Report from the Investigation Commission appointed by Rikshospitalet – Radiumhospitalet mc and the University of Oslo January 18, 2006

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Annex 5: The Dishonesty Committee’s Guidelines

The Research Council of Norway 2001
Guidelines for the implementation of research projects related to medicine and health50
Objective of the guidelines: To provide advice about the design of research plans, documentation and data storage in relation to medical and health research. The objective is to prevent disagreements between project participants and to prevent doubts from being raised about the implementation of a project.
Pre-project checklist:

• Formulate the project’s purpose and objectives clearly. Make a project plan (research protocol) which includes what you want to record (effects, variables), how you want to perform the project (method) and the materials and procedures you intend to use.

• Identify any mutuality or conflicts of interest related to the project or among the participants.

• Agree on who is in charge of the project and on the division of labor.

• Agree on who will be writing any publications that are planned. If the situation changes during the project, make a new agreement.

• Clarify questions involving the ownership and user rights to any original data or processed results.

• Any project that includes trials on humans must be submitted to the Regional Research Ethics Committee for Medicine (REK) for approval prior to initiation. Such projects require the informed consent of the subjects in the sample. Draw up your inclusion and exclusion criteria, as well as your criteria for aborting the project. Secure permits for data storage, confidentiality and other relevant conditions, where so required.

• Experiments on animals must be submitted to and approved by the Norwegian Animal Research Authority (NARA) prior to initiation.

• Document equipment that performs measurement-related functions and other measurement instruments, and establish routines for control, calibration and validation.
• Make experiment plans and appurtenant registration forms accessible, straightforward, unambiguous and comprehensible to all those involved in the project. Prepare this material far enough in advance to allow adequate time for training, and possibly for testing and adjustment.
While the project is in progress:

• All parties involved in a project have a mutual obligation to provide information about progress, results, processing, presentation and interpretation.

• Document any deviations from the original investigative plan and experiment procedures. Be sure that any changes in the project or in the potential consequences of any changes are approved by project management.

• Ensure that data on individuals gathered during the course of clinical research projects can be identified and recovered for each individual test subject according to the terms and conditions laid down by the relevant control agency/authorities. The documentation must specify who has collected the data, and when it was collected.

• Ensure that equipment used for measurement is checked and calibrated on a regular basis. The documentation must specify who have checked the equipment, and when.

• Ensure that the materials (e.g. chemicals, preparations. materials) to be used in the project can be identified and documented.

Post-project follow-up:

• Organize original data systematically, safely and so that it is readily recoverable. Pursuant to the national statutory provisions that apply at any given time, licensing terms, contractual terms and conditions, and institution-specific regulations, data, including consent forms, must ordinarily be kept for at least 10 years. The same applies to plans for studies, receipts and descriptions of deviations, if any.

• Once a project is completed, the information may be stored collectively in institutions approved for this purpose. Be sure to sign a final agreement regarding future ownership, storage rights and user rights to data and other material made available as a result of the project. Be especially careful when it comes to person-specific data in order to avoid conflicts related to agreements with the human subjects involved.
If necessary, the owner of the data should be able to establish traceability from published composite data, e.g. tables and figures, to original data.

Medical words and expressions51

Adenoma: a benign tumor emanating from and partly structured as a gland
Biopsy: a tissue sample from a living patient for microscope examination
Carcinoma in situ: term for cellular changes that indicate a beginning cancer development without spreading having yet started, a precursor of cancer
Diploid: denoting that a cell contains two sets of chromosomes
DNA aneuploidi: cells with deviating DNA amount, may be found in many malignant tumors
DNA histogram: Graphical presentation of analysis results for DNA amount used in ploidy classification (see separate explanation)
Dysplasia (mild, moderate or severe): a growth abnormality, incomplete of erroneous development of bones, cartilage and/or skin
Erythroplakia: Red patches (plaques) or lesion in the oral mucosa (also called dysplastic leukoplakia); the lesion is related to leukoplakia, but more rare and more serious as it more frequently develops into cancer
Graph theory: Analysis and numerical representation of graphical presentations
Histopathology: The study of pathological changes in tissues
Hydrolysis and Feulgen coloring: Techniques used for the preparation of tissue preparations
Carcinoma: a malignant tumor in epithelial tissues, i.e. in skin, mucosa or glands
Chemoprevention: a term used in particular for intake of various substances to prevent the development of cancer

Colorectal cancer: Cancer of the large intestine and rectum
Lesion: generic term for circumscribed injuries to the body
Leukoplakia: white patches (plaque) in the oral mucosa that cannot be scraped away, the leukoplakia may develop into cancer
Malignant: cancerous
Malign transformation potential: a lesion with a high malign transformation potential (e.g. erythroplakia) more frequently develops into cancer than a lesion with a lower malign transformation potential (e.g. leukoplakia)
Melanoma: birth mark cancer, pigment cell cancer
NSAID: Non steroidal anti-inflammatory drugs
Odontology: Dental medicine
Oral: Belonging or pertinent to the mouth
Squamous cell carcinoma: Malignant tumor developed from squamous cells in the skin or mucosa
Ploidy classification: the classification of DNA amount as diploid, tetraploid or aneuploid (see separate explanations)
Premalign illnesses: Conditions that may develop into cancer
Re-classification: Repeated classification
Referring letter: a letter from a physician to another physician, hospital, laboratory or the like asking for further care or examination
Tetraploid: Having four sets of chromosomes in the cell nucleus

Tissue block: Paraffin-imbedded tissue used for making histological biopsy specimens.
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