IF YOUR PROJECT IS AUDITED: WHAT CAN YOU  EXPECT?
 

Since September, 1999, the Bureau has carried out a program of routine quality audits of human research projects.  For those who would like to know what to expect if their project is chosen for an audit, Funeka Sihlali, the Bureau's Research Quality Coordinator, has prepared this explanation.
 

The Research Quality Coordinator implements, coordinates and monitors the quality assurance programs for all human research overseen by Cook County Bureau of Health Services Scientific Committees (IRBs). The coordinator is also an ex-officio member of the Cook County Hospital/Bureau IRB. One of the coordinator's responsibilities is to audit research projects. About 10% to 15% of our active research projects are chosen at random for routine audit each year.

Audits and Continuing Review

Most researchers know that Institutional Review Boards must approve and oversee all human research.  They may not know, however, one duty of  the IRB is "continuing review" of ongoing research to assure that the rights and welfare of human subjects are protected.  The various federal agencies that regulate research have somewhat different standards for what constitutes continuing review. For instance, one of the federal rules for FDA regulated research (21 CFR 56.108) states that "an IRB shall conduct continuing review of research covered by these regulations at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research".  Historically, most research institutions have implemented this and similar rules by way of  written reports submitted least yearly as part of the renewal process (in the Bureau we do this by way of Progress Reports). Efforts by IRBs or institutions to gather information in person about ongoing research have usually been limited to high-risk situations or when there is reason to believe a problem exists.

Numerous observers have expressed concerns that this system for continuing review does not provide enough information to assure that research is being carried out as planned. Worse, it means that a project could be operating with serious deficiencies for an entire year, or until there is a complaint, before the IRB or institutional officials have a chance to find out about it.

For these reasons, more and more institutions have adopted some form of research auditing.  The purpose of audits is to give support to researchers and to educate them when necessary, to reinforce measures designed to protect the welfare of research participants, and to promote good clinical practice. Audits are not meant to be punitive exercises. As anxiety-provoking as an audit may be, the goal is to provide an opportunity to educate and to correct myths or incorrect assumptions about how to carry out good research. In this way poor practices can be corrected before irreversible problems are created or participant welfare is compromised. 

The Audit Process

If an audit is "for cause" – that is, the audit is carried out in response to a complaint or an allegation of serious noncompliance – there will be a very small window for negotiating a time to carry out the audit. In most cases the audit will take place as soon as possible. On the other hand, when it is a routine "at random"audit, it will be scheduled at a convenient time within two weeks of your receiving the audit notification.

All routine audits are preceded by a written notice to the principal investigator and a request to make an appointment for the audit. If your project is chosen for an audit, you are expected to be responsive to this notice, to cooperate fully with the auditor and to provide her with an appropriate area on site in which to work.

During an audit, the following methods may be used:

1)   Interview with the Principal Investigator or contact person ( a person listed as an investigator who has oversight responsibilities for the project). This is done to assess the progress and direction of the study and to clarify any misunderstandings.

2)  Review of the Regulatory Binder and its contents. The Regulatory Binder is the binder or file in which you keep all the documents pertaining to your regulatory responsibilities for this project. It should include:

• The complete current protocol, including copies of study documents associated with the protocol (e.g., Case Report Forms, investigator's brochure);
• The currently approved consent form;
• All correspondence with the IRB;
• The complete current list of investigators and copies of their c.v.'s;

The Regulatory Binder will be inspected to verify that this information corresponds to the documents on file with and approved by the IRB.

3)  Inspection of the research data, materials and documentation. This will be done to:

• Monitor the accessibility and confidentiality of the records;
• Verify the accuracy and completeness of the information;
• Check the source documentation;
• If an investigational new drug is used:
 Check the storage of the medication;
 Monitor its use, timing and inventory accountability.

