For more information on Informed Consent see IRB Policies and Procedures.
“Informed consent is more than just providing a prospective participant with a form to sign. Informed consent is a process” that stems from the requirement for Respect for Persons one of the three most important principles of conducting research with human participants. (See the Belmont Report: Respect for Persons). The informed consent process is an interaction between the prospective participant and the Principal Investigator, student investigator or other designated qualified, key personnel (hereafter referred to as the “PI”). During the process, the research study is explained to the participant so that the participant can make an informed decision about whether or not to participate in the research study. This common sense process involves having a conversation with the prospective participants to ensure that the participant understands the research study and the reasons why the study is being conducted as well as the risks and benefits of the research. The conversation must allow the participant sufficient time to ask questions and to consider whether to participate in the study. This conversation must also take place in a setting that affords a sufficient level of privacy for the participant. The informed consent process is most often documented by the use of an IRB approved and validated informed consent form. The person obtaining consent must be trained in human subject protection, have an in-depth knowledge about the research study and be able to answer all questions posed by the participant.
Before beginning the conversation, the PI should discuss with the participant whether any special provisions will be needed for the consent process to take place. For example, hearing impaired individuals may want a sign language interpreter present or individuals with dyslexia may prefer to have the document read to them. The informed consent process should also be specific to each participant population and must take into consideration the participant’s native language, level of education, and maturity. Non-English speakers, educationally disadvantaged and minors are among the populations considered to be vulnerable. The IRB will look to see that the PI has taken this into consideration throughout the consent process.
Informed consent is an on-going process and this is particularly important for longitudinal studies. The PI should be available to answer participants questions at all times. In certain circumstances, it may be appropriate to remind participants of the purpose of the study and to remind them of the study procedures that will take place in the future. For example, longitudinal studies that require completion of multiple assessments over several weeks or several months should be accompanied by a brief informed consent document, not necessarily one that must be signed, to explain the research and the study procedures that must be completed at the point in time the assessment is to be completed.
The informed consent process should also take place in person. The IRB may, for extenuating circumstances or minimal risk studies, consider the possibility of obtaining consent by phone or fax.
Consent must be obtained prior to any involvement of the participant in a study. All consent forms must include instructions for the participants as to whom to contact regarding research related questions, the PI/research team members, research related injuries (if applicable) and how to contact the IRB regarding their rights as a research participant.
In general, participants must consent to any screening procedures as well as to participation in the study. The PI may choose to use two different forms or to use one form that includes both phases. Participants are considered enrolled at the time of signing the consent form. Participants must be informed that they may be withdrawn if it is determined that they do not meet inclusion criteria. Participants who did not meet the screening criteria are to be reported as withdrawals from the study at the time of continuation. Note that there are certain exceptions to obtaining consent prior to screening. Please contact the IRB Office for more information.
Consent from individuals other than the participant may need to be obtained if investigators seek information about people who are not principals to the research (“secondary participants”). These people could be members of the principal participant’s family, friends, sexual partners, co-workers, etc. Such individuals may be participants in their own right, even if the investigator never has any contact with the individual. The federal regulations define a human participant not only as someone with whom the investigator interacts, but also as someone about whom the investigator seeks information.
As explained in the federal law that governs research with human participants, the informed consent process and document must contain certain required elements. Most of the elements involve basic, common sense information – information that most people would want to know in any situation before deciding to participate. Consider the following scenario involving a decision to go to see a movie. It begins with your friend inviting you out for the night. The purpose of going out would be to see a movie. Your friend will naturally explain the procedures for the evening; suggesting the name and location of the movie and the time to leave so you will be able to go out to dinner but make it to the movie in time to see the previews. You may be hesitant about going out because you have had a tense day at work and you consider that one of the benefits of going out would be a relaxing evening. Even if the evening is relaxing, you consider that a possible inconvenience (or risk) may be giving up the time to do something else. Of course, the deal is even sweeter when your friend insists on paying for the movie so that you don’t have to worry about any economic considerations for the evening. After weighing the fun you’ll have going to the movie versus staying home or doing something else, you decide to go to see the movie. You have made a voluntary decision to go to see the movie. Of course, this example is not research but it illustrates that the elements of the informed consent process are really common sense and that providing these elements for consideration enable people to make an informed decision about whether or not to participate. For a complete explanation of the required elements of the informed consent process refer to the informed consent document templates and the IRB Policies and Procedures document.
The informed consent process is most often documented by use of an IRB approved, validated consent form. Consent must be obtained from individuals who are at least 18 years old (or who, under their state’s laws are emancipated individuals) and who are competent to give informed consent. The PI must make a practical assessment of the participant’s capacity to understand the research, weigh the risks and benefits and make an informed decision about whether to participate.
Consent will most often be documented using a full length standard signed consent form that lists the required elements of consent. The participant (or the participant’s legally authorized representative) and person obtaining the consent (PI or delegate) must sign and date the form prior to study participation. The PI must provide the participant (or the participant’s legally authorized representative) with a copy of the signed and dated document.
