COTTAGE HEALTH SYSTEM POLICY

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SUBJECT:

Informed Consent Guidelines for Research

Informed Consent Guidelines

 

DEPT: IRB POLICY #: 8012.13

 

GOAL

Cottage Health System Institutional Review Board will review all research under its purview to ensure that the regulations surrounding participant informed consent are followed appropriately.

 

POLICY

The format for ensuring and documenting informed consent has been established by law and must be strictly followed.  Except as specifically agreed to by the IRB, the investigator must have each research subject or their legally authorized representative (LAR) sign consent documents prior to being enrolled in a study.

 

This policy currently reflects:

    21 CFR 50 - Protection of Human Subjects (FDA)
    45 CFR 46 - Protecting Human Subjects (HHS)

 

DEFINITIONS

Legally Authorized Representative (LAR) - An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research (21 CFR 50.3(l))

 

PROCEDURE:

All research subjects or their legally authorized representatives must be given sufficient opportunity and information to decide, without coercion or undue influence, whether or not to participate in a research study.  The verbal and written information given must be in a language understandable to the subject or their LAR.  No representation may be made to imply that the subject is waiving any legal rights or releasing the investigator, sponsor, institution, or its agents from liability for negligence.

 

 

Except in clearly defined emergency situations, or if a waiver is granted by the IRB (see Section V), consent must be obtained prior to the initiation of any research protocol, including blood drawings for research purposes.  It is the investigator's responsibility to explain the protocol to the patient and obtain the patient's signature on the consent form.

 

I.  General Requirements of Informed Consent

  • The investigator must have each research subject or legally authorized representative sign the consent documents prior to being enrolled in the study.   Verbal consent is not a legal form of consent.  Similarly, consent cannot be obtained over the phone.  Unless a waiver of consent has been granted by the IRB, all consents must be in writing and signatures and dates must be obtained to validate the consent.  For time-sensitive treatments or interventions, the consent document shall also include time of enrollment.
  • Under California law, research participant consent involves presenting the subject first with the Experimental Subject's Bill of Rights, and then with the consent form specific to the research protocol.
  • The verbal and written information given must be in a language understandable to the subject or representative.
  • Consent must be obtained under circumstances that provide the subject with the opportunity to consider whether or not to participate, and that minimize coercive influences.
  • The consent form may not include language through which the subject is made to waive any of his legal rights or which releases the investigator, sponsor or institution from liability for negligence.
  • Consent may be waived in emergency situations, as outlined under 21 CFR 50.23 (see Section V).
  • The IRB has the authority to observe or have a third party observe the consent process or the research.

II.   Preparing the Consent Form

A. CHS IRB Consent Template

1.     A model consent form which contains all of the required elements is available from the IRB.  The investigator may use the model to develop a consent form appropriate to his/her study. 
2.     Alternatively, an investigator may submit a different version of the consent form (eg from the study sponsor) as long as it contains all of the required elements.
3.     In addition, the IRB has pre-approved “boilerplates” which fulfill regulatory standards of disclosure and should be added to the consent form whenever applicable.
4.   The consent form must be typed in size 12 font and all of the headers and footers found in the template must be included.  The HIPAA Authorization portion of the consent document must be typed in size 14 font per California state law.

 

B. Consent Form Language

1.     Consent forms should be written at the 6th – 8th grade reading level.  It is understood that biomedical research is frequently complicated and that these consent documents may contain language that is difficult for a lay person to understand.  However, investigators should take special care when developing the document to make sure that all medical terms are defined in lay terminology, and ensure, through discussion, that the subjects are able to follow the information being presented.  In addition, no acronyms are to be used unless they are defined at their first use.
2.   The consent form that has been approved by the IRB must be the same as that which is presented to potential patients.
3.   The wording of the consent form cannot be changed without approval of the IRB.

 

C.  Components of the Consent Document

Cottage Health System has established an Informed Consent document template consistent with federal requirements, and is comprised of 4 - 6 separate components, depending upon the scope of the study:

   
  • Title / Cover Page
  • Bill of Rights
  • Protocol-Specific Consent Document
  • Protocol-Specific Specimen Collection Document
  • Authorization to Use or Disclose Protected Health Information
  • Comprehensive Signature Page
  •  

    D.  Title / Cover Page

    When used, the cover page should include information such as the study title, name of investigator, IRB / study number, sponsor's protocol number, and the name of the sponsor.  Some investigators also write the participant's name on the cover page.

