ORI科学不端行为调查 - 有关原始记录部分



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送交者: aliastwo 于 2006-4-20, 11:42:40:

Sequestration of the Research Records
1. Immediate Sequestration
If the relevant research records have not been obtained at the assessment stage, the Research Integrity Officer will immediately locate, collect, inventory, and secure them to prevent the loss, alteration, or fraudulent creation of records.
2. Institutional Access
Research records produced under PHS grants and cooperative agreements are the property of the institution, and employees cannot interfere with the institution's right of access to them. Under contracts, certain research records may belong to PHS, but the institution will be provided access to contract records in the custody of the institution for purposes of reviewing misconduct allegations.
3. Original Records
The documents and materials to be sequestered will include all the original items (or copies if originals cannot be located) that may be relevant to the allegations. These include, but are not limited to, research records as defined in section II.N of this document.
4. Sequestration of the Records from the Respondent
The Research Integrity Officer should notify the respondent that an inquiry is being initiated simultaneously with the sequestration so that the respondent can assist with location and identification of the research records. The Research Integrity Officer should obtain the assistance of the respondent's supervisor and institutional counsel in this process, as necessary. If the respondent is not available, sequestration may begin in the respondent's absence. The respondent should not be notified in advance of the sequestration of research records to prevent questions being raised later regarding missing documents or materials and to prevent accusations against the respondent of tampering with or fabricating data or materials after the notification. In addition to securing records under the control of the respondent, the Research Integrity Officer may need to sequester records from other individuals, such as coauthors, collaborators, or whistleblowers. As soon as practicable, a copy of each sequestered Model Procedures for Responding to record will be provided to the individual from whom the record is taken if requested.
5. Inventory of the Records
A dated receipt should be signed by the sequestering official and the person from whom an item is collected, and a copy of the receipt should be given to the person from whom the record is taken. If it is not possible to prepare a complete inventory list at the time of collection, one should be prepared as soon as possible, and then a copy should be given to the person from whom the items were collected.
6. Security and Chain of Custody
The Research Integrity Officer will lock records and materials in a secure place. The persons from whom items are collected may be provided with a copy of any item. Where feasible, that person will have access to his or her own original items under the direct and continuous supervision of an institutional official. This will ensure that a proper chain of custody is maintained and that the originals are kept intact and unmodified. Questions about maintaining the chain of custody of records should be referred to the institutional counsel.




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