Re: Data Transfer Policies Terry Edwards 01 Jul 1999 16:23 EST
I may be off base with this one. Data comes in two forms, public or Confidential/Proprietary. Information most commonly related to research is usually confidential. Data can be collected or derived from pre-existing information. From your message it appears that the data in question involves information collected from questionnaires. Most questionnaires involve human subjects. 45CFR46 is the regulation regarding the protection of human subjects. It outlines the procedures to safeguarding and providing assurances for the confidentiality and protection of information received based on the informed consent of others. Based on the level of risks involved, some projects may require different levels of review. However, all must provide the necessary safeguards related to the level of risk. One factor in determining informed consent is a a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained (Title 45 CFR Part 46, Section 46.116 (a)(5)). It is normally part of the responsible institution's human subject review policy that governs the extent of these safeguards. In the case of research involving more than one institution, each is responsible for providing assurances as to the safeguarding of human subjects and the protection of confidentiality, regardless of how that assurance is obtained or provided (45CFR46.114). Since some flexibility is allowed, the institution's IRB has the responsibility for review of the project and deciding what appropriate measures must be taken in order to comply with these requirements. These type of questions get discussed all of the time. Before you start transferring data electronically versus sending a disk or hardcopy by courier; are you secure enough with the system on both ends to send the data? If you need further information try contacting OPRR. Terry G. Edwards Christopher Bond wrote: > Hello All: > > My department has several NIH sponsored grants which contain much data > handling. With this data handling, we are now needing to transfer > images of completed questionnaires from San Antonio to Memphis for > decoding and stats analysis, then back to San Antonio. So, the question > has arisen by some of my PIs: How do we handle this data transfer? Are > there safeguards that need to be implemented, waiver forms, etc.? Are > there any policies in effect that govern this matter? > > I have made over 20 calls to NIH and have come-up empty-handed, and I > have consulted the OMB circulars (A-110 etc.) and the NIH grant guide; > however, I still have not found the answer. Does anyone out there know > whom I could contact, or where I could look for the answer? Any help > will be appreciated! > > Desperate in Memphis, > Christopher Bond > Grant Management Analyst > Univeristy of Memphis/Prevention Center > E-mail: xxxxxx@mail.psyc.memphis.edu > Phone: 901-767-0985 Fax: 901-767-1350 > > ====================================================================== > Instructions on how to use the RESADM-L Mailing List, including > subscription information and a web-searchable archive, are available > via our web site at http://www.hrinet.org (click on "Listserv Lists") > ======================================================================