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AGA urges creation of digestive diseases research commission
Gastroenterology News Anil K. Rustgi, M.D., Section Editor
HIPAA Challenges to Clinical Research
T
he challenges to clinical practice from the Health Insurance Portability and Accountability Act, or HIPAA, extend to the clinical research arena. Originally designed to ensure employee health care insurance carryover from job to job without penalization for preexisting conditions, HIPAA also embraces the Administrative Simplification Act, which includes patient privacy issues. Since April 14, 2003, when HIPAA regulations became effective, concerns have arisen about the Act’s potential adverse impact on clinical research. However, “despite initial fears that the institution of HIPAA would impair or prevent the research process, it appears that familiarity with the rules can make it possible to continue effectively,” says Dr. William J. Tremaine, Professor of Medicine at Mayo Medical School and director of the Mayo Foundation Office of Research Protection (IRB). Tremaine says the “biggest change” is the absence of purely verbal consent followed by documentation by the physician of patient agreement. Now, under HIPAA, written consent or authorization from the patient is
AGA Urges Creation of Digestive Diseases Research Commission
T
he AGA is calling upon Congress to establish a “contemporary” digestive diseases research commission to address the continuing substantial burden of these disorders on the U.S. population. The call comes 25 years after the enactment of a congressional bill, Public law 94-562, which created a National Commission on Digestive Diseases in 1976 that laid the groundwork for GASTROENTEROLOGY 2003;125:1298 –1300
required, including for minimal risk investigations. Another impact of HIPAA involves so-called “data mining,” looking through patient files for potential research candidates. “Now the investigator needs to file a ‘Review Preparatory to Research’ with their own institutional review board, or IRB,” Tremaine explains. By doing so, “you declare that you’re going to look through the files for patients with a particular condition. You can’t just go rummage through the charts anymore.” This form needs only to be filed with the IRB and does not require approval. On the other hand, HIPAA regulations pose a greater hurdle on survey studies. Investigators seeking to survey individuals they’ve identified with a particular condition must first obtain their HIPAA authorization to either write them with the specific questionnaire or to telephone them to ask the questions over the phone. “The next big impact is on computerized databases,” Tremaine says, noting that many investigators “have gone to great efforts” to maintain research databases, placing their patients with a particular condition into a computer file. “That’s problematic now in that HIPAA specifies that if you keep a patient database it must be specific to a research question, and it must be approved by the IRB,” he says. “No
longer can you simply maintain a lot of data and then go back and pull out patients who have, for example, high blood levels associated with this or that, or colostomies showing this or that.” He points out that a more practical way is to maintain a clinical database; that is, “keep files that you’re using for clinical purposes, such as to contact patients for follow-up, say, for another colonoscopy [to check for] for polyp recurrence, and then to ask specific questions from that clinical database with IRB approval. That you can do without having to get consent from the patients.” HIPAA has also had an impact on industry. Under HIPAA, hospitals and academic institutions are charged with protecting health information and are responsible for obtaining patient consent. However, in terms of their clinical research, these entities do experience pressure from industry to modify patient consent forms with the company’s own HIPAA language. “We find that it’s important for IRBs to make sure the language that’s suggested by the company is compatible with and does not contradict or negate their own HIPAA language,” Tremaine cautions. “Thus, we want to make sure industry doesn’t ask for more than HIPAA allows legally.”
