Protocol Specific Considerations

Crowdsourcing refers to the practice of obtaining input, ideas, or content by soliciting contributions from a large group of people, typically via an online platform. Crowdsourcing platforms enable researchers to connect with a diverse, often global, participant pool for data collection.

Examples of Crowdsourcing Platforms:

Several crowdsourcing platforms are commonly used in academic research:

• Amazon Mechanical Turk (MTurk): A popular platform offering access to a large, diverse pool of participants for various tasks and surveys.
• Prolific: A platform focused on academic research, providing high-quality data from a pre-screened participant pool.
• CrowdFlower (now Figure Eight): Offers a large-scale workforce for data labeling, classification, and other tasks.
• Clickworker: Provides a platform for microtasks, including data categorization, content creation, and surveys.
• Appen: Specializes in tasks related to AI and machine learning, including data annotation and linguistic data collection.

How Are Academic Researchers Using Crowdsourcing Platforms?

Researchers use crowdsourcing platforms to recruit participants for surveys, experiments, and various research tasks. These platforms facilitate quick and cost-effective recruitment, often providing access to a more diverse participant pool than traditional methods. Researchers post tasks or surveys, specifying the details such as task description, compensation, and estimated completion time.

What Do Academic Researchers Need to Consider When Submitting a Crowdsourcing Study to the IRB?

• Recruitment: The task or survey title and description on the crowdsourcing platform serve as recruitment materials and must be included in the IRB application.
• Compensation and Timing: Specify the amount of compensation and the expected time for processing payments. Inform participants about any delay in payment.
• Task Requirements: Detail any software or technical requirements necessary to complete the task (e.g., specific browsers or software). If there is a screening process, clarify whether participants are paid for screening and how qualifications are assessed.
• Task Details: Describe the nature of the task (e.g., writing, video watching) and its requirements. Higher compensation may be necessary for tasks requiring more effort.
• Researcher Information: Include the researcher's name and institutional affiliation in the task description.

IRB Considerations:
When submitting a crowdsourcing study to the IRB, researchers should:

• Include Platform Details: Provide information about the crowdsourcing platform and how it will be used for recruitment and data collection.
• Detail Recruitment Materials: Submit the task or survey description, including compensation and any specific requirements or qualifications.
• Describe Data Management: Outline how participant data will be handled, including any steps taken to ensure confidentiality and security.
• Address Consent and Debriefing: Ensure that the consent process is clear and that any debriefing procedures are well-defined.
• Consider Participant Impact: Evaluate any potential risks to participants and ensure that appropriate measures are in place to mitigate these risks.

Community-Based Participatory Research (CBPR) is a collaborative research approach that emphasizes equitable involvement of community members throughout the research process, from design to dissemination. In CBPR, community members and researchers work as partners, combining knowledge and action to address community-defined issues and improve well-being. By integrating education and social action, CBPR strives to achieve positive outcomes both within the community and in the broader knowledge base. CBPR requires attention to ethical considerations, mutual respect, and flexibility. Researchers must ensure the protocol reflects community needs, includes input from community partners, and promotes long-term collaboration. Below are key elements to consider in protocol development.

Elements to Consider in Protocol Development

• Community Partnership and Engagement: Engage community stakeholders as co-investigators from the beginning, ensuring their active role in shaping the research topic, design, data analysis, and dissemination. Maintain balanced decision-making between researchers and community members. Provide ongoing feedback and adjust approaches based on community insights.
• Community Consultation and Risk Minimization: Identify and address potential risks to both individuals and the community (e.g., privacy, cultural sensitivity, literacy issues) in consultation with community members. Establish safeguards tailored to community norms and values, ensuring the research respects community-specific concerns.
• Local Oversight and Ethical Review: Determine if local ethical oversight is needed, such as from a community advisory board, tribal council, or local ethics committee.
• Data Ownership, Sharing, and Confidentiality: Develop clear agreements on data ownership, access, and sharing to protect community interests and privacy.
• Disclosure of Research Findings and Potential Impact: Collaborate with the community to determine how research findings will be shared, addressing any potential group harms or sensitive interpretations. Ensure findings are disseminated in ways that benefit the community and minimize any unintended consequences.
• Community Benefit and Long-Term Relationship Building: Design studies that deliver tangible benefits to the community, such as through program implementation or resource development. Establish plans for sustained partnerships beyond the research period, fostering trust and continued collaboration.
• Flexibility and Responsiveness: Allow for adjustments in procedures and data collection tools based on community feedback and evolving needs in the field.

 IRB Considerations:

• Evidence of an equitable and collaborative partnership with the community.
• Defined roles and responsibilities for both academic and community partners.
• Letters of support from community stakeholders.
• Detailed plans for community engagement and benefit.
• Appropriate funding distribution and training opportunities for all involved.
• Strategies for positive, long-term community impact and relationship building.

Internet-based research involves using the internet to collect data through online tools, studying online behaviors, or using online datasets. While offering powerful capabilities for data collection, analysis, and transmission, it also presents unique risks such as privacy ambiguities, data security concerns, and challenges with obtaining signed informed consent. All human subjects research utilizing the internet must be submitted for IRB review.

Types of Internet-Based Research

• Online Surveys: Using platforms like Qualtrics, Survey Monkey, Google Forms, etc., to gather data.
• Behavioral Studies: Examining how people use the internet by collecting and analyzing online activity data.
• Online Data Use: Utilizing datasets, databases, and repositories available on the internet.
• Crowdsourcing for Research: Using platforms like MTurk, Prolific, CrowdFlower, Clickworker, Appen, etc to recruit participants and perform tasks via an online pool.

Common Concerns in Internet Research

• Lack of anonymity
• Privacy ambiguities
• Data security
• Participant authentication
• Data Destruction
• Server/cloud storage

Preparing Your IRB Submission for Internet Research

1. Recruitment:

• Include the title and description of the study in your application.
• Clearly state the compensation, time required, and any qualification screeners.
• Specify any software requirements and the type of tasks involved.
• List the researcher’s name and affiliation.
• Include a link to the online survey if applicable.

2. Consent:

• The first page of the survey should be the consent document, with "I Agree" and "I Do Not Agree" options. The "I Agree" option leads to the survey; the "I Do Not Agree" option exits the survey.
• Address how participants will be informed about the study and any risks involved.

3. Debriefing:

• If using deception or incomplete disclosure, include a debriefing form at the end of the survey.
• The debriefing form should explain the study's true purpose, and how participants were deceived, and offer participants the option to withdraw their data.
• For particularly sensitive topics, ensure all participants, including those who exit early, receive the debriefing form. State in the consent form that participants may be contacted through the online survey platform for debriefing.

4. Confidentiality:

• Anonymity cannot be guaranteed in online research environments. Avoid collecting personally identifiable information unless necessary. If participant IDs are collected, ensure they are kept confidential, not linked to survey data, and deleted after use. Protect participant identities and data by avoiding the collection of unnecessary identifiers, ensuring secure data handling, and understanding the platform's TOS regarding data use and protection.
• Ensure worker IDs are kept confidential, not linked to survey data, and deleted after use.
• Review the Terms of Service (TOS) of the online survey platform and software for policies on data collection, tracking, and third-party data sales to understand how participant data is managed and protected. Develop a protocol for handling data breaches and coordinate with IT to ensure data security. Communicate these measures to participants through the consent process.
• Have a protocol in place for data breaches, possibly in consultation with IT, and communicate this in the consent form.

