This month in the IRB Corner we discuss considerations for researchers who are collecting data with online surveys. In particular, we explain the option of waiving documentation of informed consent, and we discuss anonymity and confidentiality settings with online surveys.
In an article discussing regulations and guidance for Internet research, the Office for Human Research Protections (OHRP) explains that current federal human subjects research regulations were written before Internet technologies existed (see http://www.hhs.gov/ohrp/sachrp/mtgings/2013%20March%20Mtg/internet_research.pdf for more information.) The Internet has changed how researchers conduct research activities, and these changes have created new challenges for researchers.
Why should I consider “waiving documentation of informed consent” with my online survey?
When collecting data with an online survey, the researcher and human subject typically do not interact in person; thus, it may be impossible to document the informed consent process with a signature. Although federal regulations are not written to allow for “passive consent” or an “opt-out” procedure, a researcher can request a waiver of documentation of informed consent. This waiver means that the researcher will not gather a signature from the subject during the informed consent process. For more on the requirements for requesting a waiver of informed consent, please see http://www.hhs.gov/ohrp/policy/faq/informed-consent/when-may-requirement-for-documentation-be-waived-or-altered.html.
If a waiver of documentation of informed consent is granted, the researcher can build the informed consent document into the first page of the survey. In these cases, the consent document still includes all required elements (see the GUIDANCE – Informed Consent document in the IRBNet Forms and Templates library for more information). However, with a waiver of documentation of informed consent, instead of signing the document, the subject is given an opportunity to “agree” to participate (taking the subject to the online survey), or “disagree” to participate (removing the individual from the study). The SurveyMonkey Help Center provides instructions for creating a consent form on the first page of a survey (see http://help.surveymonkey.com/articles/en_US/kb/How-do-I-create-a-consent-form-or-disqualify-respondents-from-a-survey).
Will my online survey data be anonymous or confidential?
Many times researchers confuse the terms privacy, confidentiality, and anonymity (for more information, see GUIDANCE - Privacy, Confidentiality & Anonymity in the IRBNet Forms and Templates library.) Anonymous data are collected without any personally identifying information or identifiers. Confidential data have identifiers, but the data are managed to protect the privacy of the individuals. When researchers waive documentation of informed consent, there is not a personal identifier associated with the informed consent process in the raw data set. However, there may be other personal identifiers associated with the data, such as a computer IP address or user email. Many online surveys are collected by sending a sample of potential subjects email requests to participate in the study. In these cases, since the researcher has email addresses and possibly other identifying information like IP addresses, it is critical that the researcher understand how survey software settings impact whether the data set will retain this identifying information.
Researchers using SurveyMonkey will find the following resources helpful in understanding how to establish an anonymous survey:
Researchers using other online survey tools will need to locate information about the software settings. It is the researcher’s responsibility to explain on the UOPX IRB application what identifiers will be included with raw data, how long identifiers will be associated with the data, how the identifiers will be destroyed once removed from the data, and how the data will be managed and stored securely (either anonymously or to maintain confidentiality). Simply stating an online survey will be kept in a locked file cabinet is not appropriate data management; the researcher must explain how cloud-based or online survey data will be protected throughout the study period. SurveyMonkey provides survey creators additional guidance about online surveys, privacy, and other IRB-related concerns here: http://help.surveymonkey.com/articles/en_US/kb/How-does-SurveyMonkey-adhere-to-IRB-guidelines.
After reviewing the guidance materials recommended in this article, please contact The University of Phoenix IRB Office at IRB@phoenix.edu if you have any questions about online surveys.