Interacting With The Scientific Committee (IRB) 
Governing Regulations
Assurance Numbers 
Types of Review 
Full Review 
Expedited Review 
Exemption From Review 
Review Decisions 
Consent Forms 
Emergency Drug Requests 
Collaborating With Other Institutions 
Recruitment For Research 
Adverse Events 
Revisions 
Payments to Subjects 
Progress Reports 
End of Study 
Filling Out The Approval Forms 
Questions or Reporting Problems 
Workshops, Newsletter, Handbook, Resources 
 

DECISION TREES 

Decision Tree I:
Level of Review, Based on Study Design
Decision Tree II: 
Level of Review, Based on Subject Population
Decision Tree III: 
When Waivers or Variations in the Consent Process May Be Allowed
Decision Tree IV: 
Consent Process Required: Persons Not Able to Consent to Research
Decision Tree V: 
Type of Review and Consent for Research Involving Human Biological Specimens

A:     Any fully qualified professional employed by a Cook County Bureau of Health Services affiliate, or any person appointed to the medical or professional staff of an affiliate, may act as a Responsible Investigator for research. Residents, fellows and students may not be Responsible Investigators, but may have their research sponsored by an attending physician willing to act in that capacity.  Likewise with other health professionals: A licensed social worker employed by Cook County Hospital, for instance, may be a Responsible Investigator on a project, or may act as Responsible Investigator on a social work student project.

For projects that are parts of larger multi-institutional studies, we ask that a qualified investigator employed by a Bureau affiliate be named "Responsible Investigator" to act as the locally responsible party. This means that even if the overall project has a Principal Investigator from another institution, the "Responsible Investigator" as indicated on the approval forms will be one of our own employees.
                                                                                                                v

 
who can be the Responsible Investigator?

guidelines
assurance

A:     At Cook County Hospital, research projects which will require a full or expedited IRB review, should be submitted to the Office of Research Development, 235 Hektoen.

Projects for which you are seeking an exemption from review may be submitted directly to the Chair of Scientific Committee of the IRB, Dr. Audrey French, 637 S. Wood Street, Durand Bldg.

At Provident Hospital, contact Dr. Mark Potter in Family Practice, 312-572-2673 or Doris Evans at 312-572-2586.

 At Oak Forest Hospital, contact Dr. B. Amarkumar 708-633-2800

A:    The Cook County Hospital IRB meets the first and third Tuesday of every month. The Provident Hospital IRB meets every month, on the last Tuesday. The Oak Forest Hospital IRB meets monthly on the second Tuesday. 

Bureau IRB's may rely on primary reviewers from among the IRB membership to read submissions and present protocols at these meetings. To allow time for the primary reviewer to prepare this presentation, we ask that you submit your protocol no less than two weeks before the meeting at which you wish to have it considered. 

After the primary reviewer has presented a protocol, the whole committee discusses it and takes a vote. You will be notified in writing of IRB approval, or of any needed changes to the protocol or consent form. 

If there are problems with the submission, or if clarifications are needed, the primary reviewer may contact the Responsible Investigator before presenting the protocol. IRB members are willing to meet with investigators to go over the documents in detail if desired. You can find out about the status of your protocol's review by contacting the appropriate IRB: 
 

Cook County Hospital/Bureau IRB:   312-864-4821. 

Provident Hospital IRB:    312-572-2586 or 2673 

Oak Forest Hospital IRB:   708-633-2800

At Cook County Hospital, any protocol which requires full review by the Scientific Committee also must be approved by the Executive Medical Staff before it can begin. At Oak Forest and Provident Hospitals, studies may begin upon receiving written notice of approval from the IRB.

