CIPSHI
Institutional Committee for the Protection of Human Subjects in Research
Safeguard the rights and wellbeing of human beings who participate as study subjects in research conducted at the Río Piedras Campus.
- Review and authorize protocols for research with human beings as participants or study subjects.
- To keep the university community informed about ethical aspects and principles (autonomy, beneficence, and justice), and the relevant rules and regulations.
- Ensure that the voluntariness and privacy of the individuals in research projects are guaranteed and that the risks of physical, mental, emotional, social, economic, and legal harm (among others) are are minimized.
- Evaluate and contrast the possible risks against the expected benefits of the research.
Announcements & Guides
CIPSHI Meeting Calendar
Academic Year 2024-25
CIPSHI Members
PRESIDENT
Yarimar Rosa Rodríguez, Ph.D.
College of Social Sciences
Vice-prresident
Claudia X. Alvarez Romero, Ph.D.
College of Education
SECRETARY
Aida Jiménez Torres, Ph.D.
College of Social Sciences
EX OFFICIO
Reinaldo Berríos Rivera, Ph.D.
Dean of Graduate Studies and Research
Margarita Moscoso Álvarez, Ph.D
Retired Professo. College of Education
Snejanka Penkova, Ph.D.
Library System
Areliz Quiñones Berrios, Ph.D.
Student Development Counseling Department
Mr. Jorge Ramos Feliciano
Occupational Safety and Environmental Protection Office
Mr. Luis Calderón Reyes
Community Representative
Applicability
The policy of the University of Puerto Rico Río Piedras Campus (UPRRP or Campus) is to provide the maximum level of protection to people who participate in research as study subjects. The UPRRP considers unacceptable and does not support or finance the conduct of research without the pertinent review and authorization from the Institutional Committee for the Protection of Human Subjects in Research (CIPSHI)—the Campus’ Institutional Review Board (IRB)—or from the Dean’s Office of Graduate Studies and Research (DEGI).
This review and authorization is mandatory for research that involves human beings as participants or study subjects and:
- is financed by the UPRRP;
- is done by or under the supervision of any professor, researcher,
- student, employee or agent of the UPRRP, regardless of the origin of the research funds;
- the participants or study subjects are students or employees of the UPRRP; or
- it entails the use of information guarded by the UPRRP about people at an individual level.
Excepciones
There are studies, projects, or research conducted at the UPRRP that, although they include people as study subjects or participants, are not subject to the requirement of review by CIPSHI. This research does not conform to the definition of research with human subjects according to federal regulation 45 CFR 46 or UPRRP regulations.
Research that is not subject to CIPSHI review:
- Institutional research conducted by units or departments whose results are exclusively for internal use, for reports, or for governing agencies that accredit, license, or finance it. CIPSHI review is also not required if the use and dissemination of the information in reports, publications, presentations or conferences is done on behalf of the institution. For example, on behalf of the Student Learning Evaluation Office (OEAE, for its Spanish abbreviation), or on behalf of an academic program. If the data generated in these investigations will be used for personal research, it will require review by CIPSHI/DEGI.
- Course projects or research conducted with the purpose of training students on research techniques and methodologies—as long as the results obtained do not transcend the limits of the classroom or whose experiences will be shared in a limited way at Campus, specifically as class projects and not evaluated by CIPSHI. Professors who teach courses that include research activities with human beings are responsible of training their students on the ethical execution of the project, ensuring that their students have the necessary competencies to intervene or interact with the population of interest, and avoiding or minimizing risks both for their students and potential study subjects. Furthermore, they must inform their students about the institutional requirements to conduct research with human beings. CIPSHI will not do retrospective reviews of completed projects. Therefore, students interested in publishing must have a CIPSHI approved protocol before starting the study.
- Journalistic investigations, including the journalistic projects of students of the College of Information and Communications done as part of their degree requirements. Theses from the College of Information and Communications are subject to CIPSHI review.
- Pilot testing to evaluate the development of a research instrument in which the instrument itself is the object of study. The aim is to evaluate how the questions are formulated and their clarity. There is no intent to collect or publish the personal answers to the questions. However, pilot testing with a sample of participants with the same characteristics as the population of interest is part of the research’s development and has to be evaluated and approved by CIPSHI/DEGI.
- Artistic or graphic projects with human resources if they are not part of an investigation in which they are subjects of study.
