WHO'S NEXT?
 

In the past year, two major research institutions in Chicago Rush-Presbyterian-St. Luke's Medical Center and the University of Illinois at Chicago have been severely penalized by the federal Office for Protection from Research Risks for inadequately protecting human research subjects. Two other large research programs, at Duke and the Westside VA Hospital in Los Angeles, were similarly reprimanded and restricted. 

This new activism from regulatory agencies is fueled in part by Congressional scrutiny and in part by continuing revelations about mistreatment of research subjects. For instance, the investigation of Rush's subject protection system revealed that elderly persons had been harassed repeatedly to consent to participate in research after they had initially refused. At UIC, patients were subjected to experimental procedures, which in at least one case caused severe emotional distress, without those procedures having been reviewed by the IRB and without informed consent having been obtained.

Could it happen in the Bureau? Some new Bureau initiatives are aimed at forestalling such problems -- specifically our reorganization for Bureau-wide oversight of research and our new program of Scientific Quality Assurance. In the end, however, the only way Cook County can insure that human subjects are protected is not by programs or paperwork, but by widespread and thorough understanding by researchers of how to protect research subjects.

The following is a series of questions that all County investigators are urged to read and answer for themselves. The questions were developed not only from the revelations at Rush and UIC, but also from issues that have arisen in our own system. None of these problems is hypothetical.
 
 
 
 
 
 
 
 
 

Is your consent procedure a conversation or a piece of paper?

When you go through the informed consent procedure, do you "talk through" all the material in a face-to-face conversation, or do you just hand the consent form to the patient to read and sign? The latter is not an acceptable consent procedure. The consent form is merely the documentation of the conversation that took place between you and the patient. It cannot be a substitute for that conversation.
 

After enrolling the patient, do you ensure that she/he receives a copy of the consent form?

The consent form is intended to be a future reference for the subject. It describes the study's schedule, its purpose, and any known side effects. It gives the names and numbers of people or offices to contact if something goes wrong. This information must be available to the subject throughout the study -- without the consent form it will not be.
 

Do you ensure that a copy of the consent form goes in the patient's medical record?

If another health provider cares for this patient, he or she must know about any research that the person is participating in, especially if investigational drugs or devices are being used.
 

Do you take sufficient time to answer the patient's questions? Do you try to elicit questions from the patient?

You need to be sensitive to the reluctance of some patients to question an authority figure or to ask questions about a complex topic. It is up to you to make the context as comfortable for questioning as possible.
 

Do you try to elicit feedback from the patient to see if he or she truly understands what the research entails?

The complexity of the material may be daunting, and may require repetition. If you don't probe respectfully to see if the subject understands, you won't have a chance to go over the unclear parts.
 

Do you give the patient the opportunity to consult with a family member or friend if he/she is not sure about what consenting to the research means?

This should always be an option, even if it means the patient will take the consent form home before signing it, and come back for another visit to enroll. Lack of time or fear that a patient will be lost to enrollment are never justifications for rushed or uninformed consent. 
 

Do you make sure that the informed consent, and all study procedures, take place in a setting that is respectful of the patient's confidentiality and that permits you to give your full attention to the interaction?

Discussing a complex study in a busy waiting room, or another place where you may be interrupted, is not an optimal context for either effective communication or maintenance of confidentiality. 

Do you take steps to ensure that your subjects feel like valued participants?

Such steps include listening respectfully, not interrupting, maintaining eye contact, and avoiding distractions during the interaction. All health care professionals should always do these things, but bad habits arise out of time pressure and other stresses. Making the subject feel valued is essential if you expect the subject to comply faithfully to the protocol, or even if you hope to retain the subject throughout the study. 
 

If someone decides not to participate in a study do you or any member of your research team ask again?

Such repeated requests are considered coercive, especially in a health care system where most patients have few or no other health care options.
 

When you enroll a patient in research, do you give the impression that the study is primarily a treatment? 

