Surveys, Interviews, and Focus Groups: A Step by Step Guide for IRB Submission

April 2022 Issue

Author(s):

  • Matthew Ogrodnik, MS, CIP, Director, Office of Human Research Affairs

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Introduction

Studies with adult subjects involving only surveys or questionnaires, interview procedures, focus groups, or a combination of all three, are one of the most common types of submissions reviewed by the Boston Medical Center (BMC) and Boston University (BU) Medical Campus Institutional Review Board (IRB). These qualitative research methods are a crucial way to obtain insights directly from research subjects. To help facilitate an efficient review process for this type of project, this month’s Feature Article will provide step-by-step guidance on submitting survey, interview, and focus group studies to the IRB. At the end of the article, we will also discuss when these types of studies involving children may qualify for an exemption determination from the IRB.

One additional note:  For ease of communication, this article refers colloquially to studies involving surveys, interviews, and focus groups.  However, the full Exempt Category 2 for this type of project is defined as 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).

 

Review Path under the Revised Common Rule

Researchers who have been conducting studies involving surveys, interviews, and focus groups for several years may remember when this type of research did not always qualify for an exemption determination (see also the CR TIMES March 2019 Feature Article “What is “Exempt” Human Subject Research, And What Does It Mean?” for more information on exempt research).  In order to qualify as exempt under the previous version of the human subjects federal regulations (“Common Rule”), this type of research either needed to be recorded anonymously or needed to be non-sensitive. If the data were identifiable, then it could not qualify for exemption if “any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.”

Now, under the 2018 Revised Common Rule, the exemption criteria for this type of research has been expanded.  Research that only involves these methods qualifies for exemption if:

  1. the data are recorded in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; or
  1. the data are identifiable, but non-sensitive (like the previous Common Rule); or
  1. the data are identifiable and sensitive AND there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. As the IRB would not permit a study to proceed without adequate privacy and confidentiality protections, this effectively means that all research involving these methods qualifies for exemption.
Therefore, if you are conducting research with adults that only involves surveys, interviews, and/or focus groups, then you may always proceed to the following steps for submitting your IRB application.

 

Steps for Completing an Exempt Category 2 Study Submission Review Process

Step 1

The instructions for setting up your account in our INSPIR II electronic research application system (if you do not have one already), and for submitting a new study are found here under "How To: General" and “How To: New Study – Initial Reviews”, respectively. Once you have your account and have created your new study draft, please move on to Step 2.

Step 2

In the new draft application, first add your study Title (Section 1), Department(s) (Section 2), and Key Study Personnel (Section 3). These 3 sections are the same for all types of research studies.

Most importantly, in Review Path section 4.1, please select the 4th option: “This study fits into one or more of the federal Exempt categories or the study does not have external funding and fits into one or more of the Equivalent Protections Exempt categories.”

This will generate the exempt human subjects research application.

Step 3

After completing Section 5 (Required Training and Conflict of Interest Disclosure), move on the Section 6 (Exemption Categories). In section 6.1, please choose Category 2.1 (Anonymous) or Category 2.2 (Identifiable), depending on whether the data you collect will be anonymously collected, or whether it will be linked to identifiers.

Please note that it is always preferable to record the data anonymously if there is no need for you to link the responses to identifiers. However, sometimes it is necessary to collect identifiable information linked to the responses; for example, if this is a longitudinal study involving multiple interactions with the same subject. This is appropriate as long as it is stored as Restricted Use Data per BU policy, or according to BMC policy for storage of protected health information. The institutional requirements for storage depend on whether the Home Institution of the Principal Investigator (PI) is  BMC or BU Medical Campus, according to the Home Institution Database.

Or, another option is to have subjects choose a unique ID to label all of their surveys, with the ID being easy to remember for them, but unknown to you.

Please also note that focus group data is almost always considered non-identifiable, as long as subjects use pseudonyms during the discussion. This is because it is not possible (nor standard practice) to somehow link comments made during a focus group to the individual speakers.

Once you select your category, then complete the rest of the application sections that are generated. If you ever have any questions about the individual sections, please reach out to the IRB at medirb@bu.edu.