When it comes to international research, IRB concerns and considerations typically include:

1. Cultural Sensitivity: Being aware of and respecting cultural norms and practices of the participants, local communities, and stakeholders. This includes understanding how cultural differences might impact consent processes and the interpretation of risks and benefits and ensuring that research benefits are shared and that local perspectives are considered, as applicable.
2. Local Standards: Ensuring that research adheres to both the laws and ethical guidelines of the host country, as well as international ethical standards like those from the Declaration of Helsinki. This includes following local data protection and privacy laws and obtaining a letter from a local ethical oversight body granting permission to conduct research in the host country. It also involves implementing mechanisms for ongoing monitoring and oversight that account for both local and international standards.
3. Informed Consent: Ensuring the consent process is culturally appropriate and that participants fully understand the research and its implications. This may involve translating consent forms and providing appropriate consent procedures.
4. Risk Assessment: Evaluating potential risks and benefits in the context of the local setting. This includes considering how what is deemed minimal risk in one country might differ in another and addressing issues related to the vulnerability of participants, such as economic or social disadvantages that might be more pronounced in some regions.

Studies planning to conduct human subject research internationally should complete the International Research Checklist and obtain a letter of cultural appropriateness. For more information, see IRB Guidance on International Research Involving Human Participants.

The IRB supports research aimed at understanding and addressing sensitive and impactful topics, such as self-harm, suicidal ideation, homicidal ideation, abuse, substance misuse, eating disorders, sexual victimization, and violence. Recognizing the importance of these research efforts, the IRB also emphasizes the need to protect participant welfare, particularly for vulnerable populations. This guidance provides comprehensive action plans for studies involving sensitive topics, with particular attention to researchers who may not be experts in these areas.

Action Plan:

If a study deals with sensitive topics, —such as substance/alcohol/child/elderly abuse, eating disorders, self-harm, suicidal ideation, or homicidal ideation— or uses tools and measures to assess depression, anxiety, trauma, and similar areas, subjects should be forewarned in the informed consent form that they will be asked questions on these topics. Subjects should also be given contact information for counseling services should they experience distress due to their participation. Studies that include prompts regarding self-harm, suicidal ideation, homicidal ideation, require an IRB-approved action plan to support participants at risk of imminent harm. Imminent risk is characterized by a heightened intent to cause harm, often indicated by frequent thoughts of suicide, a plan to carry out self-harm, or threats of violence towards others. Researchers need to determine and state if they are qualified to identify imminent risk in their proposal.  If PI is unsure or unqualified in identifying imminent risk, they are strongly encouraged to have a consultant who has expertise in suicidality, or suicidality research protocols, or have a licensed mental health professional involved during data collection.  

The action plan should address the following:

1. Prompt Review: Review responses to self-harm or suicidal ideation questions within 24 hours.
2. Identifying and Assisting High-Risk Participants:

• For Students: Immediate support (direct contact with students, consulting resources, calling emergency services, walking them to the CCPH, etc.).
• For Non-Students: Referral to mental health resources and emergency services, as necessary.
• Confidentiality: Inform participants in consent documents about confidentiality limits in cases of imminent risk.
• Follow-up: Depending on the nature of the study, it may be appropriate to also give subjects a separate handout at the conclusion of the study with a list of counseling services in case they experience any distress after completing the study.

Reportable Events:

Disclosures of suicidal intent, as well as questions or disclosures related to child and elderly abuse, may or may not be reportable depending on the study's aims and protocol. Specifically:

• Suicidal and Homicidal Intent:Disclosures of suicidal or homicidal intent should be evaluated in the context of the study’s focus. In studies specifically aimed at understanding suicidality, such disclosures may be managed according to the study’s protocol. In studies not focused on suicidality, any unexpected disclosures should be reported to the IRB.
• Abuse and Mandatory Reporting:Questions or disclosures involving child or elderly abuse must be assessed based on the study’s objectives. In studies not specifically targeting these issues, any unexpected disclosures should be reported to the IRB. Researchers are also reminded to comply with mandatory reporting laws applicable in their jurisdiction.

Researchers are responsible for determining the relevance of such disclosures to their study and ensuring that all reportable events are communicated to the IRB promptly.

Mental Health Guidance: For studies asking about issues such as depression, anxiety, trauma, etc.. but not specifically suicide, consider what responses will trigger concern. For moderate to severe depression, provide a list of resources. Inform consent forms should state that researchers are not clinicians and will not follow up on depression scores.

1. Assessment Tools: Tools measuring suicidal or homicidal ideation, and other relevant correlated symptoms (e.g., depression, hopelessness, forms of self-harm, eating disorders, etc..), must be carefully considered for their necessity in the research. Ensure that these tools are justified based on the research aims. Additionally, tools used for assessing potential child or elderly abuse should be evaluated for their relevance and appropriateness. Researchers should confirm that the use of these tools is aligned with the study’s objectives and complies with applicable reporting requirements and ethical guidelines.
2. Populations Involved: Higher-risk groups may need additional protection and cultural sensitivity training. Outline clear action plans for minors and ensure parental consent and child assent forms include information about suicide questions and action plans.
3. Actively Suicidal Populations: Consider consent capacity, access to firearms and other lethal means, and state laws on involuntary commitment.
4. Databases: Avoid collecting suicidal ideation data on subject pool screening forms that cannot be reviewed promptly.
5. Research Pre-planning: Plan for participant safety with additional monitoring, even though research shows asking about suicidality does not increase risk. Ensure non-anonymous surveys and interviews with suicide questions are reviewed within 24 hours, including weekends.
6. Technological Data Gathering: Test systems before deployment and regularly monitor them during the study.
7. NIH Considerations: NIH-funded studies may need additional staffing and data sharing plans.

1. Anonymous Surveys:

• Inform participants that responses are anonymous, and support cannot be provided.
• Provide a list of support services at the beginning (and optionally at the end) of the survey.
• Justify the benefits of asking suicide questions in anonymous surveys.

2. Identifiable Online Surveys:

• Inform consent that confidentiality may be broken if suicidal intent is disclosed.
• Review responses within 24 hours.
• Define imminent risk and outline the action plan in the protocol and consent document.

3. Non-Anonymous In-Person Surveys and Interviews:

• Inform consent that confidentiality may be broken if suicidal intent is disclosed.
• Review responses before the participant leaves.
• Define imminent risk and outline the action plan in the protocol and consent document.
• For imminent risk, ensure participants receive official support services immediately.

If you wish to record subjects, please refer to IRB Guidance on Recording.

The International Affective Picture System (IAPS) contains images designed to evoke emotional responses, categorized as pleasant, neutral, or unpleasant. Research involving these images requires careful consideration of potential psychological impacts, particularly with unpleasant images. 

General Requirements for All IAPS Research

1. IRB Review: All protocols involving unpleasant IAPS images must be submitted for full board review. Ensure to provide a thorough justification for using unpleasant images, including the specific research goals or insights they are intended to achieve.
2. Consent Form Statement:Include the following in the consent form:“If you decide to take part in this study, you will be asked to view a variety of pictures categorized as pleasant, neutral, or unpleasant. If any of the media presented makes you feel too uncomfortable to continue, you are free to withdraw from the study at any time without losing credit or payment. The images may include descriptions such as [insert specific description here]. You may end your participation at any time if any aspect of the research makes you uncomfortable. If you experience discomfort or have concerns after viewing the images, please contact the principal investigator at [insert contact information] or reach out to [list psychological services with contact information].”
3. Protocol Requirement:

• Ethical Justification: Emphasize the ethical considerations and justifications for using potentially distressing images, ensuring that the research aims and benefits outweigh the risks.
• Detailed Description: Provide a detailed description of the nature of the images, including representative samples. Attach an information sheet that explains the content and potential emotional impact of the images to all personnel involved in the study. Include specific examples of the types of images being used and how they are categorized (pleasant, neutral, unpleasant).
• Image Distribution: Specify the percentage of pleasant, neutral, and unpleasant images shown. For example: “Subjects will view 25% pleasant, 50% neutral, and 25% unpleasant images.”
• Risk Management: Identify all potential risks associated with the use of unpleasant images. Describe the measures in place to minimize risks to participants, including psychological support and procedures for withdrawal.
• Anonymity: Ensure that any participant data remains anonymous, especially if the images are categorized as unpleasant and could potentially lead to emotional responses.
• Personnel Training: Explicitly describe how research personnel will be informed about the study and how their understanding of the nature of the images will be verified.
• Debriefing: Ensure all participants receive a debriefing.
  Emergency Contact: Include information on immediate support or emergency contact resources for participants who may experience distress during or after the study.