Research is done because we don't know which treatment works best. If we knew, there would be no ethical justification for doing research on humans. When people who are ill are asked to participate in research, they often come away with the impression that the research was done primarily for therapeutic purposes. In a phenomenon termed the "therapeutic misconception" the uncertainty connected with research is ignored. 

Investigators may compound the problem by presenting the research as primarily something that could help when all else has failed, rather than emphasizing that the effectiveness of the experimental treatment is not known or that the patient has a chance of being assigned to a control group, and won't receive the experimental treatment at all. A patient whose therapeutic misconception has been boosted this way is not fully informed.
 

Do you assign the informed consent procedure to someone who is not listed as an investigator and/or is not trained to obtain informed consent for research?

The principal investigator and persons named as co-investigators are the only individuals authorized to obtain consent. The PI is responsible for insuring that all persons who obtain informed consent know what the procedure entails. Clearly, it is not something that may be assigned to whichever resident happens to be on duty.
 

When you write a consent form do you try to reduce the technical jargon as much as possible?

Remember that the average American has a reading level of not more than eighth grade, and that lower reading levels can be expected in some populations.
 

When you write a consent form, do you take care not to oversimplify so much that important information is left out?

It's fine line to walk between too much and too little technical language, but walk it we must. For a handy guide to plain language equivalents for medical terms, visit the web site at http://ovcr.ucdavis.edu/hsglossary.htm. 
 

Do you take steps to insure that all members of your research team are carrying out procedures consistently?

Even among a group of investigators committed to a project, lack of sufficient coordination can sometimes lead to inconsistency in interacting with subjects, not to mention possibly invalidating the data. Subjects who receive conflicting messages from study staff may not feel fully confident in the research or the researchers.
 

When designing a study, or agreeing to carry out a clinical trial, do you realistically evaluate staffing and time needs? 

Shortcuts are sometimes made when there is not enough staff or enough time to carry out all the steps required to do good research. Sometimes such shortcuts compromise human subject protections, as when the consent procedure is rushed and perfunctory. The time to avoid this problem is when you plan the study.
 

When you agree to carry out a multi-site trial, do you learn the protocol in depth? 

It should go without saying that a principal investigator who takes on responsibility for a clinical trial should know the protocol in detail, including the entire study schedule, the whole range of possible side effects, and various contingencies for handling problems that arise. 
 

If you use an investigational drug, device or biologic for treatment ("compassionate use" or "emergency drug request") do you always get interim approval from the IRB Chair and written informed consent from the patient or the patient's representative? 

All use of investigational drugs, devices or biologics, whether on or off a research protocol, requires IRB approval. In emergency situations, the Chair can give interim approval until the next IRB meeting. Written informed consent is required in all cases except when the patient's condition is life threatening and prior consent can't reasonably be obtained.
 

When someone not employed by the Bureau is working on site for your study, do you ensure that the person is properly qualified, supervised, and credentialed?

If you take responsibility for a research project, you assume responsibility for the activities of all study personnel on site, including those who may come in from another institution to recruit patients, carry out interviews, or provide interventions. It is not acceptable to rely on "long-distance" supervision or credentialing from the other institution.
 

When you prepare a presentation or publication based on a case report, a case series or a retrospective chart review, do you always obtain an exemption from review from the Chair of the IRB? 

Investigators are not permitted to make the final determination that a study is exempt from review. This must be confirmed in writing by the Chair of the IRB.

This is not only the law, it is also the prudent course. The rules for determining exemptions can be slippery, and not everyone is fully cognizant of them. For instance, many people don't know that no research involving pregnant women, fetuses, prisoners or jail detainees may be exempted from review, even if the research is a report of a single case. No survey, interview or focus group research with minors may be exempted from review, no matter how innocuous the questions. If you don't get confirmation that your research is exempt, you could inadvertently carry out noncompliant research. For the safety of all concerned, you must get written confirmation if you think your research is exempt. 

Do you ensure that all the research projects carried out by the residents you oversee have been approved by the IRB?

The rule about always obtaining an exemption applies to residents' projects, even if the project is a small chart review. 
 

Do you always obtain an exemption from review when you write up or present data from the Tumor Registry or other data bank?

