What You Can Do To Facilitate Efficient IRB Review

Part II:  Informed Consent

 

Columbia University Medical Center

Institutional Review Board

722 W. 168th Street

MSPH 426

(212) 305-5883

 

www.cpmcirb.hs.columbia.edu

www.rascal.columbia.edu

 

 

 

Table Of Contents

 

 

1)    Tips to facilitate efficient IRB review: Consent Form Builder

2)    Tips for Increasing Comprehension of Informed Consent Documents

3)    IRB Terminology Related to Informed Consent

4)    Elements of Informed Consent

5)    Criteria for Waiver of the Elements of Informed Consent

6)    Criteria for Waiver of the Written Documentation of Informed Consent

7)    Requirements for Consent in Pediatric Research

 

 

 

 

If you have questions about IRB review or procedures, contact the IRB office at (212) 305-5883.

 

If you have technical questions, contact the RASCAL help line

at (212) 870-3480. 


Tips to Facilitate Efficient IRB Review

Consent Form Builder

 

1.                  Create a generic form once; copy and edit as necessary for each study.

2.                  Utilize the three ways to insert text:  a) select sample text; b) copy/paste from another document; c) type.

Typing or copying text: remember that the Consent Form Builder is a web program and recognizes only basic formatting.

Inserting text from a sample consent:  All text related to one element of consent or topic (e.g., Procedures, Risks, etc.) can be copied into their respective field in the RASCAL Consent Form Builder. 

Bolding of headings:

RASCAL automatically bolds the headings of the elements of consent (e.g., Purpose and Procedures, Risks, Benefits, etc.), when the consent is created utilizing the Consent Builder.

Additional headings of a given element of consent or topic (e.g., Risks of Pregnancy under Risks) should be entered in the sub-heading field in RASCAL.

Otherwise, inserting an entire consent form into a field in the RASCAL Consent Form Builder, go to Layout and enter a “0” into all fields other than the one that contains the consent form.  This process will not print the headings in bold.  This process is not recommended by the IRB as it would decrease comprehension of the consent document.

3.                  Be familiar with the required elements of informed consent, and include the additional elements when appropriate.

4.                  Review the “Helpful Consent Form Information” available from the Consent Form menu.

5.                  Read the general instructions in each section of the consent builder.  These will guide you to submit a consent form to the IRB more successfully.

6.                  Ensure that information in the consent form is consistent with that in the protocol and all other study-related documents.

7.                  Maintain a 6th-8th grade language level throughout the form.  See the IRB’s Tips for Increasing Comprehension of Informed Consent Documents. 

8.                  Maintain the same voice (second person; e.g., “you”) throughout the consent form. 

9.                  Select signature lines cautiously, i.e., include either “study participant” or “study subject” but not both. Remove any unnecessary or inappropriate signature lines.

Minimally, a consent document that will be signed should have the following lines for signature and date:  1) Signature of the Subject or Participant; 2) Signature of the Person Obtaining Informed Consent; and 3) Investigator’s signature.

The Signature of the Subject or Participant may not be appropriate for all assent forms.

10.              After attaching the consent form to a protocol and before submitting it to the IRB, print it out and read it through to evaluate layout, appearance, flow of text, language level and accuracy.  Ensure that all required elements of consent are included or justify the removal of any element of consent in the Subjects page of the protocol.

11.              If a consent form includes a chart or table, move the chart or table into a separate document that will be used as an addendum to the consent.  Attach the addendum in RASCAL and explain in a cover letter that the attachment should be considered as part of the consent form.

12.              If an approved consent document needs to be translated into another language, the investigator can grant access of the consent document within RASCAL to the individual who will conduct the translation.  For example, if a consent form needs to be translated into Spanish, the investigator can grant access to an individual in the Hispanic Research & Recruitment Center (HRRC).  Alternatively, one can attach a scanned copy of the translated form(s) stamped by the HRRC.

13.              Contact the RASCAL help-line if technical assistance is required (whenever you are unable to perform any function in the Consent Form Builder or manipulate or edit any text). 

Contact the IRB office if questions regarding institutional policy and/or federal regulations arise during construction of the consent form.

14.              If similar text is used or required by several investigators or throughout a department, provide the sample text to the IRB.  The IRB will consider such requests and revise sample text in the Consent Builder accordingly.

 

Benefit to using the Consent Form Builder: 

As soon as the status of the protocol changes to “approved”, the consent form will receive the IRB approval stamp electronically and can immediately be printed by the researcher.

 
 

 

 

 


 

 


TIPS FOR INCREASING COMPREHENSION OF

 INFORMED CONSENT DOCUMENTS

 

 

 

These guidelines were developed for investigators at Columbia University Medical Center in an effort to increase comprehension of informed consent documents.

