Body
Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 26
Effective Date: 10/08/2021
Policy
All survey research involving human subjects requires IRB approval. That is, if your survey research is a “systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge,” then IRB approval is necessary.
IRB approval is required if the findings from the survey are to be used for any purposes other than data collection about campus programs, practices, curricula, or outcomes for use solely by the college. Students and faculty using surveys to conduct academic research should contact the IRB.
Purpose
This Standard Operating Procedure is an aid to researchers and the CSS IRB in their deliberations about whether appropriate consideration has been given to the protection of human subjects when a study involving survey interviews or questionnaires is proposed.
Survey and/or Research
Regardless of how surveys are distributed, the IRB must review the proposed research, including the survey, to evaluate subject recruitment methods, the informed consent process and document, data collection and storage methods, risks of participation, and other features of the research to assure adequate subject protections. Therefore, the appropriate IRB forms must be completed and submitted. (See, Survey Application Template attached.)
Research involving the use of surveys is usually minimal risk and can be reviewed by an expedited process or deemed exempt from IRB review, unless the survey questions are sensitive, potentially provoking psychological distress or could potentially result in civil or criminal actions against a subject.
The results of academic research are often reported through outside publications or presented in forums that include individuals outside of the college. If the intent is to publicly present or publish survey results (including via the web) an IRB application and IRB approval is required prior to collecting data.
If a survey research project does not qualify as exempt under IRB standards, the proposal must proceed through the formal IRB approval process and will require additional time for review. If there is uncertainty about a survey requiring IRB review, contact the CSS IRB for guidance.
Exempt Criteria / Risk
Participation in surveys rarely puts respondents at more than the minimal risks of everyday life. This fact is recognized explicitly in the Federal regulations which list surveys as examples of research that may be exempted by the IRB or handled with an expedited review process. Unless the intended participants are minors, in many cases, surveys meet the requirements for exemption provided in 45 CFR 46.104(d)(2) and presented in the category description below.
Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
- The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
- Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
- The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by § 46.111(a)(7) (adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data).
The CSS IRB is mindful of the ethical implications and necessary safeguards associated with soliciting sensitive information, regardless of recruitment method. Most research on sensitive topics requires IRB approval, both for the protection of respondents and the College. There are times when simply asking questions may cause momentary unhappiness but not actual distress. The risk associated with momentary unhappiness is well within the range of day-to-day experiences and activities. See however, CSS IRB SOP #24 Reporting an Unanticipated Problem Involving Risks to Subjects or Others/Adverse Event and Report Form.
Participation in certain surveys can, however, put respondents at significant risk when, for example, the inquiry concerns stigmatizing or illegal activity and inadequate attention is paid to ensuring respondent anonymity or the confidentiality of responses. Such surveys can pose significant risks to respondents since they may suffer adverse consequences if individual identities and responses are disclosed. In all surveys, but particularly in these atypical cases, two issues need to be examined by the researcher and the IRB:
- Have sufficient steps been taken to protect the identity of respondents and the confidentiality of their answers?
- Do the anticipated benefits to society outweigh the risks?
Confidentiality
It is essential in all surveys that the researcher separate all personally identifiable information (“PII”) (e.g., name, date of birth, home address, email address, telephone number, if known) from the interview itself as soon as it is no longer needed, typically, immediately after the survey has been conducted or the interview has been verified. (Verification is a standard quality control procedure following face-to-face interviewing and is normally conducted soon after the initial interview is completed.) The identifying information (if it needs to be retained) must be stored separately from the interview data in secure files. The level of security needed should be determined according to the level of risk assumed by the respondent and the likelihood that efforts will be made (by, say, law enforcement personnel) to access the identifying information. In cases where data are linked over time, for example in panel studies, identifiers may need to remain with the data for longer periods. In these cases, data security and storage must be a priority.
Personally, identifiable information should be collected only as required in relation to the expressly stated purpose of research or a project. The use of prizes or other incentives to encourage participation typically requires the collection of personal information from the respondents (i.e., name or email address). If the respondents have been promised anonymity, collection of this information may appear to be a violation of the promise. Two methods are typically used to circumvent this apparent conflict:
- Respondents can be assured that their participation and responses will be confidential, but not anonymous. In this sense, ‘confidentiality’ means that none of the information collected can be associated with a specific individual.
- A double-blind procedure is developed in which a second party ensures that the analyst does not see any personally identifiable information.
- See, Incentives section of this policy for additional important information regarding the use of prizes or other incentives.