The same rule applies to research generated from these sources of data as to research based on medical records. 
 

Are you aware that piloting or pretesting of research techniques with humans needs prior IRB approval?

The subjects' rights are the same, whether you're pretesting one technique or doing the full-scale study.
 

Do you try to remain visible and available to subjects throughout the study?

Subjects who feel they can reach the person in charge will be reassured, and you will have a better chance of dealing with problems early if they arise. 
 

Do you debrief your subjects when their participation is over? 

A conversation at the end of the study provides closure, makes the subject feel that his/her contribution was valued, and maintains the subject's interest in research participation. Such debriefings are also required by the Joint Commission. When results from the study are available, they should be distributed to the people who participated. 
 

Do you record and retain no more confidential information than is necessary to carry out the study? 

Some investigators routinely set up data sheets that include the subject's name, address, phone number, medical record number, and even social security number. This much private information is usually unnecessary to do the research, and its presence on data sheets increases the chance that a subject will be harmed by a breach of confidentiality. Standard research procedure should be to employ a code to identify each subject, linked on a master list to basic identifying information (usually a name and medical record number will suffice). The master list is kept in a locked file, and all individual data collected is identified only with the code number assigned for the study. 
 

When enrolling children in research do you make a reasonable attempt to get both parents' permission? Do you get the assent of children aged seven and older?

If both parents are reasonably reachable, both should give permission, especially for studies that might entail some risk to the child. Children old enough to understand at least some aspects of research participation should receive an appropriate explanation and be asked to assent.
 

Have you actually read the guidelines?

The application used to apply for IRB approval from the CCH/Bureau Scientific Committee includes an Investigator's Acknowledgment, to be signed by all named investigators. In this acknowledgment, investigators affirm that they have read the IRB guidelines and will abide by them. On occasion, it has been obvious to this committee -- from the content of the application, from the questions asked by the applicant, or by the applicant's own admission -- that he/she has not read the guidelines. Sometimes applicants have obtained a copy of the application forms, but not the guidelines. If you sign the acknowledgment, it is expected that you truly have read the guidelines. (Guidelines are available in the Resource Room, 603 Durand. Call 633-7792 first to make sure the room is open) 
 

WHAT ABOUT SPANISH CONSENT FORMS?

One of the criticisms aimed at UIC's human research program by federal regulators was the lack of Spanish versions of consent forms when Spanish speaking patients were enrolled in studies. Many investigators have asked if this means a Spanish version consent form must be prepared for every study.

The Cook County Hospital/Bureau IRB has a policy that a Spanish version of the full consent form must be submitted when the investigator plans to enroll 100 or more patients. For other studies, investigators are expected to use a "short form" consent procedure when enrolling patients who don't speak English. 

With the short form procedure, you must have a summary of the study, which may be in English (although the subject's language is preferable) and a "short form" consent in the subjects's own language. These materials are presented in the consent session, at which an interpreter orally translates the full consent to the patient, and signs the forms to document that the all consent information has been conveyed. The subject is given a copy of the short consent and the summary to keep.

This procedure is more workable than using a full translated consent form, because the short form consent is a boilerplate document which gives the basics of consent (e.g. that this is a research study; that you may decline to participate without endangering your care; that you may quit at any time, etc.) but does not describe the specific study. This means that the short form need only be translated once into any given language, and then may be used, in combination with an interpreter and a study-specific summary, to enroll non-English speaking subjects for any and all studies. 

The Cook County Hospital/Bureau IRB is currently working on making short form consent documents available in the languages most commonly encountered in Bureau facilities. If you think may need to use a short form procedure for your study, you must: 1) request it at the time of IRB review; 2) submit the study summary that will be used for IRB approval; and 3) obtain copies of short form consent(s) in the language(s) you will use. If you have an already-approved study for which you wish to use a short form consent procedure, submit these materials as a revision to your protocol.

A sample short form consent (in English) prepared by the Office for Protection from Research Risks is attached at the end of this newsletter to show what information should be included. A sample of a Spanish translation of this form is also included.
 
