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
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.
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.
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.
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.
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.
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)?