Impact of institutional review board stipulations on turnaround time for approvals of surgical studies.

BACKGROUND: We have examined the number and types of stipulations received following the submission of surgical study protocols to the Institutional Review Boards (IRBs) for review, and their effect on turnaround time for approval. This analysis will enable our organization to improve the quality of applications and design of study protocols, which can streamline the approval process and increase efficiency of the startup phase for clinical research. METHODS: IRB stipulations for 48 surgical studies were analyzed. Various factors were assessed: surgical specialty, type of study by design, clinical trial phase, type of investigational product, type of IRB utilized (local or centralized), study complexity score, type of review (e.g., exempt, expedited, or full board), turnaround time, and number of stipulations received. Statistical analyses were performed to examine associations between the number/type of stipulations received during the IRB review process and any of the aforementioned study-related factors. RESULTS: For analyzed surgical studies, the number of stipulations allotted to a study and time taken for approval had moderate association with the complexity of the study. The turnaround time for approval was the highest for randomized, controlled trials and studies undergoing full board review. CONCLUSION: This study elucidates characteristics that are associated with increased time for IRB approval. Analysis of IRB stipulations can help improve the turnaround time for the approval process, increase efficiency of startup phase, and transition to execution phase faster, which will allow more time for enrollment of research subjects, and increase return on investment made into research and development programs.

Adverse childhood events and self-harming behaviours among individuals in Ontario forensic system: the mediating role of psychopathy.

BACKGROUND: Adverse childhood events (ACEs), psychopathy, and self-harming behaviours are prevalent among individuals in the forensic psychiatry system. While existing literature suggests that ACEs, self-harm, and psychopathy are interrelated, little is known about the interplay of psychopathic traits in this relationship. The present study aimed to determine the mediating role of psychopathy in the relationship between ACEs and self-harming behaviours in forensic patients. METHODS: This was a retrospective study of patients under the Ontario Review Board (ORB) between 2014 and 2015. In the analysis, we included patients with complete data on ACEs, self-harming behaviours, and a Psychopathy Checklist-Revised (PCL-R) score - a measure of psychopathic traits and their severity conducted during the reporting period. Mediation analysis was based on the Baron and Kenny approach, and sensitivity analysis was performed based on the types of ACEs. RESULTS: ​​​The sample population (n = 593) was made up of adults, with a mean age of 41.21 (± 12.35) years and were predominantly males (92.37%). While there was a partial mediating effect of psychopathy on the relationship between ACEs and incidents of self-harming behaviours in the past year, the mediation was complete in the relationship between ACEs and a lifetime history of self-harming behaviours. Following sensitivity analysis based on the types of ACE, the mediating effects were more attributed to specific ACEs, especially having experienced child abuse or having an incarcerated household member before 18 years. CONCLUSION: Among forensic patients in Ontario, psychopathy mediates​ ​the relationship between experiencing ACEs and engaging in self-harming behaviours. Effective intervention to mitigate self-harming behaviours in this population should consider the potential role of psychopathy, especially among individuals who have experienced ACEs involving a history of child abuse and a family who was incarcerated.

Which Benefits Can Justify Risks in Research?

Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose a categorization of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs.

Doctoral graduates' attitudes toward scholarly work and Institutional Review Board and Quality Improvement Committee education and submission processes: A pilot study.

BACKGROUND: Educators are challenged to find better ways to prepare doctoral nursing students to conduct scholarly work involving human subjects. PURPOSE: To better understand doctoral nursing students' attitudes toward programmatic scholarly work and Institutional Review Board (IRB)/Quality Improvement Committee (QIC) education and submission processes. METHODS: Recent Doctor of Nursing Practice (DNP) and Philosophy of Nursing (PhD) graduates were recruited using convenience sampling techniques to participate in this cross-sectional, descriptive, mixed-methods pilot study. Data were collected using two researcher-developed instruments. DISCUSSION: Nineteen doctoral nursing students participated in this study. Students most often used a quantitative approach with health care providers to complete their scholarly work requirements. Both PhD and DNP participants were overall satisfied with the IRB/QIC content in the curricula and the submission process. Four themes were identified: (a) Efficiency, (b) Collaboration, (c) Faculty Mentorship, and (d) Areas for Improvement. CONCLUSION: Findings from this pilot study may be used to enhance IRB/QIC processes through revision of administrative processes and student education.

