Participant Consent Template with Waiver of Confidentiality Informed Consent
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.
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 Forms and Templates page includes templates for informed consent documents.
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.
Key Elements 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.
Key Elements of Informed Consent Documents (should match what you have indicated in the protocol questions)
- 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
Anonymity
Participants are guaranteed anonymity when there is no way for the investigator to link the data to the identity of the participant. Online surveys typically involve anonymous participation.
- Participants should not be promised anonymity unless the research data is truly anonymous. 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.
Confidentiality
Most investigators guarantee confidentiality to their participants. In this case, only the investigator knows the identity of the participant and their de-identification protocol ensures participant identities will not be disclosed in any report, presentation, or website.
Waiver of Confidentiality
In some cases, investigators ask participants to consider giving consent for their identity to be published with their data. This is common in oral history projects or when the person's identity is integral to the research. In the studies that use this option, most investigators will guarantee that the participants will have a chance to review the interview transcript or final paper and either approve, reject or revise anything that pertains to them. If you are considering this option, please review the written consent template below.
Language Level
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 7th 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.
Non-English-Speaking Participants
All study documents should be submitted to the IRB in English. Investigators are responsible for making sure all translated documents accurately reflect what is approved by the IRB.
If you are hiring a translator or guide to help with communication during interviews, they must sign a confidentiality agreement in order to protect the information disclosed by participants.
Record keeping
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.
Study-Specific Concerns
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.
- Does your study use participants who are minors (under 18 years old)? Review the Research Involving Children page.
- Does your study use participants who are members of vulnerable populations (e.g. prisoners, decisionally impaired individuals, economically disadvantaged)? Review the Vulnerable Populations section.
- Will your research be taking place outside of the US? Review the International Research page.
Information to help with the following situations is included below:
- Will you be using focus groups?
- Will the requirement for documentation of written consent hinder or prevent your research with certain populations?
- Will you be making audio or video recordings of participants?
- Will it be necessary to protect your participants' identity from being subpoenaed?
- Will you be collecting biospecimens (i.e. saliva, blood, breast milk, or sperm)?
Researchers cannot guarantee the confidentiality of all information that is shared during a focus group because the other participants may disclose what they learn to others after the meeting. Focus group consent forms must acknowledge this limit to confidentiality with a statement similar to the one provided below.
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“Please be advised that although the researchers will take every precaution to maintain confidentiality of the data, the nature of focus groups prevents the researchers from guaranteeing 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.”
Researchers may also choose to add a non-disclosure statement to the consent document above the signature prompt.
- "I agree to maintain the confidentiality of the information discussed by all participants and researchers during the focus group session."
Investigators may request approval to use oral consent instead of written consent. This is appropriate if participants have limited literacy or if written consent would be culturally inappropriate or unexpected.
Required elements of standard oral consent:
- An oral consent script for what the investigator plans to say to the participant (submit with IRB proposal).
- The participant or their legal representative’s signature agreeing that the basic consent form elements have been orally presented. The participant must receive a copy of this form.
- A third-party witness’ signature agreeing that the basic consent form elements have been orally presented.
For studies deemed “minimal risk,” the IRB may approve a process that:
- Waives the requirement to obtain informed consent (e.g., secondary analyses of existing data).
- Alters some or all of the elements of informed consent (e.g., study involves deception, requirement to obtain parental consent for participation of a child where that consent could harm the child).
- For studies that involve deception, participants must be debriefed, either orally or in writing at the end of the study. This debriefing should explain the deception and why it was necessary. The deception should never interfere with the participant’s ability to make an informed decision about participating in the study (e.g., by withholding crucial information about the potential negative impact of the study procedures).
- Studies involving minors in which obtaining parental consent could raise the risk to the minor must include another mechanism that will provide the informed consent of an adult (e.g., appointing a child advocate).
- Waives the requirement to obtain the participant's signature to document informed consent(e.g., interviews or surveys where only the consent document contains identifying information, international settings in which requesting a signature is not culturally appropriate).
- In all cases, participants should still be given all information necessary for them to make an informed decision about participating in the study.
- The completion of the interview, written survey, or online survey may serve as indications of participant consent.
Relevant Templates:
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.
Certificates of confidentiality are issued by the National Institutes of Health (NIH) and other HHS agencies. A certificate of confidentiality 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).
The NIH recommends that investigators submit their request at least three months before they plan to begin recruitment (see NIH FAQ). For more information on Certificates of Confidentiality, their limitations, and NIH contacts, see OHRP's Guidance on Certificates of Confidentiality and NIH's Certificates of Confidentiality page.
If research involves the collection of biospecimens, one of the following statements should be included in the consent document (as stated in 45 CFR 46, 46.116- General Requirements for Informed Consent):
- A statement that identifiers might be removed from identifiable biospecimens and that, after such removal, the biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
- A statement that the subject's biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
Additionally, the following should be disclosed if applicable to your study:
- biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
- whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
- whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).