Many professionals are subject to legal requirements to report the intent to harm oneself or others. The CSS IRB expects that professionals conducting research will comply with their professional reporting requirements, and although the legal requirements to do so when acting as a researcher may not always be clear, there is an argument that the ethical obligation remains even if no clear legal requirement exists. Similarly, if a study includes testing for medical conditions (beyond collecting self-reported information), such as certain sexually transmitted diseases or tuberculosis, the medical reporting requirements remain in effect and the consent information must indicate the requirement to report the findings to the appropriate state office. Consent forms should inform participants of these reporting obligations in any study in which reportable information is likely to be evoked. An example of such language is:
There is one exception to confidentiality. If information is revealed about [child abuse or neglect (MN Stat. 626.556 Reporting of Maltreatment of Minors), elder abuse or neglect (MN Stat. 626.557 Reporting of Maltreatment of Vulnerable Adults), or potentially dangerous future behavior to others (148.975 Duty to Warn; Limitation on Liability; Violent Behavior of Patient), etc. as applicable], the law requires that this information be reported to the proper authorities (MN Stat, 626.556, Subd. 3.Persons mandated to report; persons voluntarily reporting).
Although most surveys are conducted anonymously, potential exists for personally identifiable information to be provided in response to survey questions. To the extent that personally identifiable information of faculty, staff or students is contained in their responses to a survey, the CSS administration and the CSS IRB will take appropriate steps to ensure the data is protected in accordance with Minn. Stat. Ch. 13 (Minnesota Government Data Practices Act), 20 U.S.C. § 1232g (Family Educational Rights and Privacy Act) and 34 C.F.R. Part 99 (Family Educational Rights and Privacy Act Regulations).
The Protection of Pupil Rights Amendment (PPRA) (20 U.S. Code § 1232h) is a federal law that affords certain rights to parents of minor students with regard to surveys that ask questions of a personal nature. The rights under PPRA transfer from the parents to a student who is 18 years old or an emancipated minor under state law. Briefly, the law requires that schools obtain written consent from parents before minor students are required to participate in any U.S. Department of Education funded survey, analysis, or evaluation. It governs the administration to students of a survey, analysis, or evaluation that concerns one or more of the following eight protected areas:
- political affiliations or beliefs of the student or the student’s parent;
- mental or psychological problems of the student or the student’s family;
- sex behavior or attitudes;
- illegal, anti-social, self-incriminating, or demeaning behavior;
- critical appraisals of other individuals with whom respondents have close family relationships;
- legally recognized privileged or analogous relationships, such as those of lawyers, physicians, and ministers;
- religious practices, affiliations, or beliefs of the student or student’s parent; or
- income (other than that required by law to determine eligibility for participation in a program or for receiving financial assistance under such program).
PPRA also concerns marketing surveys and other areas of student privacy, parental access to information, and the administration of certain physical examinations to minors.
Incentives
Incentives to participate in surveys may be used, as long as the following guidelines are followed. If the cost or fair value of a survey incentive is greater than $25, the value of a survey incentive may be taxable to the recipient. The survey requestor needs to check with the College Finance office prior to issuing the survey incentive so that CSS can comply with tax reporting requirements.
Incentives may be offered or given only to student survey participants and not to faculty or staff members. If there is a compelling reason to offer a survey incentive to faculty and/or staff survey participants, it is imperative that the survey requestor first consult with the Director of Human Resources before the survey incentive is offered. This will help ensure that the survey incentive does not create additional compensation and/or tax reporting requirements for the College.
Informed Consent
There is always a requirement to obtain informed consent from research subjects. Researchers must discuss the study purpose, procedures, potential risks and benefits, the voluntary nature of participation, researcher contact information if subjects have questions, and the other required elements of informed consent (See, CSS IRB SOP #16 Informed Consent w/ Checklist and Templates) . However, the regulations allow the IRB to approve a waiver or alteration of the consent process in which some of the required elements may be omitted and/or the method of obtaining and documenting consent altered (See CSS
IRB SOP #15 Waiver or Alteration of Consent (Waiver Request Form Reviewer Checklist)) and CSS IRB SOP #18 Waiver of Documentation of Consent).
For research utilizing surveys, approval is usually granted for an informed consent process that includes a consent document in the form of a cover letter that is at the beginning of the survey. In this consent cover letter, subjects are informed about the study and told that they can opt out of the research simply by not continuing to the survey questions and they may withdraw at any time by exiting the survey. The requirement for obtaining written documentation of consent (a signature) is waived as subjects agree to participate is signified by completing the survey. (See, Cover Letter Template attached.)
Internet / Online Survey Research
Internet communication is extensively used and provides access to an enormous amount of information to “Internet communities.” Internet communities may be defined as:
Community has become the ‘in-term’ for almost any group of people who use Internet technologies to communicate with each other. Depending on whether one takes a social perspective or a technology perspective, online communities tend to be named by the activity and people they serve or the technology that supports them.
