Since programs aimed at reducing alcohol-related harm involve people, interventions and any data collection may be required to undergo an ethical review and approval process. This applies equally to the programmatic and evaluation components of your educational program. The inclusion of human subjects may require the approval of an Ethics Committee or Institutional Review Board (IRB), and informed consent from participants. In the case of minors, consent may be required from their legal guardians.
It is important to understand the requirements and considerations before you begin. A human subject regulations decision tree (See Resources Sidebar) can help you determine if your intervention requires approval or is exempt from the regulations guiding research with human subjects.
All human research should begin with the informed consent of participants. Informed consent means that a participant understands and agrees with the information described in the informed consent materials. The information required to be disclosed to a participant can vary. Determine the locally applicable ethics codes or other professional requirements for where your program will be implemented.
Informed consent materials generally include:
- A statement of the voluntary nature of participation;
- A description of the process of participant selection and, if relevant, how participants were assigned to intervention or control groups;
- Assurances of confidentiality;
- The purpose of the intervention and evaluation;
- Data collection procedures;
- Possible risks and benefits;
- Explanation of remuneration (including in kind), if any;
- Contact information for questions or help.
Formal approval to conduct your intervention at a site such as a school, community center, church, or other organization, may also be required before you can begin your fieldwork. Such approval may involve reporting of informed consent procedures, safeguards to protect confidentiality of participants, survey protocols, and contact information of program managers or researchers.
The Resources Sidebar also includes links to important international guidelines in human subjects research including an example of ethical principles governing professional groups (e.g. psychology). Some countries do not have codes of ethics for research. In such cases, international standards for conducting general research, such as UNESCO's Declaration of Bioethics and Human Rights, should provide commensurate guidance.