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Ethics Application

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  • Administration

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  • QualificationsInstitution 
  • If you are not a UNAM student or employee, please choose “External Applicant”. If you are requesting an expedited review please choose “Expedited Review”
  • Or equivalent statutory health council registration no. as appropriate. If registration is pending, submit proof of application. If a non-medically trained PI is overseeing research which involves medical procedures, the application must include a medical doctor registered with the MOHSS as a co-investigator.
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  • Details of Study

  • Study for Degree Purposes

  • Collaborators

  • Name and TitlePosition and RoleDepartmentInstitutionCountryQualificationsEmail Address 
  • Location of Study

  • State the site(s) of the research
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  • Human Health

  • Human Subjects Research Protection

  • Bio-hazardous material” refers to recombinant DNA molecules, viruses, fungi, parasites, bacteria and all other potentially bio-hazardous material or products that are dangerous to both the experimental patient and the researcher
  • Research with Children

  • A child is defined as a person younger than 18 years old
  • Details of Child Research

  • E.g. (12-16)
  • Therapeutic research – Interventions that hold out the prospect of direct health-related benefit for the child participant;
    Non-therapeutic research – Interventions that do not hold out the prospect of direct health-related benefit for the child participant but results may be produced that significantly contribute to generalisable knowledge about the child participant’s condition.
  • Study Type and Funding

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  • Non-Health

  • Human Non-Health

  • Tick all that apply
  • Sampling methods should be elaborated in the Research Proposal. For example, if purposive sampling is proposed, the precise criteria which would apply to identify a potential qualifying Participant should be spelled out, if it is not done in the description of the population.
  • 1 In cases where a researcher intends to re-use existing data owned by another researcher, the researcher has to comply with the intellectual property rights, copyright and licensing conditions associated with that data. The researcher is also required to obtain permission to re-use data, clarify the research data’s ownership when necessary and always provide appropriate attribution and citation” (UNAM Research Ethics Policy, Regulations and Guidelines, Section I2, pp. 29-30). Documentation with respect to these conditions should be attached to the application.
    2 Permission from the relevant authorities, offices and/or owners of the records should be sought with full disclosure of the nature of the Research Project. Relevant documentation should be attached to this application.
    3 The intended use of non-disclosed participatory observation should be fully motivated in a separate, detailed statement which spells out why the proposed instrument is the most suitable one for data collection. Contingencies, conditions, and possible interpersonal, social, and other consequences and their mitigation should be fully elaborated. The statement should be signed and dated by the Principal Investigator and the Main Supervisor.
    4 The intended use of non-disclosed public observation should be clearly motivated in the Research Proposal.
    5 Permission from the relevant authorities, offices and/or owners of non-public environment(s) and artefacts should be sought with full disclosure of the nature of the Research Project. Relevant documentation should be attached to this application. Observation/recording of public environments should adhere to posted rules/regulations, unless exception is expressly granted by the relevant authorities, in which case documentary proof to that effect should be furnished. It should be clearly explained in the Research Proposal how observation/recording of artefacts will be done using methods/technology that will not affect the state and quality of the artefact(s). (Ethics clearance for observing the natural environment should be sought from the University Engineering and Environment Research Ethics Committee.)
    6 Permission from the relevant authorities, offices and/or owners of human-made environment(s) and artefacts should be sought with full disclosure of the nature of the Research Project. Relevant documentation that details the exact source, location, quantity, nature and dimensions of samples, and methods to be employed in extracting them, should be attached to this application, as well as an agreement for their return, if relevant. (For extraction of samples from the natural environment and/or engineered phenomena, ethics clearance should be sought from the University Environment and Engineering Research Ethics Committee.)
  • 1 Intended partial disclosure should be fully motivated in the Research Proposal or in a separate, detailed statement which spells out why partial disclosure is suitable for data collection. Contingencies, conditions, possible interpersonal, social, and other consequences and their mitigation should be fully elaborated, including participant debriefing where necessary. The statement should be signed and dated by the Principal Investigator and the Main Supervisor (in the case of postgraduate studies).
  • Research ethics considerations in the research proposal