4)   Evaluate the informed consent process. Research staff will be interviewed, completed consent forms will be inspected, and at times subjects will be interviewed or a consent process will be observed. This is done to:

• Evaluate the adequacy of the process;
• Validate dates and signatures;
• Check that all required elements of consent are present;
• Review the circumstances in which consent is obtained;
• Review any compensation offered.

5)  Review adherence to the protocol. Research records will be reviewed to:

• Check the validity of the inclusion and exclusion criteria used;
• Confirm laboratory results (verified with hard copy lab reports);
• Check for unapproved concomitant medications or the possibility of simultaneous investigational drugs.

6)  Review staffing for the project. This will be done to:

• Monitor delegation of responsibility;
• Evaluate the competency and training of the personnel;
• Find out if the project is adequately staffed.

 
If you have any questions about the audit process, please contact me at 312-572-3506. Happy holidays, and watch out for post audit care!

--Funeka Sihlali
 

HEALTH SERVICES RESEARCH: 
DRAWING THE LINE BETWEEN RESEARCH AND QA

The Institute of Medicine recently published the report of a committee which looked at issues surrounding health services research and the protection of human subjects. The report focuses on privacy issues in health services research, because in most cases the major risk to human subjects with this type of study is the disclosure of personal information. 

Health services research, according to IOM, is a "multi disciplinary field of inquiry , both basic and applied, that examines the use, costs, quality, accessibility, delivery, organization, financing, and outcomes of health care services for individuals and populations...[it] includes studies of the effectiveness of health care interventions in real-world settings, as contrasted with studies of the efficacy of interventions (e.g., new drugs) under controlled settings such as a clinical trial."

In its discussion of health services research, the IOM committee acknowledges that the line between this kind of research and quality assurance (QA) studies is often blurry, and that in fact health services research and QA represent two regions in a continuum of activities designed to evaluate and improve the way health care is delivered. 

Deciding where to locate the line between research and QA is an ongoing dilemma for those who do this type of research.  In recognition of this, the IOM panel recommended that institutions and IRBs adopt more explicit standards for distinguishing between health services research and quality assurance activities. The report gives an example of a set of standards that some institutions have adopted, which may be of use to County investigators trying to make this distinction:
 
 

These characteristics need not all be present for an activity to be research, but this list does elucidate some hallmarks of research which, if present, would tend to suggest that the activity is research and not QA. If you would like to see the complete report, "Protecting Data Privacy in Health Services Research" it is available on line at http://books.nap.edu/html/data_privacy/

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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] 

Best Practices in Medical Education and Education Scholarship, will be held in Minneapolis March 15-18, 2001 under the sponsorship of the Association of American Medical Colleges and the University of Minnesota Medical School. A call for proposals will be issued in January. For more information, call 800-776-8636 or go to http://www.medlib.iupui.edu/cgea/call201.html

Responsible Conduct of Research Conference will take place May 18-19, 2001,in Arlington, VA, presented by Public Responsibility in Medicine & Research. Call 617-423-4112 for more information, or go to http://www.primr.org/conferences.html

Scientists and Subjects is a retreat and web-based seminar sponsored by NIH and Indiana University. The retreat will take place March 15-17 in Bloomington, IN. Registration is limited; applications are due January 2, 2001. For more information, call 812-855-0261 or go to http://poynter.indiana.edu/sas/app2.html

In/Sites 2001 Conference on managing clinical trials sites for clinical investigators sponsored by the Institute for International Research, will take place January 22-24 in Orlando, FL. For more information call 888-670-8200 or go to http://www.iir-ny.com 

CONSENT FORM CLINIC

The Clinic is a one-on-one session designed to help investigators to:

• Insure that all the required elements of informed consent are included;
• Check that the document is written at an appropriate literacy level;

• Identify lay terms that can be substituted for medical terminology;
• Review the ways the risks and benefits of the study are described to make sure they are clearly communicated;
• Make sure the local situation is reflected in consent forms that have been supplied by a study sponsor
 

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National Institutes of Health:

