Policies and Procedures Manual

Policy on Reviewing the Schedule of Events

Policy on the Dispensing of Pharmaceuticals Used in Approved Protocols

IRB Policy on Sponsor Statements Regarding Research-Related Injury

Policy on Proxy/Surrogate Consent

Policy on Enrolling Non-English Speaking Subjects

The IRB is charged with the responsibility for review and surveillance of all research involving human subjects carried out in the BSD and UCH. Review and surveillance are conducted to assure the protection of the rights and welfare of all research subjects. The ethical principles which guide the IRB are consistent with the Declaration of Helsinki of the World Health Organization and the Belmont Report. The IRB policies and procedures also comply with the rules and regulations of the Federal Policy for the Protection of Human Subjects (56 FR 28003; often referred to as the "Common Rule"), the Department of Health and Human Services (DHHS) Regulations (45 CFR Part 46), and the regulations of the Food and Drug Administration (FDA) (21 CFR Parts 50 and 56). Links to the full text of these regulations as well as other guidance for human subjects protections can be found on the Links page.
 

The BSD/UCH IRB has adopted a Policies and Procedures Manual to formalize Committee policies. This manual should be used as a reference point for investigators seeking more information about IRB processes.

This manual was last updated April 27, 2007 (available June 2007).

Downloadable Version:

Policies and Procedures Manual
(pdf document)
 
 

Policy on Reviewing the Schedule of Events

In June of 2006, the Office of Clinical Research (OCR) sent a notice to all faculty concerning the review of the schedule of events. All studies (including investigator-initiated studies) involving clinical care services and supplies that are considered research-related require this distinction of services to be on file with the Office of Clinical Research. During the IRB continuing review process, investigators will be asked to submit this schedule of events to the OCR.

For more information on this policy, please review the following materials from the OCR.

OCR email notification of the policy
Schedule of Events Outline
Schedule of Events Policy
PowerPoint presentation on the Schedule of Events policy

Please feel free to call the Office of Clinical Research at 4-9799 if you have questions about the policy.

As part of its responsibility to protect the health and safety of Human Subjects, the Institutional Review Board (IRB) has joined with the Department of Pharmacy in an effort to ensure that all investigational drugs dispensed under an approved IRB Protocol are in accordance with the most current dosing guidelines approved by the IRB and ensure that the Pharmacy receives timely notification of changes in dosing and/or the status of protocols.

Accordingly, the IRB will now 1) copy the Pharmacy on all IRB Notices of Expiration and Notices of Termination, thereby ensuring that the Department of Pharmacy will not dispense drugs for terminated or expired protocols, and 2) copy the Pharmacy on any or all amendments requesting a change in drug dosage. The IRB has modified the amendment form to allow staff to more easily identify those amendments involving changes in dosing. 

Once the dosage change is approved by the IRB, the Investigators will be responsible for forwarding a complete copy of the revised protocol to: Investigational Drug Pharmacist, Dept. of Pharmacy, MC 0010. Drugs will be dispensed by the Department of Pharmacy at the IRB-approved dosage. 

Questions should be forwarded to Millie Maleckar, IRB Director, at extension 2-6505.
 

Federal regulations (45 CFR 46.116) require that the consent process include a statement regarding treatment and compensation in case of injury for studies that involve a foreseeable risk of harm.  The University of Chicago Biological Sciences Division statement, which should be included (without any modifications) at the end of the “What Are The Costs” section of the written consent form, is as follows:

Often clinical trial sponsors will have compensation policies which vary from the University of Chicago policy.  Either the sponsor may remain silent on this point or a separate statement (on the sponsor’s letterhead) may be attached as the last page of the consent form.  In the event a statement from the sponsor is included as the last page of the consent form, the language in the “What Are The Costs” section should be revised to read as follows:

Introduction:

Researchers at The University of Chicago and elsewhere have been vexed by the problem of conducting studies in situations where the patient is unable to consent to participation in a research project. Such situations include many protocols in the Intensive Care Unit, the Emergency Department, the Psychiatry Department, and those involving patients with dementia. Recent changes in both federal regulations and state laws have partially remedied this situation. Researchers working in such areas now have new options for proceeding with protocols, even if the patient is unable to consent. Amendments to the Health Care Surrogate Act and the Medical Patient Rights Act provide a legal basis in the State of Illinois for the use of proxy consent in research (see Appendix for legal background).