    Have the following issues been addressed in the Research Proposal?
    If any of the answers are “No”, the Principal Investigator must provide clear motivation in the Research Proposal or by separately submitted statement(s) as required under the relevant tables in the previous sections.
  • United Nations Declaration on the Rights of Indigenous Peoples (2007)
  • Please note that the reasons mentioned here also need to be clearly described in the proposal.
  • Informed assent form for children/minors
    Informed consent for qualitative studies
    Informed parental consent for qualitative studies
    Questionnaire
    Drop files here or
    Max. file size: 1 GB.
    • I have familiarised myself with the code of conduct regarding the ethics of research at the University of Namibia, as described in the UNAM Research Ethics Policy, Regulations and Guidelines, and I agree to comply with it.
      This Research Project deals with indigenous knowledge, and as such, recognises and affirms the contents of the United Nations Declaration on the Rights of Indigenous Peoples (2007), particularly Article 31, and, therefore, I have familiarised myself with the rights contained in this Declaration, and they will be respected in the execution of this Research Project.
      The information provided in this application form and all accompanying documents is true and correct.
      All Annexes and other documents attached to this application are the final versions thereof.
      I will comply with all regulatory and monitoring requirements of the UNAM Research Ethics Committee.
      I will duly submit all required reports.
      I will ensure that every Participant shall always be treated in a dignified manner and with respect.
      I have no financial or non-financial interests which may influence me in the conduct of this Research Project.
      I do have financial or other competing interests with respect to this Research Project, which may present a potential conflict of interest, and I will provide details of this in a separate statement.
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    • Animal Research

    • Animal – any live non-human vertebrate and non-vertebrate, that is, insects, fish, amphibians, reptiles, birds and mammals, encompassing domestic animals, purpose-bred animals, livestock and wildlife.
    • Conditions of Approval


      All matters pertaining to the conduct of the approved project are to be reported to the appropriate Research Ethics Committee (DEC/AREC), which maintains oversight in accordance with the Universities Research Ethics Policy and Guidelines.
      Any variation proposed to the project, and the reasons for that change, must be submitted to the approving Ethics committee for approval and must not be implemented until approval is granted. These changes include requests for:
      1. Minor amendments
      2. Extension of time
      3. Change of main investigator
      4. Addition or deletion of co-investigators (including Honors and Postgraduate students).

      If a modification is required, the ethics committee offices must be contacted to obtain the Word version of the currently approved application.
      All activities involving the use of animals must occur as specified within the approved application or cited REC approved Standard Operating Procedures (SOPs). Records pertaining to training, numbers of animals used, monitoring and the nature, timing and detail of all experimental activities must be maintained. These records may be inspected at any time by the AREC and the department records of animal monitoring must be kept in a location accessible to all personnel involved in animal care.
      Annual and final reports MUST be submitted to the approving REC by the due date.
      Any unexpected incidents or complications that result in deaths, euthanasia or pain and suffering for the animals used in the project must be reported to the approving REC via an Adverse Incident Report. Details of the steps taken to deal with adverse incidents must be included in the notification.
      A record of details of any animals used in the project must be retained and is subject to inspection by the approving REC for auditing and monitoring purposes.
      Should the numbers of animals treated exceed that estimated for the first year of the ethics application, the main investigator should submit a request for a minor amendment to update the numbers accordingly.

      PLEASE ENSURE YOU HAVE ANSWERED ALL RELEVANT QUESTIONS!

    • Application may request approval for up to three (3) years.
      Scientific activities involving the use of animals must not commence before receipt of written approval.
      Please note your ACTUAL start date will be the date of your Ethics certificate from the relevant REC.
    • Species (and common name)Strain NameSexAge RangeTotal Number 
    • Max. file size: 1 GB.
    • Permits

      Will you require any of the following permits to acquire, hold or use these animals? Project work cannot commence until a valid permit is obtained and provided to the REC.
    • Justification for the use of animals

      The Ethics committee must be satisfied that the use of animals is justified, based on whether the scientific value of the work outweighs the potential impact on the welfare of the animals being used.

      UNSATISFACTORY COMPLETION OF THIS SECTION WILL RESULT IN A REQUEST FOR REVISION OF THE APPLICATION.



    • Answers provided in the following subsections should provide the Ethics committee members, particularly external lay and/or welfare members, with a clear idea of why the experiments are necessary and what will happen to the animals.