Preclinical efficacy in investigator's brochures: Stakeholders' views on measures to improve completeness and robustness.

AIMS: Research ethics committees and regulatory agencies assess whether the benefits of a proposed early-stage clinical trial outweigh the risks based on preclinical studies reported in investigator's brochures (IBs). Recent studies have indicated that the reporting of preclinical evidence presented in IBs does not enable proper risk-benefit assessment. We interviewed different stakeholders (regulators, research ethics committee members, preclinical and clinical researchers, ethicists, and metaresearchers) about their views on measures to increase the completeness and robustness of preclinical evidence reporting in IBs. METHODS: This study was preregistered (https://osf.io/nvzwy/). We used purposive sampling and invited stakeholders to participate in an online semistructured interview between March and June 2021. Themes were derived using inductive content analysis. We used a strengths, weaknesses, opportunities and threats matrix to categorize our findings. RESULTS: Twenty-seven international stakeholders participated. The interviewees pointed to several strengths and opportunities to improve completeness and robustness, mainly more transparent and systematic justifications for the included studies. However, weaknesses and threats were mentioned that could undermine efforts to enable a more thorough assessment: The interviewees stressed that current review practices are sufficient to ensure the safe conduct of first-in-human trials. They feared that changes to the IB structure or review process could overburden stakeholders and slow drug development. CONCLUSION: In principle, more robust decision-making processes align with the interests of all stakeholders and with many current initiatives to increase the translatability of preclinical research and limit uninformative or ill-justified trials early in the development process. Further research should investigate measures that could be implemented to benefit all stakeholders.

Self-harming behaviors and forensic system-related factors: an analysis of the Ontario review board database.

BACKGROUND: In Canada, ensuring public safety, and the safety and well-being of accused individuals under the jurisdiction of the provincial review board are very important. While previous studies have reported a significant risk of self-harming behaviors (non-suicidal self-injury and suicide attempt) in forensic psychiatric settings, no large population study has assessed any relationship between forensic system-related factors and self-harming behaviors. A better understanding of these factors can help clinicians implement protective measures to mitigate self-harming behaviors or actions. METHODS: Using the Ontario Review Board (ORB) database covering 2014-2015 period (n = 1211, mean age = 42.5 ± 13.37 years, males = 86.1%), we analyzed the prevalence and factors associated with self-harming behaviors, emphasizing the characterization of the forensic system-related factors (ORB status, legal status, type of offense, previous criminal history, and victim relationship). The relationships between the forensic system-related factors and self-harming behaviors were explored using five separate logistic regression models, controlling for clinical and sociodemographic characteristics. RESULTS: Approximately 4% of the individuals in the forensic system over the study period engaged in self-harming behaviors Among the studied patients, individuals determined to be unfit to stand trial and inpatients were significantly more likely to have self-harming behaviors. There was no significant relationship between the type of offence, victim relationship, and previous criminal history with self-harming behavior. CONCLUSION: Forensic psychiatry inpatients should have close observation, screening, monitoring, and individual tailored management strategies for self-harming behaviors. The findings of this study indicate that forensic system-related factors, especially those that pertain to the status of individuals in the forensic system (i.e., unfit to stand trial and being an inpatient) are more responsible for self-harming behaviors among forensic patients in Ontario.

IRBs and the Protection-Inclusion Dilemma: Finding a Balance.

Institutional review boards, tasked with facilitating ethical research, are often pulled in competing directions. In what we call the protection-inclusion dilemma, we acknowledge the tensions IRBs face in aiming to both protect potential research participants from harm and include under-represented populations in research. In this manuscript, we examine the history of protectionism that has dominated research ethics oversight in the United States, as well as two responses to such protectionism: inclusion initiatives and critiques of the term vulnerability. We look at what we know about IRB decision-making in relation to protecting and including "vulnerable" groups in research and examine the lack of regulatory guidance related to this dilemma, which encourages protection over inclusion within IRB practice. Finally, we offer recommendations related to how IRBs might strike a better balance between inclusion and protection in research ethics oversight.

Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need Revision?

Harms and risks to groups and third-parties can be significant in the context of research, particularly in data-centric studies involving genomic, artificial intelligence, and/or machine learning technologies. This article explores whether and how United States federal regulations should be adapted to better align with current ethical thinking and protect group interests. Three aspects of the Common Rule deserve attention and reconsideration with respect to group interests: institutional review board (IRB) assessment of the risks/benefits of research; disclosure requirements in the informed consent process; and criteria for waivers of informed consent. In accordance with respect for persons and communities, investigators and IRBs should systematically consider potential group harm when designing and reviewing protocols, respectively. Research participants should be informed about any potential group harm in the consent process. We call for additional public discussion, empirical research, and normative analysis on these issues to determine the right regulatory and policy path forward.

Institutional review boards in Saudi Arabia: the first survey-based report on their functions and operations.

BACKGROUND: Institutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers comply with the ethical guidelines concerning human research participants. Given that IRBs might face different obstacles that cause delays in their processes or conflicts with investigators, this study aims to report the functions, roles, resources, and review process of IRBs in Saudi Arabia. METHOD: This was a cross-sectional self-reported survey conducted from March 2021 to March 2022. The survey was sent to 53 IRB chairpersons and the administration directors (or secretary) across the country through email after receiving verbal consent. The validated survey consisted of eight aspects: (a) organizational aspects, (b) membership and educational training, (c) submission arrangements and materials, (d) minutes, (e) review procedures, (f) communicating a decision, (g) continuing review, and (h) research ethics committee (REC) resources. A total of 200 points indicated optimal IRB functions. RESULTS: Twenty-six IRBs across Saudi Arabia responded to the survey. Overall, the IRBs in this study scored a total of 150/200 of the points on the self-assessment tool. Relatively newer IRBs (established less than ten years ago) conducted meetings at least once in a month, had annual funding, had more balanced gender representation, tended to score higher than older IRBs. The organizational aspect score was the lowest among all items in the survey (14.3 score difference, p-value < 0.01). The average turnaround time for expedited research from proposal submission to final decision was 7 days, while it was 20.5 days for the full committee review. CONCLUSION: Saudi IRBs performed generally well. However, there is room for focused improvement with respect to extra resources and organizational issues that require closer evaluation and guidance from the regulatory bodies.

Continuous quality improvement: reducing informed consent form signing errors.

BACKGROUND: Adherence to ethical guidelines and regulations and protecting and respecting the dignity and autonomy of participants by obtaining a valid informed consent form (ICF) prior to participation in research are crucial; The subjects did not add signatures next to the corrections made to signatures or dates on the ICF, Multiple signatures in other fields, ICF missing/missing signature, Incorrect ICF version Signed after modification, Correction tape used to correct signature, Impersonated signature, Non-research-member signature, however, ICFs are often not properly completed, which must be addressed. This study analyzed ICF signing errors and implemented measures to reduce or prevent these errors. METHODS: We used the plan-do-check-act (PDCA) cycle to help improve the correctness and validity of ICF signing. RESULTS: Interim and final reports from January 2016 to February 2020 including 363 ICFs were studied. The total proportion of correct ICF signatures (200, 83.3%) following the PDCA intervention was significantly higher than that before the intervention (P < 0.05). Analysis of the types of signing error demonstrated that signature errors were significantly reduced after the intervention, particularly for subjects did not add signatures next to the corrections made to signatures or dates on the ICF (16, 6.7%) and impersonated signature (0; P < 0.05). CONCLUSIONS: The proportions of other error types-multiple signatures in other fields, missing or unsigned ICF, incorrect signature order, incorrect ICF version, use of correction tape to correct signature, and non-medical profession members signing the ICF-did not differ significantly.