Research involving physical exercise introduces unique risks and safety concerns, particularly for participants with underlying health conditions. Investigators must carefully consider factors such as participant screening, the qualifications of the research team, data security, follow-up procedures, and emergency safety measures. This section outlines key elements that Principal Investigators (PIs) must address in their IRB proposals when conducting exercise-related research, ensuring participant safety and compliance with regulatory standards.

Training & Expertise of Researcher(s)
The experience and training of individuals conducting research involving exercise must be detailed in the IRB proposal. For studies involving physical activity, at least one certified CPR/First Aid professional must be present during all data collection sessions. Informed consent documents must outline these qualifications to ensure participants are aware of the safety precautions in place. Additionally, if the study involves specialized equipment (e.g., treadmills, heart monitors), the training of research personnel on the correct use and maintenance of such equipment must be provided in detail.

PIs should also specify the specific qualifications of the personnel in relation to the subject group (e.g., experience working with elderly participants, and clinical expertise in cardiovascular conditions). This helps ensure that the research team has the appropriate background for handling participants safely.

Screening for Appropriate Participation
Investigators must implement comprehensive screening procedures to identify cardiovascular, pulmonary, or metabolic risk factors, as these conditions present heightened risks in exercise testing. The screening process should minimally include:

• A detailed health questionnaire to assess personal and family history of cardiovascular, pulmonary, or metabolic conditions.
• Pulse measurement to detect abnormal heart rates.
• Blood pressure measurement to identify potential issues.

Subjects identified as high-risk must be treated with additional safeguards, and the IRB proposal must provide details on the screening procedures, any justification for deviations, and how high-risk subjects will be handled or excluded. If higher-risk participants are included, a robust risk assessment must accompany the proposal, outlining clear steps to mitigate adverse outcomes, such as enhanced medical oversight and safety monitoring. The informed consent process for higher-risk participants should include a comprehensive discussion of the risks, potential consequences of their health status, and the specific safeguards in place for their protection.

Inclusion/Exclusion Criteria
Based on the outcomes of the screening process, the IRB proposal should clearly define inclusion and exclusion criteria, explaining the rationale behind excluding certain individuals due to health risks. This ensures that only appropriate candidates, capable of safely participating in the study, are included. PIs should emphasize the justification for including higher-risk populations if applicable, detailing why these groups are necessary for the research and what additional safeguards will be implemented.

Appropriate Safeguards During Exercise Intervention
Researchers must provide a comprehensive safety plan tailored to the population and the exercise being tested. For high-risk subjects or intense exercise regimens, enhanced safeguards, such as physician oversight or immediate access to emergency medical care, may be required.

In the IRB proposal, PIs should include:

• Whether higher-risk subjects will be enrolled and, if so, a detailed risk assessment.
• Certification and experience of researchers in CPR/First Aid and other relevant qualifications, along with evidence of recent training updates.
• Details about emergency medical equipment on-site, such as defibrillators, oxygen tanks, and other necessary tools based on the type of exercise being performed.
• Clear plans for continuous monitoring of participants during exercise (e.g., heart rate, oxygen levels, signs of distress).
• Assessment of the local emergency response system, including the average response time and proximity to medical facilities.

Post-Exercise Follow-Up
For high-risk studies or strenuous exercise regimens, the IRB proposal should include a plan for post-exercise monitoring. This follow-up could involve checking participants’ vitals after the activity or scheduling follow-up visits to detect any delayed adverse effects such as muscle soreness, dizziness, or more serious conditions like cardiac issues. This ensures that participants are continuously protected even after the exercise intervention has ended. PIs should outline specific criteria for when participants would require medical follow-up and describe the procedure for addressing any delayed adverse events that might emerge after participation.

Identifying Minimal Risk vs. Greater than Minimal Risk Research
When determining whether exercise-related research is minimal or greater than minimal risk, the IRB will assess the intensity of the exercise and the health status of the participants. The IRB proposal must explain how these factors have been accounted for, particularly when it comes to more vulnerable populations. For instance, a treadmill walking test could pose minimal risk for a healthy, young adult but could be considered greater than minimal risk for an elderly person recovering from surgery. PIs should clearly distinguish between the different risk levels and justify their classification of the study. The proposal should also provide risk mitigation strategies, particularly when enrolling vulnerable populations, and justify why the potential risks are outweighed by the potential benefits of the research.

General Safety & Emergency Plan
The PI must ensure safety throughout the research process, including participants' interaction with equipment, movement between stations, and environmental factors (e.g., crowded rooms, equipment obstructions). The IRB proposal must include:

• A detailed location-specific emergency plan, covering what actions will be taken in the event of an emergency, and contact information for local medical responders.
• Emergency contact details for all participants, ensuring immediate communication in the event of an adverse event.
• The emergency plan must ensure that emergency phones (either landlines or mobile) are functional and accessible, with instructions on which number to call and precise location details to direct responders effectively.

Dehydration and Heat-Related Risk Management
Studies that involve high temperatures or strenuous physical activity should include protocols for monitoring, managing and mitigating dehydration and heat-related risks. The IRB proposal should detail hydration strategies, cooling procedures, and break schedules to prevent heat exhaustion or dehydration during exercise, especially for vulnerable populations.

Injury Reporting
If an injury occurs during exercise-based research, the study must be paused, and the PI must notify the IRB within 48 hours. If the injury was not anticipated, the PI must submit an adverse event report detailing the incident and any changes made to the protocol to prevent further injury. The study cannot resume until the IRB has reviewed the incident and granted approval to continue. The injury reporting protocol should include criteria for temporary suspension of the research in the event of serious or multiple injuries and describe the communication process with participants and the IRB during this time.

Normal Training vs. Research
When conducting research with athletes or teams, the PI must clearly define which activities are part of normal training and which procedures are specific to the research study. This distinction must be detailed in the IRB proposal and the informed consent process, so participants understand what elements of the activity are required for research versus their regular training.

Privacy of Results
When performance data is collected in group settings or can be observed by non-research staff, the IRB proposal must address how participant confidentiality will be maintained. If other individuals may observe the exercise sessions, this must be disclosed in the consent process. Even if data remains confidential, participants should be informed that their performance may be viewed by others. The proposal should also outline specific measures to secure personal health data, particularly if sensitive health conditions are being monitored or recorded during the

An Honest Broker acts as a firewall between investigators and subjects' identifiable information, enhancing participant confidentiality and compliance with ethical standards. By managing the access and use of sensitive data, the Honest Broker facilitates research while protecting participant identities.

Definition and Role

An Honest Broker is an individual who has access to the desired data through their hospital or institutional responsibilities and is not listed as a researcher on the respective study. Their primary functions include:

• Data De-identification: The Honest Broker can generate or receive datasets and strip out subject identifiers, creating either a de-identified dataset or a limited dataset.
• Access Management: They access medical record information and provide researchers with de-identified or limited datasets, ensuring compliance with data privacy regulations.