IRB review process

A:   The Cook County Hospital/Bureau IRB reviews projects that take place at Cook County Hospital, Cermak Health Services, the Ambulatory & Community Health Network, the Hektoen Institute and the Cook County Department of Public Health, as well as all projects which will take place in more than one Bureau hospital. Projects which take place only at Provident or only at Oak Forest Hospital must be approved by their respective IRBs.

which IRB?

assurance

A:  The IRB can provide information on all the protocols for which you are listed as the Responsible Investigator. The IRB Administrator can also review any information for any particular study for which you are an investigator. It is very important, however, when making inquiries that you give the IRB number for the study in question. Likewise, when reporting an adverse event or requesting approval of revisions, please reference the study by IRB number. 
 

access to IRB information

The IRB keeps a copy of the entire protocol as submitted, as well as any revisions, progress reports, adverse event reports, and correspondence related to the protocol. Obviously, you should retain a copy in your files of any protocol for which you have accepted responsibility. However, if for some reason you need a copy of your protocol or related material, we can supply one. 

IRB files are considered confidential. In addition to the responsible investigator, a protocol file may be seen by other persons named as investigators, members of the IRB, staff for the IRB, and Chairs of Departments and Divisions in which the study takes place. The Medical Director and the Hospital Director may also request to see files on approved protocols. Representatives of regulatory agencies such as OHRP, FDA or JACOH , and representatives of the funding agency or sponsor of the study may also inspect the IRB files. 
 

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A:     The Scientific Committees (IRBs) for Bureau affiliates are bound by the regulations of two federal agencies: the Food and Drug Administration , which oversees trials of new drugs and devices, and the Office for Human Research Protection (OHRP, formerly OPRR) , which oversees subject protections in federally-funded research. The regulations maintained by these agencies are spelled out in the Code of Federal Regulations (45 CFR 46,  21 CFR 50, 21 CFR 56 ). 

Although the FDA and OHRP have jurisdiction over only a portion of the research conducted at within the Bureau, it is Bureau policy to apply the same standards for all research projects, regardless of the funding source. 

In addition to the federal regulations, JCAHO has standards and the State of Illinois has statutes which govern the protection of research subjects in health facilities. These mesh with those at the federal level, and require the same kinds of review, oversight and informed consent 
 

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regulations

guidelines
assurance: human research
 

A:    We maintain a Multiple Project Assurance with OHRP (included with this guidebook) which allows Cook County IRBs to approve federally-funded human research without consulting with federal regulators on each project individually. The number is M-1150. 

The Hektoen Institute, LLC also maintains a similar assurance for vertebrate animal research with the Office for Laboratory Animal Welfare (OLAW). That number is A3418-01. Copies of both assurances are found in Section G. 
 

assurance numbers

assurance: human
assurance: animal research

A:      For any protocol which entails more than minimal risk, and for many which do not meet criteria for either expedited review or an exemption from review, the IRB membership must approve the project by vote at a convened meeting. This is a full review. The procedures for full review at Cook County Hospital is described above. 

full review 

guidelines

A:      A section of the Scientific Committee approval form (See Section D-III) asks you to indicate if you are requesting an expedited review and, if so, to cite the criteria by which your project might qualify. See Section C.12 for the complete list of criteria. 
 

expedited review

guidelines

A:      For certain categories of research considered to be of minimal risk, one voting member of the IRB can review and approve the protocol without waiting for the next scheduled meeting of the IRB. An expedited review only speeds up the approval process; it does not mean that required approval forms or an informed consent can be omitted. Protocols approved by expedited review still require yearly renewals and notification of the IRB of any adverse events or revisions to the protocol. 

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A:      You need confirmation from the Chair or Co-Chair of the IRB that this activity does in fact fall within one of the exempt categories. As stated in the Multiple Project Assurance, the Bureau's IRBs not leave this determination solely to the investigator. In addition, the IRB is required to maintain a written record of the projects that have been exempted from review and the reasons for the exemptions. 

In this guidebook you will find a short form (D-III.d) to request an exemption. The form asks for a brief description of the project, and a citation of the criteria by which it can be exempted from review. The criteria are listed on the form and may be cited by checking off the appropriate one(s). Once you have obtained an exemption from review you will not have to report back to the IRB for yearly renewals of the protocol. 

