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5.1 Obtaining Informed Consent From Research Subjects

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for the process and documentation of informed consent.

2.0 Policy

  • 2.1. It is the policy of the Organization that the process of informed consent obtained from subjects, their Legally Authorized Representatives (LARs), or a minor subject’s parents or legal guardians will be conducted in accordance with, and to the extent required by HHS regulations at 45 CFR 46.116, FDA regulations at 21 CFR 50.20 (as applicable) and UNMC HRPP policies.
  • 2.2. It is the policy of the Organization that informed consent will be appropriately documented in accordance with, and to the extent required by 45 CFR 46.117, 21 CFR 50.27 (as applicable) and UNMC HRPP policies.
  • 2.3. For this policy reference to “subject” also refers to a subject’s LAR, or a minor subject’s parent or legal guardian, as appropriate.

3.0 General Requirements

  • 3.1. No human being may be enrolled as a subject in research unless the PI or authorized designee (see section 3.3 below) has prospectively obtained the legally effective informed consent of the subject (or LAR) unless a waiver or alteration of informed consent has been approved by the IRB in accordance with HRPP policy 5.2 (Waiver or Alteration of Informed Consent and HIPAA Authorization).
  • 3.2. The PI, in accordance with HRPP policy 1.26 (PI Qualifications and Responsibilities), is ultimately responsible for the obtainment, and documentation of valid informed consent from the subject (or LAR) prior to participation in the research, unless these requirements have been waived by the IRB.
  • 3.3. The PI may authorize other study personnel (secondary investigator, participating personnel or research coordinator) to participate in the process of consent, providing those persons have adequate knowledge of the research protocol, of UNMC HRPP policies, and of their responsibility to protect the rights and welfare of subjects.
  • 3.4. Except as provided in HRPP policy 5.4 (Waiver of the Requirement to Obtained Signed Consent Form), informed consent must be documented by the use of a written informed consent form (ICF) approved by the IRB. The PI (or authorized designee) shall seek such consent only under circumstances that provide the prospective subject (or LAR) sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.
  • 3.5. The information contained in the ICF and conveyed to the subject during the process of consent shall be in language understandable to the subject. To the extent possible, the language should be understandable by a person who is educated to the 8th grade level and, where appropriate, layman’s terms shall be used in the description of the research.
  • 3.6. The subject (or LAR) 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 must be provided with an opportunity to discuss that information.
  • 3.7. Informed consent must begin with a concise and focused presentation (summary) 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. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
    • 3.7.1. The summary must include at least the following information:
      • 3.7.1.1. A statement that consent is being sought for research, and participation is voluntary.
      • 3.7.1.2. The purpose and expected duration of the subject’s participation, and a description of the procedures to be followed.
      • 3.7.1.3. The reasonably foreseeable risks and discomforts to the subject. This section should only include the most important reasonably foreseeable risks.
      • 3.7.1.4. The benefits to the prospective subject or to others that may reasonably be expected.
      • 3.7.1.5. Appropriate alternative procedures or courses of treatment, if any, which might be advantageous to the prospective subject.
    • 3.7.2. The summary should not exceed two pages in length.
    • 3.7.3. Information included in the summary need not be repeated later in the body of the informed consent form.
  • 3.8. 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 LAR’s) understanding of the reasons why one might or might not want to participate.
  • 3.9. No ICF or process may include any exculpatory language through which the subject (or LAR) is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the PI or other study personnel, the sponsor, the institution, or its agents from liability for negligence.
  • 3.10. The consent process minimizes the potential for coercion and undue influence.
  • 3.11. The obtainment of consent for the participation of pregnant women, fetuses and neonates (nonviable or uncertain viability) in research must be conducted in accordance with this policy and HRPP policy 4.2 (Research Involving Pregnant Women, Human Fetuses, and Neonates-Nonviable or of Uncertain Viability).
  • 3.12. The obtainment of consent for the participation of prisoners in research must be conducted in accordance with this policy and HRPP policy 4.3 (Research Involving Prisoners).
  • 3.13. The obtainment of parental permission (consent) for participation of children in research must be conducted in accordance with this policy and HRPP policy 4.4 (Research Involving Children).
  • 3.14. The obtainment of assent for the participation of minors in research must be conducted in accordance with HRPP policy 4.4 (Research Involving Children).
  • 3.15. The obtainment of consent for the participation of decisionally impaired individuals in research must be conducted in accordance with this policy and HRPP policy 4.6 (Research Involving Subjects with Impaired Decision-Making Capacity).