     

    E.  Experimental Subject's Bill of Rights

    1.     Under California state law, all subjects must be given a copy of the "Experimental Subject's Bill of Rights" and be given an opportunity to ask questions about it before consenting to participate in any medical experiment.
    2.   The Bill of Rights must be in writing, in size 12 font, in a language in which the subject is fluent, and must be signed and dated by the subject.
    3.   The IRB has developed acceptable English and Spanish versions of the Bill of Rights.

     

    F.  Protocol-Specific Consent Document

    1.     Basic Elements of Informed Consent
    The federal regulations require that the following information must be provided to each research participant and must be included in the consent form:  
      a.   A statement that the study involves research, and
          •  an explanation of the purposes of the research,
          •  the expected duration of the subject's participation,
          •  a description of the procedures to be followed (in sufficient detail and in appropriate language so that the subject is fully informed),
          •  identification of any procedures which are experimental;
      b.   A description of any reasonably foreseeable risks or discomforts to the subject (in sufficient detail so that the subject is fully informed);
      c.   A description of any benefits to the participant or to others which may reasonably be expected from the research  (in sufficient detail so that the subject is fully informed);
      d.   A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
      e.   A statement describing the extent to which confidentiality of records identifying the subject will be maintained;
      f.   A statement listing the outside individuals authorized to review the research records, including the sponsor, the Food and Drug Administration (if applicable), and the CHS IRB;
      g.   For research involving more than minimal risk, an explanation as to whether any compensation and / or medical treatments are available if injury occurs and, if so, what they consist of or where further information may be obtained;
      h.   An explanation of whom to contact for answers to pertinent questions about the research, the participant's rights, and whom to contact in the event of a research-related injury to the subject;
      i.   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 that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. No representation may be made to imply that the subject or representative is waiving any legal rights or releasing the investigator, sponsor, institution, or its agents from liability for negligence.
    2.     Additional Elements of Informed Consent
    As stated under 45 CFR 46.116(b), the IRB recommends that the following additional elements of information are to be included in the consent form:
      a.    A statement that the particular treatment or procedure may involve additional risks to the subject (or the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable;
      b.   A description of the circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
      c.   Any additional costs to the subject that may result from participation in the research, including the withdrawal of sponsorship (if any) of the research program, or the approval of an investigational drug;
      d.   The consequences of a participant's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
      e.   A statement that the investigator may terminate a participant’s enrollment at any time if the investigator feels that continued enrollment may place the individual at increased/undue risk;
      f.   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 (it is generally advisable to include this statement on the form);
      g.   The approximate number of subjects involved in the study;
      h.   The amount of any payment(s) to the subject including incentives and / or expense reimbursements.
      i.   Any financial relationship or other interests between the investigator and the sponsor that may be perceived as a conflict of interest.
    3.     Clinical Trial Registration 
      a.   When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282 (j)(1)(A), the following statement shall be provided to each clinical trial subject in informed consent documents and processes.  This will notify the clinical trial subject that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank.  The statement is:
             "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law.  This Web site will not include information that can identify you.  At most, the Web site will include a summary of the results.  You can search this Web site at any time." (21 CFR 50 .25(c))

     

    G.  Protocol-Specific Specimen Collection Consent

    This document can be a stand alone document or an addendum to the complete consent document, depending on the study.  If the addendum is used, it is inserted after the protocol-specific treatment consent document.  For instructions on specimen collection, see Section VII of this policy as well as IRB policy

     

    H.  Authorization to Use and Disclose Protected Health Information

    Complete instructions regarding the use of this document and the regulations enforcing it, are described in IRB policy #8012.11

     

    I.  Comprehensive Signature Page
    The signature page validates the participant's consent, attesting that all of the appropriate documents have been received, and provides documentation regarding the informed consent procedure:

    • Who presented the consent information to the participant / LAR;
    • Who provided the consent to participate (the participant or an LAR);
    • The date (and sometimes the time) the consent signing took place.