Creation of a Data Set

When utilizing an Honest Broker, researchers should consider the following:

• If the Honest Broker is providing a limited dataset, they must present an internal data use agreement to the researcher before receiving the dataset.
• The Honest Broker can assign a code to the data, but researchers must not have access to the information linking the code to individual identities. This code allows the researcher to request additional medical information through the Honest Broker.
• If coded data is provided without the means to decode it, the information will be treated as de-identified or a limited dataset, depending on the elements included.

 Additional Protections for Confidential Information

• Enhanced Confidentiality: The Honest Broker can implement additional protections, such as encrypting data and specimens, preventing researchers from identifying individuals from whom the data was obtained. This is especially relevant for prospectively collected data.
• Limitations on Re-identification: Utilizing an Honest Broker may prevent investigators from re-identifying individual subject data or specimens, which could hinder further data collection or participant recruitment for subsequent studies. This decision should be made with care, considering the research objectives.

Converting Identifiable Data

Using an Honest Broker can alter the regulatory category of research involving existing specimens (from clinical care or prior research) by providing investigators with data and biospecimens that are not readily identifiable. This change in status may exempt the research from prior IRB review and approval. If investigators remove identifiers themselves, they must obtain an exemption determination.

• Limited Data Sets: If the data provided contains dates or zip codes, it is classified as a limited dataset. Both the data provider and recipient must enter into a data use agreement before sharing the data/specimens. At some institutions, such as the Children's Hospital of Philadelphia (CHOP), this sharing does not require IRB review or approval. However, other institutions may have stricter requirements.

Best Practices

• Clearly define the Honest Broker’s responsibilities in the research protocol.
• Ensure secure protocols for data transfer and sharing of de-identified or limited datasets.
• Document all data handling processes, including records of data requests and transfers, for audit and IRB review purposes.
• Provide training for the Honest Broker on ethical guidelines and institutional policies regarding data handling.
• Assess the effectiveness of the Honest Broker’s role and processes throughout the research project.

Ethical Considerations

• Maintain participant trust by ensuring the protection of their privacy.
• Foster transparency about the role of the Honest Broker in the research process.
• Evaluate potential conflicts of interest to ensure the Honest Broker remains independent from the research team.

When developing a research protocol involving vulnerable populations—such as children, prisoners, individuals with cognitive impairments, or economically disadvantaged groups—additional ethical considerations are necessary to protect these individuals from undue risk and to uphold their autonomy and well-being. Vulnerable populations may have limited capacity to provide informed consent, face heightened risks of coercion, or be in situations that impact their ability to make fully voluntary decisions. Researchers must implement safeguards tailored to the specific vulnerabilities of the population involved, ensuring that participation is ethical, equitable, and respectful of their rights and dignity.

Proposed studies involving pregnant persons may qualify for exempt or expedited review when no more than minimal risk is involved. The IRB will make the final determination. Studies requiring full board review will be reviewed and approved by the criteria of 45 CFR 46 Subparts A and B. For social/behavioral research involving pregnant women, the IRB determined that it would allow pregnant women to be enrolled in research involving interviews, focus groups, surveys, or similar procedures without any additional safeguards. These studies will be reviewed by the IRB following equivalent standards as outlined in the Common Rule.

To approve federally funded research involving pregnant persons or fetuses, the IRB must determine that the research meets the following conditions:

1. Where scientifically appropriate, preclinical studies, including studies on pregnant animals and non-pregnant women, provide data for assessing potential risks to pregnant women and fetuses.
2. The risk to the fetus is posed solely by interventions or procedures that offer the prospect of direct benefit for the woman or the fetus; or, if no such prospect exists, the risk to the fetus is no greater than minimal, and the research aims to acquire important biomedical knowledge that cannot be obtained by other means.
3. Any risk posed represents the smallest possible risk in achieving the research objectives.
4. If the research offers direct benefit to the pregnant woman or both the pregnant woman and the fetus, or no prospect of benefit when the risk to the fetus is minimal and the research aims to acquire important biomedical knowledge, the pregnant woman's consent is obtained in accordance with informed consent provisions.
5. If the research offers direct benefit solely to the fetus, the consent of both the pregnant woman and the father is required, except when the father is unavailable, incompetent, temporarily incapacitated, or when the pregnancy is the result of rape or incest.
6. All consent-providing individuals are fully informed of the reasonably foreseeable impact of the research on the fetus or neonate.
7. For pregnant children, assent and permission are obtained following the Special Protections for Children (45 CFR 46, Subpart D).
8. No inducements, monetary or otherwise, are offered to terminate a pregnancy.
9. Researchers involved in the study do not influence the timing, method, or procedures used to terminate a pregnancy.
10. Researchers involved in the study do not determine the viability of a neonate.

To approve research involving neonates of uncertain viability, the following conditions must be met:

1. Where appropriate, preclinical and clinical studies provide data for assessing potential risks.
2. All consent-providing individuals are fully informed of the reasonably foreseeable impact of the research on the neonate.
3. Researchers involved in the study do not determine the viability of a neonate.
4. The IRB determines that:
• The research aims to enhance the probability of survival of the neonate to the point of viability, with the smallest possible risk to achieve this objective; or
• The research aims to acquire important biomedical knowledge that cannot be obtained by other means, with no added risk to the neonate.
5. The legally effective informed consent of either parent or, if neither parent can consent due to unavailability, incompetence, or temporary incapacity, the legally effective informed consent of either parent's legally authorized representative is obtained. The father's consent is not required if the pregnancy is the result of rape or incest.

To approve research involving nonviable neonates, the following conditions must be met:

1. Where appropriate, preclinical and clinical studies provide data for assessing potential risks.
2. All consent-providing individuals are fully informed of the reasonably foreseeable impact of the research on the neonate.
3. Researchers involved in the study do not determine the viability of a neonate.
4. The vital functions of the neonate are not artificially maintained.
5. The research does not terminate the heartbeat or respiration of the neonate.
6. The research presents no added risk to the neonate.
7. The research aims to acquire important biomedical knowledge that cannot be obtained by other means.
8. The legally effective informed consent of both parents is obtained. If neither parent can consent due to unavailability, incompetence, or temporary incapacity, the informed consent of one parent is sufficient. The father's consent is not required if the pregnancy is the result of rape or incest. The consent of a legally authorized representative of either or both parents is not sufficient.

A viable neonate is one that has reached the point of gestation where it can survive outside the womb, either with or without medical assistance. This generally refers to neonates born after 24 weeks of gestation, though exact definitions can vary based on medical advancements and institutional standards. When research involves a viable neonate, it must comply with all applicable regulations for research involving children. This includes obtaining informed consent and assent as outlined in Subpart D of 45 CFR 46, which provides additional protections for minors involved in research. See the section on children/minors for more information.

To approve research involving after-delivery, placenta, dead fetus, or fetal material, the following conditions must be met:

1. Research involving the placenta, dead fetus, macerated fetal material, or cells, tissues, or organs excised from a dead fetus must comply with all applicable federal, state, or local laws and regulations.
2. If information associated with the material is recorded in a manner that enables the identification of living individuals, those individuals are considered research subjects, and all pertinent subparts of this section apply.

To approve research not otherwise approvable, the following conditions must be met:

1. The IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.
2. The Secretary of the Department of Health and Human Services, after consulting with a panel of experts in pertinent disciplines (e.g., science, medicine, ethics, law) and following a public review and comment period, including a public meeting announcement in the Federal Register, determines that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.

Research involving children is subject to the additional requirements of Subpart D. Under DHHS and FDA regulations, children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. When any protocol involves children as research subjects, an expert in pediatrics should participate in the protocol's review.