4.0 Elements of Informed Consent

  • 4.1. *Basic Elements of Informed Consent
    • 4.1.1. The consent process and form must provide the following information, in accordance with Federal Regulations at 45 CFR 46.116 and 21 CFR 50.25, other laws and regulations, and/or HRPP policy. This requirement is satisfied by utilizing the appropriate ICF/information sheet template(s) listed in sections 5.0, 6.0 and/or 7.0 below).
      • 4.1.1.1. 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 which are experimental; a description of any reasonably foreseeable risks or discomforts to the subject.
      • 4.1.1.2. A description of any benefits to the subject or to others which may reasonably be expected from the research.
      • 4.1.1.3. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
      • 4.1.1.4. A statement describing the extent, if any, to which confidentiality of records identifying the subject must be maintained.
      • 4.1.1.5. For research involving more than minimal risk, an explanation as to the availability of medical treatment in the case of research-related injury, including who will pay for the treatment and whether other financial compensation is available.
      • 4.1.1.6. For any research that involves the collection of identifiable private information or identifiable biospecimens:
        • 4.1.1.6.1. 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 LAR) authorized representative, if this might be a possibility; OR
        • 4.1.1.6.2. 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.
      • 4.1.1.7. An explanation of whom to contact on the research team for answers to pertinent questions about the research or to voice concerns or complaints about the research, and whom to contact in the event of a research-related injury to the subject.
      • 4.1.1.8. Provision of contact information for the IRB and Research Subject Advocate (as applicable) in the event the subject wishes to talk to someone other than the research staff or to obtain assistance in the event the research staff cannot be reached. The subject may wish to obtain answers to questions about the research or their rights as a research subject, or for resolution of problems, concerns, complaints or offer input about the research.
      • 4.1.1.9. 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.
      • 4.1.1.10. A statement which indicates that the IRB, institutional officials designated by the IRB, OHRP, and, as appropriate, FDA, NIH, sponsors/CROs, other institutions and investigators, third party payers, the FPBCC SRC, or others will, as necessary, have access to research records containing PHI.
      • 4.1.1.11. A statement that FDA-regulated clinical trials and federally funded interventional and observational trials must be listed on ClinicalTrials.gov.
  • 4.2. Additional Elements of Informed Consent [45 CFR 46.116(b), 21 CFR 50.25(b)] When appropriate, the consent process and form must provide some or all of the following information, in accordance with Federal Regulations at 45 CFR 46.116 and 21 CFR 50.25, other laws and regulations, and/or HRPP policy. This requirement is satisfied by utilizing the appropriate ICF/information sheet template(s) listed in sections 5.0, 6.0 and/or 7.0 below).
    • 4.2.1. A statement that the particular treatment or procedure may involve risks to the subject, which are currently unforeseeable (for example, when the research involves investigational test articles or other procedures in which the risks to the subject are not well known).
    • 4.2.2. A statement that if the subject is or becomes pregnant, the particular treatment or procedure may involve risks to the embryo or fetus, which are currently unforeseeable (for example, when the research involves pregnant women or women of childbearing potential and the risks to the fetus or embryo associated with the drugs, devices, or other procedures involved in the research are not well known). Where appropriate, a statement regarding unforeseeable teratogenic risk transferred to females from male subjects should be included.
    • 4.2.3. Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s/LAR’s consent (for example, when there are medical circumstances or compliance requirements that would necessitate involuntary withdrawal of the subject from the research).
    • 4.2.4. Any additional costs to the subject/LAR that may result from participation in the research.
    • 4.2.5. The consequence(s) of a subject/LAR decision to withdraw from the research (for example, when withdrawal from the research is associated with adverse medical consequences, such as an interruption of treatment).
    • 4.2.6. Procedures for orderly termination of the subject’s research participation (for example, voluntary notification of the PI, follow up and treatment substitution).
    • 4.2.7. An explanation whether already collected data about the subject will be retained and analyzed even if the subject chooses to withdraw from the research. The ICF cannot give the subject the option of having the existing data removed from future analysis.
    • 4.2.8. A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject and/or the LAR.
    • 4.2.9. The approximate number of subjects involved in the study. It may be appropriate to inform subjects when there is a small number of participants or a large number of subjects.
    • 4.2.10. 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.
    • 4.2.11. A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions
    • 4.2.12. For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing.
    • 4.2.13. The amount and schedule for compensation of subjects.
    • 4.2.14. When a subject withdraws from the interventional portion of the study, ask if the subject wishes to continue into the follow-up portion of the study where there are no direct study interventions. This portion of the study involves collection of associated clinical outcome information, such as medical course or laboratory results obtained through non-invasive chart review, and address the maintenance of privacy and confidentiality of the participant's information.
      • 4.2.14.1. If this is not in the original consent form, the subject must provide additional written consent for this limited participation in the study.
      • 4.2.14.2. If a participant withdraws from the interventional portion of a study and does not consent to continued follow-up collection of associated clinical outcome information, the researcher must not access for purposes related to the study the participant's medical record or other confidential records requiring the participant's consent. However, a researcher may review study data related to the participant collected prior to the participant's withdrawal from the study, and may consult public records, such as those establishing survival status.
    • 4.2.15. For research subject to ICH GCP, a description of the additional elements for informed consent are found in HRPP policy 1.13; Section 4.2.5 (Compliance with ICH Guidelines).
    • 4.2.16. For Department of Defense research, a description of the additional elements for informed consent are found in HRPP policy 1.14; Section 4.11.10 (Research Subject to Department of Defense Regulatory Requirements).
    • 4.2.17. For Department of Justice research, a description of the additional elements for informed consent are found in HRPP policy 1.15; Sections 4.1.3 and 4.2.9 (Research Subject to Department of Justice Regulatory Requirements).