creating a long-range plan to recommend the necessary resources to more effectively manage such diseases. The commission recommended creation of the digestive diseases core centers program at NIH. On September 11 and 12, 26 AGA members from 15 states and representing all regions of the nation, came to Washington, DC, to meet with federal legislative staff to advocate for the commission and for correction of the formula that determines the annual Medicare update for physician pay-
ments, also known as the sustainable growth rate (SGR). AGA members met with staff in nearly 50 Congressional offices, including those of Senate Majority Leader Bill Frist, R-TN; Sen. Edward Kennedy, D-MA; Sen. John Kerry, D-MA; Sen. Rick Santorum, R-PA; Sen. Elizabeth Dole, R-NC; Sen. Dianne Feinstein, D-CA, and Sen. John Warner, R-VA. AGA advocates suggested that an updating of the first commission’s efforts would be the most effective means for convening the best sci-
Gastroenterology News continued
entists to develop a contemporary blueprint for digestive diseases research over the next 10 years. Congressional offices found the research commission concept to be “a sound approach” to achieving this goal. In its continued advocacy for the new research commission, the AGA
points out that more than 62 million Americans each year are diagnosed with digestive disorders. Direct and indirect costs for 17 “selected” diseases such as gastroesophageal reflux disease, colon cancer, inflammatory bowel disease, and liver disease were estimated at $41 billion for the year 2000.
The AGA notes that while some promising research developments have been made in these areas, the incidence of many serious digestive conditions is increasing. More details on the subject can be found on the Public Policy/Advocacy page at www.gastro.org
Multicenter Study to Explore Drug-Induced Liver Injury
cidate the natural history of the problem. DNA analysis based on blood samples will be used to identify possible genetic risk factors that may exist for such hepatic injury. In addition, the study will seek to determine if new tests that are more sensitive than those already in use can be developed to detect the occurrence of dangerous liver injury among individuals involved in drug clinical trials. Thus, severe liver injury, although rare, may be more effectively detected before the FDA approves any new drugs for regular use in pa-
tients. A prospective clinical investigation is also planned that will include individuals who are recently diagnosed with drug-induced liver injury. Centers selected for the study are the University of North Carolina at Chapel Hill; University of California at San Francisco; University of Connecticut; University of Indiana; and the University of Michigan. Duke University will serve as the data-coordinating center, collecting information from the 5 study centers.
were research trainees. In FY 2003 nearly 500 individuals applied to the Pediatric Research LRP. NIH awarded loan repayment to nearly 300 Pediatric researchers. In Fiscal Year 2004, NIH intends to commit $38 million to fund 700 LRP-CR participants and $15 million to fund 300 PR-LRP participants. These programs provide for the repayment of educational loan debt of up to $35,000 annually for qualified health professionals conducting clinical or pediatric research for domestic non-profit or government entities. In addition, the NIH will cover up to 39% of the Federal tax liability resulting from the loan repayment, and may also provide reimbursement for state and local tax liabilities. Participants contract to conduct research for 50% of their time, or not
less than 20 hours per week for a 2-year period. Applicants must be supported by a domestic nonprofit institution or a Federal or domestic state or local government entity. Applications for these programs will be accepted September 1 through December 31, 2003. The notice describing the LRP-CR can be found at: http://grants1.nih. gov/grants/guide/notice-files/NOT-OD03057.html. The notice describing the PR-LRP can be found at: http:// grants.nih.gov/grants/guide/noticefiles/NOT-OD-03-058.html. Full details about the Loan Repayment Programs including the online application can be found at http://www. lrp.nih.gov/.