Definition of Research with Human Beings as Study Subjects
In federal regulation 45 CFR 46, the concepts of research and human subjects are defined as:
- Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
- Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
- obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
- Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
- Interaction includes communication or interpersonal contact between investigator and subject.
- Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
- Identifiableprivate information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
- Identifiable bioscpecimen is a biospecimen for which the identity of the subject is or may be ascertained by the investigator or associated with the biospecimen.
- Private information must be individually identifiable (that is, the subject’s identity may be easily identified by the researcher or may be associated with the information). Examples of direct identifiers may be name; social security, student, medical record, phone, or licenses number, among others; email address; postal address; Internet Protocol (IP) address; biological samples; photographs; voice recordings; among others. Furthermore, assigning codes that link the person and the combination of variables, such as sociodemographic variables, can indirectly identify a person.
Streamlyne Review Process
Starting in the 2025-26 academic year, the initial protocol review application process will be conducted through the IRB module of the Streamlyne platform.
Protocols reviewed and modifications or renewals of protocols approved before August 2025 will continue to follow the previous procedure.
The Streamlyne platform is an electronic system for the institutional management of the administrative aspects of research. The Streamlyne IRB (Institutional Review Board) module, in turn, facilitates the process of submitting and reviewing research protocols involving human subjects.
The IRB module also serves as a repository for a researcher’s protocols, protocols to which they have been given access as a research supervisor, department director, or other research staff.
Los pasos a seguir para solicitar la revisión inicial de un protocolo son los siguientes:
- Acceda a Streamlyne con su cuenta de correo electrónico si es personal de la UPRRP o solicite acceso si es estudiantes de la UPRRP o investigador/a externo/a.
- El personal clave de la investigación debe completar el adiestramiento requerido por el CIPSHI.
- Si es estudiante y el estudio es una tesis, proyecto o disertación, la propuesta de investigación debe estar aprobada según el procedimiento de su departamento o escuela.
- Prepare las hojas de consentimiento o asentimiento (o documentos sustitutos). Corrobore que estos documentos contienen los elementos y formato requerido por el CIPSHI.
- Prepare los instrumentos que utilizará para recopilar la información o los datos (guías de preguntas o entrevistas, cuestionarios, guías de observaciones, listas de variables de un banco de datos, etc.). Si utilizará formularios electrónicos, presente el enlace y copia en PDF del contenido tal como lo accederán las personas participantes.
- Prepare o gestione otros documentos pertinentes según el protocolo de su investigación.
- Utilice la hoja de cotejo para corroborar que su protocolo esté completo.
- Someta su protocolo a través de la plataforma de Streamlyne.
Proceso de revisión del CIPSHI
- Preevaluación del protocolo:
- El personal de cumplimiento adscrito al DEGI recibe y evalúa preliminarmente los documentos.
- Si la documentación o información está incompleta, se solicitarán los documentos o información pendiente en aproximadamente los próximos 5 días laborables.
- La Oficial de Cumplimiento determina y refiere a la revisión correspondiente: revisión administrativa, limitada o expedita o por el comité en pleno.
- Revisión del protocolo
- Revisión administrativa
- Esta revisión la realiza la Oficial de Cumplimiento.
- No tiene fecha límite para su radicación. Sin embargo, considere el periodo de receso de las labores del CIPSHI.
- La investigación debe corresponder a ciertas categorías de investigación denominada como “exenta” en el reglamento federal 45 CFR 46. Observe que hay investigaciones que califican como “exenta” según este reglamento, sin embargo, pueden requerir la revisión limitada que es prácticamente una revisión expedita o por un miembro del CIPSHI. Además, se referirá a la revisión por un miembro del CIPSHI un protocolo que requiera su peritaje o consulta.
- La revisión administrativa también es para modificaciones menores a protocolos aprobados.
- La revisión administrativa toma aproximadamente 7 días laborables una vez completada la solicitud. Si la revisión es limitada, vea el procedimiento de “revisión expedita”.
- La investigación es declarada exenta de la revisión adicional del CIPSHI.
- La autorización no tiene fecha de expiración por lo que no necesita ser renovada.
- Aunque la investigación se declare exenta, debe llevarse a cabo siguiendo los principios éticos y cumpliendo con las normativas institucionales o legales aplicables.
- La declaración de investigación exenta de la revisión regular del CIPSHI solamente es válida para el protocolo descrito.
