Humans Sample Clauses

Humans. Fifteen students (6 men and 9 women, mean age 23 years) of the University of Nijmegen, The Netherlands, participated in the experiment. They were either paid for their participation or received ‘‘research participation points’’ that the students must collect as one of the study requirements. Participants were medically examined before the experiment. Only healthy participants not using medication and without a psychiatric history were accepted. Those who agreed to parti- cipate signed a written informed consent. The regional ethics committee approved of the project (CWOM, nr. 9809-0205).
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Humans. Hazard The staff suffers diseases and accidents during their stay that cause downtimes. Risk The risk is that normal operations may not be carried out adequately, which may result in various cascading effects and incidents. Prevention and/or mitigation Prevention can be taken by carrying out regular health checks and an early warning system for diseases to occur (registration of illness factors). Mitigation may be achieved by good health care on the island, and a replacement plan for people having crucial positions in the safe functioning of key operations on the island.
Humans. I confirm that templates of the informed consent forms and information sheets (in language and terms intelligible to the participants) will be kept on file. YES NO I confirm that opinions/approvals by ethics committees and/or competent authorities for the research with humans have been obtained, and are kept on file YES NO Human Cells I confirm that confirm that authorisation has been obtained from the primary owner of cells/tissues (including references to ethics approval) and is kept on file. YES NO Data protection I confirm that a Data Protection Officer (DPO) has been appointed and the contact details of the DPO are made available to all data subjects involved in the research. YES NO I confirm that data intended to be processed is relevant and limited to the purposes of the research project (in accordance with the 'data minimisation' principle). YES NO In case of further processing of previously collected personal data, I confirm to have lawful basis for the data processing and that the appropriate technical and organisational measures are in place to safeguard the rights of the data subjects. YES NO I confirm that the data used are publicly available and can be freely used for the purpose of the project. YES NO I confirm that the transfer(s) of personal data from the EU to a non-EU country or international organisation, is(are) in accordance with Chapter V of the General Data Protection Regulation 2016/679. YES NO I confirm that the transfer(s) of personal data from a non-EU country to the EU (or another third state) comply(ies) with the laws of the country in which the data was collected. YES NO I confirm that confirm that templates of the informed consent forms and information sheets (in language and terms intelligible to the participants) are kept on file. YES NO Animal I confirm that training certificates/personal licenses of the staff involved in animal experiments have been obtained and will be kept on file. YES NO I confirm that relevant authorisations for animal experiments (covering also the work with genetically modified animals, if applicable) have been obtained, and will be kept on file. YES NO Third country I confirm that the research performed outside the EU is compatible with the Union, National and International legislation and could have been legally conducted in one of the EU Member States. YES NO I confirm that fair benefit-sharing arrangements with stakeholders from low and/or lower-middle income countries are ensured during the pr...

Related to Humans

  • Diagnosis For a condition to be considered a covered illness or disorder, copies of laboratory tests results, X-rays, or any other report or result of clinical examinations on which the diagnosis was based, are required as part of the positive diagnosis by a physician.

  • Animals The Hirer shall ensure that no animals (including birds) except guide dogs are brought into the premises, other than for a special event agreed to by the Village Hall. No animals whatsoever are to enter the kitchen at any time.

  • Diagnostic procedures to aid the Provider in determining required dental treatment.

  • Influenza Vaccine Upon recommendation of the Medical Officer of Health, all employees shall be required, on an annual basis to be vaccinated and or to take antiviral medication for influenza. If the costs of such medication are not covered by some other sources, the Employer will pay the cost for such medication. If the employee fails to take the required medication, she may be placed on an unpaid leave of absence during any influenza outbreak in the home until such time as the employee has been cleared by the public health or the Employer to return to the work environment. The only exception to this would be employees for whom taking the medication will result in the employee being physically ill to the extent that she cannot attend work. Upon written direction from the employee’s physician of such medical condition in consultation with the Employer’s physician, (if requested), the employee will be permitted to access their sick bank, if any, during any outbreak period. If there is a dispute between the physicians, the employee will be placed on unpaid leave. If the employee gets sick as a reaction to the drug and applies for WSIB the Employer will not oppose the application. If an employee is pregnant and her physician believes the pregnancy could be in jeopardy as a result of the influenza inoculation and/or the antiviral medication she shall be eligible for sick leave in circumstances where she is not allowed to attend at work as a result of an outbreak. This clause shall be interpreted in a manner consistent with the Ontario Human Rights Code.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

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