Risk/Benefit Determinations and Review Process

The IRB must classify studies that involve minors into one of four groups, each with specific added responsibilities. Proposed studies involving children may qualify for exempt or expedited review if the study falls into one of the federally approved categories defined in 45 CFR 46.101. Exemption categories 1-5 do not apply to FDA-regulated studies. The exemption noted at 45 CFR 46.101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research involving children unless the research involves the observation of public behavior, and the investigator(s) do not participate in the activities being observed.

The IRB may approve only research that satisfies the following conditions:

1. Research not involving greater than minimal risk.

• The IRB must find and document that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians. Consent from one parent is sufficient.

2. Research involving greater than minimal risk, but presenting the prospect of direct benefit to the individual subjects, only if:

• The risk is justified by the anticipated benefit to the subjects;
• The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and
• Adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians. Consent from one parent is sufficient.

3. Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition, only if:

• The risk represents a minor increase over minimal risk;
• The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;
• The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition that is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and
• Adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians. Consent must be obtained from both parents if they have custody and are reasonably available.

4. Research not otherwise approvable that presents an opportunity to understand, prevent, or alleviate a serious problem that affects the health or welfare of children, which the IRB does not believe meets the above requirements of this section, only if:

• The IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem that affects the health or welfare of children; and
• The Secretary of the Department of Health and Human Services or the Commissioner of the Food and Drug Administration, after consultation with a panel of experts in pertinent disciplines (e.g., science, medicine, education, ethics, law) and following the opportunity for public review and comment, has determined that either:
1. The research satisfies the above requirements of this section, as applicable, or
2. The following:
• The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem that affects the health and welfare of children;
• The research will be conducted in accordance with sound ethical principles;
• Adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians. Consent must be obtained from both parents if they have custody and are reasonably available

Procedures

In considering the risks of a research study involving children:

1. The IRB interprets minimal risk in relation to the normal experiences of average, healthy, normal children.
2. In evaluating risk, the IRB considers the equivalence of potential harm or discomfort anticipated in research with the harm or discomfort that average, healthy, normal children may encounter in their daily lives or experience in routine physical or psychological examinations or tests.
3. The IRB considers the risk of harm or discomfort in relation to the ages of the children to be studied and assesses the duration, as well as the probability and magnitude of potential harm or discomfort in determining the level of risk.
4. The IRB interprets the phrase used in the regulations - "a minor increase over minimal risk" - as only slightly above minimal risk.
5. The IRB must determine that adequate provisions are made for soliciting the assent of children aged 11 and above.

For children residing in Massachusetts, the Department of Children and Families (DCF) may be involved with a family in two primary ways. Only the involvement through Care and Protection (C&P) impacts the process for obtaining consent to enroll in a research study, as outlined in state regulations 110 CMR 11.23 and DCF Policy #91-005 (revised 07/08/2008).

1. Care and Protection (C&P) Consent Requirements:
• If the child is still residing with parents or family members, obtain consent from the DCF social worker managing the case. This social worker is authorized to consent for care, treatment, and research.
• If the child is in foster care, obtain consent from the DCF social worker. Foster parents cannot provide consent unless specifically authorized by DCF. Additionally, if DCF is seeking court approval for the removal of parental rights, this may delay obtaining consent.
2. Child Requiring Assistance (CRA) Consent Requirements:
• In a CRA, parents retain legal custody and must provide consent for medical decisions and research participation. DCF does not need to provide additional consent.
3. Determining Consent Authority:
• If there is uncertainty regarding how DCF is involved or if there is a need for assistance with paperwork, contact the Boston Children's Hospital Office of General Counsel for guidance.
4. Applying Federal Consent Requirements:
• Research Not Involving Greater Than Minimal Risk:
• Obtain consent from the DCF social worker managing the child's case.
• Research Involving Greater Than Minimal Risk with Prospect of Direct Benefit:
• Ensure the risk is justified by the anticipated benefit.
• The benefit-risk ratio should be favorable compared to available alternatives.
• Obtain consent from the DCF social worker managing the child's case.
• Research Involving Greater Than Minimal Risk and No Prospect of Direct Benefit:
• The risk should be a minor increase over minimal risk.
• The intervention should be comparable to experiences inherent in the child's current situation.
• The research should yield vital generalizable knowledge.
• Obtain consent from the DCF social worker managing the child's case.
• Additional Federal Requirements for Greater Than Minimal Risk with No Direct Benefit:
• The research must be related to the child's status as a ward or conducted in settings where the majority of participants are not wards.
• Appoint an advocate who has no association with the research, investigator(s), or DCF, and who will act in the best interests of the child.
5. Procedures for Investigators:
• Initial Protocol Application: Indicate whether the protocol could involve children in state custody and if you plan to offer the study to them. If Including Children in State Custody, document required findings and appointment of an advocate for research involving greater than minimal risk with no direct benefit.
• Changes in Custody Status: Notify the IRB if the custody status changes. Ensure consent is updated accordingly if the child’s custody status changes between C&P and CRA.

Research involving K-12 educational settings requires careful consideration of ethical, practical, and regulatory issues. This document provides guidance on the essential elements of formulating an IRB submission for research in these settings, with a focus on gaining access to the setting, ethics and compliance, and protocol development considerations.

Gaining Access to the Setting

1. Approval from Educational Authorities:
• Obtain formal approval from school administrators, district officials, or other relevant authorities. This should include a detailed description of the research, including objectives, methods, and any potential impact on the educational environment.
• Include a letter of support from the school or district in your IRB submission.
• Some school systems may require researchers to obtain criminal background checks before conducting research (e.g., CORI, SORI). Researchers must follow the requirements of the school system.
2. Teacher and School Involvement:
• Discuss the role of teachers and other school staff in the research process. Clarify their responsibilities and any permissions required from them.
• Provide information on how the research may affect their workload and classroom environment.
• If necessary, engage with the broader school community, including parent-teacher associations and school boards, to garner support and address any concerns related to the research project.

Protocol Development Considerations

1. Consent and Assent:
• Consent for Recording: Ensure that only participants who have consented to be recorded are included in video/audio recordings. If a participant has not agreed to be recorded, they must be out of the recording range, or their image/audio must be deleted from any recordings collected during the research process. Subsequent use of recordings must exclude participants who did not agree to be recorded.
• Informed Consent Process: Provide clear and comprehensible information to parents about the research, including its purpose, procedures, potential risks and benefits, and their right to withdraw their child from the study at any time without penalty. Ensure that consent forms are written in language that is easily understandable for parents and guardians. Provide translations if necessary for non-English speaking parents.
• Child Assent: Obtain assent from children in an age-appropriate manner. Explain the research in simple terms and ensure that children understand their participation is voluntary and that they can withdraw at any time. Use age-appropriate assent forms and adapt the language based on the child’s developmental level.
• Special Considerations:
• Students with Disabilities: Include accommodations and considerations for students with disabilities or special educational needs in your consent and assent process.
• Non-English-Speaking Students: Provide consent and assent materials in relevant languages to accommodate non-English speaking students and their families.
2. Cultural Sensitivity: Ensure the research design, methods, and interactions are culturally sensitive and respects the diverse backgrounds of students and their families.
3. Data Destruction: Outline the timeline and method for data destruction once the research is concluded to ensure that participant information is appropriately disposed of.
4. Post-Research Communication: Describe how findings will be communicated to participants, parents, and the school community after the research is concluded. Consider how you will share results in a meaningful and accessible way.
5. Long-Term Impact: Address any long-term impact the research may have on the school environment and how you will handle any ongoing issues that arise from the study.
6. FERPA/PPRA Compliance: FERPA restricts researchers’ access to student records without written permission from parents. However, there are conditions under FERPA [20 U.S.C. 1232g(b)(1)(F)] under which student records can be disclosed without parental consent. Investigators must contact each institution and follow that institution’s FERPA policy in addition to UMassD IRB requirements. PPRA outlines eight categories of protected information for survey responses. For more information, see FERPA (Family Educational Rights and Privacy Act) and PPRA (Protection of Pupil Rights Amendment).