      UNAM Ethics committees will use the SANS 10386:2008 – The care and use of animals for scientific purposes as guideline. This standard encompasses all aspects of the care and use of, or interaction with, animals for scientific purposes in medicine, biology, agriculture, veterinary and other animal sciences, as well as industry and teaching studies. It includes animal use in research, teaching, field trials, product testing, diagnosis, the production of biological substances and environmental studies. It provides general principles for the care and use of animals, specifies the responsibilities of researchers and institutions, and details the terms of reference, membership and operation of Institutional Research Ethics Committees. It also provides guidelines for the humane conduct of scientific studies and teaching activities, and for the acquisition of animals and their care, including their environmental needs. This standard covers all live non-human vertebrates and higher invertebrates such as the advanced members from the Cephalopoda and Decapoda. It also covers eggs, foetuses and embryos and their treatment in a humane manner where development of an integrated nervous system is evident.

      Where applicable, this standard is intended to be used as a supporting document to be read in conjunction with the Universities Policies and guidelines, as well as the applicable national legislation if necessary: Animals Protection Act, 1962 (Act No. 71 of 1962) and the Animal Health Act, 2011 (Act No. 1 of 2011) including applicable regulations.
      The purpose of this comprehensive application is to ensure the ethical use and the humane care of animals used for scientific purposes.
      The basis for this standard is SANS 10386:2008 – The care and use of animals for scientific purposes. The standard emphasises the responsibilities of investigators, teachers and institutions using animals to:
      • Ensure that the use of animals is justified, taking into consideration the scientific or educational benefits and the potential effects on the welfare of the animals
      • Ensure that the welfare of animals is always considered
      • Promote the development and use techniques which replace animal use in scientific activities wherever possible
      • Minimise the number of animals used in projects
      • Avoid pain or distress for each animal used in scientific activities.


      To this end, there is a need in scientific activities to consider the:
      • Replacement of animals with other methods
      • Reduction in the number of animals used
      • Refinement of techniques used to reduce the impact on animals


      Where scientific language is deemed unavoidable it must be supported by suitable plain English in the text or in a glossary of terms. All information provided in this application must be in language that can be understood by an interested, intelligent person without a scientific background. Do not use scientific jargon and abbreviations which is not stipulated in the glossary of terms.
    • Scientific TermLay Description 
    • ProcedureNumber of times procedure undertaken on any individual animalHow will you minimise impact to the animal? 
    • Impact On Animal Wellbeing And Welfare

      Consider each of the procedures listed above and indicate the potential impact to animal wellbeing as a result of the cumulative effect of all procedures throughout the duration of the project. Ensure consideration is given to phenotype and experimental model/interventions and age of the animals used.
    • Please indicate if the project involves any of the following:
    • i.e. the investigator will not intervene to kill the animal humanely before death occurs in the course of a scientific activity. Such projects require approval from the respective Department
    • DEC number/sProcedures 
    • Replacement

      The standard specifies that techniques that totally or partially replace the use of animals for scientific purposes must be sought and used wherever possible. In order to complete this section a relevant and up to date search of alternative websites and databases is required. Suitable websites and databases include:
      https://awic.nal.usda.gov/alternatives
      https://www.nc3rs.org.uk/the-3rs
      http://guides.lib.ucdavis.edu/animalalternatives/
    • Wherever possible, applications should be endorsed by a statistician or biometrician, or reference given to an appropriate statistical text.
    • Project Details

    • Procedural Details

    • Investigators are responsible for monitoring the welfare of their animals. This responsibility begins when an animal is allocated to the approved project and ends with the specified fate of the animal at the completion of the project.
      Unexpected incidents that impact on the welfare of any individual animal or group of animals must be responded to immediately and reported to the approving REC.
      All personnel identified in this section of the proposal must be aware of the criteria for monitoring the welfare of the animals and of how records are to be kept.
      An Animal Monitoring Sheet must be developed as to accommodate the procedures in this project and must accompany this application.
      For housed animals, welfare monitoring checklists must be kept with the animal so as to be readily accessible to all nominated personnel and to animal facility staff.
    • Involvement in the project

    • SpeciesTechnique/procedure </br> Every procedure listed in previous must be listedCompetent (Yes/No)Trainer(s) 
    • I hereby declare that:

      1. I have read the UREC policy and guideline and the relevant chapters of the SANS 10386:2008 – The care and use of animals for scientific purposes and accept the responsibilities detailed therein.

