The Acute Liver Failure Study Group (ALFSG) was a National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) funded network of clinical centers that collected biological samples and data on patients with varying etiologies of Acute Liver Failure (ALF). The coordinating center was located at the UT Southwestern Medical Center (UTSW) under the leadership of Dr. William M. Lee and has research records on 23,364 adult ALF and ALI patients. In addition to the extensive database, the ALFSG has accrued biosamples on more than 80% of these patients, including serum, plasma, urine, DNA, and tissue. All are valuable biosamples and the minimum amount required to perform the proposed study is required in the study protocol submission.
Internal and external investigators are invited to submit proposals to the ALFSG Ancillary Studies Committee for original research that may or may not is directly related to acute liver failure. For example, studies to date have looked at the appearance of auto-antibodies in patients with acute liver failure. All ancillary study submissions from investigators in the ALFSG will no longer reviewed by the Ancillary Studies Committee directly for review but must be submitted to NIDDK via the National Institutes of Health (NIH) NIDDK Repository website.
Ancillary study proposal submission
Ancillary study proposals should contain the following sections:
- Background
- Aims and hypothesis
- Methods
- Pilot/ preliminary data
- Qualifications of investigators
- Plans for data analysis
- ALFSG resource requirements regarding clinical data, serum, and liver tissue
- Planned funding and estimated modular budget
Update
All individuals with an approved ancillary study are required to provide updates at reasonable intervals. To standardize the reporting of studies, all reports are to be submitted within six months of sample receipt and contain the following format:
- Title of study, investigators, date of initial approval
- Number of patients enrolled/ samples analyzed
- Preliminary or final results
- Copies of all abstracts and/or publications submitted
- Detailed timeline for completing the study
It is expected that most ancillary studies should be completed within one calendar year of receiving samples. Furthermore, the committee expects that negative, as well as positive studies, move forward to final manuscript publication.
NOTE: Failure to submit an update within 6 months will preclude further release of samples and/or data to the investigator. In addition, collaborating investigators who fail to provide an update will be reviewed by the ALFSG Executive Committee for further action.
Please use the Ancillary Studies Proposal Template for study submission.