Step 4

Per our Human Research Protection Program policies for the Protection of Participants in Exempt Research, you will need to obtain “abbreviated consent” from subjects.

The abbreviated consent must disclose:

  • that this is a research study; and
  • that participation is voluntary; and
  • the purpose; and
  • what the subjects are being asked to do; and
  • confidentiality protections; and
  • how long participation is expected to take; and
  • a disclosure if the subject will be audio- or video-taped; and
  • how to contact an investigator or research staff member for questions about the study.

Abbreviated consent does not require a signature. However, if the study requires authorization for use and disclosure of PHI (see Section 8.5), then a signature must be obtained either on a separate authorization form or on an authorization combined with the abbreviated consent, unless the study qualifies for a waiver or alteration of authorization under Section 8.5.2.2.

You should use our abbreviated consent template, the Exempt Information Sheet.

The HIPAA Authorization section entitled, “Use and Disclosure of Your Health Information” is only needed if you are collecting protected health information (PHI).

You may combine the sections shown as separate paragraphs in this template into a single paragraph, if you believe the information would be clearer that way (except for the Use and Disclosure of Your Health Information section – this authorization language must be a separate section).

As outlined in the template instructions, you have multiple options for conveying the abbreviated consent language to subjects:

  • Complete and print out this template.
  • Incorporate the completed language into the first page of your printed survey.
  • Provide the completed language electronically (as an email, electronic survey, etc.). Please note that you should obtain electronic signature if you are collecting PHI by sending the survey using REDCap.
  • Provide the completed language orally. This option is acceptable if the subject is given written contact information such as on a business card. If you are collecting PHI, and it is not practicable to obtain subject signature, then you may request a waiver of HIPAA authorization in the INSPIR application (by checking Yes in the HIPAA Compliance section and completing all required sections).
If the surveys themselves are mandatory for quality improvement  or evaluation purposes (such as course evaluation), but you also would like to request to use the data for research purposes, then you should compose the abbreviated consent in such a way that you inform potential subjects that the assessments are required for evaluation purposes; but that the voluntary component is whether they will agree to let you use the responses for research purposes. You can then give them a Yes/No opt-in/opt-out for research.

 

Surveys and Interviews with Children

The BMC and BU Medical Campus HRPP has a special institutional exemption category for surveys and interviews with children. This category does not appear in the federal regulations, which states that to qualify as exempt under the Common Rule, the interactions must occur with adults. In order to qualify for exemption when involving children, the study must meet our “equivalent protections” criteria, which are detailed in our HRPP Policies and Procedures 2.1.2      Equivalent Protections for Research Without Federal Oversight.

If the research meets these “equivalent protections” criteria, it could be exempt human subjects research if it falls under this category:

Exempt Category 12:  Research with children involving survey procedures, interview procedures, or observation of public behavior where the investigators or research staff participate in the activities being observed.

In order to qualify for this category, a parent or guardian must provide permission for their children to participate.

To submit this type of category, please follow the Steps 1-4 listed above. The only differences are:

  • In Section 6.1, you should select Category 12, instead of Category 2.1 or 2.2.
  • For abbreviated consent, instead of using the Exempt Information Sheet template, you should use the Parent Permission Exempt Information Sheet. You should also explain the study in a manner that is understandable to the child, and obtain their assent to participate.
Please note that surveys and interviews with children can still be done in studies with external funding, but will follow the Expedited approval pathway instead of the Exempt pathway.  In this instance, in Section 4.1 Review Path, select the 5th option, “None of the above. This study requires Expedited review or the review of the Full Board.” You will also instead need to use the full non-exempt Parent Permission Form Template.

 

Conclusion

Studies involving surveys, interviews, and focus groups are very commonly conducted by researchers at BMC and BU Medical Campus, and for good reason. Using these methods, you are able to obtain valuable perspectives and experiences directly from the subjects.  Follow the steps outlined in this Feature Article to facilitate an efficient IRB review process, enabling you to get started on the ethical conduct of your important research.