      2. I accept responsibility for the conduct of all experimental procedures detailed in this application, in accordance with national requirements and the University Research Ethics Committee.

      3. I have listed each person engaged in this project and consider that they have the qualifications, experience and training appropriate for their role in the project and that they are competent to perform procedures described to the extent of their role. If any person is not already skilled in the procedures, I will ensure that they obtain all necessary training in advance of performing any procedure independently. All personnel have been made aware of their role and responsibilities in this project, and have been given copies of all necessary documentation.

      4. I will provide annual and final reports to the REC by the due date.
      5. I understand and agree that research documents, animal records and data may be subject to inspection by the REC , the Centre for Research Services and the Department for auditing and monitoring purposes.

      6. The Animal Facility Manager has been made aware of requirements for this application.
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    • Application for Ethics review of research involving human tissue and bodily fluid; and plant materials

    • MM slash DD slash YYYY
    • TypeProcedures 
    • Drop files here or
      Max. file size: 1 GB.
      • TypeRisk 
      • Paper Records

        Describe the duration and location of secure data storage, and the method to be used for final disposition of the data
      • Electronic Records

        Describe the duration and location of secure data storage, and the method to be used for final disposition of the data
      • Max. file size: 1 GB.
      • Agreement

      • This application for Ethics review of Research with Human Tissue and Bodily Fluids describes all the procedures for which human tissue/fluids is necessary. I agree that all procedures will be carried out according to the description in this application, and by or under the direct supervision of trained and competent staff members. Any modification to the existing procedures or human tissue/fluids use must be submitted in writing to the Centre for Research Services for prior ethics review and clearance.
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      • Disclosures

      • See here
      • If it has been approved please attach approval letter.
      • See here
      • Full NamePositionDiscipline 
      • Uploads

        Please upload all necessary and requested documentation including your Curriculum Vitae.
      • Drop files here or
        Max. file size: 5 MB.
        • Drop files here or
          Max. file size: 5 MB.
          • Drop files here or
            Max. file size: 10 MB.
            • Exemption

            • The research does not involve any of the following:

              1. human participants;
              2. human or animal tissue or fluids;
              3. plant material (leaves, sap, roots, seeds, bark, flowers, spores, fungi);
              4. samples from the environment, including (samples of) artefacts;
              5. confidential, private or sensitive records, or records not in the public domain (e.g. clinical records, criminal/police records, audio/video recordings, pictures, correspondence, journal/diary entries, memoirs);
              6. contravention of accepted ethical research practices.

              The Research Project is a desktop study.


              Research ethics considerations that apply to this Research Project



              The following research ethics considerations will apply to this Research Project:

              1. proper citing and recording in a list of references of all sources consulted;
              2. avoiding any form of plagiarism;
              3. scholarly objectivity in line with the requirements of the relevant discipline.
            • Conflict of Interest


              • I have no financial or non-financial interests, which may inappropriately influence me in the conduct of this research study; OR

              • I do have the following financial or other competing interests with respect to this project, which may present a potential conflict of interest(attach a separate detailed statement)


            • Declaration

            • 1. That I have read through the submitted version of the research protocol and all supporting documents and I am satisfied with their contents
              2. I am suitably qualified and experienced to perform and/or supervise the above research study
              3. I agree to conduct or supervise the described study personally in accordance with the relevant protocol and will only change the protocol after approval by the DEC, except when urgently necessary to protect the safety, rights, or welfare of subjects. In such case, I am aware that I should notify the DEC without delay
              4. I agree to timeously report to the DEC serious adverse events that may occur in the course of the investigation.
              5. I agree to maintain adequate and accurate records and to make those records available for inspection by the appropriate authorized agents when necessary.
              6. I agree to comply with all other requirements regarding the obligations of clinical investigators and all other pertinent requirements in the Declaration of Helsinki (2013), as well as Namibian and ICH GCP Guidelines and the Ethical Guidelines of MOHSS, as well as applicable regulations pertaining to health research.
              7. I agree to comply with all regulatory and monitoring requirements of the DEC.
              8. I agree that I am conversant with the above guidelines.
              9. I will ensure that every patient (or other involved persons), shall at all times be treated in a dignified manner and with respect.
              10. I will submit all required reports within the stipulated timeframes
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