- Las enmiendas a estos protocolos deben ser sometidas para la revisión y aprobación administrativa. La Oficial de Cumplimiento referirá a revisión expedita o al comité en pleno si los cambios son sustanciales o alteran las condiciones por las cuales se declaró inicialmente la exención.
- Al finalizar la investigación, notifique la conclusión del protocolo.
- Revisión expedita
- No tiene fecha límite para su radicación. Sin embargo, considere el periodo de receso de las labores del CIPSHI.
- Cualifican solo investigaciones de riesgo mínimo.
- La investigación debe corresponder ciertas categorías de exentas, que requieren una revisión limitada,o a las categorías expeditas establecidas la reglamentación federal 45 CFR 46 y en el Federal Register.
- Son evaluadas por un miembro o un panel de miembros del CIPSHI.
- El miembro del CIPSHI que realiza la evaluación no tiene la potestad para denegar la autorización del protocolo. Si entiende que no debe autorizarlo, lo referirá para la consideración del comité en pleno en la próxima reunión disponible. También referirá protocolos que entienda que, por su complejidad, vulnerabilidad de la población o riesgos deben ser evaluados por el comité en pleno.
- El resultado de la revisión expedita se notifica en aproximadamente los próximos 15 días laborables luego de completada la solicitud.
- Comité en pleno
- El protocolo debe ser evaluado en una reunión constituida por el quorum de los miembros del CIPSHI.
- La fecha límite para radicar solicitudes se encuentra en el Calendario de reuniones del CIPSHI.
- El resultado de la revisión del protocolo se notifica en aproximadamente los próximos 7 días laborables a partir de la fecha de la reunión.
- Revisión administrativa
- El resultado de la evaluación de un protocolo puede ser:
- Autorizado con condiciones. El protocolo no puede iniciar hasta que se cumplan con las condiciones establecidas por el CIPSHI para autorizar el protocolo. Estas condiciones pueden ser para verificación administrativa (señalamientos puntuales) o para verificación por un miembro del CIPSHI o panel de miembros.
- Revisión diferida. El protocolo está incompleto o requiere información adicional. La revisión del protocolo está suspendida hasta que se presenten los documentos o la información requerida.
- Referido al comité en pleno. La razón para referir el protocolo al comité en pleno es notificada y es asignado a la próxima reunión en calendario.
- No autorizado por el comité en pleno. La razón para no autorizar el protocolo es notificada. Puede solicitar una reconsideración respondiendo a los señalamientos del CIPSHI o una apelación si no está de acuerdo, total o parcialmente, con la decisión.
Este manual contiene las instrucciones para el procedimiento de solicitud inicial y otros procesos del ciclo de un protocolo.
Manual de Streamlyne UPRRP -documento descargable
Personal UPRRP:
- Si es personal de la UPRRP, acceda directamente a Streamlyne por Log in with SSO con su cuenta de correo electrónico @upr.edu como nombre de usuario/a (Username) y su correspondiente contraseña.
- Solamente el personal docente o no docente de la UPRRP puede acceder por Log in with SSO.
Si no puede acceder a Streamlyne o al módulo de IRB, solicite acceso completando el formulario: https://forms.office.com/r/RL4XHReR37
Estudiantes UPRRP:
- Si es estudiante de la UPRRP, solicite acceso a Streamlyne completando el formulario: https://forms.office.com/r/RL4XHReR37
- Recibirá el acceso en 2-5 días laborables.
- Acceda a Streamlyne por Log in using a local Streamlyne Research Use
Todo protocolo inicial debe incluir entre los anejos la Narrativa del protocolo.
Narrativa del Protocolo– documento descargable
Plantilla del personal clave
Aneje la Plantilla del personal si su protocolo tiene personal clave de la investigación adicional al que identifique en la sección “Personnel” de Streamlyne.
documento descargable
Formato de los documentos para los anejos
Los documentos que aneje en Streamlyne tienen que estar en un formato específico.
documento descargable
La acción o función de Streamlyne de aprobación Ad Hoc sustituye las firmas de las solicitudes de revisión de los protocolos de los/as directores/as de departamento o supervisores/as de la investigación.
El CIPSHI requiere el visto bueno de los/as directores/as de departamento o unidad para las investigaciones del personal de la UPRRP.
Si la investigación es de un/a estudiante de la UPRRP, su supervisor de tesis, disertación o proyecto tiene que aprobar la solicitud de revisión del protocolo.
