HRPP Policy - Informed Consent

Unless altered or waived by the IRB, the following information shall be provided to each prospective subject or LAR.  The IRB may require that additional information be given to subjects when, in the IRB’s judgment, the information would meaningfully add to the protection of the rights and welfare of subjects.

• 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
• A description of any reasonably foreseeable risks or discomforts to the subjects. If relevant animal data are available, the significance should be explained to potential subjects
• A description of any benefits to the subject or to others that may reasonably be expected from the research
• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
• A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained, including a statement that notes the possibility that specific regulatory authorities (e.g., HHS, FDA, ED, DoD, DOJ), as applicable, may inspect the records
• For research involving more than minimal risk, an explanation as to whether any compensation and any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained
• An explanation of whom to contact to obtain information or offer input about the research, to discuss problems, concerns, and questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject
• 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. Language limiting the subject’s right to withdraw from the study is not permitted.
• One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
  • 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 researcher for future research studies without additional informed consent from the subject or LAR, if this might be a possibility; or
  • 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.

Unless altered or waived by the IRB, the following additional elements shall also be provided to each subject or the LAR, when appropriate:

• 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
• Anticipated circumstances under which the subject’s participation may be terminated by the research personnel without regard to the subject’s or LAR’s consent
• For studies involving payment for subject participation, a payment statement explaining details and any conditions of payment
• Any additional costs to the subject that may result from participation in the research
• The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject
• 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
• For greater than minimal risk research, the approximate number of subjects involved in the study
• 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
• 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)
• A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects and, if so, under what conditions

The following information must be provided when applicable:

• When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the following statement notifying the subject that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402 of the Public Health Service Act: “A description of this clinical trial will be available on ClinicalTrials.gov, as required by U.S. law.  This website will not include information that can identify you.  At most, the website will include a summary of the results.  You can search this website at any time.”
• If research personnel have a financial interest related to a research study, a statement regarding the financial interest
• For studies where a Certificate of Confidentiality has been granted, including any study funded by the NIH, a statement regarding Certificate of Confidentiality protections (see IU HRPP Policy on Research Data Management)
• If the research involves genetic information, statement describing the protections provided by Genetic Information Nondiscrimination Act (GINA) of 2008
• If the radiation/radioactive materials in addition to what is used for standard clinical treatment are used for research purposes, radiation risk language.
• For studies conducted or supported by the U.S. Public Health Service (PHS) involving HIV testing, PHS requires that subjects whose test results are associated with personal identifiers be informed of their own test results and provided the opportunity to receive appropriate counseling unless the situation calls for an exception under special circumstances.

Research which is federally-funded

For federally-funded research, the informed consent document must also:

• Begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or LAR in understanding the reasons why one might or might not want to participate in the research, or the IRB must find that the informed consent document is concise as written

Research subject to VA regulations

The informed consent document must also begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or LAR in understanding the reasons why one might or might not want to participate in the research, or the IRB must find that the informed consent document is concise as written. 

The VA consent document must also include the following:

• Statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects and, if so, under what conditions
• A statement that the VA will provide treatment for research-related injury, per 38 CFR 17.85
• When appropriate, a statement that neither VA research subjects nor their insurance will be charged for any costs related to the research.  Certain veterans have to pay co-payments for medical care and services provided by VA; these requirements continue to apply to medical care and services that are not part of the research procedures or interventions.
• Information describing any photographs, video, and/or audio recordings to be taken or obtained for research purposes, how the photographs, video, and/or audio recordings will be used for the research, and whether the photographs, video, and/or audio recordings will be disclosed outside the VA.  The IRB cannot waive informed consent to take a photograph, video, and/or audio recording.

Research subject to Department of Justice (DOJ) regulations

For research funded by the National Institute of Justice, the consent document must also include the following:

• The name(s) of the funding agency(ies)
• Statement that private, identifiable information will be kept confidential and will be used only for research and statistical purposes.  If, due to sample size or some unique feature, the identity of the individual cannot be kept confidential, the subjects need to be explicitly notified.  If the researcher intends to disclose any information, subjects must be explicitly informed what information would be disclosed, under what circumstances, and to whom.  Subjects also must be informed of any risks that may result from this disclosure and must explicitly provide written consent prior to participating in the research.
• Statement indicating that confidentiality can be broken only if the subject reports immediate harm to subjects or others.

