Skip to main content

Informed Consent Process

Informed consent is one of the primary ethical requirements underpinning research with human subjects; it reflects the basic principle of respect for persons. Informed consent is an ongoing process, NOT strictly or only a form, script or specific moment in time. Informed consent helps to ensure that prospective as well as actively and previously participating human subjects understand the nature of the research, and that their participation is wholly voluntarily.

Any research involving human subjects requires that researchers honor and adhere to informed consent requirements. At FSU, the informed consent process is governed by FSU Policy 7-IRB-0 (University Human Subjects Policy) located on the FSU Regulations and Policies web page. Select informed consent procedures for which researchers are responsible are specified in HRP-090 -  SOP - Informed Consent Process for Research, located here in RAMP IRB or on the OHSP Policies and Procedures web page (under "Investigator Procedures").

Informed Consent Requirements: Below are listed the key federal regulatory requirements for informed consent; depending upon study aspects, including e.g., the nature of the research, study procedures, risks involved and the study sample, additional as well as stricter regulatory requirements may apply.

General regulatory requirements:

(1) Before involving a human subject in research covered by this policy, an investigator shall obtain the legally effective informed consent of the subject or the subject’s legally authorized representative.

(2) An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.

(3) The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative.

(4) The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.

(5) (i) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
(ii) Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject’s or legally authorized representative’s understanding of the reasons why one might or might not want to participate.
(6) No informed consent may include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

Basic regulatory elements of informed consent. The following information shall be provided to each subject or the subject's legally authorized representative:

(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental;

(2) A description of any reasonably foreseeable risks or discomforts to the subject;

(3) A description of any benefits to the subject or to others that may reasonably be expected from the research;

(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

(6) For research involving more than minimal risk, an explanation as to whether any 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;

(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject;

(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and

(9) One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens: (i) A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or 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
(ii) A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

Additional regulatory elements of informed consent. One or more of the following elements of information, when appropriate, shall also be provided to each subject or the legally authorized representative:

(1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable;

(2) Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s or the legally authorized representative’s consent;

(3) Any additional costs to the subject that may result from participation in the research;

(4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;

(5) A statement that significant new findings developed during the course of the research that may relate to the subject’s willingness to continue participation will be provided to the subject;

(6) The approximate number of subjects involved in the study;

(7) A statement that the subject’s 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;

(8) A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and

(9) For research involving biospecimens, 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).

 

OTHER Important Topics regarding Informed Consent

Exculpatory Language in Informed Consent Documents:

Federal policy provides that no informed consent, whether oral or written may include any exculpatory language, through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence. OHRP and the FDA have applied a broad interpretation to the exculpatory language prohibition, as opposed to a narrow reading. In general, exculpatory statements relate to the releasing of liability or fault for wrongful acts. An example of an acceptable clause in a consent form would be:

  • The Institution has no policy or plan to pay for any injuries that you might receive as a result of participating in this research protocol; or
  • This institution is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research.

An example of unacceptable language would be the following: 

I understand that I will not sue the sponsor or investigator for any negligence; or Subjects agree to hold harmless the institution, investigators, and sponsors affiliated with or in any way a part of this research protocol.

Waiver of Informed Consent:

The federal regulations do permit the IRB, under very limited circumstances, to approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB unambiguously finds and documents that:

  • the research involves no more than minimal risks to subjects;
  • the waiver or alteration will not adversely affect the rights and welfare of the subjects;
  • the research could not practicably be carried out without the waiver or alteration; and
  • whenever appropriate, the subjects will be provided with additional pertinent information after participation.

A waiver of informed consent may also be approved on certain research and demonstration projects designed to study public benefit or service programs as specified in the regulations. A sample waiver form is provided on the webpage, and should be submitted at the time of IRB application submission.

Waiver of Documentation of Informed Consent:

The IRB is also permitted by federal regulations, again only under very limited circumstances, to waive the documentation of informed consent (the use of a written consent form), provided that the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality as described in the regulations; or that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context. In cases in which the documentation requirement is waived, the IRB may require the researcher to provide subjects with a written statement regarding the research.