(Journal of Computer-Mediated Communication, Volume 10, Issue 4, 1 July 2005, JCMC10410, https://doi.org/10.1111/j.1083-6101.2005.tb00264.x
(Published: 17 July 2017.)
Access to these communities and the information associated with them raises a number of ethical questions and challenges for researchers and the CSS IRB. Perhaps the biggest challenges that are faced relate to privacy and informed consent.
Research proposal should describe:
- The Internet methods and technology that will be used to interact with “Internet communities.”
- Potential risks and benefits of the research and how risks will be minimized.
- The informed consent process that will be used, i.e., how Internet community members will be informed that research data is being collected, how community members can “opt-out” of having their data collected, etc. or justify why a waiver from the requirement to obtain informed consent is appropriate.
- The methods that will be used to assure protection of privacy for subjects and how confidentiality of the data will be provided.
Proposals for Internet research may meet criteria for exemption from IRB review (See above). However, other issues may dictate a higher, more stringent level of review such as:
- The complexity of reducing potential risks.
- Protecting privacy and confidentiality.
- Obtaining true informed consent.
- Justifying a waiver.
The CSS IRB strongly recommends the use of the Qualtrics Survey Software for consistency in survey appearance.
Researchers who utilize e-mail surveys must add the following information to their message:
- The words “Research” should be in the “Subject” line.
- The message should state at the outset where the e-mail addresses were obtained.
- Include either a statement that there will be no future mailings or an “opt-out” message that directs the researcher to remove the subject’s name from future mailings.
- If there will be future e-mails, add the statement, “If you do not respond to this survey or return the “opt-out” message, you will receive repeat e-mail messages X times during the next X weeks.
- Include a contact e-mail address and telephone number in the last sentence of the e-mail message.
- Use a “blind copy format” so that the list of recipients will not appear in the message header.
Informed Consent Process For Online Survey-Based Research
Internet consent documents should be written like a cover letter and should include all the elements of the regular signed consent, including the confidentiality disclaimer given below. The consent line should say, "By completing the survey you are agreeing to participate in the research.” Other Internet-based surveys include "I agree," or "I do not agree" buttons on the website for participants to click their choice of whether or not they consent to participate.
- The following statement is required to be listed on the consent form: “Confidentiality will be maintained to the degree permitted by the technology used. Your participation in this online survey involves risks similar to a person’s everyday use of the Internet.”
- The consent must disclose that if a participant completes an anonymous survey and then submits it to the researcher, that the researcher will be unable to extract anonymous data from the database should the participant wish it withdrawn.
- If the IRB approves research, which requires documented consent, and does not maintain the anonymity of participants, the researcher may email the consent form to participants who may then type their name and the date into the spaces provided on the consent form, and return it to the researcher via email, if the CSS IRB determines that documented consent is required. Some survey programs allow a similar consent process to be built into the survey itself, which can also be permitted by the IRB.
Resources
American Association for Public Opinion Research (AAPOR) Guidance for IRB’s and Researchers https://www.aapor.org/Standards-Ethics/Institutional-Review-Boards/Full-AAPOR-IRB-Statement.aspx
IRB EasyEd. Do sensitive research questions cause emotional distress and harm? Volume 1 Number 10. © 2017 Apex Ethical Govregs.com -
https://www.govregs.com/regulations/expand/title45_chapterA_part46_subpartA_section46.104#title4
5_chapterA_part46_subpartA_section46.111
The CSS IR&A Policy http://www.css.edu/academics/institutional-research-and-assessment.html Georgia State University – Office of Institutional Effectiveness - Does Your Survey Research Need IRB Approval? https://oie.gsu.edu/institutional-research/survey-approval/does-your-survey-research-need-irb-approval /
Antioch College Survey Policy and Procedures -
https://antiochcollege.edu/wp-content/uploads/migrate/05.061%20Survey%20Policy%20and%20Proced ures%20FINAL.pdf
University of Texas at Austin -
https://research.utexas.edu/ors/human-subjects/irb-policies-and-guidance/policies-and-procedures/
Loyola University Chicago Policy for Online Survey Research Involving Human Participants https://www.luc.edu/irb/irbonlinesurveys2.shtml University of Massachusetts – Amherst)
https://www.umass.edu/research/form/informed-consent-template-paper-survey-consent-paragraph UC Davis Office of Research Template Protocol https://research.ucdavis.edu/policiescompliance/irb-admin/researchers/irb-forms/#Templates
Protection of Pupils Rights Amendment - 20 U.S. Code § 1232h
Family Educational Right Privacy Act - 20 U.S.C. § 1232g; 34 CFR Part 99
Protecting Student Privacy – U.S. Department of Education https://studentprivacy.ed.gov/frequently-asked-questions