Office of Human Research
Page Title

SOP No.: 601   COMMUNICATION

Author:    Office of Human Research

Effective Date:  October 1, 2007

Supercedes document dated:              N/A

Last Reviewed on:     N/A                                 

Results of Review:               N/A

This SOP pertains to:  all Investigators involved in the conduct of FDA-regulated human subject research within Thomas Jefferson University.

Responsibility for executing this SOP:  Investigator and Designated Research Personnel

Approved By:

 

J. Bruce Smith, MD

 

Associate Vice President for Research

 

(signature on file at OHR)

Approved By:

 

Steven E. McKenzie, MD, Ph.D.

 

Vice President for Research

 

(signature on file at OHR)

 

1. PURPOSE

This procedure describes the preparation, review, and approval of the informed consent form, and documentation of the informed consent process.

2. GENERAL INSTRUCTIONS

The ultimate responsibility for ensuring that informed consent is obtained, and that the consent interview is conducted in such a way that all of the subjects’ questions and concerns are answered rests with the Principal Investigator (PI).

Informed consent must be legally effective and prospectively obtained (45 CFR 46.116; 21 CFR 50.20). Except as delineated in Office of Human Research, Division of Human Subjects Protection Policy, Waiver of Informed Consent and HIPAA Authorization (http://www.jefferson.edu/ohr/irb/documents/PolicyandProcedureManual2007.pdf), no investigator may enroll a human being as a research subject unless s/he has obtained legally effective informed consent from the subject or the subject's legally authorized representative. Consent shall be sought only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate in the study, and that minimize the possibility of coercion or undue influence.

Subject authorization also must be obtained for prospective use or disclosure of protected health information (PHI) for research conducted within the Thomas Jefferson University Hospital (TJUH). Except as described in the Division of Human Subjects Protection Policy manual   (www.jefferson.edu/ohr/irb/documents/PolicyandProcedureManual2007.pdf), no investigator may prospectively collect PHI unless s/he has obtained legally effective authorization from the subject or the subject's legally authorized  representative.

The IRB requires documentation of informed consent by use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. Authorization will be obtained by the use of the IRB-approved Informed Consent Document template that contains a federally-compliant HIPAA Confidentiality Section or as appropriate, a separate HIPAA Authorization document

The consent form document may be either of the following:

The PI is responsible for ensuring that:

  • The informed consent form is submitted to the IRB with the appropriate IRB Submission Forms.
  • The IRB approves the informed consent form and that the IRB approval letter and approved informed consent form are in the site's study file.
  • Each potential participant is properly informed regarding study events, risks/benefits, and other information detailed in elements of informed consent.
  • An informed consent form is personally signed and dated by each participant or other legally authorized representative.
  • Subjects are given a copy of their signed and dated informed consent form and recording in the source document that the participant was provided a copy. The original, signed form is retained in the site's individual participant files.
  • There is adequate documentation in the source documents that informed consent was obtained before protocol-related procedures were performed.
  • There is adequate documentation in the source documents regarding the steps involved in consenting the subject
  • The person who obtains consent is personally signing and dating the informed consent form at the same time as the participant, unless otherwise specified by the IRB.

3. SPECIFIC PROCEDURES

3.1 Informed Consent Development, Review and Approval

The PI should:

  1. Provide an informed consent draft (at a 6th grade level) including all elements of 21 CFR 50.25 and ICH 4.8.10 and relevant protocol procedures for consideration by each investigative site for obtaining informed consent from participants
  2. Work closely with the institutional IRB in obtaining certified translators to develop forward and reverse translations of informed consent forms if studies are to be conducted in a non-English speaking population 
  3. Review the informed consent form to ensure it meets state, local and institutional requirements, and to add any elements required by these authorities

The PI will ensure that:

  1. The informed consent form is submitted to and approved by Thomas Jefferson University’s IRB before any subject is enrolled or any study procedure is done
  2. The IRB approved informed consent form was given an approval stamp and date and ensure the correct version is used
  3. The original stamped IRB approved informed consent form and approval letter are maintained 
  4. They and all participating Investigators or designees note the IRB approval date on the form to ensure that no lapse in IRB approval occurs during the conduct of the study.

In conducting investigator-initiated multi-site trials, the Investigator is responsible to ensure the above is being conducted for each participating site.

3.2 Informed Consent Process

For the purposes of this SOP, reference to participant includes legally effective representative as applicable

The PI will ensure that a  prospective participant is fully informed about the study  before any protocol-related procedures are conducted.  See DHSP policy IC 701, http://www.jefferson.edu/ohr/irb/documents/PolicyandProcedureManual2007.pdf.