    III.  Securing Informed Consent

    A.   Explanation of the Research

    1.   The investigator, or his designee, shall explain the protocol to the patient and obtain the patient's signature on the consent form.  The investigator is ultimately responsible for ensuring the satisfactoriness of the consent process.
    2.   The investigator, or designee, shall give either the subject or his / her LAR adequate opportunity to read the consent form before it is signed.

     

    B.  Securing Signatures

    1.   Each section of the consent document must be signed and dated by the subject or his / her legally authorized representative prior to any investigational interaction with the subject.  If the intervention is to take place on the same day as a procedure, the consent form should also include the time of signature to ensure that the consenting process preceded any intervention.
    2.   The person actually obtaining consent from the subject or LAR must sign and date the consent form.
    3.   A signed and dated copy of the consent document, including all of its sections, must be provided to the subject.

     

    C.  Use of Legally Authorized Representatives

    1.   Legally Authorized Representatives are not appropriate for all research studies.  As a result, the use of an LAR must be requested prior to the initiation of the study as part of the original IRB application, and must be approved by the IRB.
    2.   The IRB's consent form template signature page has a section designed to determine the appropriateness of LAR signatures.
    3.   If the consent form is signed by the LAR, the investigator may wish to note on the consent form and in the patient's medical record how the LAR was determined to fulfill California state law for surrogate consenting (Section 24178 of the Health and Safety Code; see IRB Policy 8012.07).

     

    D.  Illiterate Subjects

    1.   Investigators are not to assume that subjects / families are able to read and, when appropriate, are to inquire in a sensitive way as to whether the subjects / families are able to do so.
    2.   If illiterate (in whatever language of the consent process) but cognitively competent, the consent process proceeds as usual.  The informed consent is to be read to the subject / family, and the subject / family is to be encouraged to ask questions.
    3.   This process must be conducted with an impartial witness present who is not otherwise associated with the research team and who is not a member of the subject's family.  In this case, the witness is to observe the entire process, not just the signature.
    4.   If able, the subject or LAR is to affix a signature to or make an "X" on the consent document.
    5.   The witness is to sign and date the consent form, and is to document, in writing, that the process took place and that the subject or LAR voluntarily consents to participate.
    6.   For clinical research, it is suggested that the investigator document the process of using and determining the LAR in writing in the patient's medical record.

     

    IV.  Documentation of Informed Consent

    A.   The original signed consent documents shall be maintained by the investigator and filed in the subject's research / medical record.
    B.   A copy of the signed consent form must be placed in the patient's hospital chart at the time of admission.  If the patient is admitted to the hospital for any reason other than the research study (i.e. illness secondary to the disease under investigation), and the investigator is aware of the admission, he / she will be asked to provide a copy of the signed consent form for the hospital chart.
    C   Whenever possible, the enrollment of a patient in a research study should be noted in the patient's chart each time he / she is admitted to the hospital.  The IRB recommends that research participants carry study ID cards in order to inform their healthcare providers of their enrollment in a research protocol.  This can help identify patients upon admission to the hospital and is especially important for those individuals receiving investigational agents (drugs and devices).

     

    V.  Special Exceptions to Informed Consent Rules

    A.  Circumstances in Which a Written Consent Form May Not Be Required

    1.   An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirements to obtain informed consent provided the researcher documents in the IRB Application and the IRB finds that: [45 CFR §46.116(d)]:
        a.     The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from breach of confidentiality (each subject must be asked whether subject wants documentation);  
        b.     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;  
        c.      The waiver or alteration will not adversely affect the rights and welfare of the participants;  
        d.     The research could not practicably be carried out without the waiver or alteration;  
        e.     Whenever appropriate, the participants will be provided with additional pertinent information after participation;  
        f.     The research is not a clinical investigation subject to FDA regulations.  
    2.   In cases where documentation is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research, such as a summary of the results of the study.  

    B.  Waiver of Informed Consent in Emergency Situations

    1.  

    An investigator may administer a test article without first securing informed consent if all of the conditions for emergency use of the test article are met (See IRB Policy 8012.08), and:

        a.     Informed consent cannot be obtained from the subject because of an inability to communicate with or obtain the legally effective consent from the subject; and,
        b.     Time is not sufficient to obtain consent from the subject's legally authorized representative.
    2.  