Waiver of Consent in Emergency Medicine Research:

Federal regulations provide criteria for the waiver of consent in emergency medicine research. The regulations are applicable to only a narrow class of research activities, and the waiver is explicitly excluded when the research involves certain protected research populations such as fetuses and pregnant women.

Parental Permission and Child Assent:

The consent process for research involving children requires that parents or legal guardians give permission for their children to become research subjects. The children, as appropriate for their developmental stage, provide assent. Assent is an individual's voluntary, affirmative agreement to participate in research. A participant's failure to object cannot be construed as assent. As with all consent processes, the parental permission and child assent processes must include all of the information that potential participants need to make an informed decision. Permission and assent forms/materials must be presented in the appropriate language and reading level and the voluntary nature of participation must be made clear.

In Florida, the legal age of consent for research is 18 years of age (there is an exception in the emancipated minor laws - see section entitled "Florida Law"). Usually, children aged seven (7) or above have the ability to read a simple assent form, adjusted for developmental stage, to agree to participate in a research project. A verbal script is permitted by the IRB whenever children are involved, as appropriate. Assent scripts should be brief, to the point, and at a language level appropriate to the participant. Examples of parental permission forms and assent forms are provided.

Waiver of Parental Permission:

Federal regulations provide four basic criteria for waivers of any of all of the elements of informed consent. The same criteria apply to waivers of parental permission (and also to child assent). In order to waive or alter any or all of the elements of informed consent, the IRB must find and document that all of the following criteria have been met:

  • the research involves no more than minimal risk to the subjects;
  • the waiver or alteration will not adversely affect the rights and welfare of the subjects;
  • the research could not practically be carried out without the waiver or alteration (inconvenience and expense are not acceptable factors - scientific validity would be acceptable);
  • whenever appropriate, the subjects will be provided with additional pertinent information after participation.

"Passive" Consent and Parental Notification:

"Passive Consent" has been used in school based research in response to the challenges of securing prior written permission from parents. The passive consent process involves notifying parents that research will take place and giving them an opportunity to state that they do not want their children to participate. Thus, if parents do not affirmatively indicate that they do not extend such permission, they might be considered to have provided such permission. However, the passive consent process is not equivalent to informed consent, and the IRB will consider such process to constitute a waiver of parental permission to which waiver only the IRB can grant.

The federal regulations require that parental or guardian permission for children to participate in research must be secured or waived in accordance with the four criteria provided in the regulations. On a very practical level, sending notice does not mean that notice is received for a variety of reasons, including parents' inability to read. The parental notification process can be used to provide parents with the option to remove their children from research, but only if the requirement for parental permission has been waived by an IRB.

Child Abuse and Neglect:

Some research has the potential to reveal child abuse and neglect. A study about behaviors for at-risk children might do so, and study about art and reading abilities would probably not touch on this possibility. If the potential does exist, then researchers should inform parents and older children during the informed consent process that the confidentiality they can provide is limited by Florida's child abuse reporting requirements.

Witness Signature on the Consent Form:

Federal regulations do not require a witness signature when the research uses a standard informed consent document that embodies all of the required elements of informed consent. Nor do the regulations require the investigator's signature when a standard consent document is used. Federal policy only requires that the consent document is signed by the subject or the subject's legally authorized representative. However, a witness is required when the IRB authorizes the use of a short form written consent document. In this situation, the witness should observe the oral presentation, sign the short form consent document, and sign a copy of the summary of the oral presentation approved by the IRB. In addition, the subject or legally authorized representative must also sign the summary and the short-form consent document. FSU follows this same federal policy.

Deception of Research Subjects:

Deception relates to research in which the subject is intentionally deceived about research participation. Deception is often used in studies that evaluate fundamental aspects of human behavior. The rationale for deception is that it is not possible to obtain accurate information about how people behave when they know that they are being observed or evaluated. The American Psychological Association explicitly states that:

Psychologists do not deceive prospective participants about research that is reasonably expected to cause physical pain or severe emotional distress. APA Ethical Principles of Psychologists and Code of Conduct. Effective June 1, 2003.

