Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339508
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2006-06-19
Brief Title:
Exploratory Data Analysis for Disease Pedigrees and Cancer Genetics
Sponsor:
National Human Genome Research Institute NHGRI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Exploratory Data Analysis for Disease Pedigrees and Cancer Genetics
Status:
COMPLETED
Status Verified Date:
2017-05-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The researchers have developed and distributed several software packages for pedigree analysis FAST CASPAR PedHunter IIC and cancer genetics oncotree METREX Users who need assistance with the software or who want to see new features added often send the researchers data files that include human data The information is normally coded and the researchers do not have access to the identification of the people whose information is in the files Sometimes the content of the files gives rise to collaborations between the software developers and the providers of the files Because concerns over the confidentiality of medical information have increased significantly over the past few years the researchers must apply for exemptions from detailed ethics committee oversight for every data set they receive This process is cumbersome and makes it difficult to assist software users The amount of information required to apply for an exemption also poses a barrier to collaborations
A full protocol will subject all data sets to ethics committee oversight without the need for individual exemption requests enabling the researchers to assist users with software problems and to collaborate with other researchers
From January 1 2000 through December 15 2001 the researchers received 71 requests for assistance 19 of which included data files None of the data files had any names or patient identifiers Of these 19 in 8 cases the researchers sent back modified output files In two of these eight cases the researchers could see results of research interest one of them concerned human data In 2 of the 19 cases the researchers sent back modified input files in one such case they established a collaboration with the originator of the files In sum most requests come under the heading of customer service with no research contents A few however do lead to research results or collaborations for which ethics committee oversight is required
Over the three-year time frame of this protocol the researchers anticipate receiving data on a maximum of 10000 individuals They have modified their software documentation to explicitly instruct users to make sure the data files they send have no names Should they receive files with names they will delete the files and ask the originator to resubmit them with names encoded Users submit data through unencrypted e-mail The data are stored in password-protected computers at the National Institutes of Health
A full protocol will subject all data sets to ethics committee oversight without the need for individual exemption requests enabling the researchers to assist users with software problems and to collaborate with other researchers
From January 1 2000 through December 15 2001 the researchers received 71 requests for assistance 19 of which included data files None of the data files had any names or patient identifiers Of these 19 in 8 cases the researchers sent back modified output files In two of these eight cases the researchers could see results of research interest one of them concerned human data In 2 of the 19 cases the researchers sent back modified input files in one such case they established a collaboration with the originator of the files In sum most requests come under the heading of customer service with no research contents A few however do lead to research results or collaborations for which ethics committee oversight is required
Over the three-year time frame of this protocol the researchers anticipate receiving data on a maximum of 10000 individuals They have modified their software documentation to explicitly instruct users to make sure the data files they send have no names Should they receive files with names they will delete the files and ask the originator to resubmit them with names encoded Users submit data through unencrypted e-mail The data are stored in password-protected computers at the National Institutes of Health
Detailed Description:
We have developed software packages for pedigree analysis FAST CASPAR PedHunter IIC and cancer genetics oncotrees METREX The purpose of this protocol is to allow us to work on software problems reports that may contain human subjects data in them The data should be coded by which we mean that if there are any links between identifiers and names we do not possess the links to decode the names Occasionally our assistance leads to a more formal research collaboration This protocol seeks to clarify the guidelines under which we can provide assistance to users of our human genetics software and to establish a formal procedure under which we can seek IRB approval for the serendipitous collaborations that arise from providing that assistance We cannot predict the sizes of samples or the diseases studied in the data sets sent to us so most of the medical aspects of this protocol are necessarily general We rely on the data being coded and the collectors of the data having their own institutional approvals to protect against most risks The scientific aspects of investigating problem reports cannot be hypothesis driven because we cannot guess what problems will arise On the engineering side the basic hypotheses are that 1 our software is likely to contain some bugs or other weaknesses which cannot be easily found except by having others use the software and 2 a good way to improve the functionality of the software is to encourage users to submit problem reports and other suggestions
This protocol has been in effect since early 2002 The only amendments during that time were to set up three collaborations as described in Sections 46 and 47 and 48 The protocol has been quite useful and no changes are proposed in procedures
This protocol has been in effect since early 2002 The only amendments during that time were to set up three collaborations as described in Sections 46 and 47 and 48 The protocol has been quite useful and no changes are proposed in procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-HG-N152 | None | None | None |