 

  1. All informed consent documents not created in RASCAL should be printed on CUMC letterhead or include information identifying the institution and research team or center.  One inch margins are to be used on either side and on the bottom with 1.5 inches at the top.  The type size to be used should be 12 point.  Number all pages and use a header beginning with the second page of the document.

 

  1. The document should be written at the eighth grade reading level.  Suggestions for meeting an eighth grade reading level include:

 

·         Use one or two syllable words whenever possible

·         Write short sentences and paragraphs

·         Define all medical or technical terms in lay language

·         Organize information in sections with clear headings

·         Print all headings in bold

·         Use spacing to emphasize important concepts

·         Avoid contractions such as don’t

 

  1. Address the consent document to the reader by using the active voice and the word “you” throughout, i.e. “You are being asked to take part in a research study . . .”

 

  1. Detailed information on do’s and don’ts, complex drug dosing, and concomitant medications should not be included in a consent form.  This information could be in a separate information sheet for subjects.

 

  1. Providing information in a question and answer format is one method of increasing comprehension.  This format is particularly useful when the study procedures are complex and the target subject population has a below average education or reading level.

 

  1. Include version number and/or date on each version of a consent document.

 

 

 

 

 

 

 

 

IRB Terminology Related to Informed Consent

 

Informed Consent    A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence [Federal Policy §116; 21 CFR 50.20 and 50.25].

 

Consent Form           Documentation of informed consent, which may be:

(1) A written consent document that embodies the elements of informed consent required by 45CFR46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; or

(2) A short form written consent document stating that the elements of informed consent required by 45CFR46.116 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.

Assent            Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.

 

Parental Permission             A type of surrogate consent in which a parent agrees to enroll their child in research.

 

Information Sheet     Document provided to research subject that contains the elements of informed consent but does not require a signature.  Used either in exempt research, (in which informed consent is not required but may be desirable) or when written documentation of informed consent has been waived by the IRB in accordance with 45CFR 46.117(c).

 

Legally Authorized Representative           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.  In New York State, an LAR is a parent of a minor or a court appointed guardian. 

 


General requirements for informed consent (45 CFR 46.116)

Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

(a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject:

(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;

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

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

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

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

(6) for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

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

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

(b) additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:

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

(2) anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;

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

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

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

(6) the approximate number of subjects involved in the study.


 

Waiver of Elements of Informed Consent (45 CFR 46.116)

(c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that:

(1) 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

(2) the research could not practicably be carried out without the waiver or alteration.

(d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

(1) the research involves no more than minimal risk to the subjects;

(2) the waiver or alteration will not adversely affect the rights and welfare of the subjects;

(3) the research could not practicably be carried out without the waiver or alteration; and

(4) whenever appropriate, the subjects will be provided with additional pertinent information after participation.


Waiver of Written Documentation of Informed Consent (45 CFR 46.117)

(c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

(1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or

(2) 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.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.


 

Excerpt from Subpart D (45 CFR 46):  Additional DHHS Protections for Children Involved as

Subjects in Research

 

(See Section 408 Below for Assent and Parental Permission Requirements)

§46.404 Research not involving greater than minimal risk.

DHHS will conduct or fund research in which the IRB finds that no greater than minimal risk to children is presented, only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in §46.408.

§46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.

DHHS will conduct or fund research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, only if the IRB finds that:

(a) the risk is justified by the anticipated benefit to the subjects;

(b) the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and

(c) adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in §46.408.

§46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.

DHHS will conduct or fund research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject, only if the IRB finds that:

(a) the risk represents a minor increase over minimal risk;

(b) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;

(c) the intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and

(d) adequate provisions are made for soliciting assent of the children and permission of their parents or guardians, as set forth in §46.408.

§46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

DHHS will conduct or fund research that the IRB does not believe meets the requirements of §46.404, §46.405, or §46.406 only if:

(a) the IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and

(b) the Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, has determined either:

(1) that the research in fact satisfies the conditions of §46.404, §46.405, or §46.406, as applicable, or (2) the following:

(i) the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;

(ii) the research will be conducted in accordance with sound ethical principles;

(iii) adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in §46.408.

§46.408 Requirements for permission by parents or guardians and for assent by children.

 

(a) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with §46.116 of Subpart A.

(b) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine, in accordance with and to the extent that consent is required by §46.116 of Subpart A, that adequate provisions are made for soliciting the permission of each child's parents or guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted under §46.404 or §46.405. Where research is covered by §46.406 and §46.407 and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.

(c) In addition to the provisions for waiver contained in §46.116 of Subpart A, if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, State, or local law. The choice of anappropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.

(d) Permission by parents or guardians shall be documented in accordance with and to the extent required by §46.117 of Subpart A.

(e) When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.