A critical ethnographic perspective on risk and dangerousness in forensic psychiatry.

In the Canadian forensic psychiatric context, the concepts of risk and dangerousness interact, intersect, and morph into the notion of significant threat to the safety of the public. Stemming from the results of a critical ethnography of the Ontario Review Board, this article unpacks the central role of forensic psychiatric nursing, as an example of a 'psych' discipline (e.g., psychiatry and psychology), in a system that is built to produce risky persons and to legitimize their detention and supervision. By using excerpt of interviews conducted with nurses, ethnographic observations of Review Board hearings, and other documentary artifacts, the findings illustrate how rationalizations of risk and dangerousness are contingent on space, time, and observer. Depending on the time of the assessment or on the health-care professional who performs it, different elements including, but not limited to, mental illness, interpersonal relationships, financial instability, and sexual vulnerability, are relied upon in very fluid, interchangeable, and discretionary ways to justify findings of dangerousness. Such a dynamic expands the reach of psychiatry's legitimacy at identifying risky conduct and controlling risky persons to domains very loosely associated with the notion of dangerousness. The work of Foucault and Castel provides the theoretical backdrop on which rests the discussion and the implications for nursing.

A Scoping Review Of The Literature Of Research Ethics Committees And Ethics Review Framework In Pakistan: What We Know And What We Still Need To Learn.

OBJECTIVE: To map literature on research ethics committees, institutional review boards and ethics review framework in Pakistan to identify key insights during public health emergencies and normal times. Method: The systematic scoping review was conducted in April 2022, and comprised literature search on PubMed, World Health Organisation Global Index Medicus and Summons databases for articles published between January 2005 and February 2022. Information extracted included authors' names, year of publication, title, study methodology, and key insights under the heads of challenges and solutions. Due to data heterogeneity, key themes were identified and analysed. RESULTS: Of the 2,190 studies initially identified, 21(0.95%) were subjected to full-text review, and, from among them, 9(45%) were analysed in detail. There were 4 key insights identified: research ethics committees and institutional review boards in Pakistan remain unregulated as they are currently not registered or accredited by a competent national-level authority; most members of such committees are not formally trained to implement the mandate; internal and external pressures hinder independent decision-making of such committees; and other issues hindering the functionality and performance of research ethics committees and institutional review boards. CONCLUSIONS: Despite existing publications calling for urgent policy and regulatory reforms, there is a dearth of literature and minimal policy actions underlying the fact that ethics review remains a neglected area in Pakistan.

Research ethics in practice: An analysis of ethical issues encountered in qualitative health research with mental health service users and relatives.

The ethics review of qualitative health research poses various challenges that are due to a mismatch between the current practice of ethics review and the nature of qualitative methodology. The process of obtaining ethics approval for a study by a research ethics committee before the start of a research study has been described as "procedural ethics" and the identification and handling of ethical issues by researchers during the research process as "ethics in practice." While some authors dispute and other authors defend the use of procedural ethics in relation to qualitative health research, there is general agreement that it needs to be supplemented with ethics in practice. This article aims to provide an illustration of research ethics in practice by reflecting on the ways in which we identified and addressed ethical and methodological issues that arose in the context of an interview study with mental health service users and relatives. We describe the challenges we faced and the solutions we found in relation to the potential vulnerability of research participants, the voluntariness of consent, the increase of participant access and the heterogeneity of the sample, the protection of privacy and internal confidentiality, and the consideration of personal and contextual factors.

Assessment of knowledge, attitude, and practice of antibiotics prescription among healthcare residents at King Abdulaziz medical City, Jeddah, Saudi Arabia.