All NIH announcements from the past several years, including full text versions of RFA's and PA's, can be reached on the web at:  http://grants.nih.gov/grants/guide/index.html

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 

NIH RFA'S AND RFP'S: 

These are one time only opportunities. 
MECHANISMS UNDERLYING THE INNERVATION OF SPECIFIC TASTE RECEPTOR CELLS (RFA-DC-01-002) National Institute on Deafness and Other Communication Disorders

MINIMALLY INVASIVE SURGICAL THERAPIES TREATMENT CONSORTIUM FOR BENIGN PROSTATIC HYPERPLASIA (RFA-DK-01-024) National Institute of Diabetes and Digestive and Kidney Diseases

COMMUNITY-BASED PARTICIPATORY RESEARCH IN ENVIRONMENTAL HEALTH  (RFA-ES-01-003) National Institute of Environmental Health Sciences

THE INFLUENCE OF GENDER ON HIV RISK  (RFA-HD-01-002) National Institute of Child Health and Human Development, National Institute of Mental Health

DEVELOPMENT OF INNOVATIVE TREATMENT APPROACHES TO AUTISM  (RFA-MH-01-010) National Institute of Child Health and Human Development, National Institute on Deafness and Other Communication Disorders, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke

THE TRANSITION FROM DRUG USE TO ADDICTION: UNEARTHING THE SWITCH (RFA-DA-01-004) National Institute on Drug Abuse

COOPERATIVE REPRODUCTIVE SCIENCE RESEARCH CENTERS AT MINORITY INSTITUTIONS  (RFA-HD-00-019)
National Institute of Child Health and Human Development, Office of Research on Minority Health, Office of Research on Women’s Health

CLINICAL TRIAL PLANNING GRANTS FOR PEDIATRIC REHABILITATION (RFA-HD-01-006) National Institute of Child Health and Human Development, National Institute of Arthritis and Musculoskeletal and Skin Diseases

NON-MOUSE MODELS OF DIABETES COMPLICATIONS IN CARDIOVASCULAR AND MICROVASCULAR DISEASES
(RFA-HL-01-010) National Heart, Lung, and Blood Institute, National Institute of Diabetes and Digestive and Kidney Diseases

MOUSE MODELS OF DIABETIC COMPLICATIONS CONSORTIUM (RFA-DK-01-009) National Institute of Diabetes and Digestive and Kidney Diseases, National Heart, Lung, and Blood Institute, National Eye Institute, National Institute of Dental and Craniofacial Research, Juvenile Diabetes Foundation International

NIDDK BIOTECHNOLOGY CENTERS (RFA-DK-01-019) National Institute of Diabetes and Digestive and Kidney Diseases

INTERNATIONAL INITIATIVES TO PREVENT HIV/STD INFECTION (RFA-MH-01-004) National Institute of Mental Health, National Institute of Nursing Research

EXPLORATORY RESEARCH ON FACIOSCAPULOHUMERAL DYSTROPHY (RFA-AR-01-002) National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Neurological Disorders and Stroke

TOXICOGENOMICS RESEARCH CONSORTIUM (RFA-ES-01-002) National Institute of Environmental Health Sciences

MICROBICIDE PRECLINICAL DEVELOPMENT PROGRAM (RFA-HD-00-018) National Institute of Child Health and Human Development, National Institute of Allergy and Infectious Diseases

COOPERATIVE SPECIALIZED INFERTILITY RESEARCH CENTERS (RFA-HD-01-001) National Institute of Child Health and Human Development

DEVELOPMENTAL CENTERS FOR EVALUATION & RESEARCH IN PATIENT SAFETY (RFA-HS-01-007) Agency for Healthcare Research and Quality

DEVELOPING TRANSLATIONAL RESEARCH IN BEHAVIORAL SCIENCE  (RFA-MH-01-005) National Institute of Mental Health,  National Institute on Drug Abuse