For research conducted within the Bureau of Prisons, the consent document must also include the following:

• Identification of the investigators
• Anticipated uses of the results of the research
• Statement that participation is completely voluntary and that the subject may withdraw consent and end participation in the project at any time without penalty or prejudice (e.g., the inmate will be returned to regular assignment or activity by staff as soon as practicable)
• Statement regarding the confidentiality of the research information and exceptions to any guarantees of confidentiality required by federal or state law (e.g., an investigator may not guarantee confidentiality when the subject indicates intent to commit future criminal conduct or harm himself or herself or someone else, or, if the subject is an inmate, indicates intent to leave the facility without authorization)
• Statement that participation in the research project will have no effect on the inmate subject’s release date or parole eligibility.

The IRB may waive the requirement to obtain informed consent, or approve a consent procedure that omits some, or alters some or all, of the elements of informed consent if the IRB determines all of the following criteria are met:

• 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 manner
• The waiver or alteration will not adversely affect the rights and welfare of the subjects
• Whenever appropriate, the subjects or LARs will be provided with additional pertinent information after participation.

Research or demonstration projects:

The IRB may also waive the requirement to obtain informed consent, or approve a consent procedure that omits some, or alters some or all, of the elements of informed consent if the IRB determines all of the following criteria are met:

• The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs
• The research could not practicably be carried out without the waiver or alteration

Emergency research requesting exception from informed consent (EFIC)

The IRB may approve research without requiring that informed consent of all research subjects be obtained for a limited class of research activities involving human subjects who are in need of emergency medical intervention and for whom informed consent cannot be sought due to their medical condition and unavailability of LAR. See the IU HRPP Policy on Emergency Research Requesting Exception from Informed Consent for additional information.

Waiver or alteration for research subject to FDA-regulations

Pursuant to FDA Guidance "IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More than Minimal Risk to Human Subjects: Guidance for Sponsors, Investigators, and Institutional Review Boards" (July 2017), the IRB may waive the requirement to obtain informed consent, or approve a consent procedure that omits some, or alters some or all, of the elements of informed consent if the IRB determines all of the following criteria are met:

• 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
• The waiver or alteration will not adversely affect the rights and welfare of the subjects
• 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 manner
• Whenever appropriate, the subjects or LARs will be provided with additional pertinent information after participation

Exception for research subject to FDA-regulations

An exception to the informed consent requirement may be made if both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following:

• The subject is confronted by a life-threatening situation necessitating the use of the test article
• Informed consent or authorization cannot be obtained because of an inability to communicate with or obtain legally effective consent or authorization from the subject
• Time is not sufficient to obtain consent or authorization from the subject's LAR
• No alternative method of approved or generally recognized therapy is available that provides equal or greater likelihood of saving the life of the subject

If, in the investigator's opinion, immediate use of the test article is required to preserve the life of the subject and time is not sufficient to obtain the independent determination required in advance, the determination shall be made by the investigator and, within five (5) business days after the use of the article, be reviewed and evaluated in writing by a physician who is not participating in the clinical investigation.

Use of this exception must be reported to the IRB within five (5) business days. The investigator must submit notification via Kuali Protocols and provide the documentation from both the investigator and the physician who is not participating in the clinical investigation.

Research subject to Department of Defense (DOD) regulations

For research involving experimental subjects that involves no more than minimal risk, the IRB may alter or waive other required elements of informed consent pursuant to 32 CFR 219, so long as it still preserves informed consent of the subject (i.e., the consent indicates the subject’s participation in the research is completely voluntary and includes the requirement that the subject is informed of research risks).

Unless waived by the IRB, informed consent is documented by the use of an approved, written consent document, signed and dated by the prospective subject or prospective subject's LAR at the time of consent. A copy is given to the person signing the form.