Research involving adults with decisional impairment—due to psychiatric, cognitive, developmental disorders, substance abuse, chronic pain, or temporary conditions such as sedation—poses unique ethical considerations. These individuals may still be capable of providing informed consent; however, additional protections are required to safeguard their rights and welfare. If evidence indicates they cannot provide informed consent due to incapacity to understand, a legally authorized representative must sign and date the consent document. The IRB will determine whether the target population is appropriate, the research focuses on issues unique to the populations, the level of risk, and its participants are capable of providing consent/assent and whether a legally authorized representative must provide consent. Additional protections may be required, such as a witness to the consent process or requiring the PI to assess each individual's ability to provide consent, including asking participants to articulate the study's purpose, risks, and benefits in their own words. If participants cannot answer such questions, consent from a legally authorized representative must be obtained. The IRB must ensure that research involving this population adheres to federal and state regulations and maintains the highest ethical standards.

IRB Considerations: 

Selection of Subjects:

Absent extenuating circumstances, adults with decisional impairment may only be enrolled in:

• Research that does not involve more than minimal risk.
• Research that involves greater than minimal risk but presents the prospect of direct benefit to the individual.

UMassD generally does not enroll adults with decisional impairment in:

• Research involving greater than minimal risk with no prospect of direct benefit, even if it may yield generalizable knowledge about the participant’s disorder or condition.
• Any other research not otherwise approvable.

A PI may request an exception to these principles by providing:

• A description of why impaired adults should be enrolled.
• Specific steps to protect these individuals.

Assessing Competency:

When an adult is competent to give informed consent when they can:

• Receive and understand information.
• Process information.
• Appreciate the situation and its consequences.
• Weigh potential benefits, risks, and alternatives.
• Make and communicate a decision.
• Distinguish between research and treatment.

Competency assessments may include general measures such as the Clinical Dementia Rating, Mini-Mental Status Exam, or activities of daily living scale. These should not be the sole mode of evaluation; higher-risk protocols may require formal medical assessments and open-ended interviews focusing on the study’s risks, benefits, and alternatives.

Informed Consent Process:

A two-part consent process is recommended:

• Assessment of Comprehension: Understanding the factual details of the study.
• Personalized Understanding: Understanding how the study’s benefits, risks, and alternatives apply to the individual’s situation.

Consider using an independent professional to assess competency, especially for higher-risk studies. The PI must ensure that informed consent is obtained from capable individuals or their legally authorized representatives The consent process must clearly distinguish between research and treatment, ensuring participants are aware that they are consenting to research, not clinical care.

Surrogate Decision Maker:

If an adult participant cannot provide consent and has not expressed dissent, a legally authorized representative must provide consent. According to federal law, this representative could include:

• A court-appointed guardian with authority to make health care decisions.
• A person designated as a health care agent under a valid health care proxy with express authority to consent to research.
• A durable power of attorney with health care decision-making authority that includes express authority to consent to research.

The research team must document the process for determining the legally authorized representative and attach or reference the relevant documentation in the research record.

Participant Turning 18:

If a child participant turns eighteen during the study, informed consent must be obtained from the now-adult participant to continue their participation. If the now adult participant is impaired, the PI must follow the consent policies for impaired adults and a new consent document must be signed by the appropriate legally authorized representative.

Involvement of an Adult with Decisional Impairment in a Protocol Not Previously Considered:

If an impaired adult is enrolled in a protocol where their involvement was not anticipated, and the IRB did not consider the special protections for this population, the investigator must contact the IRB to discuss any necessary special arrangements to include the participant in the research.

Unless the IRB has waived the requirement to obtain consent, when research involves adults unable to consent, permission must be obtained from a legally authorized representative. Investigators are to follow this procedure when obtaining permission for adults unable to consent or children to take part in research.

When research is conducted in Massachusetts, the following individuals meet these definitions:

For research that involves medical treatment:

• A “health care agent” refers to an individual authorized under M.G.L. c. 201D to make medical decisions on behalf of another who lacks the capacity to consent. This authority is granted through a health care proxy executed by a competent adult. If no health care proxy exists, medical care providers may accept consent from a "responsible party" as defined by common law principles.
• A “guardian” as defined in M.G.L. c. 190B § 5-101; however, the health care decision of a health care agent takes precedence over that of a guardian.

For minimal-risk non-medical research:

• A “guardian” as defined in M.G.L. c. 190B, § 5-101. (“a person who has qualified as a guardian of a minor or incapacitated person pursuant to court appointment and includes a limited guardian, special guardian and temporary guardian, but excludes one who is merely a guardian ad litum.”)
• For non-medical research that presents more than minimal risk, it is unclear whether a legally authorized representative for an incapacitated adult in Massachusetts can provide consent. The IRB should consult with legal counsel before approving such studies to ensure that the proposed representatives meet the federal definition of a “legally authorized representative.”

In Massachusetts:

• All individuals under the age of 18 years are considered children. Massachusetts law recognizes two instances where teenagers under 18 may have the legal capacity to consent to medical treatment: the emancipated minor and mature minor rules (e.g., married, widowed, divorced, a parent, member of the armed forces, managing their own finances, or pregnant). Note that these rules apply to medical treatment and not to participation in research, and they are specific to Massachusetts. For more information, consult legal counsel.
• Unless the IRB has waived the requirement for consent, when research involves children, consent must be obtained from biological or adoptive parents or an individual legally authorized to consent on behalf of the child to general medical care. Contact legal counsel before obtaining consent from someone other than a parent.
• Children aged seven and older should be given the opportunity to assent.

• Federal regulations provide additional protections for children involved as research subjects. They require adequate provisions for the assent of the child when capable, considering the child's age, maturity, and psychological state. Although there are formal requirements for consent forms, assent forms are less formal. Investigators should create assent content that effectively informs children about the study.

Guidelines for Assent Forms:

• For research involving children, the IRB requires consent from the parent/legal guardian and, if the children are aged 7 years or older, assent from the children.
• Assent is defined as the child’s affirmative agreement to participate. Failure to object is not considered assent.
• The assent document should explain the study’s purpose, any discomforts or inconveniences the child may experience, and that participation is voluntary.
• The length of the assent form should be proportional to the study’s complexity and the participants' age.
• The use of headings may improve readability.

Exception: If the research involves abortion, a female under the age of 18 who is not and has never been married is considered a child.

For research outside Massachusetts, a determination of who is a legally authorized representative is to be made with consultation from legal counsel.

Economically and educationally disadvantaged individuals may face unique vulnerabilities in research contexts. These vulnerabilities necessitate additional protections to ensure that their participation is ethical and informed. The IRB must carefully review protocols involving these populations to prevent coercion and ensure adequate understanding of the research.

IRB Considerations:

1. Protections and Safeguards:

• The IRB may require the use of a witness to the consent process of the consent process to ensure that participants are properly informed, and consent is obtained ethically.
• The IRB must evaluate whether the proposed protections for economically and educationally disadvantaged participants are adequate, strategies for minimizing coercion and ensuring clear understanding should be detailed in the proposal. Participants with educational disadvantages may struggle to understand complex research concepts. Investigators must present information in an accessible format, using clear and simple language, and provide additional explanations as needed. Compensation must be set at a level that fairly compensates participants for their time and effort without being so high that it unduly influences their decision to participate. The risks associated with participation should be clearly communicated. The IRB may require adjustments to the proposed protection measures to better safeguard the rights and welfare of economically and educationally disadvantaged individuals by revising consent procedures or altering compensation structures.
• The IRB may recommend continuous monitoring of the research protocol to ensure that the protections remain effective throughout the study and review feedback from participants to make recommendations for necessary adjustments to the research protocol.