Proxy consent should involve all the same considerations that informed consent from a competent patient involves. It also involves identifying the proper surrogate and ensuring that the research decision reflects the wishes of the subject, if known or, if not known, the best interests of the subject. In addition, the IRB will be concerned about whether the research could be accomplished in situations involving the consent of a competent patient, and will consider whether the intervention is likely to offer therapeutic benefit to the subject of the study. The IRB will always view these considerations as paramount. 

Implementation:

The University of Chicago believes in the importance of the informed consent process and believes that subjects should be given every opportunity to provide their consent. Understanding, however, that medical circumstances may preclude a subject from participating in the consent process, the University of Chicago and University of Chicago Hospitals IRB will implement the following procedures to consider requests for surrogate consent in keeping with the Medical Patient Right Act and the Health Care Surrogate Act.
 

A. Protocol Submission and Review

1. Researchers wishing to utilize surrogate consent will be asked to provide additional information (see Supplemental Form P) in addition to completing the IRB Protocol Submission Form in full. 

2. The IRB will utilize the prioritized listing of surrogates in the Health Care Surrogate Act in evaluating protocols requesting to use surrogate consent. The priority order specified by the Act is as follows: 1) subject's guardian; 2) subject's spouse; 3) any adult son or daughter of the subject; 4) either parent of the subject; 5) any adult brother or sister of the subject; 6) any adult grandchild of the subject; 7) a close friend of the subject; and 8) the subject's guardian of the estate. 

3. In determining whether to approve the use of surrogate consent in a particular protocol, the IRB will consider such factors as whether the research could be done without using surrogate consent or whether the proposed intervention offers direct benefit to the subjects of the research. 

1. The attending physician must determine that the subject lacks decisional capacity.

2. An attempt should be made to determine whether there is an operable and unrevoked living will, durable power of attorney for health care, or declaration for mental health treatment ("Advance Directive") which is applicable to the subject's decision about whether to participate in the research. Surrogate consent should be invoked only in cases when, after reasonable inquiry, no Advance Directive applies or, despite efforts to contact the person authorized in an Advance Directive, that person is unavailable. 

3. The researcher must attempt to identify a surrogate of the highest priority. (Note: If there is more than one surrogate of the highest priority and there is a disagreement between them, majority rules. If there is disagreement and no majority, consult with the Ethics Consult Service or the Office of Medical Legal Affairs.) 

4.The University of Chicago/UCH Health Care Surrogate Act Certification Concerning Research must be used in all instances of surrogate consent. The certification shall be placed in the subject's medical record and a copy attached to the research consent form or, if written consent is not required, kept with the subject research records. 

5. The consent process with the surrogate should include a discussion with the attending physician and an inquiry into the extent to which the surrogate is able to speak for the subject. Following the requirements of the Health Care Surrogate Act, this discussion should emphasize the surrogate's ability to make a decision that would conform as closely as possible to what the subject would have done or intended under the circumstances. The surrogate should take into account evidence that includes the subject's personal, philosophical, religious, and moral beliefs and ethical values relative to the purpose of life, sickness, medical procedures, suffering and death.

6. In circumstances in which the subject's wishes are unknown after reasonable efforts to discern them, the decision shall be made on the basis of the subject's best interests as determined by the surrogate decision maker. In determining the subject's best interests, the surrogate shall weigh the burdens and benefits of the proposed research and shall take into account any other information, including the views of family and friends, that the surrogate decision maker believes the patient would have considered if able to act for herself or himself. 

7. The surrogate should express his/her decision to the researcher in the presence of an adult witness (at least 18 years of age.) 

8. The University of Chicago/UCH Hospitals Health Care Surrogate Act Certification Concerning Research attached to the consent form should document the surrogate decision making process described in points 5, 6 and 7. 

9. The subject should be made aware of the research and the identity of the surrogate as soon as feasible. If the subject objects and the surrogate is not a court-appointed guardian, the subject should be withdrawn from the research. 