 

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[A long-term calendar showing most of the major academic medical society meetings can be found on the web at: http://www.aamc.org/meetings/mjmtgcal.htm] 

IRBs in Crisis Institutional Responsibilities is a conference sponsored by the Association of American Medical colleges, to be held October 21 in Washington, DC. Call 202-828-0417 for more information.

Toxicology Testing Issues and Alternatives, is a workshop to be presented by the Scientists' Center for Animal Welfare, November 9 in Indianapolis. Call 301-345-3500 for more information.

Contemporary Issues in Behavioral Research, sponsored by Arizona State University, will be held November 11-12 in Tempe, AZ. For more information call 301-496-8101.

Privacy and Confidentiality in Clinical & Social Research Myth or Reality, will be held February 10-11, 2000 in Houston, sponsored by the University of Texas Houston Health Science Center and OPRR. For information call 713-500-5828.

Transforming Health Care Through Informatics, an annual symposium offered by the American Medical Informatics Association will take place November 6-10 in Washington, DC. Call 301-657-1291.
 

Office of Research Development Workshops 

These workshops are open to any County-affiliated investigator or grant-seeker. Enrollment for some sessions is limited, so please register only for those you will be able to attend. 

Grant Writing Seminar:

Gives an overview of the entire process of developing a project and applying for funding. Includes information on approaching both governmental and private funders, describes an approach to developing grant budgets, discusses stylistic and content issues that are frequent stumbling blocks in writing grant applications.

Constructing a Grant Budget:

Covers many of the technical aspects of developing an accurate time line and budget for a grant proposal.

What Are All These Forms? Interacting With the Scientific Committee: 

Gives an orientation to procedures -- and the associated forms -- used by the Scientific Committee to 
ensure that patients are protected from undue risks in research. The Bureau forms will be discussed, and new policies and changes in federal regulations will be covered.

To register for any of these, call Bennetta Anderson at 312-633-4941. If you would like to schedule one or more of these workshops in your Department or at another site, please call Karen Smith at 633-4940. 

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To have the NIH Guide sent automatically to your e-mail address every week, click on the LISTSERV link on this page and follow the instructions.

To ask specific questions about NIH grant programs, send e-mail to: grantsinfo@nih.gov 
 
 

These are one time only opportunities. Call 312-633-4940 to check for due dates or to get copies of full announcements

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HIGH RISK ARTHRITIS, MUSCULOSKELETAL AND SKIN DISEASES RESEARCH (RFA-AR-99-008) National Institute of Arthritis and Musculoskeletal and Skin Diseases

CANCER INTERVENTION AND SURVEILLANCE MODELING NETWORK (CISNET) (RFA-CA-99-013) National Cancer Institute

DIAGNOSTIC IMAGING AND GUIDED THERAPY IN PROSTATE CANCER (PHASED INNOVATION AWARD) (RFA-CA-99-015) National Cancer Institute, National Institute on Aging

INITIATIVE FOR MINORITY STUDENTS: BRIDGES TO THE BACCALAUREATE
(RFA-GM-99-010) National Institute of General Medical Sciences

INITIATIVE FOR MINORITY STUDENTS: BRIDGES TO THE DOCTORATE
(RFA-GM-99-011) National Institute of General Medical Sciences

SPECIALIZED CENTERS OF RESEARCH (SCOR) IN HEMATOPOIETIC STEM CELL
BIOLOGY (RFA-HL-99-021) National Heart, Lung, and Blood Institute

UNDERREPRESENTED MINORITY FELLOWSHIP PROGRAMS IN MENTAL HEALTH (RFA-MH-00-001) National Institute of Mental Health

SPECIALIZED NEUROSCIENCE RESEARCH PROGRAMS ON HEALTH DISPARITY: HIV AND THE NERVOUS SYSTEM (RFA-NS-99-007) National Institute of Neurological Disorders and Stroke 

ENVIRONMENTAL HEALTH SCIENCE AS AN INTEGRATIVE CONTEXT FOR LEARNING (RFA-ES-99-011) National Institute of Environmental Health Sciences