2. Voluntary Participation:

• Incentives, whether financial or medical, must be proportionate to the risks, discomforts, and inconveniences of participation. Excessive incentives can be coercive, particularly for those with limited resources.
• Recruitment Materials must avoid promises of free treatment or overly emphasize the medical care provided during research. These materials should be written at an appropriate level for the target population and clearly convey the nature of the study and any associated risks.

3. Informed Consent Process:

• Use appropriate methods and materials for delivering consent information, considering educational deficits, learning disabilities, or cultural differences. Present research information in a format that suits the participant’s comprehension level (e.g., visual aids, verbal explanations) and in a language they understand.

Research involving non-English speaking participants presents unique challenges with informed consent as well as their inclusion and exclusion in research. Ensuring participants can fully understand and consent to research requires careful attention to language barriers and cultural differences.  While these studies may qualify for exempt or expedited review, the Chair or authorized designee reserves the right to require full board review. The IRB must ensure that protocols involving non-English speaking participants are designed to address these challenges adequately.

IRB Considerations:

1. Informed Consent:

• Translation of Materials: Consent forms, informational documents, and other study materials must be translated into the participant's primary language. Translations should be done by qualified individuals or professional services to ensure accuracy and clarity. The IRB requests attestation to verify that translations are accurate and culturally appropriate.
• Communication: Consent discussions and any verbal explanations must be conducted in the participant’s primary language. Utilize qualified interpreters or bilingual research staff to facilitate these discussions.
• Comprehension: The participant’s understanding of the research study is assessed; this can include follow-up questions or discussions to confirm comprehension or via a key point in the participant’s language to reinforce understanding. Monitor participant feedback to address any issues that arise related to language barriers or comprehension.

2. Recruitment and Outreach:

• Culturally Appropriate Materials: Recruitment materials are available in the participant’s primary language and tailored to their cultural context and avoid using jargon or complex language that may not be easily understood.
• Community Engagement: If appropriate, engage with community leaders or organizations that serve non-English speaking populations to facilitate recruitment and build trust.

3. Consent Process:

• When using interpreters, the interpreters must be impartial and understand the confidentiality requirements of the research. PIs must inform the participant that the interpreter’s role is to facilitate communication, not to provide personal opinions or advice.
• Obtain written or verbal consent in the participant’s primary language. Document the use of an interpreter and the translation of consent materials in the research records.

4. Cultural Sensitivity:

• Understanding Cultural Differences: PI must demonstrate awareness of cultural norms and practices that may affect the participant’s perceptions and understanding of research within the research protocol. The submission adapts communication and consent processes to respect cultural differences.
• Training for Research Staff: PI is responsible for ensuring research staff are trained in cultural competency and understand the specific needs of non-English speaking participants.

5. Confidentiality and Data Security:

• Language and Data Handling: Implement measures to ensure that non-English speaking participants’ data is securely handled, including using secure methods for storing and transferring data.
• Access to Data: Restrict access to study data to individuals who understand the participant’s primary language to avoid misinterpretation.

Research involving refugees and undocumented immigrants presents unique ethical challenges due to their substantial vulnerabilities. As this population often faces legal, social, and economic difficulties, it is crucial to adhere to ethical principles and ensure that their participation is handled with utmost sensitivity and respect. Below is IRB guidance on the process and considerations for reviewing research involving these groups.

IRB Considerations:

• Study Design and Purpose: Respect the autonomy of participants by avoiding intrusive questions about their immigration status or social networks. The research questions and protocols are relevant and beneficial to the specific needs of refugees or undocumented immigrants and does not exploit their vulnerabilities. The study offers potential benefits to the participants or their communities.
• Recruitment and Consent: The study provides clear information, ensuring participants understand their rights and the scope of data use. A waiver of signed consent is requested if the study poses a risk to participants or consent is obtained before data collection.
• Data Security: The study does not directly ask about immigration status or personal social networks. Data protection measures are in place, including encrypted digital storage and secure physical storage for paper records. Ensure confidentiality and consider using a Certificate of Confidentiality (COC) from the respective entity/funding agency to protect privacy. Be aware of the COC's limitations in fully safeguarding undocumented immigrants.
• Cultural and Linguistic Sensitivity: Study materials are tailored to accommodate different languages and cultural contexts. Materials are understandable and appropriate for the participants’ education levels.
• Continuous Communication: PI plans to maintain an ongoing dialogue with participants about their involvement in the study, ensuring they are kept informed about the research progress and any findings that may affect them.
• Plan for Adaptation: PI plans to regularly review and adapt research protocols based on participant feedback and address unforeseen issues or risks.

Reporting: Present research findings in a way that respects participants' confidentiality and highlights their contributions and experiences authentically.

Incarceration places prisoners under constraints that may impact their ability to make truly voluntary and uncoerced decisions about participation in research. Prisoners are therefore considered a vulnerable population that warrants additional protections. Research involving prisoners must adhere to 45 CFR 46 Subpart C, which provides specific protections for this population. Key provisions ensure voluntary consent, confidentiality, and appropriateness of research. These protections apply to research involving individuals who are prisoners at enrollment or become prisoners during the study.

Categories of Permitted Research: The IRB must ensure the research falls into one of the following categories:

1. Study of incarceration effects, criminal behavior, or prisons, presenting no more than minimal risk and inconvenience.
2. Study of institutional structures or prisoners as incarcerated persons, presenting no more than minimal risk and inconvenience.
3. Research on conditions particularly affecting prisoners, such as prevalent health issues, with required consultation and notice by the Secretary.
4. Research on practices intended to improve health or well-being, with required consultation and notice if control groups are involved.

Examples of Prisoner Definitions

• Prisoner: Includes individuals sentenced to institutions, detained by statutes, or those pending legal proceedings.
• Not Prisoners: Includes individuals in community-based programs, voluntarily admitted psychiatric patients, or those incarcerated briefly without affecting research participation.

IRB Review Process

Protocol Submission Requirements

• Justification for prisoner inclusion.
• Procedures conducted within facilities.
• Involvement of detention facility staff.
• Recruitment and consent processes.
• Confidentiality and data protection measures.
• Incentives and distribution methods.
• Risk minimization and transportation arrangements if necessary.

IRB Reviewer Considerations

• Researchers are experienced or working with a mentor knowledgeable about research with prisoners.
• Research protocols are adjusted to account for the controlled nature of detention facilities.
• Detailed descriptions of research procedures, consent processes, confidentiality measures, and follow-up care are provided.

Convened IRB Review: All new research involving prisoners must be reviewed via a convened IRB.

1. Prisoner Representative: A qualified prisoner representative must be present at the IRB meeting when research involving prisoners is reviewed. This individual must be a voting member and review all materials related to the research.
2. IRB Composition: A majority of the IRB members (excluding prisoner members) must have no association with the prison(s) involved apart from their IRB membership.
3. Findings Required: The IRB must find before approving research that the research falls into one of the permissible categories under 45 CFR 46.306(a)(2):

1. 1. Studies of possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than an inconvenience to the subjects.
   2. Studies of prisons as institutional structures or of prisoners as incarcerated persons provided that the study presents no more than minimal risk and no more than inconvenience to the subjects.
   3. Research on conditions particularly affecting prisoners as a class, for example: 

• • • Vaccine trials and other research on hepatitis which is more prevalent in prisons than elsewhere.
    • Research on social and psychological problems (alcoholism, drug addiction, and sexual assaults). The study may proceed only after the HHS Secretary (through OHRP) has consulted with appropriate experts and has published notice of approval in the Federal Register.

4. Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject. Non-therapeutic research with a control group must be approved by the IRB and subsequently reviewed by the HHS Secretary. The Secretary’s ruling, informed by consultation with experts, will be published in the Federal Register.
   • Any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired.

• Risks are commensurate with those accepted by non-prisoner volunteers.
• Procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides to the Board justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that research project.
• Information is presented in understandable language.
• Privacy and confidentiality issues are addressed in the prison environment, such as the availability of private rooms to conduct interviews and involving prison staff in any part of the study.
• Adequate assurance exists that parole boards will not consider a prisoner's participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole. AND
• Where the IRB finds it necessary, adequate provisions are made for follow-up care.

4. Minutes: IRB meeting minutes must summarize protocol reviews, board discussions, stipulations, and actions taken. Documentation of Subpart C findings is required.
5. Certification: For HHS-funded research, the HRPP office will submit an electronic certification to OHRP indicating the study's approval, category, and compliance with six criteria under 45 CFR 46.306(a)(2). Research may not commence until OHRP approval is received.

 Expedited Review: Expedited review procedures for research involving prisoners may only be used under specific conditions:

• Minor changes in previously approved research.
• Continuing review of research that is closed to new subjects, has completed all interventions, and is limited to long-term follow-up.
• Research with no subjects enrolled, no additional risks identified or limited to data analysis.
• Continuing review of minimal risk research with no additional risks.

If the research population includes people who are likely to be jailed during a study — and whose participation the investigator would like to continue — the study should be reviewed as prisoner research. When individuals who may be incarcerated during the study—such as individuals on parole, those facing substance use challenges/addiction, individuals involved in sex work, or those experiencing homelessness—it is crucial to address these considerations with respect and cultural sensitivity as these individuals are at an increased risk of being arrested when compared to the general population. Research involving these populations should be reviewed under the standards applicable to research involving prisoners.

Key Considerations:

1. Anticipate Potential Incarceration: Investigators should assess and anticipate the likelihood that participants may become incarcerated during the study. This includes understanding the unique risks faced by these individuals and how such situations might impact their participation.
2. Study Continuity: The study protocol should outline how activities will be managed if a participant becomes incarcerated. Specify which aspects of the study will continue and how the research team will handle potential disruptions in a manner that is respectful and maintains the participant’s dignity.
3. Adherence to Standards: Research involving individuals who may be incarcerated must adhere to the same ethical and review standards as other research involving prisoners. This includes ensuring that the study meets the ethical requirements and protections specified for research involving incarcerated individuals.

By approaching the inclusion of these populations with sensitivity and respect, researchers can help ensure that the research is conducted ethically and with consideration of the unique circumstances of participants.

When a participant becomes a prisoner during a non-prisoner study:

• All research procedures must cease immediately.
• An amendment must be submitted to include prisoners if continued participation is desired.
• If continued participation is deemed in the best interest of the prisoner, the IRB Chair may allow it until the amendment is reviewed.

Studies that focus on students as participants may raise concerns about issues of coercion, undue influence, and privacy. While these studies may qualify for exempt or expedited review, the Chair or authorized designee reserves the right to require full board review. For more information, please see IRB Guidance on Students as Research Participants.

Studies that focus on UMassD employees as participants may raise concerns about coercion, undue influence, and privacy. While these studies may qualify for exempt or expedited review, the Chair or authorized designee reserves the right to require full board review. The IRB may consult with employees when considering approval of a study that involves them as participants.

Within each application that involves employees as participants, the PI must outline procedures to ensure that the employees will not be subject to undue influence or coercion and to ensure that the employee’s privacy will be respected. While a PI/supervisor may use his/her own direct report employees as participants, the preference of the IRB is that the PI recruits employees with whom the PI does not have a direct relationship. For example, if the research study is an analysis of the performance evaluation process, the PI may recruit employees from the general population of the institution as opposed to employees from the PI’s department. If colleagues or subordinates are recruited the PI must provide a rationale for their recruitment other than for convenience’s sake.

Additional suggestions to minimize concerns of coercion, undue influence, and privacy include the general recruitment of participants through IRB-approved advertisements, the collection of data in an anonymous method, and the use of an independent third party to recruit, consent, and/or collect data. The IRB will also closely review how study data is reported back to management.

The employee’s participation must be voluntary and based on the disclosure of complete and accurate information. Employees should not be asked to participate in any study that will interfere with their job obligations. An employee’s decision to participate or not participate cannot have any bearing on the employee’s performance evaluation.

Researchers and the IRB share the responsibility for establishing a recruitment environment that adequately protects the rights and welfare of prospective participants (Belmont Report; 45 CFR §46.111(a)(3)). This ethical and regulatory guidance requires appropriate procedures for the initial identification, contact, and recruitment of potential subjects, demonstrating respect for the dignity and autonomy of participants while preserving confidential information and minimizing undue influence.

Generally, subject contact information acquired in a study should be destroyed at the end of the study. UMassD researchers wishing to maintain subject information for future recruitment must submit a request to the IRB. Such information would be intentionally maintained as a prospective tool to recruit volunteers for research. Databases must be maintained by one responsible, qualified UMassD researcher, and in most cases, subjects will fill out a consent form agreeing to the inclusion of their information into such a system.

NOTE: A collection of names, contact information, and date of birth only is not considered a subject recruitment database. This information may be maintained with the subject's permission. However, if personal information is to be maintained with the name, UMass researchers must seek approval to maintain a subject recruitment database.

Establishing a Recruitment Database

Establishing a subject recruitment database requires prior IRB review and approval. Applications to establish databases are requested via email outlining the researcher's plan for establishing a database and should address the following guidance:

1. Responsibility and Access: The database must be controlled by a qualified UMassD investigator (CITI-trained faculty member) who will oversee the data. Only qualified and authorized researchers with current IRB approval can access the data. The plan must describe:

• Roles of other researchers with access.
• Data update procedures.
• Frequency of subject contact.
• Expanded procedures for databases with sensitive data.

2. Informed Consent: A separate informed consent document specific to the recruitment database must be used. Standard elements of informed consent apply.
3. Privacy and Confidentiality Protection Plan: Describe how confidentiality will be protected, including:

• Training for personnel and limiting access to authorized and qualified individuals.
• Methods of organizing, storing, and protecting information against accidental or inappropriate release. Password protection and other security measures for portable devices.

4. Recruitment Methods: Provide all proposed methods for recruiting to the database. Standard recruitment methods apply. Recruitment from existing subject lists should occur only if subjects have previously agreed to further contact.
5. Data Retention and Destruction: Specify retention duration and detailed destruction protocols for when data is no longer needed or if a participant withdraws consent.
6. Participant Communication: Outline methods for keeping participants informed about the use of their data and any updates to the recruitment database. Provide mechanisms for participants to offer feedback or express concerns about their data.
7. Participant Withdrawal: Explain the process for participants to withdraw their information from the database. Detail how withdrawal will be managed to ensure participant rights and data integrity.
8. Monitoring, Security, and Compliance

• Implement procedures for regular audits to ensure compliance.
• Use encryption for storing and transmitting data.
• Discuss strategies for minimizing risks associated with maintaining the recruitment database.
• Implement physical security measures for non-electronic data formats.
• Ensure the recruitment process is inclusive and does not disproportionately target or exclude specific groups.
• Ensure the database complies with local, state, and federal regulations.