10. The surrogate will have the same rights as the subject to receive information on the research, to withdraw consent for further participation, etc. 

Legal Background:

Informed consent is one of the fundamental principles of research with human subjects. It has traditionally been recognized that proxy consent by someone other than the subject is not the same as the subject's own consent. The federal regulations require that informed consent be provided by the subject or the subject's legally authorized representative, except 1) in cases where the IRB has altered or waived some of the requirements for informed consent and the research presents no more than minimal risk or 2) in cases which meet the criteria for waiver of consent in emergency situations (45 CFR 46 and 21 CFR 50). It is State law that defines who can act as a subject's "legally authorized representative" to make treatment and /or research-related decisions on the subject's behalf.

The State of Illinois has two pieces of legislation which provide family members or others with legal authority to provide consent in situations where the patient is unable to provide consent. The Medical Patient Rights Act indicates that consent to participate in a research program or experimental procedure may be given by "the patient or, if the patient is unable to consent, the patient's guardian, spouse, parent, or authorized agent." It should also be noted that on June 27, 1997, the State of Illinois amended the Medical Patient Rights Act to align state law with the recently enacted federal (DHHS and FDA) regulations on the waiver of consent in emergency situations. 

The Health Care Surrogate Act also provides authority for a surrogate decision maker to act on behalf of patients (minor or adult) who lack decisional capacity. This statute initially applied only in situations concerning withdrawal of life sustaining treatment. Recent amendments to the statute extend the surrogate's authority to general medical treatment decisions, which can include research-related decisions.

For the purposes of this law, relevant surrogates in order of priority are as follows: 1) patient's guardian of the person; 2) patient's spouse; 3) any adult son or daughter of the patients; 4) either parent of the patient; 5) any adult brother or sister of the patient; 6) any adult grandchild of the patient; 7) a close friend of the patient; 8) the patient's guardian of the estate. 

For copies of The Medical Patient Rights Act and The Health Care Surrogate Act, please contact the Office of Medical Legal Affairs. 

For research in which investigators expect to enroll non-English speaking subjects, a consent form translated into the native language of the subjects to be enrolled must be provided to the IRB with the original submission or, if this study population is being added, with the amendment. A certified translator should perform the translation and proof of certification should be provided to the IRB along with the translated consent form. 

Due to the large Spanish-speaking population, the Office of Research Services has had a certified translator translate the written consent form template into Spanish. This template is available to investigators on the IRB Forms and Guidelines webpage. All other language translations must be done by investigators. 

Any recruitment materials (flyers, radio advertisements, etc.) that have been translated should also be provided to the IRB. In addition, investigators should translate all study materials that will be distributed to non-English-speaking subjects, such as surveys or questionnaires, and submit these to the IRB when the translated consent is submitted. 

The translated documents must be approved by the IRB before non-English speaking subjects can be enrolled into the study. 

Note that the exclusion criteria in certain protocols may specifically exclude non-English-speaking subjects from participating. Check your full written protocol for inclusion/ exclusion criteria before enrolling non-English speaking subjects. 

What if investigators encounter a potential subject who is Non-English-speaking, but do not already have a translated consent?

In some cases, a non-English speaker may be eligible for a study for which there is no translated consent document, and for which the study investigators could not have foreseen enrollment of a potential subject who speaks that language. In this case, the federal regulations allow investigators to enroll the potential subject using a "short form" consent that has been translated into the subject's native language. 

The consent process must involve a translator who can verbally translate the information in the full written informed consent into the subject's native language. This translator must sign the full written informed consent as well as the short form consent to document that he or she participated in the consent process and that the subject has been fully informed regarding the study. A witness to the translation must also sign the consent form; the translator may him/herself function as the witness. 

Like the translated full written consent document, the IRB must approve the translated short form consent prior to its use. However, expedited review of an amendment to approve a translated short form consent is possible if the IRB has previously approved both the protocol in question and the protocol's full English-language informed consent document. 

The IRB has approved a short form consent document and has had this consent translated into several languages. For any language not listed below, the investigator is responsible for obtaining a certified translation. 

Short form consent (English)

Spanish translation

Arabic translation 
Bosnian-Serbian translation 
Macedonian translation
Polish translation 
Portuguese translation