5.0 ICF Templates

All investigators are required to utilize one or more of the following ICF templates as applicable:

  • 5.1. Adult biomedical research ICF template
  • 5.2. Adult social and behavioral research ICF template
  • 5.3. Adult tissue banking ICF template
  • 5.4. Adult registry ICF template
  • 5.5. Parental biomedical research ICF template
  • 5.6. Parental social and behavioral research ICF template
  • 5.7. Parental tissue banking ICF template
  • 5.8. Parental registry ICF template
  • 5.9. Legally authorized representative biomedical research ICF template
  • 5.10. Legally authorized representative Social and behavioral research ICF template
  • 5.11. Legally authorized representative tissue banking ICF template
  • 5.12. Legally authorized representative registry ICF template
  • 5.13. Humanitarian use device ICF template
  • 5.14. Emergency treatment ICF template

6.0 Study Information Sheet Templates

All investigators are required to utilize one or more of the following information sheet templates as applicable:

  • 6.1. Youth information sheet
  • 6.2. Child information sheet
  • 6.3. Adult information sheet (for the decisionally impaired)

All investigators are required to utilize one or more of the following other consent templates as applicable:

  • 7.1. Cover letter consent template
  • 7.2. Narrative ICF template
  • 7.3. National Cancer Institute Central IRB or other Central IRB ICF templates

8.0 Process of Informed Consent

  • 8.1. Informed consent may only be obtained from subjects who have the legal and mental capacity to give consent. For subjects without that capacity, consent must be obtained from an LAR, as described in HRPP policy 4.6 (Research Involving Subjects with Impaired Decision-Making Capacity).