Instrucciones para la aprobación Ad Hoc
documento descargable
Hoja de cotejo
Evite someter una solicitud incompleta. Corrobore la documentación de su protocolo con la hoja de cotejo.
Todas las actividades de una investigación deben llevarse a cabo de acuerdo a lo establecido en el protocolo autorizado por el CIPSHI. Cualquier modificación a un protocolo aprobado, incluyendo cambios en los documentos de consentimiento o asentimiento e instrumentos, requiere la consideración y reautorización del CIPSHI.
El único cambio permitido sin la previa autorización del CIPSHI es aquel para proteger a las personas participantes o sujetos de estudio o evitar que sufran daños. De esto ocurrir, se debe notificar al CIPSHI en o antes de los próximos dos (2) días laborables luego del suceso.
Vea en el Manual Streamlyne UPRRP las instrucciones para someter la solicitud de enmienda o modificación.
Los protocolos revisados y aprobados mediante el procedimiento administrativo o expedito del CIPSHI no tienen fecha de expiración de la autorización a menos que el CIPSHI determine y justifique una autorización por un tiempo fijo. Periódicamente, el CIPSHI monitoreará a estos protocolos mediante breves informes de progreso hasta que el/la investigador/a notifique el cierre del protocolo al concluir la investigación.
En cuanto a los protocolos aprobados por el comité en pleno, el CIPSHI determina si la investigación cualifica para una autorización extendida (sin fecha límite) o por un periodo fijo de un año o menos.
La determinación del CIPSHI para autorizar un protocolo por un periodo fijo de un año o menos la fundamentará en los riesgos de la investigación, vulnerabilidad de la población, incidentes o eventos adversos ocurridos, historial de incumplimiento del personal a cargo de la investigación o surgimiento de nueva información, entre otros criterios.
Si la autorización de un protocolo expiró, debe detener las actividades de la investigación relacionadas con las personas participantes. Deberá informar inmediatamente al CIPSHI si detener la investigación puede perjudicar a alguna persona participante que se encuentre recibiendo un servicio o intervención como parte de la investigación.
Vea en el Manual Streamlyne UPRRP las instrucciones para someter la solicitud de renovación.
La investigación con seres humanos como sujetos de estudio conlleva riegos para las personas que directamente participan en la investigación o para terceras personas indirectamente involucradas.
Los/as investigadores/as suelen anticipar los riesgos e incomodidades que podría conllevar para las personas participantes de sus investigaciones.
El CIPSHI evalúa y aprueba las medidas que proponen los/as investigadores para eliminar o minimizar estos riesgos e incomodidades.
Sin embargo, no siempre es posible anticipar todos los problemas o incidentes que podrían suceder durante el desarrollo de una investigación y que puedan afectar el bienestar y la seguridad de las personas participantes.
Los/as investigadores/as son responsables de informar al CIPSHI los eventos adversos o no esperados en o antes de 10 días laborables.
Si el incidente es de tal magnitud que afecta de forma inminente la seguridad y bienestar de la persona participante o terceras personas, deberán suspenderse de inmediato las actividades de la investigación relacionadas con el problema y notificar el incidente en o antes de 5 días laborables. Las actividades investigativas podrán ser reanudadas luego que el CIPSHI así lo autorice.
Utilice la Guía para el informe de incidente inesperado o evento adverso para preparar su informe.
Vea en el Manual Streamlyne UPRRP las instrucciones para notificar la ocurrencia de un evento adverso o inesperado.
Los/as investigadores/as son responsables de notificar el cierre o conclusión de sus protocolos.
Un protocolo de investigación se considerada concluido cuando se completa, se transfiere a otra jurisdicción o se cancela.
Para propósitos del CIPSHI, un protocolo se considera completado cuando:
- La interacción o intervención con las personas participantes y la recopilación de datos ha concluido, se ha realizado un análisis primario de la investigación y se concluye que no es necesario volver a la fuente original que contiene la identidad de los sujetos (personas, expedientes, datos crudos, listado de participantes, etc.) para recopilar más información.
- En los proyectos de investigación de estudiantes como tesis y disertaciones, el protocolo se considera concluido cuando la tesis o disertación es aprobada por su correspondiente comité o programa de estudio.
Antes de cerrar un protocolo, también tiene que considerar las especificaciones de las agencias que regulan o financian la investigación. Estas agencias pueden requerir que el protocolo permanezca activo por un período más extenso y tenga vigente la aprobación del CIPSHI.
