Non-Engagement in Research

Nonengaged Recruitment refers to recruitment which occurs from an external entity requesting that IRB-approved protocols from external institutions be forwarded by a UMassD entity to potential participants at UMassD.

These recruitment activities do not require IRB approval under the following conditions:

• Intent: The primary intent of nonengaged recruitment is to facilitate access to research opportunities for potential participants without involving the UMassD entity in the research process. By forwarding information about research studies, the nonengaged recruitment process contributes allows diverse potential participants to be informed about research opportunities, promoting inclusivity and broadening the participant pool and to the generation of generalizable knowledge.
• Informing Prospective Subjects: The nonengaged individual will communicate the availability of the research to potential participants, ensuring they are aware of the study’s existence.
• Providing Information: The nonengaged individual will provide relevant research information, which may include a copy of the informed consent document or other IRB-approved materials, and details on how to contact study investigators for additional information or to express interest in participation. Most importantly, the nonengaged individual will not answer study-specific questions, obtain consent, nor conduct research procedures, nor act as a representative of the research team.
• Seeking Permission for Contact: The nonengaged individual may seek permission from prospective subjects for investigators to reach out to them.

In this non-engaged capacity, the actions are restricted to the aforementioned activities, and there is no involvement in any substantive research tasks or decision-making processes. Once confirmation of understanding and agreement to these terms is received by the IRB, the IRB will issue a letter of non-engagement.

However, IRB approval is required if:

• Direct Involvement in Recruitment Procedures: If the UMassD entity is actively involved in the recruitment process beyond simply forwarding information, such as directly contacting potential participants or engaging in the consent process.
• Sensitive or High-Risk Research: If the research involves sensitive topics or high-risk procedures that could potentially affect the safety, well-being, or privacy of participants, IRB review is needed to ensure that appropriate safeguards are in place.
• Engagement in Study Procedures: If the UMassD entity or its members are directly involved in any research procedures, data collection, or interactions with participants, IRB approval is required to ensure that all ethical and regulatory requirements are met.
• Data Handling and Confidentiality: If the UMassD entity handles or processes any data collected from participants, especially if it includes identifiable or sensitive information, IRB review is needed to ensure that privacy and confidentiality measures are appropriately addressed.
• Informed Consent Management: If the UMassD entity is responsible for obtaining or managing informed consent from participants, IRB approval is required to ensure that the consent process adheres to regulatory and ethical standards.
• Unclear or Complex Protocols: If there is any ambiguity about the role of the UMassD entity or if the recruitment involves complex or unique aspects not covered by the general nonengaged recruitment guidelines, IRB review is needed to clarify responsibilities and ensure compliance.

The IRB will review the submitted details about the recruitment process and involvement to understand the investigator's roles. Researchers or UMassD entities must provide a detailed description of the recruitment activities, any data handling procedures, and the role of the UMassD entity in the study. If the UMassD entity is involved in research tasks or decision-making processes, the IRB will assess whether the recruitment activities to ensure compliance with ethical and regulatory standards. If necessary, the IRB may request additional information or modifications before granting approval. Note, this procedure may require the establishment of a reliance agreement.

Educational Research encompasses systematic investigations aimed at understanding and improving teaching methods, instructional strategies, curriculum development, and student outcomes. Educational Research is designed to enhance educational practices and outcomes. It can involve various methods and approaches, including both localized studies and broader investigations. This type of research can be conducted by educators or researchers and may vary in scope and intent. It generally falls into two main categories: Action Research and Pedagogical Research. Educational Research must adhere to ethical boundaries set forth for human research, similar to other social and behavioral research, and may need IRB approval.

Action Research: Involves systematic inquiries conducted by educators within their own practice to address immediate issues and improve teaching methods. It is often focused on specific educational settings with the goal of refining practices directly within that context.

• Context-Specific Inquiry: Conducted within the educator’s own classroom or educational environment.
• Local Impact: Aims to directly address and improve immediate issues and practices.
• IRB Oversight: May not require IRB approval if it does not involve generalizable knowledge or broader dissemination and focuses on practical improvements within the specific setting.

