Types of Conflict of Interest Disclosures
In response to a recommendation by the UC system, we have created a document that explains the different types of conflict of interest disclosures (COI Disclosure Table). While federal agencies have been asked to reduce burden by adopting a standard conflict of interest policy, we are seeing agencies continue to create agency-specific requirements. Unfortunately, this means that investigators who propose or receive funding from multiple agencies may need to submit multiple conflict of interest disclosures. Given ongoing government scrutiny on unreported conflicts of interest and commitment, it is important that investigators understand the disclosure requirements from the agencies supporting their research.
Investigators and Key Personnel on funded projects may be assigned conflict of interest disclosures to complete through the Office of Research COI (ORCOI) system. The requirements for who must disclose and what must be disclosed varies depending on the type of disclosure. The most common disclosures assigned are:
- Public Health Service (PHS) which includes the National Institutes of Health (NIH)
- National Science Foundation (NSF) which also meets NASA (National Aeronautics and Space Administration) requirements
- Department of Energy (DOE)
- 700U
Some federal sponsors are also requiring investigators to certify that they are not participating in a Malign Foreign Talent Recruitment Program (MFTRP). This is a separate form that is assigned to applicable personnel through the ORCOI system.
Our office is here to help investigators understand and navigate these requirements and urge you to contact us at coi@research.ucsb.edu if you have any questions related to reporting or managing potential financial conflicts of interest.
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Notice of Future Drone Restrictions
As of December 22, 2025, the American Security Drone Act of 2023 will prohibit the purchase and use of drones on federally-funded projects. The National Science Foundation has publicly shared their implementation of this restriction in their draft PAPPG. Since the federal regulation applies to all agencies, we expect that all sponsors will enact similar restrictions by the end of the year. The Act provides limited exceptions for certain national security or NOAA activities, and it remains to be seen if those will apply to any federally-funded university research.
The restriction will prohibit use of NSF funds to (1) procure unmanned aircraft systems (drones) that are manufactured or assembled by a covered foreign entity; or (2) in connection with the operation of such a drone or unmanned aircraft systems. Prohibited sources of drones include entities on the Entity List (e.g., DJI) and any other drones manufactured or owned by a Chinese company.
We realize that this restriction may be particularly impactful to researchers using DJI drones and who have invested in specialized accessories and sensors for these drones. In order to help us understand the impact of this forthcoming restriction, we encourage you to reach out to exportcontrol@research.ucsb.edu.
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The Use of Third-Party Platforms in Human Subjects Research
The IRB has seen a marked increase in the use of third-party platforms for various stages of human subjects research. These can range from interview or transcription services (e.g., Zoom, Otter.ai) to data storage (e.g., Google Drive, Box) to survey distribution and participant recruitment (e.g., Qualtrics, Prolific). Basically, “third-party platforms” can be any external services or software providers that use participant data to complete tasks and/or facilitate analysis. While these services can greatly benefit human subjects research in terms of efficiency and convenience, it is important to be sure that potential subjects are aware of the possible risks involved in allowing these companies to access their data.
Many of the issues for researchers to consider when using third-party platforms fall into the categories of data storage and security. Researchers must make it clear in their consent forms or consent scripts when they will be using one of these tools, as well as specify what the tool(s) will be doing. There are some companies that UCSB already contracts with, and that are incorporated into the university’s dual-factor authentication process (e.g., Box and Google Drive). The IRB considers it best practice to use university-affiliated versions of these accounts whenever possible, as they already incorporate an extra layer of data protection. If researchers have questions about specific services that they intend to use, they can check with the Office of the Chief Information Officer.
In the interests of consistency and transparency, the Office of Research Integrity provides template language that researchers can use in their consent process to ensure that potential subjects are made aware of the risks of using third-party platforms. While there may need to be slightly different versions of this text depending on the research, the general language reads: “Third party platforms used to [complete the task at hand, such as recording or transcribing an interview, etc.] may have access to the [data type, such as recordings] under their privacy policy.” Providing this language will help to ensure that researchers can continue to use these tools, while also taking into account the ethical, privacy, and regulatory concerns that subjects may not be aware of when choosing to participate in a research study that involves third-party platforms.
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Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP)
On May 6, 2025, a new government policy will impact the conduct and oversight of research involving Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP). DURC is a subset of life science research that could generate biological materials, knowledge, or technologies which could be used to harm public health, agricultural crops, the environment, or national security. PEPP is a specific type of DURC research where the research is reasonably anticipated to create novel pathogens that are more transmissible or lethal.
While UCSB has not historically engaged in DURC research, the new U.S. government policy significantly expands the scope subject to review. Researchers who work with potentially infectious agents or biological toxins should familiarize themselves with the new policy and implementation guidance. Federal sponsors, such as NIH and NSF, will start asking PIs to certify whether they are proposing research that uses any of the covered agents or toxins, or has the potential to meet the criteria for DURC-PEPP research. Such research will need to be reviewed by UCSB and the federal sponsor.