A
3-year study at five U.S. medical centers will be the first largescale investigation of severe drug-induced liver injury. Sponsored by NIH-NIDDK, the study initially will conduct retrospective evaluations of already established cases of drug-induced liver injury with a focus on drugs that are known to be associated with the problem. Clinical information will be explored for the emergence of patterns that may be predictive of liver injury and to elu-
This Month at the NIH: NIH FY2004 Loan Repayment Program for Clinical and Pediatric Researchers
T
he National Institutes of Health has announced the 2004 Extramural Loan Repayment Programs for Clinical Researchers (LRP-CR) and Pediatric Researchers (PR-LRP). The objective of these programs is to recruit and retain highly qualified health professionals as clinical investigators or as pediatric investigators. For LRP-CR, nearly 500 individuals applied in FY 2002 and nearly 1200 in FY 2003. The number of LRP-CR awards in FY 2003 increased to nearly 750. In FY 2002, two-thirds of LRP-CR awards went to applicants with M.D. or M.D./Ph.D. degrees. Also, a majority of LRP-CR awardees
Stories by Les Lang
Stephen P. James National Institutes of Health 1299
HIPAA Challenges to Clinical Research
T
he challenges to clinical practice from the Health Insurance Portability and Accountability Act, or HIPAA, extend to the clinical research arena. Originally designed to ensure employee health care insurance carryover from job to job without penalization for preexisting conditions, HIPAA also embraces the Administrative Simplification Act, which includes patient privacy issues. Since April 14, 2003, when HIPAA regulations became effective, concerns have arisen about the Act’s potential adverse impact on clinical research. However, “despite initial fears that the institution of HIPAA would impair or prevent the research process, it appears that familiarity with the rules can make it possible to continue effectively,” says Dr. William J. Tremaine, Professor of Medicine at Mayo Medical School and director of the Mayo Foundation Office of Research Protection (IRB). Tremaine says the “biggest change” is the absence of purely verbal consent followed by documentation by the physician of patient agreement. Now, under HIPAA, written consent or authorization from the patient is
AGA Urges Creation of Digestive Diseases Research Commission
T
he AGA is calling upon Congress to establish a “contemporary” digestive diseases research commission to address the continuing substantial burden of these disorders on the U.S. population. The call comes 25 years after the enactment of a congressional bill, Public law 94-562, which created a National Commission on Digestive Diseases in 1976 that laid the groundwork for GASTROENTEROLOGY 2003;125:1298 –1300
required, including for minimal risk investigations. Another impact of HIPAA involves so-called “data mining,” looking through patient files for potential research candidates. “Now the investigator needs to file a ‘Review Preparatory to Research’ with their own institutional review board, or IRB,” Tremaine explains. By doing so, “you declare that you’re going to look through the files for patients with a particular condition. You can’t just go rummage through the charts anymore.” This form needs only to be filed with the IRB and does not require approval. On the other hand, HIPAA regulations pose a greater hurdle on survey studies. Investigators seeking to survey individuals they’ve identified with a particular condition must first obtain their HIPAA authorization to either write them with the specific questionnaire or to telephone them to ask the questions over the phone. “The next big impact is on computerized databases,” Tremaine says, noting that many investigators “have gone to great efforts” to maintain research databases, placing their patients with a particular condition into a computer file. “That’s problematic now in that HIPAA specifies that if you keep a patient database it must be specific to a research question, and it must be approved by the IRB,” he says. “No
longer can you simply maintain a lot of data and then go back and pull out patients who have, for example, high blood levels associated with this or that, or colostomies showing this or that.” He points out that a more practical way is to maintain a clinical database; that is, “keep files that you’re using for clinical purposes, such as to contact patients for follow-up, say, for another colonoscopy [to check for] for polyp recurrence, and then to ask specific questions from that clinical database with IRB approval. That you can do without having to get consent from the patients.” HIPAA has also had an impact on industry. Under HIPAA, hospitals and academic institutions are charged with protecting health information and are responsible for obtaining patient consent. However, in terms of their clinical research, these entities do experience pressure from industry to modify patient consent forms with the company’s own HIPAA language. “We find that it’s important for IRBs to make sure the language that’s suggested by the company is compatible with and does not contradict or negate their own HIPAA language,” Tremaine cautions. “Thus, we want to make sure industry doesn’t ask for more than HIPAA allows legally.”
creating a long-range plan to recommend the necessary resources to more effectively manage such diseases. The commission recommended creation of the digestive diseases core centers program at NIH. On September 11 and 12, 26 AGA members from 15 states and representing all regions of the nation, came to Washington, DC, to meet with federal legislative staff to advocate for the commission and for correction of the formula that determines the annual Medicare update for physician pay-
ments, also known as the sustainable growth rate (SGR). AGA members met with staff in nearly 50 Congressional offices, including those of Senate Majority Leader Bill Frist, R-TN; Sen. Edward Kennedy, D-MA; Sen. John Kerry, D-MA; Sen. Rick Santorum, R-PA; Sen. Elizabeth Dole, R-NC; Sen. Dianne Feinstein, D-CA, and Sen. John Warner, R-VA. AGA advocates suggested that an updating of the first commission’s efforts would be the most effective means for convening the best sci-
Gastroenterology News continued
entists to develop a contemporary blueprint for digestive diseases research over the next 10 years. Congressional offices found the research commission concept to be “a sound approach” to achieving this goal. In its continued advocacy for the new research commission, the AGA
points out that more than 62 million Americans each year are diagnosed with digestive disorders. Direct and indirect costs for 17 “selected” diseases such as gastroesophageal reflux disease, colon cancer, inflammatory bowel disease, and liver disease were estimated at $41 billion for the year 2000.