Pedagogical Research: Involves systematic investigations aimed at understanding and improving educational practices on a broader scale. It often contributes to educational theories and practices that extend beyond the specific context.

• Broader Scope: Includes studies that aim to generalize findings and contribute to wider educational knowledge.
• Generalizable Knowledge: Seeks to develop or refine theories or practices applicable beyond the immediate setting.
• IRB Oversight: Generally, requires IRB approval if the research involves generalizable knowledge, publication, or public dissemination.

Educational Research does not require IRB approval under the following conditions:

• Intent: The primary goal is to improve teaching practices and student learning within the educational setting.
• Professional Benefit: The research is conducted to enhance the educator’s own practice rather than for professional advancement or career benefits.
• Generalizable Knowledge: The research is not designed to contribute to generalizable knowledge or scientific theories; instead, it focuses on immediate improvements in the specific educational context.
• Mandate: The research is typically conducted as part of the educator’s personal initiative rather than an institutional or funder’s mandate.
• Impact: Findings are intended to directly influence and enhance teaching methods and learning outcomes within the specific educational setting.
• Inclusivity: The research may involve all students within the classroom or educational setting to address broad teaching issues.
• Direct Benefit: The primary benefit is to improve the educator’s practice and student outcomes rather than providing direct benefits to participants.
• Dissemination: Results are usually shared within the educational institution or with other educators but are not intended for broader publication or presentation outside the educational context.

Once IRB confirms the project meets the above conditions, the IRB will issue a confirmation that IRB oversight is not required.

Educational Research studies require IRB approval if it involves:

• Human Subjects: Direct interaction or observation of students or educators, including interviews, surveys, or focus groups.
• Data Collection for Generalizable Knowledge: Studies intended to generalize findings beyond the specific context or institution.
• Potential Risks: Research involving sensitive topics or potential psychological, emotional, or social risks.
• Dissemination Plans: Research intended for dissertation, publication, presentation at conferences, or broader dissemination.

Classroom Projects are educational inquiry activities conducted solely to fulfill a course requirement that lacks the intent to develop or contribute to generalizable knowledge and does not involve the public dissemination of findings. For more information, see IRB Guidance on Classroom Projects.

Classroom Projects do not require IRB approval under the following conditions:

• Intent: The primary goal is to educate individual students through inquiry or experiential approaches to discover known principles or phenomena.
• Professional Benefit: The project is designed to meet educational requirements, not for the professional benefit of the instructor or students conducting it.
• Generalizable Knowledge: Classroom projects are not designed to develop or contribute to generalizable knowledge and typically do not involve the randomization of different practices or processes.
• Institutional Mandate: The activity is part of the coursework mandated by the educational institution.
• Impact: The findings are used only within the classroom context to meet educational objectives.
• Inclusivity: Data collected is intended to be used only within the classroom context, and data from all or most students participating in the project is expected to be included. Data will be destroyed upon completion of the course.
• Direct Benefit: Participants (students) benefit directly from the educational experience and skills gained through the project.
• Dissemination: Data gathered may be shared only with the course instructor, faculty advisor, or, in the case of an internship/practicum, the collaborating party. The intent to publish or present the findings beyond the classroom context is generally not presumed. When dissemination occurs, it is to demonstrate the educational process rather than to contribute to generalizable knowledge.
• Exclusions: The following are not considered classroom projects and may require IRB approval: Doctoral dissertations, master’s and honors theses, funded research, or research conducted via external entities

Once IRB confirms the project meets the above conditions, the IRB will issue a confirmation that IRB oversight is not required.

