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116.1 Organization Policy on Informed Consent Process and Documentation

November 2012

Informed Consent

It is the policy of the Organization that no one may involve a human being as a participant in research or in a clinical investigation unless the investigator has obtained IRB approval and, when required by the IRB, that person’s legally effective informed consent.  The JHM IRBs may alter or waive the requirement of informed consent under the Department of Health and Human Services (DHHS) regulations governing human subject research [46.116(c)], but may not waive consent for studies regulated by the Food and Drug Administration (FDA) unless the subject is in a life-threatening condition and criteria under 21 CFR 50.23 or 50.24 are met.  If the participant is an adult who is unable to consent for him/herself, the investigator must describe the process of evaluating the individual’s capacity to provide consent, and if that capacity is lacking in a subject, must obtain informed consent from a legally authorized representative in accordance with State law.  If the participant is a minor, the investigator must describe the consent/assent process in accordance with federal and state law.

Informed Consent Process

The JHM IRBs must review the proposed consent process.  Investigators must seek consent under such circumstances that provide the prospective participant with sufficient time and opportunity to consider whether or not to participate.  The JHM IRB’s evaluation of the investigator’s proposed participant selection/recruitment process and informed consent process will include:

  • Considering the capacity of the participant to make an independent and voluntary informed decision whether or not to participate in a study;
  • Reviewing who will obtain consent and under what circumstances;
  • Determining how the investigator will assess the understanding of the participant; and,
  • Deciding whether consent will be documented.

The JHM IRB must judge the information to be presented to a potential participant in a written or oral form to be understandable to the participant or the participant’s legally authorized representative.  The informed consent may not include any language which waives, or appears to waive, any of the participant’s legal rights, or releases or appears to release the parties to the research from liability for negligence.

Informed Consent Documentation

The content of the written information provided to the potential participant must include the elements outlined in 45 CFR 46.116(a) and, if subject to FDA regulations, 21 CFR 50.25(a), and when appropriate, the additional elements provided in 45 CFR 46.116(b) and 21 CFR 50.25(b). The IRB will review all documents that are part of the informed consent process.  If a standard informed consent document is used, the Organization requires use of standard boilerplate language in consent forms.  The standard boilerplate language includes:

1)      the HIPAA Privacy Authorization, and

2)      “What other things should you know about this research study” including:

  • a description of the IRB;
  • contact information for questions about the study;
  • instructions about who to call if injured or ill as a result of being in the study;
  • a statement concerning ownership of data, tissue, blood, and samples collected in the study;
  • an explanation about the “Organizations” of Johns Hopkins;
  • a provision explaining significance of the subject’s signature on the consent form; and
  • the standard signature page.

Changes proposed to the boilerplate language must be approved by the IRB.  As of January 1, 2009, the JHM IRB approved consent document(s) will have an approval date, but will not include an expiration date. The approval for the consent document will last the life of the study, or until it is amended – whichever comes first. Only copies of IRB approved documents may be presented to participants.

Short Form Documentation of Informed Consent

The federal regulations under 45 CFR 46.117(b)(2) and 21 CFR50.27(b)(2) permit the use of a short form consent document stating that the required informed consent elements have been presented to the subject or the subject’s legally authorized representative (LAR) orally, with a witness present.  The witness must be fluent in both English and the language of the participant.  Additionally:

  • The participant or the participant’s LAR must sign and date the short form consent;
  • The witness must sign and date both the full consent form and the short form;
  • The consent designee must sign and date the full consent form;
  • The consent designee must give to the participant or the representative:
  • A copy of the consent form and
  • A copy of the short form.

OHSR has several IRB-approved short form consents posted on the JHM IRB website.  For a short form consent in a language that has not been approved by the JHM IRB:

  • The investigator must prepare:
  • A translation of the English Version of the short-form consent posted on the JHM IRB website;
  • A certificate of translation
  • The IRB must approve the submitted short form.

The witness to the consent process may also be the translator of the short form.  If, however, the translator is the PI or a study team member, that individual may not also serve as the witness, who must be unaffiliated with the study.

Waiver or Alteration of Informed Consent or Documentation of Informed Consent

The IRB may for some or all participants, waive the requirement to sign a written consent document if the IRB makes the following determinations under DHHS regulations 45 CFR 46 and documents them with protocol specific findings justify those determinations:

  • That the only record linking the subject and the research would be the consent document
  • The principal risk would be potential harm resulting from a breach of confidentiality.
  • Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern
  • The research is not subject to FDA regulation, or Department of Defense (DoD) regulations, or Department of Education regulations.

The IRB is authorized to waive documentation for either the participant, or the adult participant's legally authorized representative, or waive parental permission for research involving children. The IRB may not waive the requirement for a consent process under FDA regulations.  However, the IRB may require the research to include an oral consent process rather than require written, documented consent.

The IRB may for some or all participants, waive the requirement under FDA regulations 21 CFR 50 if the IRB makes the following determinations and documents them with protocol specific findings to justify those determinations:

  • The research presents no more than minimal risk of harm to subjects
  • The research involves no procedures for which written consent is normally required outside the research context

The IRB may approve waiver or alteration of the consent procedure, or waive the requirement to obtain informed consent, if the IRB makes the following determinations and documents them with protocol specific findings to justify those determinations:

  • 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; and

  • The research could not practicably be carried out without the waiver or alteration.
  • The research is not subject to FDA regulation or DoD regulations.

The IRB may approve waiver or alteration of the consent procedure, or waive the requirement to obtain informed consent, if the IRB makes the following determinations and documents them with protocol specific findings to justify those determinations:

  • 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 practicably be carried out without the waiver or alteration; and
  • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
  • The research is not subject to FDA regulation or DoD regulations.

The IRB may not waive the consent process for any research to be conducted under DoD regulations where the research participant meets the DoD definition of an ‘experimental subject.”  A waiver of the consent process for such DoD regulated research requires permission of the Secretary of Defense.

For research subject to Department of Education regulations, the IRB will follow the requirements of the Family Educational Rights and Privacy Act (FERPA) when considering whether it may grant exceptions to parental/student consent to release of records for research.

Research Data Retention

  • When a subject withdraws from a study, the data collected on the subject to the point of withdrawal remains part of the study database and may not be removed.  The consent document cannot give the subject the option of having data removed.
  • The investigator may ask a subject who is withdrawing whether the subject wishes to provide continued follow-up and further data collection subsequent to his or her withdrawal from the interventional portion of the study.  Under this circumstance, the discussion with the subject must distinguish between study-related interventions and continued follow-up of associated clinical outcome information, such as medical course or laboratory results obtained through noninvasive chart review, and address the maintenance of privacy and confidentiality of the subject’s information.
  • The investigator must obtain the subject’s informed consent for this limited participation in the study (assuming such a situation was not described in the initial consent form).  The IRB must approve the consent document.
  • If a subject withdraws from the interventional portion of a study and does not consent to continued follow-up of associated clinical outcome information, the researcher must not access for purposes related to the study the subject’s medical record or other confidential records requiring the subject’s consent.  However, an investigator may review study data related to the subject collected prior to the subject’s withdrawal from the study, and may consult public records, such as those establishing survival status.

AAHRPP

 

 

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