COMMUNITY-BASED PREVENTION AND INTERVENTION RESEARCH (RFA-ES-99-012) National Institute of Environmental Health Sciences

PREVENTION OF HEALTH RISK BEHAVIORS IN MIDDLE CHILDHOOD (RFA-HD-99-014) National Institute of Child Health and Human Development, Office of AIDS Research, National Institute of Mental Health

POPULATION RESEARCH CENTERS (RFA-HD-99-011) National Institute of Child Health and Human Development

BUILDING INTERDISCIPLINARY RESEARCH CAREERS IN WOMEN'S HEALTH (RFA-OD-99-008) Office of Research on Women's Health, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute of Allergy and Infectious Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Cancer Institute, National Institute of Child Health and Human Development, National Center for Complementary and Alternative Medicine, National Institute of Deafness and Other Communication Disorders, National Institute of Dental and Craniofacial Research, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute on Drug Abuse, National Institute of Environmental Health Sciences, National Institute of Neurological Disorders and Stroke, Agency for Health Care Policy and Research
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NIH PROGRAM ANNOUNCEMENTS 
(PA'S): These are ongoing funding priorities, with due dates usually October 1, February 1 and June 1 of each year. Note that HIV-related applications are due January 2, May 1 and September. Past PA's, many of which are still open, can be searched at the NIH Guide web site.
 

RACIAL AND ETHNIC DIFFERENCES IN THE ETIOLOGY OF TYPE 2 DIABETES IN
THE UNITED STATES (PAS-99-166)
National Institute of Diabetes and Digestive and Kidney Diseases

CORE SUPPORT PROGRAM FOR MENTAL HEALTH/AIDS RESEARCH
(PAR-99-153) National Institute of Mental Health

NHLBI CAREER TRANSITION AWARD (K22) (PAR-99-154) National Heart, Lung, and Blood Institute

HEPATITIS C INFECTION AND ALCOHOLIC LIVER DISEASE (PAS-99-155) National Institute on Alcohol Abuse and Alcoholism

PEPTIDE REGULATION OF ALCOHOL INTAKE (PAS-99-156) National Institute on Alcohol Abuse and Alcoholism

NIDCR CLINICAL TRIAL PLANNING GRANT (PAR-99-157) National Institute of Dental and Craniofacial Research

NIDCR CLINICAL TRIAL PILOT GRANT
(PAR-99-158) National Institute of Dental and Craniofacial Research

THE ROLE OF GROWTH FACTORS IN THE DEVELOPMENT OF DIABETES
COMPLICATIONS (PA-99-159) National Institute of Diabetes and Digestive and Kidney Diseases, National Eye Institute, National Institute for Dental and Craniofacial Research, National Institute of Neurological Disorders and Stroke, National Heart, Lung, and Blood Institute

SECONDARY ANALYSIS IN DEMOGRAPHY AND ECONOMICS OF AGING (PA-99-160) National Institute on Aging

ALCOHOL RESEARCH RESOURCE AWARDS (R24) (PAR-99-161) National Institute on Alcohol Abuse and Alcoholism

STAGES OF BREAST DEVELOPMENT: NORMAL TO METASTATIC DISEASE
(PA-99-162) National Cancer Institute, National Institute of Child Health and Human Development, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute on Aging, National Institute of Environmental Health Sciences

EXPLORATORY GRANTS FOR BEHAVIORAL RESEARCH IN CANCER CONTROL (PA-99-163) National Cancer Institute

INDEPENDENT SCIENTIST AWARD (PAR-99-164) Agency for Health Care Policy and Research

ALCOHOL EDUCATION PROJECT GRANTS (R25) (PAS-99-165) National Institute on Alcohol Abuse and Alcoholism 

SMALL BUSINESS INNOVATION RESEARCH ADVANCED TECHNOLOGY: NIAID (SBIR-AT-NIAID) - UPDATED (PAR-98-073) National Institute of Allergy and Infectious Diseases

