Health and Wellness Sciences

Health and Wellness Sciences

HWS-REC 3.1

HEALTH AND WELLNESS SCIENCES

Code of Ethics for Research on Human Participants

The role of the Health and Wellness Sciences Research Ethics Committee with regard to research on human participants is to review the ethics of research proposals and protocols in order to assess the risks and benefits to the informant or participant. The committee is responsible for looking at critical factors such as the extent to which research could be socially or psychologically invasive or damaging. Further to this, the role of the Health and Wellness Science Research Ethics Committee is to ensure that all research in which humans are involved, either as informants or participants (carried out by undergraduates, post-graduates, staff or affiliated staff in the name of the Cape Peninsula University of Technology) respects the rights of individuals and that:

  1. The informant or participant has consented to the research without coercion;
  2. The questions posed are not insulting or embarrassing;
  3. Confidential matters that could place the informant in an embarrassing, false or compromising position, are handled circumspectly;
  4. The privacy and wishes of participants are respected, i.e. anonymity of the informant is maintained wherever possible and the standard of confidentiality is upheld always;
  5. Each participant is informed as fully as possible as to the aims and possible implications of the research;
  6. Participants have the right to withdraw from the research process at any time and without explanation, reason or prejudice.

The Committee's procedures include the scrutinyof proposals and protocols. The Committee should also scrutinise any research instrument (e.g. a questionnaire) for use by the researcher to preclude the use of inappropriate questions.

The Health and Wellness Sciences Research Ethics Committee sees research involving human participants as falling broadly into two categories:

1)The human participant is the object of study

2)The human participant is an informant

This ethics document is intended to provide guidelines for both categories of human participant.

Where a human participant is a participant in a study

A researcher's paramount responsibility is to the participants. Where there is conflict of interest, the participant’s well-being must come first. Researchers must do everything within their power to protect their participants’ physical, social and psychological welfare and to honour their dignity and privacy.

All research in which human participants are involved, that is carried out by undergraduates, post-graduates, staff or affiliated staff, in the name of the CPUT, using CPUT resources or property should:

  • be safe
  • ethical
  • scientifically sound
  • respect the right of individuals
  • include a process of informed consent.

The research proposals or protocols that include therapeutic and/or diagnostic research on patients as well as research on healthy participants, be this through physical research, questionnaires or examination of records, require ethics approval before any research activities commence.

Where the research participant is an informant

  1. The aims of the investigation should be communicated as well as possible to informants.
  2. Informants should have the right to remain anonymous.
  3. Questions asked should not be insulting or embarrassing.
  4. The use of monitoring devices such as tape recorders and cameras should be open, and fully understood by the people concerned. They should be free to reject them if they wish.
  5. Results should be consonant with the informant’s right to dignity and privacy.
  6. There should be no exploitation of informants for personal gain. Fair returns should be given to them for all services.
  7. There is an obligation to reflect on the foreseeable repercussions of research and publication on those studied.
  8. The privacy and wishes of informants should at all times be respected.
  9. No reports should be provided to sponsors that are not also available to the general public and, where possible, to the group studied itself, subject to the protocol laid down in the Protocol on Matters Relating to Sensitive and Confidential Research.

Protocol on Matters Relating to Sensitive and Confidential Research

The CPUT subscribes to the freedom of its staff, students and persons appointed or working under its umbrella to pursue self-initiated research consistent with the CPUT's vision and mission. In addition, the CPUT recognises the importance of its contributions to society in the form of making its expertise and facilities available for contract research and development work. In many cases, this requires that certain information be dealt with confidentially. The CPUT encourages the maximum possible contribution to, and contact with, industry even when confidential work is involved.

This freedom to undertake research, however, is always subject to the dictates of the researcher's conscience and to the CPUT's right to know of all such activities. By informing the Health and Wellness Sciences Research Ethics Committee of all such activities, the review process will judge whether any particular activity is alien to the values of the CPUT. For the purposes of this document ‘research’ must be understood to include all activities related to research.

Sensitive Research

The declared values of the CPUT would be brought into potential conflict with research activities, whether undertaken as part of a person's academic duties or in terms of the rules governing private work, if it were, for example, to fall into one of the following categories:

a)research likely to have an adverse impact on the environment;

b)research which is in potential conflict with human rights, or human dignity, or health.

These are merely examples and they are not intended to be exhaustive. Furthermore, they merely describe categories of potential conflict with the CPUT’s values. The decision as to whether a research activity is actuallyin conflict with the University’s values must be taken at the highest level.

The onus is on those undertaking research at the CPUT to draw every case of potential conflict to the attention of the Health and Wellness Sciences Research Ethics Committee, who in turn, will ensure that every case of potential conflict is brought to the attention of the Dean, Academic Deputy Vice Chancellor or Vice Chancellor. Where, in the opinion of the Executive Director (Research), it may be inappropriate for the proposed research to be undertaken, a final ruling will be obtained from the CPUT Ethics Review Board.

Confidentiality

After careful consideration of a request for full or partial confidentiality, a moratoriumof up to two yearsmay be placed on publication or conferencepresentation by the Health and WellnessSciences Research Ethics Committee.

Under no circumstances will any delay be permitted in the submission of theses and dissertations or in the process of examination, but a moratorium of up to two years may be granted for the lodging of such theses and dissertations on the CPUT library shelves.

General

In the case of all research on human and other vertebrate animals, or their foetuses/embryos and invertebrates of the class Cephalopoda, including research that involves drug trials or clinical trials, the clearance of the Health and Wellness Sciences Research Ethics Committee must be obtained.

Document reviewed annually

Last reviewed: April 2008

Bibliography

These broad guidelines are to be found in more detail in the Medical Research Council's publication (4th edition) entitled Guidelines on Ethics for Medical Research: General Principles.

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