The informed consent document may be either of the following:

• A written informed consent document approved by the IRB that meets the requirements of this policy. Research personnel shall give either the subject or the subject's LAR adequate opportunity to read the informed consent document before it is signed; alternatively, this form may be read to the subject or the subject's LAR.
• When enrolling subjects who cannot speak or read English, a short form written informed consent document stating that the elements of informed consent required by 45 CFR 46.116 were presented orally to the subject or the subject's LAR.
  • The IRB approves a written summary of what is to be said to the subject or LAR.
  • An adult witness who is conversant in both languages observes the oral presentation, if applicable.
  • The short form is signed by the subject or the subject's LAR.
  • The witness signs both the short form and a copy of the summary.
  • The person actually obtaining consent signs a copy of the summary.
  • A copy of the summary is given to the subject or the subject's LAR, in addition to a copy of the short form.

The IRB may waive the requirement for research personnel to obtain a signed informed consent document for some or all subjects if the IRB determines any of the following criteria are met:

• That the only record linking the subject and the research would be the informed consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or LAR) is asked whether the subject wants documentation linking the subject with the research, and the subject's wishes govern.
• 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 of the research context.
• If the subjects or LARs are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

In cases in which the documentation requirement is waived, the consent process must include all elements listed in 2.1. The IRB may require research personnel to provide subjects or LARs with a written statement regarding the research.

Research subject to FDA regulations

The IRB may waive the requirement that the subject or the subject's LAR sign a written consent document only if the IRB determines 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.

The study team describes the informed consent process in the IRB application and provides an informed consent document for the IRB's review and approval, when appropriate. The IRB reviews the information and ensures that all requirements consistent with this policy are met.

Informed consent is more than just a signature on a form. It is an ongoing process of information exchange that provides the prospective subject or subject's LAR with adequate information pertaining to the research study; sufficient opportunity to consider aspects of the research, including the risks and benefits, and whether to participate; and the opportunity for the subject to ask questions and receive answers to those questions, thus minimizing the possibility of coercion or undue influence.

The informed consent process is often conducted via a conversation between the study team and the prospective subject or subject's LAR, unless the IRB approves a consent process which does not include a conversation. If the informed consent conversation cannot be conducted face-to-face, the informed consent process may be conducted over the telephone or via other electronic means.

Unless the IRB grants a waiver of documentation of informed consent as described above, informed consent must be documented as follows:

• Subjects must be provided with a copy of the informed consent document prior to the conversation, so they can review during the discussion. Subjects who are willing to participate in research must sign a copy of the IRB-approved informed consent document prior to participating in research procedures.
  • Signature may be provided via physical, “wet”, or electronic signature which meets the requirements of state law in the jurisdiction where the research is being conducted.
  • For VA research, consent may be documented electronically so long as it meets all VA requirements for use of electronic signature, including use of VA compliant systems and prior approval by the Office of Research and Development (ORD).
  • If the consent conversation is not conducted face-to-face, the subject may fax or email a signed copy of the informed consent document to the research site (preferably to the interviewer and/or research personnel). Unless the IRB approves otherwise, the study team must receive a copy of the signed informed consent document prior to beginning research procedures.
  • If the subject is physically unable to provide a signature, he/she makes a mark on the informed consent document and the study team must document the circumstances. If the subject is unable to make a mark, a witness must observe the documentation process and sign the consent document.
• The subject (or LAR) must enter the date of signature on the consent document.
• The person conducting the consent discussion must also sign and date the informed consent document as the "person obtaining consent" The signature of the PI is not required on the informed consent document, unless he/she is the person conducting the consent discussion.

If research personnel plan to enroll non-English-reading individuals, plans for language-appropriate consent procedures and informed consent document(s), as applicable, are considered and described in the IRB submission.