UCSB is in the process of developing its implementation strategy and will provide additional guidance to the campus. At this time, UCSB life sciences researchers should be aware of the following:
- UCOP has circulated a draft university policy on DURC-PEPP research, for system review. If you have comments, please submit them to RPAC@ucop.edu by Monday, March 17th.
- PIs and UCSB will be responsible for identifying proposals that could potentially be considered DURC or involve enhanced PEPPs.
- Researchers who work with “select agents” or agents/toxins listed in Appendix C of the implementation guidance should familiarize themselves with the government policy.
- The scope of review is expanded to include risk group 2/biosafety level 2 agents and even permissible amounts of biological toxins.
- Any new requirements are in addition to existing biosafety and export control policies and procedures.
- Any research activity reasonably anticipated to fall within the scope of the policy, regardless of funding source, is subject to the new requirements.
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When Researchers Use Their Own Students for Human Subjects Research
Over the past few years, the IRB has also seen an increase in human subjects protocols where researchers are looking to recruit subjects from their own classes. While this can be common practice in academic settings (particularly in Psychology, Communications, and Education classes), there are significant ethical concerns relating to power dynamics, informed consent, and perceived coercion that researchers must address before commencing their studies. It is important to keep in mind that instructors should only recruit their own students as research subjects if it is necessary for the study, not because it is a convenient option.
Our Human Subjects FAQs has a section on this topic, titled, “What should be considered when using one’s own students or any participant who has a lower position of power, or personal relationship, with the PIs or senior members of the research team as subjects?” To briefly summarize, when students are used as research subjects, there is an inherent power imbalance between the students and their instructor, which can lead to students feeling pressured to participate. To address this, the IRB takes special notice of these protocols where Principal Investigators are proposing to use their own students or lab members in research.
If it is necessary for an instructor to use their own students due to the nature of their research, then there are safeguards that can be put into place. Researchers can incorporate third-party recruitment and data collection by bringing in someone who is not affiliated with the study to complete these tasks. Additionally, instructors can state in their consent forms that they will not have knowledge of which students choose to participate in the study until after grades are submitted, in the instance that they need to identify participating students for the purpose of awarding extra credit (another issue to keep in mind in this scenario is that PIs must also provide an equivalent non-research alternative for students to earn the same amount of extra credit).
Importantly, instructors must ensure their research does not interfere with students' learning opportunities, and that the research is closely aligned to the subject matter of the class. The informed consent process must include language stating that participation is voluntary and optional, and that whether a student chooses to participate or not will not affect their standing in the course or with UCSB in any way. Finally, for studies recruiting students from the PI's own course, approval from the Department Chair may be required.
These considerations can help to ensure that students in the PI’s classes are being recruited because they are the best, or only, source for the research data, and not because they are a captive audience for the instructor. If researchers have questions about specific studies or scenarios, they can always email HSC staff at hsc@research.ucsb.edu.
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When to Submit a Modification for a Human Subjects Research Protocol
As a research project progresses, there may be circumstances that require researchers to submit a “modification” to their approved protocol. It can be hard for PIs to know when to submit a modification, versus when any changes they are making do not rise to the level requiring a formal modification. The HSC website has an FAQ on this subject titled, “Modify or Renew a Project”, but it is helpful to expand on that information here.
Generally speaking, the following scenarios require researchers to submit a modification: changes to the research design (e.g., new interventions, alterations to procedures, changing the eligibility criteria for participants), adding or removing research personnel, adding study materials (such as new surveys, activities, or recruitment methods), changes in data collection or analysis (e.g., different types of data being collected, changing the final disposition of participant data), changes in the risk level of a study, or changes to approved consent forms.
A modification may not be needed in instances where the changes do not affect the overall research design, methodology, risk level, or participant involvement. For instance, making minor edits to survey or interview questions in a way that does not affect the overall topic or purpose of a study may not require a modification. Or changing the design of a recruitment tool, like a flyer, without changing the content of the flyer, may not require a modification.
In terms of logistics, a modification must always be submitted before any changes are implemented by the researcher, as these types of adjustments can have implications for participant safety, confidentiality, and informed consent processes. When a researcher is ready to submit a modification, our ORahs Tutorial website has step-by-step instructions for how to do so. If questions arise that are not addressed by the tutorial, researchers can contact HSC staff at hsc@research.ucsb.edu.
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Upcoming Events
Interested in hosting a human subjects webinar for your department, class, or research team? We can present on a variety of topics from recruitment to informed consent. Contact us at hsc@research.ucsb.edu to schedule a webinar today!
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