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Home > Making Common Non-Compliance Issues in SBER Less Common

Making Common Non-Compliance Issues in Social, Behavioral, and Educational Research (SBER) Less Common

How IRB Professionals Can Help

The following guidance assists IRB and human research protection program (HRPP) professionals in helping principal investigators (PIs) and study teams avoid common SBER non-compliance issues. On this page, you will find best practices, tips for addressing specific areas of non-compliance, and links to helpful resources.

General Recommendations

  • Start with good communication. Good communication with the research community is perhaps the most valuable tool in avoiding non-compliance.
  • Provide guidance to the research community via an easily accessible website.
    • Easy access to institutional guidelines and expectations encourages researchers to refer to them early and often.
  • Conduct IRB sessions with the research community.
    • Sessions may be comprehensive, bootcamp-style sessions, or specific to non-compliance.
  • Host office hours, “ask me anything” chats, and other low-stakes opportunities for the research community to ask questions early and often, without fear of judgement.
    • Doing so creates a low-pressure and supportive environment.
  • Provide post-approval monitoring with options for post approval check-ins and not-for-cause audits, in addition to for-cause audits and other monitoring required by your institutional policy.
    • Emphasize that the relationship between IRBs/HRPPs and PIs/study teams is intended to be supportive, not adversarial.

Enrollment

Common Issue: Over-enrollment and enrollment of ineligible participants.

  • Include guidance/instructions in the IRB submission form related to proper estimation techniques for determining appropriate sample size and study population.
  • Advise PIs and study teams on instances where it would be more appropriate to consult with a statistician or perform a power analysis, rather than estimate sample size. Whereas an estimate may be sufficient for a simple, minimal risk study, this would not be appropriate for a study with a lab component, or when SBER activities are part of a clinical trial.
  • Provide guidance on how to best formulate recruitment messaging and how to use screening techniques.
  • Include guidance/instruction on how ethnographic or other non-individually-specific data should be described in the IRB form.

Consent 

Common Issues: Failure to obtain proper consent, use and/or collection of minors’ data without parental consent.

  • Ensure that PIs and study teams understand consent-related issues, including, but not limited to:
    • Assent, including how age of consent differs between states and countries.
    • Legally authorized representatives (LARs), and the types of studies that most commonly involve them.
    • Waivers of documentation of consent, and acceptable alternatives to documentation.

Data

Common Issues: Failure to follow data collection methods described in the IRB-approved protocol, improper use, management, and storage of data.

  • If there are institutional polices regarding collecting data at or through external organizations or groups, ensure researchers are aware of these requirements.
  • Educate PIs and study teams (via training sessions, webpages geared toward the research community, and/or IRB consultations, for example) on applicable laws, institutional policies, and agreements, including, but not limited to:
    • The Health Information Portability and Accountability Act (HIPAA)
    • Data use agreements (DUAs)
    • Business associate agreements (BAAs)
    • California Consumer Privacy Act (CCPA)
  • Provide guidance to the research community related to secondary analysis of data, proper data management, and techniques for understanding data.
  • Point researchers to other institutional resources (e.g., Research Computing, IT, etc.) that can help them understand how to manage and protect data.
  • Provide guidance to the research community related to best practices and record keeping requirements throughout the study lifecycle.

Modifications

Common Issues: Failure to watch for and report emerging risk-related issues to the IRB; failure to submit modifications as needed related to emergent trends during study implementation; failure to obtain organizational approval for research at particular sites; and changing and/or adding study locations.

  • Understand that ethnographic research is particularly fluid, and often requires some degree of flexibility built into the study protocol.
    • Create guidance that explains where and how PIs may address the need for flexibility in their research proposals.
  • Instruct investigators to submit a modification if there are significant changes.
  • Identify and provide guidance on aspects of SBER protocols that tend to evolve when the study is implemented.
  • Ensure the section of the protocol that collects information about study location is clear.

Mandated Reporting

Common Issue: Failure to comply with institutional and/or state mandated reporting laws.

  • Provide information on who is considered a mandated reporter at your institution/site.
  • Provide or create guidance about mandated reporting requirements, including examples that illustrate the types of incidents that require reporting versus incidents that do not legally meet the threshold for reporting, but may cause the participant discomfort.
  • Consider adding language to informed consent form templates related to mandated reporting.
  • Consider creating a standard operating procedure (SOP) for how to handle mental health emergencies and other interpersonal dynamics that may raise questions around mandated reporting.

Helpful Links 

Harvard Catalyst has an extensive library of resources for supporting PIs, study teams, and IRB/HRPP professionals, all designed to be adapted to suit your institutional needs. Below, we’ve included those most relevant to this guidance. If you spot a need unfulfilled by the resources linked below or others available in our Publication and Document library, please feel free to contact us at regulatory@catalyst.harvard.edu.