Regulatory Foundations, Ethics, and Law Program

• Go to your IRB office with questions. Before starting any study activities, get confirmation directly from IRB staff that your study does not require prior IRB review or approval.
• Locate and consult any relevant guidance or policies provided by your IRB office.
• For projects involving secondary analysis of data, make sure you understand the nature and identifiability of the data you are obtaining and how these aspects may affect IRB determinations.

• Understand your role regarding mandated reporting and maintain contact information for all institutional, state, and other officials to whom such information must be reported.
• Make sure all members of the study team have a strong understanding of the concepts and definitions of “imminent risk” and “harm.”
• Consider designating a point person, or obtaining an outside consultant, to support research staff in assessing situations that may meet the threshold of mandated reporting.
• Recognize that mandated reporting requirements vary from state to state.
• Be aware of local context, and ensure that study staff follow institutional regulations and state laws at all sites.
• Consider adding language to informed consent forms related to mandatory reporting.

• Be thoughtful when assessing how many participants you will need to conduct your research and answer your research questions.
• For simple, minimal risk SBER studies, be generous in your estimation of the number of participants you need. Keep in mind it is better to overestimate, rather than underestimate.
• For clinical trials with an SBER component, or an SBER study with a lab component, conduct a power analysis to determine the appropriate sample size.
• If you are at risk of over-enrollment, consult your IRB to determine whether you must submit a modification.

• Understand and follow the processes required by your IRB.
• Review guidance, resources, and templates provided by your IRB/HRPP office.
• Obtain IRB approval prior to initiating any human subjects research.
• Understand the ins and outs of waivers of documentation of consent. For example, a waiver of documentation does not necessarily mean you do not record consent, only that you have a plan other than the traditional method of obtaining a wet-ink or electronic signature.
• Follow your IRB-approved protocol and use your IRB-approved consent forms.
• If an error occurs and consent is not obtained or not properly obtained, report this to your IRB immediately.
• For additional information on informed consent in SBER, see our Consent Template Instructions for Simple Minimal Risk Social, Behavioral, and Educational Research (SBER) Studies.

• Carefully assess the criteria for enrollment and clearly define the study sample.
• Include eligibility questions at the start of the study to ensure only eligible participants enroll.
• Include enrollment and eligibility criteria in the recruitment materials to limit potential enrollment of ineligible participants.

• For ethnographic research, it can be hard to establish clear limitations for what information should be recorded and used as data. It is a good idea to discuss your plans with your IRB office while drafting your interview and survey questions as well as any other planned data collection.
• You may also wish to consult with academic experts in evaluation, methodology, and survey design, to ensure that your study is feasible and measures what it intends to measure.
• Best practice is to gain approval from the organization(s) and/or other entities where you intend to collect data. The type of approval or agreement required may depend on institutional requirements.
• For additional information on ethnographic research, see our Ethnography Guidance for Researchers.

For primary data collection

• If you are collecting data that includes minors, ensure you understand consent/assent laws, and confirm with your IRB office the proper steps to obtaining parental permission and child assent.
• Recognize that cross-state studies may be subject to different laws, that the age of consent varies, and that you must follow laws in the state of data collection as well as the state of your home institution.

For secondary data analysis

• Make sure you understand the nature of the data you will be analyzing prior to receiving the data (e.g., work with the data provider to better understand the dataset; review the data dictionaries).
• Work with the data provider to ensure the data they are providing does not include data from minors.
• Review the dataset upon receiving it, and immediately delete unneeded data where allowed by federal regulations. For example, if you have received a data set that has not been deidentified, using a dataset that contains identifiers may affect IRB approval.
• Note that deleting data and destroying data are not the same; it is good practice to confirm appropriate handling of data with your institution’s IT department.

• Understand and follow the processes required by your IRB.
• Review guidance, resources, and templates provided by your IRB/HRPP office.
• Engage with the IRB review process and understand what your IRB approved protocol allows.
• If you have questions about whether a modification is needed, consult with your IRB office. If a modification is deemed necessary, obtain approval for any modifications prior to implementing any required changes.
• If there is a deviation from the IRB-approved protocol, report it to your IRB immediately.

• In a changing socio-political climate, research with certain populations may impact the risk level and/or protections needed to ensure participant privacy, confidentiality and safety.
  • Listen to, and take note of, participant concerns. If you notice a pattern, consult with your IRB to assess whether newly-emergent risks or concerns signal the need to change how the study is conducted.
  • Notice legal or socio-cultural climate changes that may affect actual risk or participants’ safety concerns. Consult with your IRB to discuss whether changes in perceived or present risk require study modifications.
• Pay close attention to patterns, and report concerns and potential impacts on risk assessment to the IRB via a modification to ensure risks are appropriately mitigated and adequate protections are in place. Reassess variables that may have affected the initial risk/benefit analysis, but are hard to anticipate ahead of time, such as:
  • How long an interview/focus group/survey may take.
  • Participants’ comfort with the means of data collection (e.g., in-person, over the phone, using video conferencing software, or other web-based tool).
  • How long it will take to recruit participants/how long the study will run.
• As appropriate, submit a modification to expand data collection methods, update informed consent documents, or make other necessary changes over the course of the study.

• Understand what your IRB approved protocol allows; do not assume flexibility. Although a change may seem inconsequential (e.g., a different room in the same building), it is best to confirm with your IRB.
• If you have questions about whether a modification is needed to add or change study locations, consult with your IRB office. If a modification is deemed necessary, obtain approval for any modifications prior to implementing any required changes.
• If there is a deviation from the IRB approved protocol, report it to your IRB immediately.