes place between a researcher and participant must be captured in a document called an “informed consent form” or “consent form.” Unless the IRB gives an investigator permission to alter the consent process, all research participants must indicate in writing their willingness to participate by signing the consent form. However, written consent may not be necessary or appropriate in certain studies, such as surveys, interviews and other minimal risk research or in research where the participants are to remain anonymous. In these cases, the investigator should prepare an “information sheet” appropriate for the study. Federal regulations identify certain specific elements required for informed consent, and, depending on the nature of the research, the IRB may require additional elements. This assures that the criteria for obtaining informed consent are met and understood by all parties involved in the study.
The Forms and Templates section of this web site includes a guidelines for Informed Consent procedures and a sample Informed Consent Document that can be modified to fit many research procedures. However, because each human participants research (HSR) proposal is different and carries unique risks to participants, care must be taken to make sure that the Informed Consent documentation used in each individual study satisfies all of the following provisions with regard to the specific research being conducted:
- A Description of the Informed Consent procedure
- Legally effective informed consent will be obtained from the participant or the participant's legally authorized representative prior to including the participant in research.
- Informed consent will be documented by the use of a written consent form, which is signed by the participant or the participant's legally authorized representative.
- A copy of the consent document will be given to the person signing the form.
- The participant will be given opportunity, without coercion or undue influence, to consider whether or not to participate.
- Information given to the participant will be in language understandable to the individual.
- The informed consent should not contain any language that waives or appears to waive the participant's legal rights, or releases or appears to release the researcher, the sponsor, or the College from liability for negligence.
- Statement about the type of consent form to be used: Written or Oral Consent
- A Written consent document:
- contains the elements as listed in (ii) below (A Sample Informed Consent document…)
- will be read to or by the participant or participant's legally authorized representative
- will be signed by the participant or participant's legally authorized representative
- An Oral ( “Short Form”) consent document:
- states that the elements of informed consent have been presented to the participant or participant's representative
- duplicate documents, one kept by participant and one retained by the researcher, must both be signed by the participant or their representative, a witness, and the investigator
- A Sample Informed Consent Document that includes the following:
- a statement that the study involves research
- an explanation of the purposes of the research
- expected duration of the individual's participation in research
- description of procedures to be followed
- description of risks or discomforts to the participant
- description of any benefits to participant or others
- disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant
- statement regarding confidentiality
- for research involving more than minimal risk: a statement regarding compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained
- contact information for questions about the research or in the event of injury
- statement that participation is voluntary
- statement that participant may discontinue participation at any time without penalty
- Additional elements as appropriate:
- A statement that the particular treatment or procedure may involve risks to the participant which are currently unforeseeable
- Conditions under which the individual's participation may be terminated by the investigator without regard to the participant's consent
- Any additional costs to the individual that may result from participation in the research
- The consequences of a participant's decision to withdraw from the research and procedures for their orderly termination of participation
- A statement that significant new findings developed during the course of the research, which may relate to their willingness to continue participation, will be provided to the participant
- The approximate number of participants involved in the study
The following factors must be taken into account when writing a consent document.
The consent form/information sheet must be written in language “understandable to the participant”. The IRB reviews consent forms very carefully to ensure that they would be understandable to a wide audience. Key elements to consider when writing a consent form are:
- It should be written at no higher than an 8th grade level (similar to a popular magazine or newspaper; language copied out of a grant or proposal is not appropriate).
- It should be written in the second person (“you are invited to participate, you will be asked to give a blood sample…”)
- It should be written as if the author and the reader are engaged in conversation.
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.
Anonymous and Confidential Data
Participants should not be promised anonymity unless the research data is truly anonymous. Anonymity cannot be guaranteed unless there is no method by which the investigator can connect the research results with individual participants providing the data. If there are codes or a master list that would enable the investigator to identify participants, the research is not anonymous even though the participants' names do not appear in the research data. In this case the IRB would consider the data to be confidential. More information about anonymous online surveys can be found here.