Research involving subjects who cannot speak or read English

• If a non-English-reading subject is unexpectedly encountered and a translated informed consent document cannot be provided, the subject may be enrolled through oral presentation of the informed consent information in conjunction with a short form written consent document.
  • The oral presentation and the short form must be in a language understandable to the subject. An interpreter may be used to help conduct the oral presentation.
  • Appropriate short form documents in various languages are available on the IU HRPP website. Each document states that the elements of informed consent required by 45 CFR 46.116 have been presented orally to the subject or the subject's LAR, and that key information was presented to the subject first, before other information, if any, was provided.
  • A witness, other than the person obtaining consent, must observe the oral presentation. The witness must be conversant in both English and the language of the subject. The interpreter may serve as the witness.
  • An IRB-approved written summary of information to be presented orally must be available for use during the oral presentation. The IRB-approved English informed consent document serves as the summary.
  • The subject or the subject's LAR signs the short form consent document.
  • The witness signs both the short form consent document and a copy of the summary.
  • The person actually obtaining consent signs a copy of the summary.
  • A copy of the signed short form consent document and summary are given to the subject or the subject's LAR.
  • The informed consent process is documented in the subject's records. The interpreter or other appropriate individual should be part of the ongoing communication throughout the research study and must be conversant in both English and the language of the subject.
• Unless an exception is met, following use of the short form, the informed consent document must be translated to the language of the subject, and the subject must be re-consented using the translated informed consent document.  The translated informed consent document must be reviewed and approved by the IRB prior to re-consent of the subject.  Exceptions to this requirement include:
  • Research procedures the subject provided consent for are minimal risk, or
  • Research interventions are short term and will be completed before the informed consent document could be translated into the subject’s language.
  • Additionally, the IRB may grant an exception to the requirement for translation and re-consent in other circumstances when it determines an exception is appropriate.

Research involving subjects who speak but cannot read English

• If a subject who cannot read written English is unexpectedly encountered and an accessible informed consent document cannot be provided, the subject may be enrolled through oral presentation of the informed consent information.
  • A witness, other than the person obtaining consent, must observe the oral presentation.
  • The subject or the subject’s LAR, the witness, and the person actually obtaining consent signs the informed consent document.
  • A copy of the informed consent document is given to the subject or the subject’s LAR.
  • The informed consent process is documented in the subject’s records.
• Unless an exception is met, following use of the oral presentation described above, the informed consent document must be provided in an accessible format, and the subject must be re-consented using the accessible informed consent document. The accessible format is subject dependent. This may include Braille or an electronic consent that is compatible with a screener reader, amongst other options. The informed consent process must be reviewed and approved by the IRB prior to re-consent of the subject. Exceptions to this requirement include:
  • Research procedures the subject provided consent for are minimal risk, or
  • Research interventions are short term and will be completed before the informed consent document could be made accessible.
  • Additionally, the IRB may grant an exception to the requirement for accessibility and re-consent in other circumstances when it determines an exception is appropriate.

Certain populations of subjects (including children, prisoners, pregnant women, and individuals lacking consent capacity) require additional protections regarding their consent to participate in a research study. Please see applicable IU HRPP Policies for additional consent requirements when involving these populations in research.

For further information about Informed Consent procedures in transnational research, please see the IU HRPP Guidance on Transnational Research.

Revisions to the informed consent document must be reviewed and approved by the IRB prior to implementation.

• Newly enrolled subjects must sign the most recently approved version of the informed consent document.
• When submitting a revised informed consent document for IRB review and approval, the study team must notify the IRB whether previously-enrolled subjects will be notified of the new information and, if so, the timing and mechanism of the notification. The IRB will consider the study team's plan for notification and ensure its appropriateness.
• If the study team is aware of new or increased risks that are not reflected in the IRB-approved informed consent document, study teams must not enroll new subjects until the revised informed consent document incorporating these risks is reviewed and approved by the IRB.
• If the IRB agrees that previously-enrolled subjects must be re-consented using the new informed consent document, the re-consent process should be documented and a note made in the subject's record when the re-consent process is completed. Any previously signed consent documents must be retained and not discarded.

If a subject wishes to discontinue participation in the research, data collected on the subject to the point of the subject's withdrawal from a study remains part of the study records and may not be deleted. The subject may request that the data collected previously may not be used, but the informed consent document cannot give the subject the option of having data removed.

If research personnel would like to seek the subject's permission to follow the subject's health and collect clinical data from his/her medical records after withdrawal from research interventions, the subject must consent to such collection. A separate IRB-approved informed consent containing all required elements must be developed and presented to the subject at the time of his/her withdrawal from the study. If the subject declines to consent to the follow-up, the researcher must not access the subject's medical record or other confidential records for purposes related to the research, but may consult public records, such as those establishing survival status.