The AGA notes that while some promising research developments have been made in these areas, the incidence of many serious digestive conditions is increasing. More details on the subject can be found on the Public Policy/Advocacy page at www.gastro.org
Multicenter Study to Explore Drug-Induced Liver Injury
cidate the natural history of the problem. DNA analysis based on blood samples will be used to identify possible genetic risk factors that may exist for such hepatic injury. In addition, the study will seek to determine if new tests that are more sensitive than those already in use can be developed to detect the occurrence of dangerous liver injury among individuals involved in drug clinical trials. Thus, severe liver injury, although rare, may be more effectively detected before the FDA approves any new drugs for regular use in pa-
tients. A prospective clinical investigation is also planned that will include individuals who are recently diagnosed with drug-induced liver injury. Centers selected for the study are the University of North Carolina at Chapel Hill; University of California at San Francisco; University of Connecticut; University of Indiana; and the University of Michigan. Duke University will serve as the data-coordinating center, collecting information from the 5 study centers.
were research trainees. In FY 2003 nearly 500 individuals applied to the Pediatric Research LRP. NIH awarded loan repayment to nearly 300 Pediatric researchers. In Fiscal Year 2004, NIH intends to commit $38 million to fund 700 LRP-CR participants and $15 million to fund 300 PR-LRP participants. These programs provide for the repayment of educational loan debt of up to $35,000 annually for qualified health professionals conducting clinical or pediatric research for domestic non-profit or government entities. In addition, the NIH will cover up to 39% of the Federal tax liability resulting from the loan repayment, and may also provide reimbursement for state and local tax liabilities. Participants contract to conduct research for 50% of their time, or not
less than 20 hours per week for a 2-year period. Applicants must be supported by a domestic nonprofit institution or a Federal or domestic state or local government entity. Applications for these programs will be accepted September 1 through December 31, 2003. The notice describing the LRP-CR can be found at: http://grants1.nih. gov/grants/guide/notice-files/NOT-OD03057.html. The notice describing the PR-LRP can be found at: http:// grants.nih.gov/grants/guide/noticefiles/NOT-OD-03-058.html. Full details about the Loan Repayment Programs including the online application can be found at http://www. lrp.nih.gov/.
A
3-year study at five U.S. medical centers will be the first largescale investigation of severe drug-induced liver injury. Sponsored by NIH-NIDDK, the study initially will conduct retrospective evaluations of already established cases of drug-induced liver injury with a focus on drugs that are known to be associated with the problem. Clinical information will be explored for the emergence of patterns that may be predictive of liver injury and to elu-
This Month at the NIH: NIH FY2004 Loan Repayment Program for Clinical and Pediatric Researchers
T
he National Institutes of Health has announced the 2004 Extramural Loan Repayment Programs for Clinical Researchers (LRP-CR) and Pediatric Researchers (PR-LRP). The objective of these programs is to recruit and retain highly qualified health professionals as clinical investigators or as pediatric investigators. For LRP-CR, nearly 500 individuals applied in FY 2002 and nearly 1200 in FY 2003. The number of LRP-CR awards in FY 2003 increased to nearly 750. In FY 2002, two-thirds of LRP-CR awards went to applicants with M.D. or M.D./Ph.D. degrees. Also, a majority of LRP-CR awardees
Stories by Les Lang
Stephen P. James National Institutes of Health 1299