When doing research which does not easily fit with the sample informed consent documentation, researchers should consider composing their own consent documents. The documents below contain different versions of language for each of the major sections of the consent document, identified by the varying research circumstances that would indicate their usage.
Information About the Research
HIPAA language at a 7th Grade Reading Level (where applicable)
Compensation for Injury
There are many ways in which research studies are conducted that require extra attention to the protection of the rights of the participants. If you answer any of the following questions in the affirmative, it is likely that you will need to add additional or specialized language to your consent document. Please follow the links embedded in each question to read more on guidelines relating to your specific research project.
- Does your study use participants who are minors (under 18 years old)?
- Does your study use participants who are members of special populations (e.g. prisoners, decisionally impaired individuals, economically disadvantaged)
(see here for more information on which groups are considered vulnerable)
- Will you be making audio or video recordings of participants?
- Will you research be taking place in a foreign country?
- Are there barriers to consent, either language-related or physical, that apply to your participants?
- Will the requirement for written consent hinder or prevent your research with certain populations?
- Will it be necessary to protect your participants' identity from being subpoenaed?
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All research participants under the age of 18 or not enrolled in college must provide written parental (or guardian) consent in order to participate in College-sponsored research projects.
In addition, an assent form must be signed by those participants capable of understanding a simplified version of the consent form, and signing their names. A copy of both the consent and assent forms must accompany the proposal. For participants too young to read, but who are capable of understanding an oral explanation of the procedures, a copy of the oral explanation (a script) must accompany the proposal. The age, maturity, and psychological state of the participants must be taken into account by the researcher when creating an assent form or an oral explanation for minors.
Written Assent: From age 7 and up, a child's written assent is needed (in addition to parental or guardian consent). The assent form should be written in a way the minor participant can understand. For participants 7-13 years old, follow the assent form sample provided. For participants aged 14-17, follow the format of the standard consent form as these participants will be old enough to understand the language of this form. The researcher should use supplementary verbal explanations as needed.
Oral Explanation: For participants who are 6 and younger, the researcher should obtain the child's assent to participate, but a signature is not required. The explanation to the child should contain elements of consent expressed in a way the child can understand. A conversational question/answer setting is often the most useful form of communication. With very young children, the child's nonresistant behavior may be interpreted as assent, but the researcher must use special care to discontinue the participation of any child who appears to experience undue stress from the research procedure.
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 (see here for more information on which groups are considered vulnerable). Participants in these categories need not be excluded from research; rather, 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.
Besides children, numerous other 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 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 when used as research participants. Researchers wishing to use these populations as research participants must contact the IRB 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 falling in the special/vulnerable populations category.
The consent form should clearly state if the research involves the use of video or audio taping of participants. In addition, there should be a statement about how the recordings will be used and how long they will be kept. This statement should include who will see/hear the recording and where it will be used (e.g., in a classroom, professional meeting). If the investigator wants permission for the recording to be viewed/heard by anyone other than the research staff, or if it involves sensitive material, participants should also be given an opportunity to view (or listen to) the recording after it is completed. Permission for the tape to be used should then be obtained. The consent form must also clearly state who will transcribe the tapes and, if third-party transcriptions will be used, what steps will be taken to protect participant confidentiality.
Field research done outside of the United States, 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, the investigator must provide the IRB with a statement of the reasons why it should waive written consent, and also provide an acceptable alternative method of obtaining oral consent, which is appropriate to both the participants and their culture.
If the participants may be economically or educationally disadvantaged, the investigator should pay particular attention to these issues and ensure that appropriate safeguards have been implemented.
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 IRB review. Any translators 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 IRB to waive or alter some of the elements of consent.
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 informed consent.
The IRB may waive part or 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 IRB 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 IRB 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 IRB. The IRB 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.
Exemptions from Written and Oral Consent
Some research which qualifies for Exempt review status does not require the use of an informed consent document. If you are submitting a proposal which you believe meets the criteria for Exempt status, you may request an exemption from the Consent requirement in the appropriate section in the proposal form.
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.