In order to ask the questions that you have identified, it is important to let participants know how you plan to use and protect their information. You may also need to ask for their consent to participate in your assessment.
- Privacy refers to the right of an individual to keep his or her health information private.
- Confidentiality refers to the duty of anyone entrusted with health information to keep that information private.
How you plan to protect participants’ privacy and confidentiality should be included in a study fact sheet and/or an Informed Consent form or script when you ask someone to participate in your assessment.
- A fact sheet provides an overview of the purpose of the study, how data will be collected, what types of questions will be asked, and how data will be used and protected.
- An Informed Consent Form/Script includes the same elements of a fact sheet but also asks participants to consent to participate either through providing a signature or verbal agreement.
IRBs and obtaining Permission For Data Collection
Depending on your agency and your assessment design, you may need to obtain Institutional Review Board (IRB) approval to conduct your assessment. The role of an IRB is to review research studies involving human participants to ensure that people’s welfare, rights, and privacy are protected appropriately.
Generally, if you plan to collect identifying information (names/contact information) with your data, ask highly sensitive questions, or plan to publish your findings, you may need to obtain IRB approval and/or collect consent from participants. If you are planning to collect only anonymous responses, your questions are less sensitive in nature, and you plan to only use the findings internally for planning purposes, you may not need to obtain IRB approval and/or collect consent. Consult your agency to determine when IRB approval is needed and whether a fact sheet or an informed consent form/script would be appropriate for your assessment.
For the Fundamental approach, plan to include a research fact sheet describing your assessment and how you will protect participants’ privacy and confidentiality. See Appendix E for a customizable fact sheet and Appendix D for a customizable informed consent form/script.
Developing a Study Fact Sheet or an Informed Consent Form or Script
Documents should include the following elements.
- Inform respondents of the general purpose of the assessment and how the results will be used.
- Explain the nature of the assessment and the kind of information that respondents will be asked to share. Specifically, respondents must be informed that the assessment will ask them about their experiences with pregnancies, violence and trauma, and other potentially sensitive issues.
- Explain that respondents have the right to refuse to participate in the assessment.
- Explain that respondents have the right to withdraw from the assessment at any time.
- Inform respondents of the potential risks associated with participation in the assessment. These risks may include psychological discomfort related to discussing sensitive topics.
- Inform respondents of the length of time they will participate (amount of estimated time to complete the survey or participate in an interview or focus group session), which may involve some inconvenience.
- Inform respondents of potential benefits associated with participation in the assessment, such as the contribution the assessment will make to generating awareness about the impact of the disaster on needs in the area.
- Inform respondents about confidentiality. Describe how, if at all, respondents’ information will be shared. State whether responses will remain anonymous, which means respondents’ names or contact information will not be on the questionnaire or tracking form, and their names or contact information will never be reported as part of the results.
- Describe how the data (spreadsheets, completed paper forms, notes from interviews/focus groups, and recordings of interviews/focus groups) will be stored and protected.
- Provide respondents with contact information if they have any questions about the assessment.
Check out this helpful Informed Consent checklist from U.S. Department of Health & Human Services Office for Human Research Protection if you are interested in learning more.
How to request consent
How you obtain consent may depend on your assessment method. You can request a participant to consent in several ways.
- Asking a participant to provide verbal consent to participate after reading an informed consent script. Only those who consent to participate should be given your survey or participate in the interviews or focus groups. A helpful best practice is to keep a record using a document or spreadsheet to track which participants have consented to participate and who have not.
- Including an informed consent page in front of your paper survey. At the end of the informed consent document, ask participants to sign and date the form if they consent to participate in your assessment. Only those who consent to participate should see the rest of the assessment.
- Including consent information at the beginning of an online survey and include a question asking if they do or do not consent to participate. Or, include language that states if the respondent clicks “Next” to move to the next page of the survey, they are providing consent to participate in the assessment. Only those who consent to participate should see the rest of the assessment.
Helpful tip 1: Go back and double check that your informed consent form/script is aligned with how you plan to collect consent. You may need to revise your informed consent form/script based on any changes to data collection.
Helpful tip 2: If you are interested in speaking to a minor, you will also need parent or guardian consent to allow their youth to participate.
