Requirements of Informed Consent

PLEASE NOTE: The CITI Program Training provides information on informed consent.  This document supplements that training and provides the specific requirements established by the St. Lawrence University’s Institutional Review Board. 

If you have any questions or concerns about informed consent, please contact the IRB chair, Dr. Cathy Crosby, at ccrosby@stlawu.edu or (315) 229-5167.

What is Informed Consent?

The following quote from the U.S. Department of Health and Human Services, Office for Human Research Protections (OHRP), provides an excellent overview of the purpose and content of informed consent.  Please read this quote as you consider your own informed consent process:

"The requirement to obtain the legally effective informed consent of individuals before involving them in research is one of the central protections…This requirement is founded on the principle of respect for persons… [which] requires that individuals be treated as autonomous agents and that the rights and welfare of persons with diminished autonomy be appropriately protected…The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research…The informed consent process is the critical communication link between the prospective human subject and an investigator, beginning with the initial approach of an investigator to the potential subject (e.g., through a flyer, brochure, or any advertisement regarding the research study) and continuing until the completion of the research study.

The informed consent process should be an active process of sharing information between the investigator and the prospective subject…Prospective subjects should be provided with ample opportunity to ask questions and seek clarification from the investigator. The     prospective subjects should be in a position to freely decide whether to initially enroll in the research, or later, to withdraw or continue participating in the research. The informed consent process should ensure that all critical information about a study is completely disclosed, and that prospective subjects or their legally authorized representatives adequately understand the research so that they can make informed choices.

The procedures used in seeking and obtaining informed consent should be designed to communicate with the subject population in terms that they can understand. Information about a research project must be presented in such a way that enables each person to voluntarily decide whether or not to participate as a research subject." (http://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-con...)

Information Necessary in All Informed Consent Statements:

For all research studies, a legally effective informed consent statement must include the following:

  • ­Name, title, affiliation, address and phone number of the Principal Investigator(s) and the names of all collaborators.  If the research is conducted as part of a course, the course name must be provided.  NOTE: typically, student contact information should not be included.
  • Statement that the study involves research
  • Procedure/methodology to be followed
  • Purpose of the study
  • How the data will be used (e.g. a student research report, publication in a scholarly journal)
  • Form of published results; typically, data will be reported in the aggregate only, but sometimes direct quotes or specific data points may be reported; see the discussion below regarding confidentiality
  • Statement regarding the confidentiality of the data and who will have access to the data.  Confidentiality refers to the privacy of the raw data the participant is providing.  Raw data can include completed questionnaires, recordings, transcripts of interviews or focus groups, or behavioral records.  If verbatim responses will be reported (e.g., direct quotes from an interview or focus group), provisions for protecting the privacy of the participants must be discussed, such as the use of pseudonyms.  Confidentiality is particularly important when data will not be anonymous; see discussion of anonymity below.   
  • Measures to protect the security of the data while it is being collected and afterwards
  • Expected duration of the participant’s involvement
  • All potential risks to the participant and benefits
  • Statement that the participant’s participation is voluntary
  • Statement that the participant may withdraw from the study, or any activity which is part of the study (e.g., refuse to answer any specific question or questions or engage in any particular activity), and the specific requirements/limitations regarding that withdrawal (e.g., anonymous data cannot be withdrawn after it is submitted.)  If there are consequences of withdrawal, those need to be specified.
  • Explanation of how the participant can withdraw his or her participation
  • Offer to answer any questions the participant may have about the study at any time, including after the completion or his or her participation, by contacting the PI.  NOTE: typically, student researchers should not be the contact person for this purpose.
  • Statement that the participant must be 18 years of age or older to participate.  See the special instructions below if your participants will be under 18 years of age or unable to render competent informed consent for other reasons. 
Information Necessary in Many Informed Consent Statements:

Many research projects will also require the following in their informed consent statements:

  • Statement regarding the anonymity of the data and how anonymity will be guaranteed: 

Data are anonymous only if the identities of participants could never be connected to their responses in any way, through direct or indirect means.  For example, interviews and focus groups are almost never anonymous because the person collecting the data sees the speaker.  Researchers who cannot provide anonymity can usually provide confidentiality of the participants’ identity, which should be discussed.

  • Space for the signature of the participant with the date:

Participants must engage in an affirmative action to indicate their consent to participate.  Therefore, a signature is typically required as that affirmative act.  However, if the study involves completing a survey, the participant is engaging in implied consent when her or she begins to complete the survey.  In these circumstances, a signature should not be obtained to protect the privacy of the participant’s identity.

  • Separate space for a signature with date indicating consent to be recorded, if the participant’s responses will be audio or video recorded 
  • Information on how and when the participant can obtain a summary of the results of the study after its completion from the PI:

Allowing participants an opportunity to learn about the results of the study helps to fulfill the ethical principle of beneficence.  Therefore, participants should be provided with the opportunity to obtain a summary.  The researcher must provide a rationale in the IRB proposal if this opportunity is not provided.

Other Important Issues Regarding the Informed Consent Process:
  • Two copies of the informed consent statement are needed: One copy will have the participant’s signature and is for the researchers’ records.  This copy needs to be retained for three years and kept in a secure location.  The second copy is for the participants; it contains information the participants will need after they complete their participation. 
  • If your participants are expected to be under 18 years of age, the parent or legal guardian will provided consent for participation.  If that individual consents, the minor participant must also assent to participate.  Although the requirements of assent will differ depending on the age of the participant, the process must ensure that the minor’s participation in the research is voluntary.  If your participants are over 18 but have developmental or intellectual disabilities, you may need to obtain consent of a legal guardian/parent.
  • Participants should always be referred to as “participants” not “subjects.”  As a researcher, you should respect the autonomy and self-determination of the individuals who are providing you with your necessary data.  Referring to them as “subjects”—beings on whom you are subjecting your procedures—lessens that sense of respect.  They truly are participants, because without their participation, you would have no research.
  • The informed consent statement must be written in the participants’ primary language.  In their IRB proposal, the researchers must include the informed consent statement in the participants’ language as well as the English translation.
  • If some participants are likely to be illiterate or too young to read, the researcher should read the informed consent statement to all participants.  The researchers should always treat participants with respect.  In addition, informed consent must be competent and informed.  Reading the statement to all participants in this situation avoids any potential embarrassment or misunderstanding by the participants.
  • Retroactive informed consent is not possible.  On occasion, researchers will collect data that is exempt from IRB approval and involves no informed consent process, but we later want to use the data for purposes that would require IRB approval of the research.  Given the nature of informed consent, it must happen prior to data being collected because the participants might decline participation.  Hence, research cannot receive retroactive IRB approval if no informed consent was obtained at the time the data were collected.