  • 8.2. Prospective subjects (or LARs) should be approached sufficiently far in advance of their involvement in research to enable them to have time to make an informed decision whether or not to participate in the study.

  • 8.3. The environment where informed consent will be obtained should be a private and quiet location, conducive to discussion and thoughtful consideration by the prospective subject with consideration given to the need to minimize the possibility of coercion or undue influence.

  • 8.4. The process of informed consent can be described as the transmission of relevant information to the prospective subject (or LAR). The exchange of information between the PI/designee and the prospective subject (or LAR) should occur by face-to-face contact. However, depending upon the nature and risks of the study or other factors, the IRB may permit an alternate method of communication and consent, such as, telephone, video conference (for example, Skype), other form of electronic communication, mail or fax.

  • 8.5. The PI/designee must fully explain all elements of informed consent (as described in sections 4.1 and 4.2 above) to the prospective subject (or LAR).

  • 8.6. The PI/designee involved in the process of consent should take all necessary steps to minimize the possibility of coercion or undue influence. In addition, no exculpatory language should be used which suggests or implies in any way that the subject is waiving any of their legal rights or appears to release the investigator, sponsor, or the institution from liability for negligence.

  • 8.7. Subjects such as those who are educationally or economically disadvantaged or disabled may be vulnerable to coercion or undue influence to participate in research. Additional protections during the process of consent may include but are not limited to appointment of a subject advocate, involvement of the subject’s family or friends, use of a short form consent, reading the consent to the subject, and use of teaching aids.

  • 8.8. The PI/designee must fully explain the rights of research subjects and provide the prospective subject (or LAR) with a written copy of the “Rights of Research Subjects” or “los Derechos de los Participantes de Investigaciones” (Spanish version). (Copies are available on the IRB website.

  • 8.9. The PI/designee must provide the prospective subject (or LAR) with a written copy of “What Do I Need to Know before being in a Research Study?” to use as a guide for questions to be answered before agreeing to participate in the study.

  • 8.10. The prospective subject (or LAR) must be given sufficient time and opportunity to read the ICF and to ask questions, which must be fully answered. In some cases, the consent process should be extended over several days and involve other individuals such as the prospective subject’s family members, clergy, nurses, and others. In all cases, if at any time the prospective subject (or LAR) is uncomfortable making a decision, he/she should be encouraged to consult with family members or other individuals of their choosing.

  • 8.11. The PI/designee have a legal and an ethical obligation to ensure that the prospective subject (or LAR) has sufficient knowledge and comprehension of all of the elements of informed consent to enable him/her to make an informed and enlightened decision whether or not to participate in research.

    Note: The fact that an individual is prepared to sign the ICF and has no unanswered questions does not necessarily represent sufficient evidence of an adequate level of comprehension. A prospective subjects’ comprehension may be assessed by: a) questioning the individual concerning his/her understanding of all the elements of informed consent, or b) asking the individual to describe the research in sufficient detail whereby the subject demonstrates an acceptable level of comprehension of all of the elements of consent.

  • 8.12. In certain studies, it may be appropriate to seek active re-consent from subjects (or LARs). A subject's preferences and interests may change over time, even in the absence of material changes in the research protocol. Therefore, investigators should consider obtaining re-consent, or at least reaffirmation of the willingness to continue participation, on a routine basis. In most cases, such re-consent need only be a verbal agreement on the part of the subject after questioning by the investigator or research team member. In some cases, more formal re-consent (for example, quarterly or at the time of each research intervention) may be appropriate. Re-consent whether verbal or written should be documented in the research record.

  • 8.13. Each subject (or LAR) must be given a copy of the signed and dated ICF after signing. If the IRB has approved a waiver of signed informed consent, each subject (or LAR) must be offered a copy of the unsigned ICF.