 Classroom Projects require IRB approval if:

• Research Intent: If the project aims to develop or contribute to generalizable knowledge or to influence broader practices beyond the educational context, it requires IRB approval.
• Study Design: If the project involves systematic investigation or experimentation that includes randomization, manipulation of variables, or significant risk to participants, IRB review is necessary.
• Public Dissemination: If there is an intent to publish or present the findings to a broader audience beyond the classroom or educational setting, it may necessitate IRB approval.
• Sensitive Information: If the project involves collecting sensitive or identifiable information about participants, the project requires IRB review to ensure adequate privacy protections are in place.
• External Funding: If the project is funded or sponsored by external entities, it may require IRB review, regardless of its educational context.
• Potential Risks: If the project introduces potential risks or harm to participants beyond the scope of typical classroom activities, IRB approval is required to assess and mitigate these risks.

Program/Service Evaluation/Assessment/Reporting refers to a systematic method for collecting, analyzing, and using information to answer specific questions about the effectiveness and efficiency of projects, policies, programs, or services. The primary purpose is to assess whether the program/service is achieving its intended goals and to measure the current situation regarding a specific phenomenon or set of factors. These evaluations are typically used for internal decision-making or informational purposes and data may be shared only with the sponsor/client/requesting party and, where appropriate, the faculty advisor.

These activities typically do not require IRB approval under the following conditions:

• Intent: The primary goal is to improve a specific program or service.
• Professional Benefit: The project is not initiated by the evaluator and occurs regardless of whether the individual(s) conducting it may benefit professionally.
• Generalizable Knowledge: Program evaluations are not designed to develop or contribute to generalizable knowledge and do not involve randomization of individuals, though they may involve comparisons of variations in programs.
• Institutional Mandate: The activity is mandated by the program or its funder as part of its operations.
• Impact: Findings are expected to directly affect the conduct of the program and identify needed improvements.
• Inclusivity: Information on all or most participants within or affected by receiving a particular treatment or undergoing a particular practice or process is expected to be used. Exclusion of information from some individuals significantly affects conclusions.
• Direct Benefit: No direct benefit to participants is expected; the evaluation focuses on program improvements or determining whether the program should continue.
• Dissemination: The intent to publish or present is generally presumed at the outset of the project. Dissemination of information is to program stakeholders and participants and may be publicly posted (e.g., on a website) to ensure transparency of results. When published or presented to a wider audience, the intent is to suggest potentially effective models, strategies, and assessment tools, or provide benchmarks or base rates, rather than to develop or contribute to generalizable knowledge.

Once IRB confirms the project meets the above conditions, the IRB will issue a confirmation that IRB oversight is not required.

Program/Service Evaluation/Assessment/Reporting require IRB approval if:

• Intent to Contribute to Generalizable Knowledge: If the evaluation is designed to develop or contribute to generalizable knowledge, such as through systematic research methods, comparisons, or statistical analyses intended for publication or presentation beyond the specific program or service context.
• Involvement of Vulnerable Populations: If the evaluation involves vulnerable populations, such as children, prisoners, or individuals with cognitive impairments, and includes procedures that might pose risks to these groups.
• Informed Consent: If the evaluation involves collecting data where participants are directly asked for their consent to participate in research activities or where their data is used in ways that might not align with standard program/service evaluation practices.
• Risk of Harm: If there is a risk of harm to participants beyond the typical scope of program/service evaluation, including sensitive or personal data that could impact participants' well-being or privacy.
• Use of Deception: If the evaluation involves deception or withholding of information that might impact participants’ willingness to participate or their understanding of the study.

Quality Improvement (QI) Projects refer to a systematic pattern of actions aimed at constantly optimizing productivity, communication, and value within an organization to measure the attributes, properties, and characteristics of a product or service in the context of the expectations and needs of customers and users. QI projects are designed to improve the quality of a service, program, or process within a specific institution.