Los/as investigadores/as son responsables de utilizar, almacenar, conservar y disponer de los datos, documentos y materiales relacionados con las personas participantes o sujetos según las condiciones y el tiempo establecido en el protocolo autorizado por el CIPSHI.
Vea en el Manual Streamlyne UPRRP las instrucciones para notificar el cierre de un protocolo
Review process prior to August 1, 2025
If you began your protocol review process (initial, modification, or renewal) or if it was approved before August 1, 2025, continue with the following procedures:
Training
It is institutional mission of the Río Piedras Campus of the University of Puerto Rico (UPRRP) to protect human beings who participate as study subjects in research. Additionally, the UPRRP is committed to training the research personnel on issues related to the ethics and integrity of research, as well as the wellbeing, the rights, and the protection of people’s privacy.
Any research protocol to be considered by the Institutional Committee for the Protection of Human Subjects in Research (CIPSHI) must have certification that all key personnel associated with the research has completed training on research with human beings, regardless of the type of review requested. Without evidence, the request for review is incomplete.
Key personnel includes: the principal investigator, co-investigators, student’s research supervisors, students, assistants, and employees assigned to a research who will have direct contact with participants or with private information that may help identify them directly or indirectly. Student research supervisors are responsible for these investigations and therefore must have access to the raw data.
Todo protocolo de investigación a ser considerado por el Comité Institucional para la Protección de los Seres Humanos en la Investigación (CIPSHI), independientemente del tipo de revisión, tiene que tener la certificación de que el personal clave asociado a la investigación ha completado el adiestramiento sobre la investigación con seres humanos. La solicitud de revisión está incompleta sin esta evidencia.
El personal clave incluye a investigador/a principal, coinvestigadores/as, supervisores/as de investigaciones de estudiantes, estudiantes, asistentes y empleados/as adscritos/as a una investigación que tendrán contacto directo con las personas participantes o mediante información privada que pueda identificarles directa o indirectamente. Los/as supervisores/as de investigaciones de estudiantes son responsables por estas investigaciones y, por lo tanto, tienen que tener acceso a los datos crudos de la investigación.
CIPSHI requires all key research personnel take the human subjects research course provided by theCollaborative Institutional Training Initiative (CITI Program). The certificate must be datedfive (5) yearsold or less;Circular Letter No. 18. (2018-19).
To register for theCITI Program, locate our institution with its name in Spanish: “Universidad de Puerto Rico, Recinto de Río Piedras”.
Please ensure that you select one of the following alternatives for human subjects research courses:
- In English (Question 1):
- Biomedical Research Investigators
- Social & Behavioral Research
- IRB Members
- Research with data or laboratory specimens
- In Spanish (Question 5):
- Investigaciones con seres humanos
TheCITI Program course on research with human subjects includes several required, elective and optional modules on ethical principles, federal regulations, conflict of interest, and international considerations. In addition, it contains modules focused on different contexts such as research with students, minors, staff, prisoners, patients, vulnerable populations, Internet research and research with data, files or samples of individuals, among others.
The CITI Program courses are considered basic. It its the responsibility of all key research personnel to be trained in all the specific aspects of their investigation.
The CITI Program Responsible Conduct of Research course—although it is recommended for all research personnel—is not required by CIPSHI for the evaluation of the protocol.
Research personnel from outside the UPRRP may present the training certification required by the institution to which they are affiliated. Whether the training content is equivalent to that required by CIPSHI will be evaluated.
The Organic Act (Act No. 2012 approved on January 3, 2012) requires that each public employee receive every two years a minimum of twenty (20) hours of continuing education on government ethics, standards of sound public administration and values.
Personnel from the UPRRP or the public system may request that training related to research with human beings be validated as hours of continuing education for purposes of the Government Organic Act. The validation request must be managed by each individual as an alternative method of education through the platform of the Center for the Development of Ethical Thought (CDPE, for its Spanish abbreviation) of the Puerto Rico Government Ethics Office.
For more information you can also contact the UPRRP liaison staff with the Government Ethics Office (http://etica.uprrp.edu/) attached to the Human Resources Office (787-764-0000, Ext. 84400).
El personal de la UPRRP o del sistema público puede solicitar que los adiestramientos relacionados con la investigación con seres humanos sean convalidados como horas de educación continua para propósitos de la Ley de Ética Gubernamental. La solicitud de convalidación la debe gestionar cada individuo como un método alterno de educación a través de la plataforma del Centro para el Desarrollo del Pensamiento Ético de la Oficina de Ética Gubernamental de Puerto Rico.