  • 8.14. The IRB is authorized to randomly audit any on-going process of informed consent, as per HRPP policies 1.21 (Post-Approval Monitoring of Research) and 8.4 (Review of Noncompliance Involving the PI and Study Personnel).

9.0 Documentation of Informed Consent

  • 9.1. Unless a waiver of the requirement to obtain signed consent in accordance with HRPP policy 5.4 (Waiver of the Requirement to Obtain Signed Consent Form), informed consent must be documented by the use of a written or electronic ICF approved by the IRB.
  • 9.2. Study personnel who are permitted to document informed consent must be:
    • 9.2.1. Authorized by the PI.
    • 9.2.2. Listed by name in the documentation of consent section of the IRB Application and consent form.
    • 9.2.3. Approved by the IRB.
  • 9.3. Individuals authorized to document consent must have the:
    • 9.3.1. Sufficient knowledge of the protocol.
    • 9.3.2. Sufficient knowledge of UNMC HRPP policies and of their responsibility to protect the rights and welfare of subjects.
    • 9.3.3. Required licensure to perform the procedures described in the protocol, as applicable.
    • 9.3.4. Authorization per hospital policy to perform the procedures in a non-research context, as applicable.
  • 9.4. Once it is determined the prospective subject (or LAR) has fully understood all of the elements of the consent, has no further questions, and has voluntarily (without coercion or undue influence) agreed to participate in the study, the subject (or LAR) should sign and date the current IRB-approved and stamped ICF at the time of consent.
  • 9.5. Provided the IRB has not approved an alternate method of communication and consent (per section 8.4 above) the subject (or LAR), PI (or other person authorized to document consent), and the witness (if required per section 9.6 below) must sign and date the ICF in the physical presence of each other. The PI (or other person authorized to document consent) must be present at this time to certify that the subject (or LAR) provided valid informed consent.
  • 9.6. The signature of a witness is required for all research studies involving populations where the IRB has determined that a witness provides additional protection. The witness should be someone who is not listed on the IRB Application and ICF as study personnel.
  • 9.7. For clinical studies involving significant risk, only licensed physicians or dentists are authorized to obtain and document consent.
  • 9.8. For studies involving an FDA unapproved drug or biologic, or an FDA unapproved significant risk device, only licensed physicians or dentists are authorized to obtain and document consent.

10.0 Documentation in the Research and Medical Records

  • 10.1. The research record must contain the original signed ICF.
  • 10.2. For any protocol where a research procedure or intervention may result in a billable charge from the hospital or clinic, the subject’s medical record must contain a copy of the signed ICF (per specified hospital policy), except as below:
    • 10.2.1. Consent forms for research which includes genetic testing will not be placed in the subject’s medical record if the IRB determines that (1) the subject’s health insurance status or employability may be jeopardized, and (2) the subject’s medical safety will not be compromised by excluding the ICF from the medical record.
    • 10.2.2. Consent forms for research where breach of confidentiality constitutes a significant risk will not be placed in the subject’s medical record.
  • 10.3. For all studies greater than minimal risk, the process of consent must be documented in the medical or individual study subject record, if applicable, or in a separate consent log. This documentation should include the names of the individuals involved in the process of consent, and the period of time over which the process of consent was conducted.