Please note that any exempted studies will be funded externally still require the institutional approval forms (Section D-I). These forms are used to obtain administrative approval for the use of resources and the receipt of funding when a study will be externally funded, regardless of its IRB review status. 

In order to do retrospective research at Cook County Hospital, Medical Records requires that you fill out a request form, and follow its guidelines to protect the confidentiality of patient records. 

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exemptions from review

guidelines

A:     At the end of this section are two decision trees which summarize the major criteria by which the level of review is determined. Decision Tree I shows the characteristics of the project which determine type of review; Decision Tree II those of the subject population which affect the type of review required. If these charts don't answer your questions, consult with the IRB Chair. 
 

If these charts don't answer your questions, consult with the IRB Chair.

deciding what type of review is appropriate

A:     The sample consent form is intended only as a guide and a reminder of the required elements of informed consent. Investigators are welcome to use whatever wording or format meets the needs of the project as long as: 
 

1.    All required elements of consent are included (see Section C.24 of this Guidebook); and 

2.    The final consent form is produced on institutional letterhead to show that it is an official document.

tailoring the standard consent forms

guidelines

A:      No. Under federal regulations the local IRB is the final arbiter of the acceptable documentation of informed consent. A local IRB might, for instance, request that some portions of a consent form be reworded to make them more culturally appropriate for the local patient population. If necessary, IRB will work with you and the study sponsor to write a mutually acceptable consent document. 

If the NIH is the sponsor, any deletion or substantive modification of information about risks or alternative treatments has to be justified in writing, and approved by the IRB, with that justification and approval reflected in the minutes. Some institutes (NCI, NIAID) request that these materials be forwarded to the institute and/or coordinating center. Note that this applies only to substantive changes in the content of the consent form, not to editorial or formatting changes intended to make it easier to understand. 

A:      At the very minimum, the permission of one parent or legal guardian. Investigators are expected to make an effort to obtain both parents' permission, especially for research involving more than minimal risk. It is understood, however, that both parents may not be reachable or available. If reasonable efforts to contact the other parent fail, or cannot be made, then one parent's permission is acceptable. 

In addition, for children old enough to understand research participation, you are expected to explain the research in developmentally appropriate terms and obtain the child's assent to participate. As a general rule, this applies to children about age 7 or above. Where age-appropriate, this assent should be indicated by the child's signature on the consent form. 

Please note that interviews, surveys or focus groups with minors may not be conducted without parental consent. Nor may these projects be exempted from IRB review. 
 

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permission for children

guidelines
assurance

A:     Adolescents legally defined as emancipated are permitted to participate in research without their parents' permission. Under some circumstances, such as when research focuses on services for which parental permission is not required, older minors might be able to consent for themselves. The IRB will determine for each project requesting such an exception if it may be allowed, and may require that you document for each case the reason for not being able to obtain parental permission. 

Decision Tree IV at the end of this section summarizes consent requirements for various types of research participants who may not be able give consent for themselves. 

consent for adolescents

guidelines

A:      Under some circumstances you may request either a waiver of written informed consent, or a short form consent procedure. A waiver would be appropriate if the consent form itself is the only identification of subjects for whom participation in the research might put them at legal or other risk as, for instance, in a study of drug dealers. Waiving written consent does not mean that the consent procedure is omitted, just that it is not documented (see Section C.27). 

With a short form consent procedure, you may summarize the key points of the research and conditions of participation in writing and have a witness attest by his/her signature that a full verbal explanation was given. A short form may be used when enrolling non-English speaking subjects, provided that the short form is in the patient's own language. In this case, the translator for the full consent may also be the witness. 

With IRB approval, written consent may also be waived for such minimal risk research as telephone surveys. In some narrowly defined circumstances, the requirement for informed consent may be waived if the research is minimal risk and cannot feasibly be performed without such a waiver (see Section C.28) 

Note that any of these waiver or variations on full written informed consent must be explicitly requested and approved by the IRB. 