When it is feasible, the PI or his/her delegate must sign and date the form in the presence of the participant. 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. An Information Sheet is similar to a consent form; it contains the same required elements but omits the signature section.
The IRB has prepared a number of informed consent templates. The templates should be used; however, the IRB will consider alternative formats (e.g. letter format) on a case-by-case basis. The PI must explain why the templates are not feasible for this research in the documentation of consent section of the IRB-1 or in the informed consent section of the IRB-5. The templates also provide guidance and suggested language that may be used to inform participants about the research study, the requirements for participation and the participants’ rights and responsibilities.
1.) The consent document must be written with language that is understandable 2.) It should include plain conversational language, at an 8th grade reading level, similar to the level used in popular magazines and newspapers to the participant population. 3.) Jargon and field specific terms should be avoided or if unavoidable must be defined. 4.) It must also be written in the second person (e.g., you are invited to participate, your child will be assigned, etc.). The IRB has tips on writing for lay audiences and Microsoft Word has a tool to assess readability. The consent document should be prepared with a font that is easy to read such as Times Roman, Arial, or Garamond and use a font size no smaller than 12 point. Instructions that accompany the informed consent templates also have additional suggestions for preparing the consent form.
In some circumstances, the IRB may waive or alter some or all of the elements of informed consent. A waiver or alteration of consent may be granted by the IRB when certain regulatory criteria under 45 CFR 46.116 are met.
The IRB must find and document the following:
- The research involves no more than minimal risk to the subjects;
- The research could not practicably be carried out without the requested waiver or alteration;
- If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
- Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
In all cases the IRB is required to find and document justification for any alteration to the requirements of consent.
As described earlier, the PI must make a practical assessment of the participant’s capacity to understand the consent discussion in order to be certain that the participant can give informed consent. This must be done in all circumstances even for minimal risk studies with participants who are not considered to be vulnerable. Such an assessment is also useful in order to gauge whether the participant may be able to understand and carry out the research procedures. The PI can facilitate this process by asking the participant open-ended questions that ask for explanations rather than closed ended answers that can be answered by a “yes” or “no” answer. For example: “Please tell me in your own words what we’re going to ask you to do?” vs. “Do you understand the procedures?”
The use of deception in research (e.g., participants are initially misinformed deliberately for purposes of the study) raises special issues that the IRB will review closely. One consideration is whether the deception is necessary. A PI proposing to use deception must justify its use in the procedures section of the IRB-1. Federal regulations prohibit the use of deceptive techniques that place participants at greater than minimal risk. The IRB may modify the informed consent process for research involving deception when participants are not placed at risk. However, potential participants should be advised in the consent form that the information they are given is not complete and that they will be debriefed after the research procedures are completed.
The debriefing should include a detailed description of the ways in which deception was used and the reason why deception was necessary in order to carry out the research. The investigator is responsible for ensuring that the participant leaves the research setting with an accurate understanding of the purpose of the research and why deception was used. The debriefing process, including any written materials, should be provided to the IRB as a part of submitted protocols. The following statement, or some similar statement, must appear in every consent form/information sheet for studies involving deception:
“Research designs often require that the full intent of the study not be explained prior to participation. Although we have described the general nature of the tasks that you will be asked to perform, the full intent of the study will not be explained to you until after the completion of the study. At that time, we will provide you with a full debriefing which will include an explanation of the hypothesis that was tested and other relevant background information pertaining to the study. You will also be given an opportunity to ask any questions you might have about the hypothesis and the procedures used in the study.”
It is possible to conduct an oral presentation of informed consent information in conjunction with providing 1) a short form written consent document stating that the elements of informed consent have been presented orally and 2) a written summary of what is presented orally. This procedure is most often used when a witness to the informed consent process may be required for certain vulnerable populations (i.e. educationally disadvantaged, illiterate or non-English speaking individuals or when the study is complex in nature. For example, the IRB may require that the entire consent process be witnessed by a research participant advocate, a representative of the IRB, research study personnel, a primary caregiver or other appropriate individual.
For participants not fluent in English, the consent process and document as well as study related documents (e.g., survey instrument, medical release forms) must be presented in a language (preferably native) understandable to them. If it is expected that participants who do not speak English will be enrolled in a study, translated documents should be made available. The IRB must review and approve all foreign language versions of the consent documents. The IRB recommends the use of one of two methods for translation. If one of the two recommended methods is not feasible, the IRB will accept certification from the PI that he/she or a member of the research staff translated the document and that the translation is accurate. This should be explained in the documentation of consent section of the IRB-1.
The informed consent process must also be conducted in a language understandable to the participant and may therefore require the use of a translator or sign language interpreter. In most cases, the translator may be a family member or friend of the participant, an employee of the institution or may be hired by the PI. The IRB will determine whether a professional translator is required on a case-by-case basis.