INDIVIDUAL POSTDOCTORAL NRSA FELLOWSHIPS IN EPIDEMIOLOGY /CLINICAL TRIALS RESEARCH /OUTCOMES RESEARCH IN SKIN DISEASES (RFA-AR-01-003) National Institute of Arthritis and Musculoskeletal and Skin Diseases

DEVELOPMENT OF HIGH-YIELD TECHNOLOGIES FOR ISOLATING EXFOLIATED CELLS IN BODY FLUIDS (RFA-CA-01-016)  National Cancer Institute

DEVELOPMENT OF THE GUT, LIVER AND EXOCRINE PANCREAS (RFA-DK-01-023) National Institute of Diabetes and Digestive and Kidney Diseases

STEM CELL PLASTICITY IN HEMATOPOIETIC AND NON-HEMATOPOIETIC TISSUE  (RFA-HL-01-007) National Heart, Lung, and Blood Institute, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Neurological Disorders and Stroke

SPECIALIZED NEUROSCIENCE RESEARCH PROGRAMS ON HEALTH DISPARITY: HIV AND THE NERVOUS SYSTEM (RFA-NS-01-009) National Institute of Neurological Disorders and Stroke, Office of AIDS 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.

SMALL GRANTS PROGRAM FOR CANCER EPIDEMIOLOGY (PA-01-021) National Cancer Institute

COLLABORATIVE RESEARCH ON THERAPY FOR VISUAL DISORDERS (PAR-01-022) National Eye Institute

DRUG ABUSE ASPECTS OF HIV/AIDS AND OTHER INFECTIONS (PA-01-023) National Institute on Drug Abuse

CORRELATIVE STUDIES USING SPECIMENS FROM MULTI-INSTITUTIONAL PREVENTION AND TREATMENT TRIALS (PA-01-015) National Cancer Institute

PHYSICAL ACTIVITY AND OBESITY ACROSS CHRONIC DISEASES (PA-01-017) National Cancer Institute, National Heart, Lung, and Blood Institute, National Institute on Aging, National Institute of Arthritis and Musculoskeletal and Skin Diseases,
National Institute of Child Health and Human Development, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Nursing Research

DESIGN, MEASUREMENT, AND STATISTICAL ANALYSIS IN MENTAL HEALTH RESEARCH (PA-01-018) National Institute of Mental Health

NCI MENTORED CAREER DEVELOPMENT AWARD FOR UNDERREPRESENTED MINORITIES (K01) (PAR-01-016) National Cancer Institute

DEVELOPMENT OF HIGH-YIELD TECHNOLOGIES FOR ISOLATING EXFOLIATED CELLS IN BODY FLUIDS (PAR-01-019) National Cancer Institute

EXPLORATORY/DEVELOPMENTAL GRANT APPLICATIONS (R21) (PA-01-012) National Institute on Drug Abuse

ECONOMICS OF DRUG ABUSE TREATMENT AND PREVENTION SERVICES (PA-01-013) National Institute on Drug Abuse

BEHAVIORAL SCIENCE TRACK AWARD FOR RAPID TRANSITION - NIDA (PAR-01-014) National Institute on Drug Abuse

MOLECULAR AND CELLULAR BIOLOGY OF METASTATIC TUMOR CELLS (PA-01-020) National Cancer Institute, National Institute of Diabetes and Digestive and Kidney Diseases

NIMH CAREER OPPORTUNITIES IN RESEARCH EDUCATION AND TRAINING (COR) HONORS UNDERGRADUATE RESEARCH TRAINING GRANT (T34) (PAR-01-008) National Institute of Mental Health

NIMH CAREER OPPORTUNITIES IN RESEARCH AND TRAINING (COR) HONORS HIGH SCHOOL RESEARCH EDUCATION GRANT (R25) (PAR-01-009) National Institute of Mental Health

EXPLORATORY STUDIES IN CANCER DETECTION, PROGNOSIS AND PREDICTION (PA-01-010) National Cancer Institute