In addition, with interview or survey research which is exempted from review no formal documented consent is required. However, ethical principles require that respondents be informed that this is a research project, that they may refuse to participate without penalty, that they may refuse to answer specific questions and may stop at any time without penalty, that they may contact the IRB if there are any questions or complaints, and that answers will be kept confidential. 

Decision Tree III at the end of this section summarizes the conditions for allowing variations and waivers of informed consent.

waivers of written consent

guidelines

short form consent

waivers with minimal risk research

A:      Exclusion of potential volunteers because of an easily-anticipated language barrier might violate the principle of inclusiveness in research. Although the IRB does not require that all consent forms be translated to languages other than English, if you anticipate recruiting a substantial number of non-English speakers for your study, translated consent forms are required. You should especially consider whether there are likely to be many Spanish-speaking patients in the recruitment pool. 

At Cook County Hospital the IRB has adopted a guideline that for any study planning to recruit 100 or more subjects a Spanish language consent document will be required. Provident or Oak Forest IRB's may require Spanish consent documents as appropriate for individual projects. 

For non-English-speaking subjects, when a full translated consent has not been prepared, the consent procedure may be translated verbally by an interpreter, with that person also signing the consent form and a "short form" consent document in the subject's own language. It is not advisable to rely on a family member or a person not trained in interpretation to translate. Standard short form consents in Spanish and other languages are available from the Scientific Committee. 
 

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non- English consent forms

guidelines: short form

guidelines: translated consent

A:     Under the Illinois Health Care Surrogate Act, when a person lacks decision making capacity, permission to participate in clinical research from which the individual patient may derive a benefit may be obtained from a legal guardian or from someone close to the patient, according to a hierarchy of relationship (see Section C.30). In Bureau facilities, before a mentally incompetent person may be enrolled in a study, a physician not associated with the study must attest that the patient is not competent to consent, that any persons with relationships higher in the hierarchy than the person giving permission are not reasonably available to either give or withhold permission, and that the research holds a possibility of benefiting the patient personally. 

When a patient is not able to give consent because of an emergency medical condition, and the research involves experimental treatment for that condition, under some conditions that patient may be enrolled without any surrogate's permission. In order to carry out such research the investigator must first carry out a process of community consultation and notification. If you are interested in emergency medical research requiring such a waiver of consent, consult with the IRB Chair or the Office of Research Development. 

Decision Tree IV at the end of this section summarizes consent requirements for various types of research participants who may not be able give consent for themselves.

permission for persons without decision making capacity 

guidelines
 
 
 
 
 
 
 
 
 
 

guidelines

A:     Detainees and prisoners can only be asked to participate in research which might potentially benefit the persons themselves or a group to which they belong. No research with prisoners or detainees may be exempted from review. Consent procedures must include clear language that there will be no repercussions to the potential subject should he/she decide not to participate, and no special consideration (such as early release) will be given should they decide to participate. Procedures for maintaining strict confidentially should also be used, and described in the consent form. 

By law, a prisoner advocate must participate in the the IRB review of all research with Jail detainees. For this reason, you may not enroll Jail detainees in an approved protocol unless recruiting from this population was specifically requested and approved. Responsible Investigators are responsible for instructing research personnel about this restriction, and remind them that detainees are usually distinguishable from the general patient population by the presence of a Sheriff's deputy, the use of restraints, and with outpatients, a Department of Corrections uniform worn by the detainee. 

enrolling jail detainees 

guidelines
assurance

A:      Usually this means you will follow some routine research practices: substituting codes for personal identifiers; removing sheets containing such items as names and addresses from survey instruments containing data; properly disposing of documents; limiting access to identified data; and storing research records in locked cabinets. 