Introduction: Antibiotic resistance (ABR) is defined as bacteria's resistance to therapy despite therapeutic levels of antibiotics. It is a global health concern. Data on the antibiotic prescription practice of physicians, in general, are limited in Saudi Arabia. Therefore, we aim to assess the knowledge, attitude, and practice of antibiotic prescription between surgical and non-surgical residents at King Abdulaziz Medical City (KAMC). Methods: A cross-sectional study was conducted at KAMC in Jeddah, Saudi Arabia, from September 2019, until March 2020. The questionnaire contained demographic information and 31 questions based on the studied variables: knowledge (17), attitude (4), and practice (10). Results: The response rate was 83 %. Male to female response rates were 54 % and 46 %, respectively. The majority of respondents (72 %) were non-surgical residents. Positive practice skills showed that 55 % of all healthcare residents always used practice guidelines for antibiotic prescription in their daily work (P-value < 0.001). Most residents (50 %) sometimes used delayed prescriptions. Non-surgical residents discussed ABR with patients more than surgical residents (P-value = 0.028). Lack of patient interest was the common cause for not discussing ABR with patients (42 %). Non-surgical residents had significantly more training on antibiotic prescription (p-value = 0.001). The fear of infection spread due to not prescribing an antibiotic was significantly higher in non-surgical residents (P-value < 0.001). Non-surgical residents (76 %) took a past medical history of antibiotic consumption more than surgical residents (24 %) (P-value = 0.003). Antibiotic prescription for residents was not influenced by advertisements (91 %). The most common resistant organisms reported by residents were insignificant between the two groups. The results also showed that the residents' common choice of antibiotics was not statistically different between surgical and non-surgical residents in most antibiotic classes. Conclusions: We found that practice guidelines, formal training, and taking patients' past medical histories were significantly higher among non-surgical residents. In contrast, surgical residents were prescribing more antibiotics due to the fear of the spread of the infection. Proper training is essential for all healthcare residents to overcome differences among different specialties.

Patients' and primary carers' views on clozapine treatment for schizophrenia: A cross-sectional study in Qatar.

Subjective views of clozapine treatment among patients with schizophrenia in the Middle East and North African MENA Region have not previously been assessed. Globally, few studies have assessed the views of carers to clozapine treatment. We conducted a cross-sectional survey, using a clinician administered structured interview, of patients with schizophrenia/schizoaffective disorder prescribed clozapine in Qatar, and their primary carers. Participants were asked to rate clozapine against prior their antipsychotic treatment in terms of specific benefits and side effects. Forty-two patients and 33 carers participated in the study. Of the patients, two thirds were male, approximately half were Qatari and the mean age was 33.9 years. Patients and carers rated clozapine as superior to prior antipsychotic treatment on all 7 potential benefits inquired about. The greatest perceived benefit was improved mood. Patients rated clozapine as less likely to cause extrapyramidal side effects but more likely to cause 18 other potential side effects compared to prior antipsychotic treatment, with the greatest difference being for nocturnal salivation, increased appetite, and constipation. Nearly half of patients (48 %) and two thirds of carers (64 %) stated that they would have preferred to start clozapine earlier in their illness. Sixty percent of patients and 37 % of carers regarded the information that they had received from health professionals on clozapine as inadequate. Less than half of patients and approximately-two thirds of carers had adequate knowledge of haematological monitoring for clozapine. Generally, there were significantly positive correlation between patients and carers regarding the overall side effects of clozapine treatment. Likewise, improvement in hearing voices paranoid thoughts correlated with improved quality of life. In summary, the results show that patients and carers appreciate the benefits of clozapine despite its side effects being problematic. The results support clozapine being offered earlier in treatment and services providing more information on clozapine to patients and carers.

A Research Ethics Framework for the Clinical Translation of Healthcare Machine Learning.

The application of artificial intelligence and machine learning (ML) technologies in healthcare have immense potential to improve the care of patients. While there are some emerging practices surrounding responsible ML as well as regulatory frameworks, the traditional role of research ethics oversight has been relatively unexplored regarding its relevance for clinical ML. In this paper, we provide a comprehensive research ethics framework that can apply to the systematic inquiry of ML research across its development cycle. The pathway consists of three stages: (1) exploratory, hypothesis-generating data access; (2) silent period evaluation; (3) prospective clinical evaluation. We connect each stage to its literature and ethical justification and suggest adaptations to traditional paradigms to suit ML while maintaining ethical rigor and the protection of individuals. This pathway can accommodate a multitude of research designs from observational to controlled trials, and the stages can apply individually to a variety of ML applications.