RESEARCH CORE CENTERS (P30) FOR THE NIDCD (PA-01-011) National Institute on Deafness and Other Communication Disorders

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CENTERS FOR DISEASE CONTROL AND PREVENTION

For more information, go to http://www.cdc.gov/od/pgo/funding/grantmain.htm
 

HEALTH RESOURCES AND SERVICES ADMINISTRATION 

Training, service and research grant opportunities for the next six months are summarized in the current HRSA Preview, which can be found at http://www.hrsa.dhhs.gov/grantsf.htm, or can be ordered by calling 1-877-477-2123.
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January 31, 2001 
Integrated Health and Behavioral Services for Children, Adolescents and Their Families (CFDA 93.110AF )

February 2, 2001 
Special Projects of Regional and National Significance: Community-Based Abstinence Education under Title V of the Social Security Act (CFDA 93.110NO )

February 2, 2001, Letter of Intent due December 29, 2000 
Health Insurance and Financing Cooperative Agreements: Assuring Adequate Health Insurance for Families of Children with Special Health Care Needs (CFDA 93.110C)

DEPARTMENT OF EDUCATION 
Details on open opportunities can be found at http://www.ed.gov/GrantApps/
 

SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION 
Details on grant opportunities can be found at http://www.samhsa.gov/GRANT/0100titles.htm

January 10, May 10 
Comprehensive Community Treatment Program for the Development of New and Useful Knowledge 

January 10, May 10 
Targeted Capacity Expansion Program 

January 10
CSAT Community Action Grant Program

ENVIRONMENTAL PROTECTION AGENCY 
Details on grant opportunities can be found at: http://es.epa.gov/ncerqa/rfa/

March 7, 2001 
Aggregate Exposure Assessment for Pesticides: Longitudinal Case Studies 

February 21, 2001
Environmental Monitoring for Public Access and Community Tracking (EMPACT) 

JUSTICE DEPARTMENT
Details on grant opportunities can be found at:  http://www.ncjrs.org/fedgrant.html

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ADMINISTRATION FOR CHILDREN AND FAMILIES
Office of Community Services
Details on grant opportunities can be found at: http://www.acf.dhhs.gov/programs/ocs/kits1.html

U.S. ARMY MEDICAL RESEARCH AND MATERIEL COMMAND 
Details on grant opportunities can be found at:  http://cdmrp.army.mil

TBA
Prostate Cancer Research Program for 2001 

OFFICE OF POPULATION AFFAIRS
Details on grant opportunities can be found at: http://www.hhs.gov/progorg/opa/grnt-ann.html

NATIONAL SCIENCE FOUNDATION
Information on NSF programs can be found at http://www.nsf.gov/
Note:   NSF strongly favors basic research not closely tied to clinical applications

OFFICE OF NAVAL RESEARCH
Details on grant opportunties can be found at:  http://www.onr.navy.mil/

FOOD AND DRUG ADMINISTRATION
Details on grant opportunities can be found at: http://www.fda.gov/oc/ofacs/grants/default.htm

DEPARTMENT OF ENERGY
Details on grant opportunities can be found at: http://www.sc.doe.gov/production/grants/grants.htm

January 5, 2001
CELL-TARGETED ABLATION THERAPY FOR CANCER USING IN-VIVO RADIATION

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Note:  Hundreds of  biomedical research grants may be searched by going to the AAAS/Howard Hughes Medical Institute at http://www.grantsnet.org/   This site includes many grants offered by professional societies. You must register to use the search engine, but the service is free.
 

Open
COMMUNITY HEALTH AND HUMAN SERVICES, Tellabs Foundation (630-378-6112 or http://www.tellabs.com/news/tfg.shtml)

January 16
MOLECULAR PATHOGENIC MYCOLOGY, MOLECULAR PARASITOLOGY,  Burroughs Wellcome Fund (919-991-1500 or http://www.bwfund.org)
 

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