    The investigator is required to follow the procedure outlined for emergency use (as described under 21 CFR 50.23)  and must, in addition, document in the patient's medical record that the above conditions were met.

    C.    Exception from Informed Consent Requirement for Emergency Research

    Per the  Code of Federal Regulations, Title 21, Part 50.24, the IRB may approve an investigation without requiring informed consent of all research subjects if the IRB finds (with the concurrence of a licensed physician who is a member of or consultant to the IRB and who is not otherwise participating in the clinical investigation) and documents each of the following:

    1.   The human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness of particular interventions.
    2.   Obtaining informed consent is not feasible because:
        a.   The subjects will not be able to give their informed consent as a result of their medical condition;
        b.   The intervention under investigation must be administered before consent from the subject's legally authorized representative is feasible; and
        c.   There is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the clinical investigation.
    3.   Participation in the research holds out the prospect of direct benefit to the subjects because:
        a.   Subjects are facing a life-threatening situation that necessitates intervention;
        b.   Appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence support the potential for the intervention to provide a direct benefit to the individual subjects; and
        c.   Risks associated with the investigation are reasonable in relation to what is known about:
            i.    The medical condition of the potential class of subjects;
    ii.   The risks and benefits of standard therapy, if any; and
    iii.   What is known about the risks and benefits of the proposed intervention or activity.
    4.   The clinical investigation could not practicably be carried out without the waiver.
    5.   The proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator has committed to attempting to contact a legally authorized representative for each subject within that window of time and, if feasible, to asking the legally authorized representative contacted for consent within that window rather than proceeding without consent.
    6.   The IRB has reviewed and approved an informed consent document to be used when at all possible.
    7.   Additional protections of the rights and welfare of the subjects will be provided, including at least:
        a.   Consultation with representatives of the communities in which the investigation will be conducted and from which the subjects will be drawn;
        b.   Public disclosure to the communities prior to initiation of the investigation; public disclosure of sufficient information following completion of the investigation to apprise the community and researchers of the study results;
        c.   Establishment of an independent data monitoring committee to exercise oversight of the clinical investigation; and
        d.   That the investigator has committed, to attempting to contact the subject's family within the therapeutic window, if the subject is unable to consent and an LAR is unavailable.  The investigator must summarize efforts made to contact family members and make this information available to the IRB at the time of continuing review.
    8.   The IRB is responsible for ensuring that procedures are in place to inform, at the earliest feasible opportunity, each subject or the LAR of the subject's inclusion in the study.  If an LAR or family member is told about the investigation and the subject's condition improves, the subject is also to be informed as soon as feasible.  If a subject is entered into a clinical investigation with waived consent and the subject dies before an LAR or family member can be contacted, information about the investigation is to be provided to the subject's LAR or family member, if feasible.
    9.   Protocols involving an exception to the informed consent requirement must be performed under a separate investigational new drug application (IND) or investigational device exemption (IDE) that clearly identifies such protocols as protocols that may include subjects who are unable to consent.  The submission of those protocols in a separate IND / IDE is required even if an IND for the same drug or an IDE for the same device already exists.

    D.   The Requirement for Informed Consent Involving Special Subjects

    1.   Research conducted on children requires the signed assent of the child (if the child is old enough to consent to treatment - usually around age 7) and the permission of one or both parents (see IRB Policy 8012.20).
    2.   Consent for research on pregnant women and / or fetuses may also require the written consent of the father.
    3.   An investigator planning to use special classes of subjects, including vulnerable subjects, should contact the IRB office for specific information about the special circumstances surrounding their enrollment.

     

    VI.  Use of Biological Materials

    A.    When research involving human biological material is conducted in the context of therapeutic research protocols, informed consent for the former should be obtained separately from consent for the clinical aspects of the study (see IRB policy 8012.12).  
    B.   The subject should be provided the option of choosing whether or not to participate in the ancillary study involving biological material, and participation in therapeutic research should not be made contingent on such participation.  
    C.   The subject should be informed that his refusal to permit the use of his / her tissue or blood for such research will not affect the quality of the clinical care he / she receives (this should be addressed in a separate subsection of the consent document provided to the patient).  
    D.   The IRB requires that the investigator set forth the following information in the consent form to use/store biological materials:  
        1.   A thorough justification of the research design, including a description of procedures used to minimize risk to subjects;
        2.   A full description of the process by which samples will be obtained;
        3.   Any plans to obtain access to medical records of the subjects,
        4.    A full description of the mechanisms that will be used to maximize the protection against inadvertent release of confidential information (these mechanisms must be HIPAA-compliant);
        5.   A statement allowing the participant to withdraw permission to use his tissues;
        6.   An explanation of how the samples would be destroyed once permission is withdrawn; and,
        7.   A statement indicating that all samples may not be retrievable if permission is withdrawn, and why.
    E.   A specimen collection consent template which includes all of the required information is available from the IRB department.  