Common sense and IRB requirements dictate that participants must be reconsented if there have been developments that may affect a participant’s willingness to continue to participate. To continue the movie analogy given above, such developments may be a discovery that the movie may be scarier for the participant than anticipated or that the movie is sold out and another must be selected. Re-consent more commonly occurs in biomedical studies, but may occur in social and behavioral research in cases where participants in an on-going study are asked to provide consent for their data to be used for another research purpose or in cases where the PI has a need to retain data (de-identified) indefinitely. In most cases, re-consent can take place at the participant’s next regularly scheduled visit. In some circumstances, depending upon the level of risk and the nature of the information to be conveyed to participants, the PI or the IRB may require that participants need to be contacted immediately.
It should be noted that minor participants who are actively participating in a research study when they research the age of majority should be re-consented as adults at their next regularly scheduled visit.
In the State of Connecticut only individuals who are 18 years old (the age of majority, Conn. Gen. Stats. §1-1d) or older, may legally consent to participate in research. This legal authority may be withheld from some classes of individuals with limited decision-making or cognitive ability. Further, some individuals voluntarily give over this authority to another through a power of attorney or a health care proxy. Individuals who do not have the authority to consent to participate in research must still provide their “assent,” which may be in writing, oral or in some circumstances, by action or behavior, e.g., with very young children.
Assent is a knowledgeable agreement to participate in the project. It differs from “consent” which is recognized as being granted from an individual with the legal authority to do so. Children cannot legally give consent; however, they can provide assent. Adequate provisions should be made for soliciting the independent, non-coerced assent from children or cognitively impaired persons who are capable of a knowledgeable agreement. In cases where assent is obtained from a child or cognitively impaired participant, permission must also be obtained from parents or legally authorized representatives. In accordance with the ethical principal of respect for persons, if the person from whom assent is sought refuses, the person should not be enrolled, even if the parents or legally authorized representatives give permission. Alternatively, if the person from whom assent is sought agrees to participate, the person may not be enrolled if the parents or legally authorized representatives do not give permission. In rare circumstances, depending on the nature of the study and the age and circumstances of the child or decisionally impaired person, the IRB may waive the requirement for permission from parents or legally authorized representatives.
The IRB will determine whether one or both parents must sign a parental permission form. The IRB may find that permission from one parent (or legally authorized representative) is sufficient for research involving no greater than minimal risk or for research involving greater than minimal risk but holding out the prospect of direct benefit to the participant.
As a general guideline, if the participant is 12 years of age or older, the child signs and dates an assent signature line on the parental permission form and a parent or guardian signs the same form. Note that the language used to describe the consent form has changed. Parents give their permission, not their consent, for their child to participate. In certain circumstances, the PI may propose or the IRB may require that a separate assent statement is necessary. For example, the PI may wish to reinforce the voluntary nature of participation and the nature of the study with minor participants in studies taking place at a school where the parents have already given permission of the minor participant to participate in the study.
If a separate assent form is required, both the form and the assent discussion with the participant should be in a language especially tailored for participant, i.e., age appropriate and should describe the following:
- Explain why the study is being conducted;
- Describe what will happen and for how long or how often;
- State it is up to the child/individual to participate and that it is okay to say no;
- Explain if it will hurt and for how long and how often;
- Say what the child’s/individual’s other choices are;
- Describe any good things that might happen;
- Say whether there is any compensation for participating; and,
- Ask for questions.
The assent form should be limited to one page. Illustrations might be helpful and larger type makes it easier for some individuals to read. In studies involving older children or adolescents it may be possible for the child to read and indicate their written assent on the assent form.
If the child is between 7-12 years of age, and the study is a therapeutic trial, the parent signs the parental permission form and the child participant does not have to sign. If the study is not a therapeutic trial, the parents or guardians sign the parental permission form and the participant signs an assent statement that is either included at the end of the parental permission form after the signature lines or as a separate document.
If the child is less than 7 years of age, the parent or guardian signs the parental permission form, the participant signs nothing. No written assent statement is required; however, the PI should provide a script that will be followed to describe the study to participants. However, the PI or person obtaining consent must document in the study record that the child was willing to participate.
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 PI 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 (refer to Ethnographic Research section).
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.
A certificate of confidentially protects the participant’s confidentiality by protecting identifiable research records from subpoena. The certificate goes 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 (often as part of a criminal investigation of the participants). Regardless of a study’s funding source or whether it is funded, Certificates of Confidentiality are issued by the National Institutes of Health (NIH) and other Department of Health and Human Services (HHS) agencies. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in civil, criminal, administrative, legislative, or other proceedings, whether federal, state, or local.
The IRB has prepared language to explain Certificate of Confidentiality requirements in the consent form. Either this or similar language must be used when the PI obtains a Certificate of Confidentiality.