CANCER COMMUNICATION AND INTERACTIVE MEDIA TECHNOLOGY
(PAR-99-141) National Cancer Institute

OCCUPATIONAL SAFETY AND HEALTH RESEARCH (PA-99-143) National Institute for Occupational Safety and Health, National Cancer Institute, National Heart, Lung, and Blood Institute, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute of Allergy and Infectious Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute on Deafness and Other Communication Disorders, National Institute of Environmental Health Sciences

OCCUPATIONAL SAFETY AND HEALTH RESEARCH (PA-99-144) National Institute for Occupational Safety and Health

PLANNING GRANTS FOR BIOMEDICAL EPIDEMIOLOGIC AND INTERVENTION STUDIES (PA-99-145) National Institute on Aging, National Institute of Environmental Health Sciences

EVOLUTIONARY MECHANISMS IN INFECTIOUS DISEASES (PA-99-147) National Institute of General Medical Sciences, National Institute of Dental and Craniofacial Research

RESEARCH METHODS FOR OCCUPATIONAL CANCER (PA-99-148) National Institute for Occupational Safety and Health, National Cancer Institute, National Institute of Environmental Health Sciences

DIAGNOSTIC IMAGING AND GUIDED THERAPY IN PROSTATE CANCER: SBIR/STTR INITIATIVE (PAR-99-149) National Cancer Institute, National Institute on Aging
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October 29
HEALTH POLICY RESEARCH SCHOLARS, Robert Wood Johnson Foundation (617-353-9220)

December 1
COOPERATIVE RESEARCH: US AND SPAIN, U.S. State Department (202-647-2245 or http://www.fulbright.es/welcome.html)

October 27
SURGICAL BREAST IMAGING, Army Medical Research and Materiel Command (301-682-5517 or http://cdmrp.army.mil)

February 4, 2000
REHABILITATION DEMONSTRATIONS, Department of Education (202-205-8494 or http://ocfo.ed.gov/fedreg.htm)

Various deadlines, Nov 13 -Feb 18
TECHNOLOGY AND MEDIA SERVICES FOR PEOPLE WITH DISABILITIES, Department of Education (http://ocfo.ed.gov/fedreg.htm)

January 30
VOCATIONAL REHABILITATION: MIGRANT AND SEASONAL WORKERS, Department of Education (http://ocfo.ed.gov/fedreg.htm)

October 4
LABORATORY MARKERS OF RECENT HIV INFECTION, Centers for Disease Control and Prevention (770-488-2733 or http://www.cdc.gov)

January 7
SPECIAL EDUCATION: TECHNICAL ASSISTANCE AND DISSEMINATION, Department of Education (http://ocfo.ed.gov/fedreg.htm)

Various deadlines, Nov 29 -May 19
RESEARCH AND INNOVATION FOR CHILDREN WITH DISABILITIES, Department of Education (202-205-9817 or http://ocfo.ed.gov/fedreg.htm)

Open
HUMANISM IN MEDICINE, Arnold P. Gold Foundation (201-567-4931 or http://www.humanism-in-medicine.org)

October 1 (Letter of Intent) 
ADENOID CYSTIC CARCINOMA RESEARCH, National Organization for Rare Disorders (203-746-6518)

October 1 (Letter of Intent) 
ESSENTIAL THROMBOCYTHEMIA RESEARCH, National Organization for Rare Disorders (203-746-6518)

October 1 (Letter of Intent) 
HEREDITARY TYROSINEMIA TYPE I RESEARCH, National Organization for Rare Disorders (203-746-6518)

October 1 (Letter of Intent) 
CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY RESEARCH, National Organization for Rare Disorders (203-746-6518)

February 15
LEUKEMIA: NEW INVESTIGATORS, Leukemia Research Foundation (847-424-0600 or http://www.leukemia-research.org)

November 12 
MEDICAL EDUCATION RESEARCH, National Board of Medical Examiners (215-590-9657 or http://www.nbme.org)
 
 

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LOST A LINK? 
Look in the 
alphabetical index to links on this site

THIS DOCUMENT MUST BE WRITTEN IN A LANGUAGE UNDERSTANDABLE TO THE SUBJECT

Consent to Participate in Research

You are being asked to participate in a research study.