Elements of the informed consent process are noted below:

  • The PI or designee should discuss the elements of informed consent with the potential participant and take all reasonable measures to ensure that the potential participant understands the content and meaning of the informed consent form.
  • After the potential study participant reads and reviews the informed consent form (with the IRB stamped approval date), the participant must personally sign and date the form prior to the initiation of any protocol-related procedures, unless exceptions are noted in the protocol.
  • The PI or designee who conducts the informed consent process with the participant, must sign and date the form at the same time as the participant.  (See DHSP policy  IC 701, http://www.jefferson.edu/ohr/irb/documents/PolicyandProcedureManual2007.pdf)
  • The PI will ensure the original of each signed informed consent form is filed in the participant's source documents and a copy of the signed informed consent form is given to the participant.
  • The PI or designee will examine the form to confirm it is properly completed before the participant leaves.
  • The PI or designee will ensure that:
    • each informed consent form was signed and dated prior to any protocol-related procedures
    • a notation is made in the source document that the participant signed the form before any protocol-related procedures were performed and the date of the signature
    • each participant received a copy of his/her signed, IRB-approved informed consent form and a notation is made to this effect in the source document
  • Any changes to the protocol that are not minor or the acquisition of significant new information that affects participant safety may result in the need to revise the informed consent form. The Investigator and all participating Investigators or designees should make those revisions when necessary and forward to the IRB for review and approval
  • Revised informed consent forms should be presented and explained to participants who are still actively participating in the study as soon as possible after IRB review and approval.

3.3 Oral Presentation Using Short Form (See DHSP Policies IC 701-702)      

A “short form” written consent document stating that the elements of informed consent as required have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be an impartial witness to the oral presentation. The IRB must approve a written summary of what is to be said to the subject or representative. Only the subject or the representative will sign the short form.  However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining the informed 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 signed short form".

3.4 Assent of Children and Other Vulnerable Groups

  • Assent of children and Parental Permission for minors is subject to the guidelines of and approval by the IRB, which should be contacted by the Investigator for consultation and specific procedures before proceeding. Reference the Office of Human Research, DHSP, Policies IC 703  and IC 704 (http://www.jefferson.edu/ohr/irb/documents/PolicyandProcedureManual2007.pdf).
  • For other vulnerable groups (e.g., pregnant women, fetuses, participants of genetic research, the cognitively impaired or mentally disabled, terminally ill patients, employees, etc.), the Investigator should contact the IRB for consultation and specific procedures prior to proceeding.

3.5 Waivers and Exceptions

  • An IRB may, for some or all study participants, waive the requirement that the participant sign a written informed consent form in certain circumstances. The Investigator should contact the IRB for consultation and specific procedures prior to proceeding. Reference the  Office of Human Research, DHSP IC 706. (http://www.jefferson.edu/ohr/irb/documents/PolicyandProcedureManual2007.pdf)
  • (Emergency Situation Informed Consent) Regarding the use of an investigational product in an emergency situation, obtaining informed consent shall be deemed feasible except in certain emergency situations where the Investigator and a physician who is not otherwise participating in the clinical study meet certain conditions as outlined in the Office of Human Research, DHSP IC 708. (http://www.jefferson.edu/ohr/irb/documents/PolicyandProcedureManual2007.pdf)

4. APPLICABLE REGULATIONS AND GUIDELINES

21 CFR 50.25

Elements of informed consent

21 CFR 56.109

IRB review of research

21 CFR 56.111

Criteria for IRB approval of research

21 CFR 312.54

Emergency research under §50.24 of this chapter

21 CFR 312.60

General responsibilities of investigators

21 CFR 312.62

Investigator recordkeeping and record retention

45 CFR 46.116

General requirements for informed consent

 

FDA Internal Compliance Program Guidance Manual,

1994; 7348.811: Clinical Investigators

FDA Information Sheets, October, 1998

Frequently Asked Questions, A Guide to Informed Consent Documents, Informed Consent and the Clinical Investigator, The Belmont Report and Declaration of Helsinki

May 9 1997

International Conference on Harmonisation; Good Clinical Practice: Consolidated Guideline

5. REFERENCES TO OTHER APPLICABLE SOPs

GA-102

Responsibilities of the Research Team

PM-302

Interactions with the Institutional Review Board

PM-303

Regulatory Files and Subject Records

SM-403

Subject Management While on Study

SM-404

Adverse Event Reporting

6. ATTACHMENTS

A. Informed Consent Template

B.   Checklist

7. DEFINITIONS AND GLOSSARY

The following definitions from the International Conference on Harmonisation; Good Clinical Practice: Consolidated Guideline apply to this SOP.

Confidentiality: Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity.

Impartial witness: A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.

Informed consent: A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form.

Institutional Review Board (IRB): An independent body constituted of medical, scientific, and nonscientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trials, of protocols and amendments, and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

Legally acceptable representative: An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical trial.  (See DHSP policy IC 707) ****

Vulnerable subjects: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

   ****  (AT TJU, THE HIERARCHY, IN ORDER OF REFERENCE IS:)

1.  LEGALLY AUTHORIZED REPRESENTATIVE  (COURT APPOINTED GUARDIAN)

2.  HEALTH CARE PROXY GIVEN POWER OF ATTORNEY BY THE SUBJECT

3.  SPOUSE

4.  NATURAL OR ADOPTIVE PARENT

5.  ADULT CHILD

6.  ANY OTHER ADULT RELATIVE RELATED THROUGH BLOOD OR MARRIAGE

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