Informed Consent is an ethical requirement of the research process. It must be considered at the proposal and writing stage of a research project and be tailored towards the specific research questions and the sample to be used during the project. If informed consent is not given, this could result in preventing opportunities for archiving and subsequent secondary analysis of the research.
Ensuring that participants are engaging voluntarily, without coercion and in the knowledge they can withdraw at any time, is a fundamental ethical principle of research. Participants must also feel confident that there will be no adverse consequences of their involvement in the research.
Often, research includes sensitive and/or confidential information and this issue should be dealt with as part of the process of gaining informed consent. Ways of dealing with confidentiality vary widely depending upon the research project in question, often the main concern is with the disclosure of names, addresses and sometimes occupational and locational details.
Written consent should be gained wherever possible to ensure that information is being collected and provided in a consistent and uniform way. It also acts as a guarantee should any form of dispute arise. Obtaining written consent can be seen as a barrier to participating in research, but is necessary under current ethical and data protection requirements.
For further information on gaining informed consent and how to apply data protection principles to your research click here
Although the format of a written consent form may be tailored to the needs of a particular project, a number of basic issues must be addressed. This falls into two main areas:
- Purpose of the Research
- What is Involved in Participation?
- Benefits and Risks
- Withdrawal of Consent (and mechanism for withdrawal)
- Usage of Data
- Strategies to Ensure Appropriate Confidentiality
- Storage of Data
- Access to Data