QI Projects do not require IRB approval under the following conditions:

• Intent: The primary goal is to improve a practice or process within a particular institution or ensure it conforms with expected norms.
• Professional Benefit: The project occurs regardless of whether the individual(s) conducting it may benefit professionally.
• Generalizable Knowledge: QI projects are not designed to develop or contribute to generalizable knowledge and generally do not involve the randomization to different practices or processes.
• Institutional Mandate: The activity is mandated by the institution or clinic as part of its operations.
• Impact: Findings are expected to directly affect institutional practice and identify corrective actions needed.
• Inclusivity: Information on all or most individuals receiving a particular treatment or undergoing a particular practice or process is expected to be included. Exclusion of information from some individuals significantly affects conclusions.
• Direct Benefit: Participants are expected to benefit directly from the activities.
• Dissemination: The intent to publish or present is generally not presumed at the outset of the project. Dissemination of information often does not occur beyond the institution's evaluated, although it may occur in quality improvement publications or forums. When published or presented to a wider audience, the intent is to suggest potentially effective models, strategies, and assessment tools, or provide benchmarks or base rates, rather than to develop or contribute to generalizable knowledge.

Once IRB confirms the project meets the above conditions, the IRB will issue a confirmation that IRB oversight is not required.

QI Projects require IRB approval if:

• Research Intent: If the QI project is designed to generate generalizable knowledge or contribute to scientific literature beyond improving internal practices, it requires IRB approval.
• Study Design: If the project involves randomization of participants, experimental interventions, or manipulation of variables that could affect participants’ well-being or rights, it must undergo IRB review.
• Involvement of Sensitive Information: If the QI project collects, uses, or discloses sensitive or identifiable information that could impact participants’ privacy, the project requires IRB review to ensure adequate protections are in place.
• Human Subjects Involvement: If the project involves human subjects in a way that goes beyond routine clinical or operational practices, such as interacting with participants or obtaining informed consent, IRB approval is necessary.
• Potential Risk to Participants: If the project introduces potential risks or harm to participants that are not typical of standard practices or procedures, IRB review is required to assess and mitigate these risks.
• Dissemination of Results: If the results of the QI project are intended for widespread dissemination or publication in a manner that aims to influence broader practices or contribute to scientific knowledge, IRB approval is necessary.

Social media research involves using any online and mobile resource for generating, sharing, or discussing ideas and content. This includes various platforms such as online communities (e.g., patient support groups), social networking sites (e.g., Facebook, Twitter), professional networking sites (e.g., LinkedIn), content production and sharing sites (e.g., YouTube, Tumblr), and location-based services (e.g., Tinder, Grindr). Research utilizing social media (e.g., public Twitter feeds, public Facebook profiles, information from public forums) is generally not considered Human Subjects Research as defined by federal regulations as long as there is no interaction or intervention with the individuals about whom data are being collected. 

Social Media Research does not require IRB approval under the following conditions:

1. Privacy and Reporting: The proposal ensures to avoid quoting social media posts verbatim if not from public figures to prevent easy identification through search engines. Removes all private information about individuals when reporting findings.
2. Publicly Available Data: Social media posts intended for public engagement are considered publicly available data. However, the proposal is mindful of the potential for reputational harm and the privacy of third parties mentioned in posts.
3. No Human Interaction: The research involves no direct interaction with any individuals.

If needed, submit an IRB application to seek formal confirmation of non-human participant research status for the study. The IRB office may require a protocol submission depending on the study's nature.

Social Media Research requires IRB approval if:

1. Interaction or Intervention: If the research involves interacting with individuals through social media or intervening in any way, it requires IRB approval.
2. Sensitive or Private Information: If the research involves data that is not truly public or if there is a risk of identifying individuals through data analysis, IRB oversight is necessary.
3. Potential Harm or Reputational Risk: If the research could cause reputational harm or affect the privacy of individuals mentioned in the data, IRB approval is required.
4. Ethical Concerns: If the research raises ethical concerns about privacy, consent, or potential harm, it should be reviewed by the IRB.

Secondary data analysis of publicly available data is a common research method. Increasingly, federal agencies supporting research require investigators to make the data they collect publicly available. Additionally, many professional organizations and journals require that research datasets of published works be made accessible to encourage scholarly interpretation and replication of research. Data are not considered publicly available if access to the data is limited. Public Use Datasets are datasets prepared by investigators or data suppliers with the intent of making them available for public use. The data available to the public are not individually identified or maintained in a readily identifiable form.

