The resources in this guide are meant to be used to evaluate nature’s impact on people.
The resources in this guide are meant to be used to analyze nature’s impact on human beings (people). For instance, human subjects (i.e., community members asked to respond to these tools) may be repeatedly asked to participate in research projects, or the information gathered through the assessment may be used to mischaracterize individuals or communities.
To avoid doing harm to human subjects during a research or evaluation project, most institutions – academic, non-profit, government, etc. – have policies and procedures in place to ensure no harm is done to project participants. In academic institutions and larger non-profit organizations, an Institutional Review Board will review your research plan and determine the risk to human subjects, and approve or deny the plan accordingly.
There are inherent risks to engaging human subjects in either a research or evaluation setting – before, during and after the research or evaluation project. It is recommended to consult with your institution’s relevant authority on engaging human subjects in a research or evaluation project.
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
One of the most noteworthy resources for understanding basic ethical principles of working with human subjects is the Belmont Report, a report written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The identifies ethical principles and guidelines that address ethical issues arising from research conducted with human subjects.
The U.S. Department of Health & Human Services (HHS) website provides a thorough introduction to the Belmont Report and includes a step by step guide to help practitioners through the planning process when research and evaluation includes human subjects.
Institutional Review Boards (IRB) PROCESS
Please note that some types of research or evaluation may require review and approval by an appropriate external Institutional Review Board (IRB) before working with human subjects. When working with populations such as minors, people who are incarcerated, biomedical research participants or participants from populations that might reasonably be considered at risk or of special concern, be prepared to seek review and approval by an external IRB.
In addition, any research involving human subjects that is funded, in whole or in part, by any U.S. federal department or agency will also require external IRB oversight if it falls into certain high risk categories as defined by the U.S. government. Researchers using any U.S. federal funds for research involving human subjects should notify their organization’s attorney or legal representative.
Note that it is the IRB’s responsibility for reviewing applications for research involving human subjects and working with researchers to help ensure that their research is conducted in accordance with the laws protecting humans as subjects in research.
Most universities have IRBs, but there are also a great number of for-profit IRBs that provide this service for a fee.
All research or evaluation involving human subjects includes voluntary and prior informed consent. This consent may be elicited orally and in a culturally appropriate way. Research that requires review and approval by an external IRB will need to comply with the standards set out by the board. Examples of Informed Consent scripts and documents can be found on the public websites of many universities that conduct research involving human subjects.
The following are examples of security measures that should be taken for research involving human subjects:
- All hard copy documents containing private information must be stored in a locked container (e.g, file cabinet or dedicated storage closet); and
- All information stored electronically (e.g., computers or devices storing data) that contains private identifiable information (see below) is considered Highly Sensitive Information. Consult with your legal and technology departments to ensure security measures are in compliance with organization data classification and information and security systems requirements.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Information is considered private if it is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).
If you need assistance with encryption software, please contact your organization’s technology representative.
Studies Involving “Indigenous Peoples”
As with research involving minors, individuals who are incarcerated, biomedical research, and research that includes participants from populations that might reasonably be considered at risk or of special concern will require review and approval by an external IRB. In many countries and contexts, this will include groups known as “indigenous people.” Because the legal definition of “indigenous people” varies among the locations, practitioners and lead investigators should contact their organization’s attorney to ensure that research is in compliance with all applicable laws.
If your research involves indigenous people as research participants, researchers may consider the guidance in the following resources:
- World Health Organization’s guidance, Indigenous peoples & participatory health research: Planning & management; Preparing research agreements
- Linda Tuhiwai Smith: Decolonizing Methodologies: Research and Indigenous
- Ethics and Research Methodologies for the Study of Traditional Forest-Related Knowledge
In all cases, a surveyor should get consent to participate directly from the respondent. Note that the Nature’s Impact on Human Health Question Bank includes consent initially, before the assessment begins.