In some studies, where subjects are selected because of a sensitive, stigmatizing, or illegal characteristics (e.g., they have sexually abused children) keeping the identity of participants confidential may be as or more important than keeping the data obtained about them confidential. Occasionally such research will require guaranteeing total anonymity, even to the point of eliminating signed consent forms (see Section C.27). If research data might be subject to subpoena, there are ways to shield it, at least at the federal level. Contact the Office of Research Development for more information 

protecting privacy

guidelines

A:       It is mandatory that the subject or subject's representative have a copy to keep, that a copy be put in his/her medical record, and that you retain a copy in your files for at least three years after the end of the study. If a copier is not readily available at the site where consent is obtained, you can obtain original signatures on multiple copies of the form. 

If you use a translated consent form or a short form consent in another language, both a copy of the form signed by the subject and a copy of the full consent form in English must be put in the medical record. 
 
 

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copies of consent forms

guidelines

A:      No. Research use of the agent requires prospective review and approval by the IRB. Emergency or compassionate use normally does not allow such a prospective review. In order to separate the clinical use of experimental agents from research use, federal regulators have made clear that an individual patient may be given such an agent either for clinical purposes (Emergency Drug Request) or for research purposes, but not both. 

emergency drug requests

guidelines

A:     Emergency IND: An Emergency IND is the only circumstance in which you may use an investigational drug to treat a patient without prior IRB review and approval. An Emergency IND may only be employed when the patient's condition is life-threatening, when there are no approved alternative treatments, and when there is not enough time, due to the condition of the patient, to bring the request to the IRB. You must seek verbal approval from the Chair or Co-Chair of the Scientific Committee prior to administering the drug, and report in writing to the entire committee within 5 days. 

Off-Label Use: Physicians collecting data on efficacy, reactions, tolerance, etc. of FDA approved drugs used for unlisted (unapproved) indication as part of a research protocol must obtain IRB approval prior to the onset of the study. 

In contrast, when a physician prescribes an approved drug for treatment for unlisted indications, IRB approval usually will not be required. A physician with a permanent Illinois license may prescribe any approved, marketed drug to treat a patient for an unlisted indication, provided he/she writes a valid order or prescription. If this off-label use comes to the attention of the Pharmacy because of an unusual dose, route, patient population or potential for an adverse effect, the Pharmacy may require the physician to justify such use from the literature. This literature will be reviewed by a clinical pharmacist, the Chairman of the Drug and Formulary Committee and the chairman (or designee) of the prescribing physician's department. If this group approves of such use, it may continue. Only if they do not agree with such use, will it be referred to the IRB for final determination. 

If off-label use of an approved drug is questioned by the Pharmacy Department and subjected to review by the group described above, the physician wishing to use the drug may request interim approval for such use from the Chair of the IRB. If the Chair gives interim approval, the drug may be used for the purpose under question until a decision is reached by the process described above. An Off-Label Request may be approved verbally by the Chair if the situation requires, to be followed within 5 days by a written report 

Treatment IND: A Treatment IND allows you to use an investigational drug for serious for life-threatening conditions under an ongoing protocol. Such use requires prior IRB approval (see Section C.22) 
 

treatment use of experimental drugs

guidelines

off-label use of approved drugs

A:     With IRB approval, you may continue such subjects in either a Treatment IND or an open-label protocol. These and several other options for treating patients with investigational drugs are described in Section C.21. 

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continuing patients after the trial is over 

guidelines

A:      When two institutions which both have IRBs collaborate, usually both IRBs must approve the project. Consent forms will be formatted according to the standards of the institution(s) where subjects will give their consent for the research. If subjects will be enrolled at both sites, two versions of the consent form will be necessary. 