All public-use de-identified data sets that are accessible from the sources listed below have been deemed acceptable for use in research.  A public-use dataset is considered as a de-identified dataset that can be freely downloaded (or may require a short application to request access to the data) but does not require for UMassD to enter into a formal written agreement with the provider of the data. Under the federal regulations for human subjects (45 CFR Part 46), research involving publicly available data sets would not require IRB review – no application is required– as long as:

• the data come from sources that are publicly available, and
• the data is deidentified and uncoded and stripped of identifiers.

Restricted use data are not publicly available and are defined as files distributed by federal agencies, repositories, and research organizations upon which use restrictions are imposed. These files are usually, but not always, accompanied by a data use/transfer agreement, data access agreement, or user terms and conditions that detail restrictions on use of the data. The restrictions vary, but they typically involve secure data storage, encryption, password protected computers, access limitations or destruction parameters.

Data Analysis of Publicly Available Data Sets do not require IRB approval under the following conditions:

• The data set(s) is (are) published and publicly available without restriction (e.g., data are published by a reputable source in a publicly available journal, textbook or website) and neither the researcher nor any collaborating researcher on the project(s) has access to links that would connect the data to the individuals from whom they were derived.
• The data set(s) are publicly available to researchers and others, but the data holder requires a “responsible use statement” or similar attestation to ensure appropriate use and protection of the data. Such an agreement or attestation may be automated. In this case, neither the researcher nor any collaborating researcher on the project can have access to any links that would connect the data to the individuals from whom they were derived, nor may any researcher on the project attempt to re-identify any person from whom the data were derived. 
• The researcher will obtain a data set available from a Federal or State agency and will enter into an agreement with the data provider that includes language that: a) the data provided to the researcher does not contain any identifiers, including those specified under the HIPAA Privacy Rule; b) if the data are coded, the data provider will not release a link to the code to the researcher; and c) the researcher receiving the data set must agree to not attempt to re-identify any person from whom the data were derived.
• In all cases, the IRB expects that investigators have reviewed the data sources’ terms of service, responsible use statements, and data access agreements, if any. Questions about compliance with such terms should be directed to the IRB.research@umassd.edu.

Once IRB confirms the project meets the above conditions, the IRB will issue a confirmation that IRB oversight is not required.

Examples of Non-Public Data:

• Data in the electronic medical record.
• Social media data labeled as "private" by the data owner, or not readily available without permission of the site Owner/Administrator under the Terms of Service of the site. 
• Data protected by Copyright, data use agreement, terms of use agreement, etc.; and 
• Data or biospecimens that have access restrictions [e.g. are only available to clinicians or qualified researchers or may only be accessed on a secure server].

Public Use Data Sets require IRB Approval if any of the following are met:

1. Re-identifiable Data: If the data originally contained identifiers and the data has not been fully de-identified or if there is a risk that the data could potentially be re-identified.
2. Restricted Use Data: If the data comes from restricted-use data sets, which require a data use or transfer agreement detailing restrictions on use, such as secure storage, encryption, or access limitations.
3. Merging Data Sets: If the research involves merging public use data sets with identifiable or potentially identifiable data.
4. Non-Public Data Integration: If the research involves secondary analysis of non-public data sets that require agreements for procurement or use, including interaction or intervention with human subjects.
5. Enhanced Analysis: If the research involves enhancing a public use data set with additional identifiable information or if it is not clear whether the data meets the criteria for public use.
6. Data Triangulation: If the information or data that will be collected can be used together or triangulated in a way where a participant can be identified, prior to initiating data collection. This includes scenarios where combining multiple data sources might lead to the identification of individuals.