     

    VII.  Foreign Language Consents

    A.    General Requirements

    1.     Department of Health and Human Services (HHS) regulations for the protection of human subjects require that informed consent information be presented in a language understandable to the subject.  In order for the consent process to fulfill regulatory guidelines, both the verbal and written information must be presented in a language in which the subject is fluent.  The regulations stipulate that the written materials, including the consent form must be in a language that the participant can read.
    2.     Verbal information may be presented in English by the Study Coordinator or other member of the investigator's research team, if a friend or family member who is fluent in the subject's native language accompanies the subject, and is fluent in English and able to translate the verbal information to the subject (see Section VIII (C)(3) below).
    3.     If an investigator suspects that more than10% of his / her patient population will come from a particular ethnic group, the IRB recommends creating a translated version of the consent form and submitting it with the original IRB application.
    4.     If it is not known what percentage of non-English speaking patients may enroll, the investigator may use the short form written consent document translated into the appropriate language when needed (see section B). Although the IRB maintains Spanish templates, other languages will require translation at the time they are needed.  After receiving expedited review and approval of the translated short form, the investigator will follow all of the guidelines for the short form consent process.
    5.     It is the responsibility of the IRB to determine which of the procedures is appropriate for documenting informed consent in protocols that it reviews.

    B.    Short Form

    1.   Oral presentation of informed consent information is permitted in conjunction with a short form written consent document (stating that the elements of consent have been presented orally) and a written summary of what is presented orally. A witness to the oral presentation is required, and the subject must be given copies of the short form document and the summary.
    2.   When this procedure is used with subjects who do not speak English:
        a.   the oral presentation and the short form written document should be in a language understandable to the subject;
        b.   the IRB-approved English language informed consent document may serve as the summary; and
        c.   the witness should be fluent in both English and the language of the subject.
    3.   3. At the time of consent:
        a.    the short form document should be signed by the subject (or the subject's legally authorized representative);
        b.   the summary (i.e., the English language informed consent document) should be signed by the person obtaining consent as authorized under the protocol; and
        c.   the short form document and the summary should be signed by the witness.  (When a translator assists the person obtaining consent, the translator may serve as the witness).
    4.   The IRB must receive all foreign language versions of the short form document. Expedited review and approval of these versions is acceptable if the protocol, the full English language informed consent document, and the English version of the short form document have already been approved by the convened IRB.

    C.   Informed Consent for Spanish-Speaking Participants

    1.   Due to local demographics, there is a high probability that an investigator may enroll an individual who may not be proficient in English and for whom Spanish is the primary language.
    2.   As a result, investigators are advised by the IRB to take measures to ensure that Spanish-speaking individuals receive and sign a Spanish consent document and receive the verbal information in Spanish.
    3.   For research conducted at CHS, SBCH Translation Services may be available during the informed consent process to interpret the verbal presentation to the patient.  If possible, they will also translate the written consent form into Spanish.  Off-site investigators may use a member of their own staff to interpret verbal communications (in the absence of a friend or relative) and to develop Spanish consents.  These consents will be reviewed for accuracy by a Spanish-speaking member of the IRB (or other IRB-approved translator).  Alternatively, a list of individuals who have been pre-approved by the IRB for translation services is available from the IRB office.

     

    07/13

     


    COTTAGE HEALTH SYSTEM POLICY

    RECOMMENDED BY: Leilani Price DATE: 6/03

    ORIGINAL POLICY EFFECTIVE DATE: 11/03

    DATE REVIEWED: 4/06, 9/08, 1/09

    DATE REVISED: 8/05, 1/08, 9/08, 11/11, 5/13