Note also that within the Bureau, there are three IRBs. When a project takes place only at Provident Hospital, it will be overseen by the Provident IRB. When it takes place only at Oak Forest, it will be overseen by that IRB. All other projects at Bureau sites, including those which take place at more than one site, will be overseen by the IRB at Cook County Hospital. 
 

dual IRB reviews

assurance

A:      The Responsible Investigator must ensure that all personnel working on his/her research or grant-funded project have the required credentials to work on site. In addition to your assuring that they have the appropriate skills and training, this entails obtaining a temporary ID from the appropriate office (CCH: Human Resources, 312-864-7571, Provident: Mr. Robert Triplett,  312-572- 1400;  Oak Forest Hospital, Dr. B. Amarkumar, 708-633-2800). Orientation in infection control and safety is required, as is a written medical clearance for certain infectious diseases. 
 

credentials for outside research staff

A:     The IRB which originally approved the study must be notified of the transfer of any enrolled patient to another hospital. Appropriate staff of the receiving hospital (e.g., attending physician, nursing supervisor, pharmacist), must be notified that an enrolled patient is being transferred, and should receive copies of the protocol and signed consent form. A copy of the consent form must also be put in the chart at the receiving hospital, and appropriate staff must be informed about how to contact you should the patient experience an adverse event, or if the patient requires a change in medications or treatment. 
 

hospitalization or transfer of enrolled subjects

guidelines
assurance

A:     In most case, if the specimens have already been collected for clinical purposes before the start of your study, and if personally identifying information has been removed from them, the study may be eligible for an exemption from review. 
 

Please note, however, that ethical considerations and institutional policy require that you not collaborate on research in any way with an institution which does not appropriately protect human subjects in research. 

Most teaching hospitals and universities have subject protection procedures in place. Most private practitioners and many community hospitals and community clinics do not. If you are to receive specimens -- or accrue subjects or otherwise collaborate on research from such a site, please contact the Office of Research Development for arranging for an affiliation agreement to assure the protection of human subjects at your collaborating site. 
 

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when a collaborator is outside the Bureau

guidelines
assurance

A:     All organized recruitment of potential research subjects at Bureau facilities must be reviewed. Organized recruitment would include contacting patients whose names have been extracted from medical records; stationing recruiters in clinic waiting rooms or other hospital areas; posting flyers or handing out recruiting leaflets on site. 

This is in contrast to an individual physician informing a patient during a clinical interaction about a research study that is available at another institution. As long as only descriptive information is given to the patient ( i.e., a summary of the research and the name and phone number of the physician conducting the trial), without any implied endorsement of the research, this interaction is considered to be a clinical referral, not organized recruitment. 
 

recruiting on behalf of other researchers

guidelines
 
 
 
 
 
 
 
 

guidelines

A:      Releasing the names and addresses of your patients to someone not employed by the facility treating the patient, who does not have any clinical reason to know this information, would violate the confidentiality of your patients' medical information. The general rule is that only employees with a clinical reason to know about patients' conditions should contact them about possibly participating in research. That means you could call or write and ask permission to forward their names to your colleague, without breaching the confidentiality of your relationship. Likewise, someone under your direct oversight a resident or a nurse for example could make this initial contact. Until the patient gives permission to be recruited, however, your colleague and/or his employees should not be given this information. 

 guidelines

A:      Yes. Direct recruiting advertisements are seen as part of the informed consent and subject selection processes. IRB review is necessary to ensure that the information is not misleading to subjects. No claims should be made, either explicitly or implicitly, that the drug, biologic or device is safe or effective for the purposes under investigation. Claims also cannot be made that the test article is known to be equivalent or superior to any other drug, biologic or device. 

Generally, the FDA believes that any advertisement to recruit subjects should be limited to the information the prospective subjects need to determine their eligibility and interest. When appropriately worded, the following items may be included in ads: 
 

1.    The name and address of the clinical investigator and/or research facility; 

2.     The condition under study and/or the purpose of the research; 

3.     In summary form, the criteria that will be used to determine the eligibility for the study; 

4.     A brief list of participation benefits, if any (e.g., no-cost health examination); 

5.     The time or other commitment required of the subjects; 

6.     The location of the research and the person or office to contact for further information

advertising for volunteers

guidelines