Para más información también puede contactar al personal de enlace de la UPRRP con la Oficina de Ética Gubernamental (http://etica.uprrp.edu/) adscrito a la Oficina de Recursos Humanos (787-764-0000, Ext. 84400).
Informed Consent
The process of taking informed consent is essential for the protection of people who participate as volunteers in research. No research can be conducted ethically if people are not adequately informed about what it means to be a study subject or research participant.
Informed consent is the process by which a person, as a potential research participant, is informed of the purpose of the research, the procedure to which the person will be exposed, alternative procedures, risks and possible benefits of the research. The participant’s rights are discussed, it is settled how their information or data will be handled and divulged and the strictly voluntary nature of their participation is also discussed. This dialogue includes corroboration of the person’s understanding.
Typically, this process includes a document—informed consent form—which contains the elements required by CIPSHI to communicate to the person the aspects concerning their participation in a simple and understandable language.
If the person agrees to participate in the research, they sign the informed consent form and receive a copy of the consent form. This is the standard process for taking informed consent. If it is not feasible to carry out a specific investigation with this standard process, it can be adapted through waivers if certain conditions are met and justified.
- Examples of waivers in the informed consent standard process:
- Exempt the written document for oral consent.
- Eliminate one or more of the elements of the standard consent form (official title of the research, participant’s signature, etc.).
- Provide partial or false information.
- Taking consent after the intervention.
- For participants who are minors, obtain the permission of only one parent or representative.
- Recruit minors without the permission of their parental or legal representatives (for example, university students).
- Some of the criteria for granting waivers:
- The research is minimal risk.
- Research is not viable without the waiver.
- The research does not infringe on the rights or safety of the participants.
- The purpose of the waiver is to protect people’s identities.
- Participants will receive the appropriate information (for example, the information sheet in an electronic form).
If the person has limited autonomy or capacity for consent, such as minors, the document is titled informed assent form. Minors or people with physical or mental limitations who are under the legal guardianship of someone else must give their consent to the extent their capacity allows.
Use the following guides and documents to prepare the informed consent form.
Modifications to Authorized Protocols
All research activities must be carried out in accordance with the provisions of the protocol authorized by CIPSHI. Any modification to an authorized protocol, including changes to consent or assent documents, requires consideration and reauthorization by CIPSHI.
The only change permitted without prior authorization from CIPSHI is that to protect participants or study subjects or prevent them from suffering harm. If this occurs, CIPSHI must be notified on or before the next two (2) business days after the event.
El único cambio permitido sin la previa autorización del CIPSHI es aquel para proteger a las personas participantes o sujetos de estudio o evitar que sufran daños. De esto ocurrir, se debe notificar al CIPSHI en o antes de los próximos dos (2) días laborables luego del suceso.
- Send the following documents in Word or PDF format to cipshi.degi@upr.edu:
Authorized Protocol Modification Request Form
- Other added or amended documents such as consent or assent forms, instruments, call flyers, etc. If you use electronic forms, please submit the link and PDF copy of the contents.
- Administrative and compliance staff verify that the request is complete and will refer it for the appropriate review:
- Administrative, if the changes are minor (for example, correcting or updating information on the consent form).
- Expedited, if the changes do not alter the minimum risk level.
- Full Committee; see the Meeting Calendar for the application submission deadline.
- The results of the modification request evaluation are reported in approximately:
- 7 business days for administrative review,
- 10 business days for expedited review or
- 7 business days after the date of the full committee meeting.
- The result of the modification request evaluation can be:
- Authorized.
- Authorized with conditions. The modification should not be executed until the conditions established by CIPSHI to authorize the protocol modification are met.
- Deferred review. The application is incomplete or requires additional information. The review is suspended until the required documents or information are submitted.
- Referred to the full committee. The reasons for referring the request to the full committee are informed and it is assigned to the next meeting on the calendar.
- Not authorized by the full committee. The reasons for not authorizing the modification are notified. You may request a reconsideration by responding to CIPSHI’s findings, or an appeal if you disagree, in whole or in part, with the decision.