Investigator Responsibility:

1. No IRB Approval Needed: PIs whose research project only involves secondary analysis of publicly available data from public data sets/repositories which do not require an agreement do not need to obtain IRB approval or determination of exemption before access to the data and do not need to seek approval nor submit an application to, the IRB.
2. Notification for Inclusion: PIs whose research project only involves secondary analysis of public use data from a data set which is not identified may notify the IRB to have the data set included in UMassD’s list.
3. IRB Application Required: PIs whose research project involves secondary analysis of public use data from one or more of the public data sets/repositories, data from a non-public data (requires an agreement to procure), and/or interaction or intervention with human subjects must submit an application to the IRB for review and approval of exemption request. PIs who intend to merge public use data sets or enhance one with identifiable or potentially identifiable data must apply for IRB review and approval of exemption request.
4. Compliance with Agreements: PIs must abide by the conditions of any applicable data use agreements governing the data to be accessed. If use of data is directed by the terms of a data use agreement that requires IRB review of research that may not meet the federal definition of human subjects research, the PI must submit an application for IRB review and approval.

IRB Responsibility:

1. The IRB will assess whether any identifiers or surrogates for identifiers remain, and if statistical methods or data summarization are necessary to ensure anonymity. The reviewer will consider the following factors when reviewing public use data set registration requests for data originally collected with identifiers:
   1. removal of any identifiers of a human subject or persons named by a human subject.
   2. removal of any variables that by definition would serve as surrogates for the identity of a human subject.
   3. collapse or combine categories of a variable to remove the possibility of identification due to a human subject being in a small set of persons with specific attributes regarding a variable (e.g., due to the infrequency of subjects in a lower or upper range).
   4. collapse or combine variables to provide summary measures to mask what otherwise would be identifiable information.
   5. use of statistical methods, where necessary, to add random variation with variables otherwise impossible to mask; and
   6. removal of any variables that could be linked to identifiers by secondary users.
   7. The IRB will then provide written notification of the results of the review of the public use data set registration request to investigators.

For a list of available public data sets, please see Resources Appendix: Available Public Datasets.

Secondary data analysis involves the re-examination of existing data originally collected for other purposes. UMass Dartmouth requires researchers to determine whether their use of secondary data constitutes human subjects research and may require IRB review.

Secondary Data Analysis Does Not Require IRB Review Under the Following Conditions:

• Publicly Available Data: The data is from publicly accessible sources, such as government databases, public records, or open-access datasets. Anyone can access the data without restrictions.
• De-identified Data: The data has been fully de-identified, with all direct and indirect identifiers removed, making re-identification of individuals impossible.
• Anonymous Data Collection: The data was collected anonymously, meaning no identifiers were attached to individuals at the time of data collection, and the dataset was designed to be completely anonymous.
• Non-Human Subjects Determination: The data does not involve living individuals or identifiable private information as defined by the Common Rule, meaning it does not meet the regulatory definition of human subjects research.

Caveat: UMass Dartmouth does not participate in the use of broad consent for secondary research. Therefore, researchers cannot rely on broad consent as a basis for exemption and must follow other applicable criteria. Once the IRB confirms secondary data analysis meets these conditions, it will issue a determination that IRB oversight is not required.

Secondary Data Analysis Requires IRB Review If:

• Identifiable Private Information: The data contains identifiable private information, such as names, dates, or other direct identifiers that can link the data to individuals.
• Coded Data with Re-identification Potential: If coded data can be linked back to individuals through a key accessible to the researcher, IRB review is required.
• Incomplete De-identification: The data is not fully de-identified, meaning there is still a possibility of linking it to individuals, particularly if indirect identifiers or unique combinations of variables are present.
• Original Consent Limitations: The original consent form did not authorize the use of the data for secondary analysis, or the new research falls outside the scope of the consent, requiring IRB review to ensure ethical compliance.
• Sensitive or Vulnerable Populations: Even with de-identified data, if the research involves vulnerable populations such as children, prisoners, or adults with decisional impairment, IRB review may be required to ensure protections are in place.
• International or Sensitive Data: For data obtained from international sources or involving sensitive topics, researchers must confirm adherence to local ethical standards, and IRB oversight may be necessary.

If the secondary data analysis meets any of these criteria, IRB approval is required to proceed. For additional information about honest brokers used for de-identification see section on Honest Broker.