  • 11.1. Non-English Speaking Subjects

    • 11.1.1. Expected Enrollment of Non-English Speaking Subjects
      • 11.1.1.1. For research where it is reasonable to expect that a significant number of non-English speaking persons will participate, the IRB may require that a translated CF be prepared and used.
      • 11.1.1.2. Consent forms must be prepared by a certified translator, or must be back-translated by a certified translator.
      • 11.1.1.3. Consent Forms prepared by a commercial sponsor, or by an NIH or equivalent funded cooperative group may be used without back-translation.
      • 11.1.1.4. An Official Interpreter who is fluent in both English and the language of the subject/LAR must be identified and can be any of the following in order of priority listing:
        • 11.1.1.4.1. A UNMC, Nebraska Medicine, CH&MC, UNO or study site staff or contracted person who is a specifically trained interpreter/translator. This individual must be fluent in both languages and have a basic understanding of the research.
        • 11.1.1.4.2. A commercial interpretation/translation service (such as CyraCom).
      • 11.1.1.5. If a prospective subject/LAR/parent wishes to designate their own interpreter, then:
        • 11.1.1.5.1. This must be documented in the medical/research record.
        • 11.1.1.5.2. The Official Interpreter that qualifies under 11.1.1.1 and 11.1.1.2 above must be present to ensure the quality and accuracy of the interpretation and this must also be documented.
        • 11.1.1.5.3. A minor cannot be used as an interpreter.
      • 11.1.1.6. Procedures for Using an Interpreter
        • 11.1.1.6.1. Interpreters should be provided with a copy of the IRB-approved ICF. Whenever possible, the ICF(s) should be provided in advance of initiating the consent process with the subject/LAR.
        • 11.1.1.6.2. Upon conclusion of the consent process the subject/LAR and the Interpreter must sign and date the non-English version of the ICF.
        • 11.1.1.6.3. The person obtaining consent must sign and date the English version of the ICF.
        • 11.1.1.6.4. A copy of the signed and dated non-English and English version of the ICFs must be given to the subject/LAR.
        • 11.1.1.6.5. The process of consent must be fully documented and maintained on file which includes the following:
          • 11.1.1.6.5.1. The time over which the process of consent was conducted.
          • 11.1.1.6.5.2. The name and contact information of the interpreter.
    • 11.1.2. Unexpected Enrollment of a Non-English Speaking Subject

    If a non-English speaking prospective subject is unexpectedly eligible to enroll in research and there is no IRB-approved translated ICF, the following requirements apply: * 11.1.2.1. If the research offers no prospect of direct therapeutic benefit the person can only be enrolled a) after the IRB has reviewed and approved a translated ICF, and b) an interpreter who is fluent in both languages is used during the process of consent. The PI or other study personnel may serve as the interpreter. * 11.1.2.2. If the research offers the prospect of direct therapeutic benefit, the person can be enrolled using the IRB-approved short form, providing the requirements of HRPP policy 5.5 (Use of the Short Form Consent Document) are satisfied.

  • 11.2. Braille consent

    For research where it is reasonable to expect that a significant number of blind or low vision subjects who read Braille will participate, the IRB may require an ICF prepared in Braille. In order to ensure that a Braille ICF is accurate, the IRB may require a transcription into print text or review of the document by a qualified person who reads Braille. If possible, the subject (or LAR) will sign the Braille ICF; otherwise oral consent will be obtained, witnessed and documented in accordance with Section 11.4 of this policy.

  • 11.3. Consenting in American Sign Language (ASL)

    For a deaf subject (or LAR) who is fluent in ASL, the IRB may require a consent process using ASL and the IRB-approved ICF. When this process is approved, the individual authorized to consent the prospective subject (or LAR) must use a qualified interpreter fluent in ASL to conduct the consent process and the documentation of the consent process must conform to the requirements set forth previously in this policy.