The IRB will review whether the procedures are potentially of a nature such that they would cause distress sufficient to cause a participant to withdraw from the study if they were known in advance. The fact that all participants are informed that they may choose to withdraw from a study at any time for any reason does not reduce the responsibilities of the researcher. At the conclusion of the experiment, it is the researcher's responsibility to institute procedures to alleviate any discomfort that was experienced during the course of the study. Although participants may not be fully informed, they should be informed of as much as possible without compromising the ability of the research to test the true hypothesis of the study. A recommendation is that the consent form should never be used as part of the deception and should not include anything that is untrue. In some research, it may be advisable to reveal to participants that possibility of deception in the consent form.

Research Involving Decisionally Impaired Persons:

The researcher needs to provide a consent form to ask the research subject's legally authorized representative for consent to the participation of the research subject. An assent form should also be provided to the research subjects, depending on whether the subjects are capable of assenting. Under Florida law, several classes of persons can consent for incapacitated/incompetent adults. See the section entitled Florida State law for the list, which is in order of who has the greatest legal authority to consent for an incompetent adult. Consent should be sought first from the person at the top of the list. If the first reasonably available person refuses consent, that refusal is final.

Confidentiality in the Consent Form:

After the IRB has decided that there are adequate provisions in the research plan to protect the privacy and confidentiality of the subjects, it must also ensure that the consent form accurately provides the subject with information concerning the confidentiality of the research records. This allows the subject to make his/her own determination of whether the provisions for protecting privacy and confidentiality are adequate to participate in the proposed research. A basic element of consent is that each subject be provided with a statement describing the extent if any, to which confidentiality of records identifying the subject will be maintained. The FDA also requires the subject be provided with a statement also describing the possibility that the FDA may inspect the records.

Certificate of Confidentiality:

Certificates of Confidentiality (CoC) can serve to promote recruitment in studies requiring disclosures of sensitive personal information, and the IRB can suggest that investigators apply for them when appropriate. CoCs are automatically deemed to be issued for any NIH-funded research that collects or uses identifiable, sensitive information that was on-going on or after December 13, 2016. For these projects, the CoC is issued as a term and condition of the award, and NIH does not issue a physical certificate (see this NIH CoC link).

Fo studes that are not NIH-funded, an investigator should consider applying for a certificate on research topics which are likely to be subject to legal proceedings or risk and for research that may involve the use or disclosure of sensitive personal information. In some cases, the IRB may require investigators to obtain a CoC. The website of the OHRP contains information about contacting different agencies to obtain Certificates of Confidentiality. As long as a certificate is in place when a subject enrolls in a study, the protection provided by the certificate is permanent. Information identifying the subject will never be disclosed unless it is volunteered by the subject or investigator.

CoC Consent Language: when a CoC is issued for any study, a statement to the following effect MUST be included in the consent form:

This research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means that the researchers cannot release or use information, documents, or samples that may identify you in any action or suit unless you say it is okay. They also cannot provide them as evidence unless you have agreed. This protection includes federal, state, or local civil, criminal, administrative, legislative, or other proceedings. An example would be a court subpoena. There are some important things that you need to know. The Certificate DOES NOT stop reporting that federal, state, or local laws require. Some examples are laws that require reporting of child or elder abuse, some communicable diseases, and threats to harm yourself or others. The Certificate CANNOT BE USED to stop a sponsoring United States federal or state government agency from checking records or evaluating programs. The Certificate DOES NOT stop disclosures required by the federal Food and Drug Administration (FDA). The Certificate also DOES NOT prevent your information from being used for other research if allowed by federal regulations.

Researchers may release information about you when you say it is okay. For example, you may give them permission to release information to insurers, medical providers, or any other persons not connected with the research. The Certificate of Confidentiality does not stop you from willingly releasing information about your involvement in this research. It also does not prevent you from having access to your own information.