Performance of IRBs in China: a survey on IRB employees and researchers' experiences and perceptions.

BACKGROUND: Performance evaluation is vital for IRB operations. As the number of IRBs and their responsibilities in reviewing and supervising clinical research grow in China, there is a significant need to evaluate their performances. To date, little research has examined IRB performance within China. The aim of this study was to ascertain the perspectives and experiences of IRB employees and researchers to (1) understand the current status of IRBs; (2) compare collected results with those of other countries; and (3) identify shortcomings to improve IRB performance. METHODS: This study was conducted in China from October 2020 to September 2021, using an online survey with the IRB-researcher assessment tool-Chinese version. RESULTS: 757 respondents were included in the analysis and classified into IRB employees, researchers, or those who are both IRB employees and researchers. Overall, the score for an ideal IRB was significantly higher than that of an actual IRB. Compared to the US National Validation study, Chinese participants and American participants both agree and differ in their perspectives on the most and least important ideal items. CONCLUSION: This investigation provides a benchmark of the perceived performance of actual IRBs in China. IRBs in China can be precisely adjusted by targeting identified areas of weakness to improve their performances.

Electronic informed consent criteria for research ethics review: a scoping review.

BACKGROUND: The research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent (eConsent) may be used to assess the research subject's comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby adhering to the beneficence and nonmaleficence principle. This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes. METHODS: The search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation guideline was used to report this work. RESULTS: Of 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs (27%, n = 65) followed by accessibility (24%, n = 56), comprehension engagement (18%, n = 43), autonomy (14%, n = 34), confidentiality (11%, n = 25), language (5%, n = 13), and parental consent (1%, n = 2). Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent. CONCLUSION: The current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/REC members during a review process on electronic informed consent and useful to the future preparation of a checklist.

Professional and academic profile of the Brazilian research ethics committees.

BACKGROUND: Brazil is among the sixteen countries that conducts the most clinical trials in the world. It has a system to review research ethics with human beings made up by the National Commission on Research Ethics (CONEP) and 779 Research Ethics Committees (RECs), in 2017. The RECs are supposed to follow the same rules regarding their membership, although the RECs that review Social Science and Humanities (SSH) researches must respect Resolution 510/16. There are Brazilian RECs that review SSH and clinical trials. This study aimed to analyze the academic professional profile of the members of the CONEP and Brazilian RECs, their adequacy to the norms, and the challenges faced by the REC's Chairs to compose their membership. METHODS: All 779 Brazilian RECs' chairs are invited to fill in a questionnaire informing academic and professional background of the RECs members, and 92 answered. However, eight were excluded for having sent an incomplete questionnaire, leaving a total of 84 participants. The variables were described by absolute and relative frequency. The Chi-square test and ANOVA was used to analyze regional differences related difficulties to compose the committee. The significance level was 95%. RESULTS: The results showed a predominance of members from the biomedical area (57%), while 33% were members of the Social Sciences and Humanities and 5.5% were community representatives. As for the academic degree, there were (45.2%) PhD and (27.9%) masters. The divergences in relation to the guidelines result from the difficulties of having participants in some areas and the little interest in the work carried out by the committees. CONCLUSION: The RECs are partially adequate to the norms and their performance may be compromised by the low participation of community representatives. The organization of REC's specifics to review biomedical research could improve the ethical review process, ensuring a membership more qualified for these protocols.

Using Social Media for Clinical Research: Recommendations and Examples From the Brown-Lifespan Center for Digital Health.

Social media integration into research has increased, and 92% of American social media participants state they would share their data with researchers. Yet, the potential of these data to transform health outcomes has not been fully realized, and the way clinical research is performed has been held back. The use of these technologies in research is dependent on the investigators' awareness of their potential and their ability to innovate within regulatory and institutional guidelines. The Brown-Lifespan Center for Digital Health has launched an initiative to address these challenges and provide a helpful framework to expand social media use in clinical research.