  • 11.4. Oral Consent

    • 11.4.1. When a subject (or LAR) is unable to read an ICF (such as blind or illiterate subjects), the IRB chair may approve an oral consent process.
    • 11.4.2. The ICF must be read to the subject (or LAR) and the subject (or LAR) must be given an opportunity to ask questions. If capable of doing so, the subject (or LAR) signs, or marks an X to signify consent.
    • 11.4.3. A witness must be given a copy of the ICF in advance for their review and be present throughout the entire process of informed consent.
    • 11.4.4. The person obtaining consent and the witness will sign the written ICF with a statement that documents that an oral process was used and, if necessary, that the subject (or LAR) gave verbal consent. Whenever possible, the verbal presentation and explanation of ICF(s) should be provided to the subject (or LAR) on audio or video tape.
      • 11.4.4.1. By signing the consent document, the witness attests that the information in the consent document and any other written information was accurately explained to, and apparently understood by, the participant or the participant's legally acceptable representative, and that consent was freely given by the participant or the participant’s legally acceptable representative.
    • 11.4.5. The consent process must also be documented in accordance with 10.3 above. Signed copies of the ICF are given to the subject (or LAR).
    • 11.4.6. For research that is no more than minimal risk, documentation of consent may be waived if it satisfies the additional requirements as described in HRPP policy 5.4 (Waiver of the Requirement to Obtain Signed Consent Form).
    • 11.4.7. In an ongoing study when a subject (or LAR) is encountered who cannot read a written ICF, a protocol deviation form must be submitted to the ORA before enrollment takes place HRPP policy 2.4 (IRB Review of Changes in Previously Approved Research).

12.0 Requirements for Re-Consent of Subjects

  • 12.1. A formal re-consent procedure is not required for minor changes in protocol or the ICF. Examples of “minor changes are provided in HRPP policy 2.4 (IRB Review of Changes in Previously Approved Research). In general, minor changes are those that do not alter the risk-benefit relationship and that a reasonable person would not consider justification for withdrawing from the research. This new information may be presented, as necessary, through a verbal exchange between the subject/LAR and PI/designee), for example at the time of the next planned interaction with the subject.
  • 12.2. Changes in the protocol or in the ICF that are more significant than those described in section 12.1, or new information relevant to the subject, requires formal re-consent of the subject (or LAR) through the use of an IRB-approved revised ICF or an addendum to the ICF. This process of re-consent must follow the requirements for the process of initial consent discussed above, as well as include full documentation in the medical and research record. Depending on the nature of the new information or changes, re-consent may occur at the time of the next planned interaction with the subject
  • 12.3. When new information could potentially have a significant impact on the health and welfare of subjects (e.g., information concerning a serious adverse event), subjects/LARs should be notified immediately by telephone with the transmission of information documented and witnessed. If contact cannot be achieved by telephone, certified mail with required signature must be used. The ORA must be notified as soon as possible, but no later than two business days from the time the change was initiated.
  • 12.4. The PI is required to notify the ORA when all subjects/LARs have been contacted. This notification should include identification of subjects by number and the date they were contacted. Notification must be followed up as soon as possible by re-consent using the IRB-approved revised ICF or addendum. This process of re-consent must follow the requirements for the process of initial consent discussed above, as well as include full documentation in the medical and research record.
  • 12.5. Re-consent of currently enrolled subjects (or LARs) is not required following issuance of IRB-approved ICF(s)/study information sheet(s) associated with continuing review unless the IRB identified new information during the process of continuing review which requires re-consent of the subject (or LAR).
  • 12.6. Since consent must be an on-going process throughout the duration of the study, investigators (or authorized designees) should regularly verbally reaffirm the subject’s (or LAR’s) willingness to continue participation in the study as well as solicit and answer questions from the subject (or LAR).
  • 12.7. If a subject withdraws consent to participate in a study, the subject must provide additional written consent for continued routine follow-up of clinical outcomes which will be used for research purposes. This must be clearly disclosed in the ICF.

13.0 Telephone Consent

Refer to HRPP policy 5.3 (Use of a Telephone Consent Process).

14.0 Short Form

Refer to HRPP policy 5.5 (Use of the Short Form Consent Document).

15.0 Waiver or Alteration of Informed Consent

Refer to HRPP policy 5.2 (Waiver or Alteration of Informed Consent and HIPAA Authorization).

16.0 Waiver of the Requirement to Obtain a Signed ICF

Refer to HRPP policy 5.4 (Waiver of the Requirement to Obtain Signed Consent Form).

ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED JANUARY 26, 2018

 INITIAL FEBRUARY 5, 2016

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