Before you agree, the investigator must tell you about (i) the purposes, procedures, and duration of the research; (ii) any procedures which are experimental; (iii) any reasonably foreseeable risks, discomforts, and benefits of the research; (iv) any potentially beneficial alternative procedures or treatments; and (v) how confidentiality will be maintained.

Where applicable, the investigator must also tell you about (i) any available compensation or medical treatment if injury occurs; (ii) the possibility of unforeseeable risks; (iii) circumstances when the
investigator may halt your participation; (iv) any added costs to you; (v) what happens if you decide to stop participating; (vi) when you will be told about new findings which may affect your willingness to participate; and (vii) how many people will be in the study.

If you agree to participate, you must be given a signed copy of this document and a written summary of the research.

You may contact ___[name of investigator]____ at ___[phone number]__ any time you have questions about the research.

You may contact ____[name]___ at ___[phone number]__ if you have questions about your rights as a research subject or what to do if you are injured.

Your participation in this research is voluntary, and you will not be penalized or lose benefits if you refuse to participate or decide to stop.

Signing this document means that the research study, including the above information, has been described to you orally, and that you voluntarily agree to participate.

___________________________ ____________
signature of participant date

___________________________ ____________
signature of witness date
 
 
 
 

Se le est  pidiendo que participe en un projecto de investigaci¢n cl¡nica.

Antes de que usted d‚ su consentimiento, el investigador debe informarle acerca de: (I) el prop¢sito, los procedimientos, y la duraci¢n del projecto de investigaci¢n, (II) cualquier procedimiento que sea experimental, (III) cualquier riesgo, molestia y beneficios que sean razonablemente predecibles, (IV) cualquier otro procedimiento o tratamiento alternativo que sea potencialmente beneficioso y (V) c¢mo se mantendr  confidencialmente toda informaci¢n que se obtenga de usted.

Cuando sea indicado, el investigador tambi‚n debe informarle acerca de (I) cualquier compensaci¢n o tratamiento m‚dico disponibles en caso de que usted sufra lesiones relacionadas con el estudio, (II) la posibilidad de riesgos predecibles, (III) las circunstancias en las cuales el investigador puede parar su participaci¢n en el estudio, (IV) cualquier costo adicional para usted, (V) qu‚ pasar  si usted decide parar su participaci¢n, (VI) cuando ser  usted informado sobre nuevos hallazgos que puedan afectar su deseo de participar, y (VII) cuantas personas participar n en este estudio.

Si usted acepta participar, usted debe recibir una copia de este documento con todas las firmas y un resumen del projecto de investigaci¢n por escrito.

Usted puede comunicarse con ----------- (nombre del investigador), al n£mero telef¢nico ---------en cualquier momento que usted tenga preguntas acerca del projecto de investigaci¢n.

Usted puede comunicarse con -----(nombre del m‚dico o del encargado de su atenci¢n m‚dica) al n£mero telef¢nico ---------si usted tiene preguntas acerca de su atenci¢n m‚dica.

Usted puede comunicarse con el Comit‚ Cient¡fico del Hospital del Condado de Cook (al n£mero telef¢nico (312) 633-7792, durante horas laborales) si usted tiene preguntas acerca de sus derechos como sujeto de investigaci¢n o acerca de qu‚ hacer en caso de que usted sufra lesiones relacionadas con el projecto de investigaci¢n. 

Su participaci¢n en este projecto de investigaci¢n es voluntaria y usted no ser  penalizado y tampoco perder  los beneficios que le corresponden si usted decide no participar o decide parar su participaci¢n.

Su firma en este documento significa que el projecto de investigaci¢n, incluyendo la informaci¢n mencionada anteriormente, ha sido descripto para usted oralmente y que usted ha aceptado participar voluntariamente.
 
 
 

__________________________________ ____________________
Firma del Participante Fecha
 

__________________________________ ____________________
Firma del Testigo Fecha