Renewals or Continuous Reviews of Authorized Protocols
Protocols reviewed and authorized by CIPSHI’s administrative or expedited procedure have no expiration date unless CIPSHI determines and justifies the authorization be for a fixed period of time. Those protocols will be periodically monitored by CIPSHI through brief progress reports until the researcher notifies that the investigation has concluded.
Regarding the protocols authorized by the full committee, CIPSHI will determine whether the research qualifies for an extended authorization (with no deadline) or for authorization for a fixed period of one year or less.
CIPSHI’s determination to authorize a protocol for a fixed period of one year or less will be based on the risks of the research, the vulnerability of the population, incidents or adverse events that have occurred, history of non-compliance of the personnel in charge of the research or emergence of new information, among other criteria.
En cuanto a los protocolos aprobados por el comité en pleno, el CIPSHI determina si la investigación cualifica para una autorización extendida (sin fecha límite) o por un periodo fijo de un año o menos.
La determinación del CIPSHI para autorizar un protocolo por un periodo fijo de un año o menos la fundamentará en los riesgos de la investigación, vulnerabilidad de la población, incidentes o eventos adversos ocurridos, historial de incumplimiento del personal a cargo de la investigación o surgimiento de nueva información, entre otros criterios.
As long as the protocol remains active, it is subject to continuous reviews by CIPSHI.
CIPSHI’s authorization must be renewed if the research has not been concluded during the authorization’s effective date. Typically, these authorizations are granted for one year from the date of the approval of the protocol. For example, if the initial approval was on May 17, 2022 and is established to be valid for one year, the authorization expiration date is May 17, 2023.
CIPSHI authorization automatically expires if the renewal process is not carried out on or before the end of the approval date. If CIPSHI’s authorization expires without being renewed, initial contact, recruiting, and activities involving participants or study subjects must be halted until the authorization is resumed. The only exception to this is when stopping the research would harm the participants. These are usually investigations with direct benefits for the participants such as, for example, a psychological or therapeutic treatment or the implementation of a teaching method. This situation must be notified to CIPSHI on or before the next two (2) business days.
The renewal request must be submitted on or before 15 business daysbefore the authorization expires. If the renewal request must be evaluated by the full committee, it must be submitted according to the deadlines established in the CIPSHI meeting calendar.
Renewal requests may be reviewed through the expedited procedure if:
- The protocol was initially reviewed using the expedited procedure.
- The protocol was initially reviewed by the full committee and CIPSHI determined and documented that the continuous reviews (renewal) qualify for expedited procedure. This means that the risks of the research were minimized by the proposed measures to protect the participants or the research does not involve risks greater than the minimum. This information is found in the CIPSHI authorization document.
- CIPSHI’s president or designated member has preliminarily or completely evaluated the renewal application documents and states that the review qualifies for expedited review if:
- The research is permanently done with recruiting new participants, the intervention with all participants has concluded and the research remains active only for long-term follow-up of the participants.
- Recruitment of participants has not begun and no additional risks have been identified.
- Research activities are limited to data analysis.
- Send the following documents in Word of PDF format to cipshi.degi@upr.edu:
Renewal Request
- Consent or assent forms used and, if applicable, to be used in the research.
- If applicable, copy of the current training certificate of key research personnel.
- Administrative and compliance personnel will verify that the request is complete and will refer it for appropriate review.
- The result of the evaluation is notified in approximately:
- 10 business days if the review is expedited or
- 7 business days from the date of the meeting.
- The result of the evaluation of the protocol renewal request can be:
- Authorized with conditions. The protocol cannot continue until the conditions established by CIPSHI in order to authorize the renewal are met.
- Deferred review. The application is incomplete or requires additional information. The review is suspended until the required documents or information are submitted.
- Referred to the full committee. The reason for referring the application to the full committee is informed and the application is assigned to the next meeting on the calendar.
- Not authorized by the full committee. The reason for not authorizing the renewal is notified. You may request a reconsideration by responding to CIPSHI’s findings, or an appeal if you disagree, in whole or in part, with the decision.
Protocol Termination Notice
Researchers are responsible for notifying the termination of the protocol authorized by CIPSHI.
A research protocol is considered terminated when it is completed, transferred to another jurisdiction, or canceled.
For CIPSHI purposes, a protocol is considered completed when:
- Interaction or intervention with participants and data collection has concluded; a primary analysis of the research has been conducted and it is concluded that it is not necessary to go back to the original source containing the identity of the subjects (people, records, raw data, participants list, etc.) to collect more information.
- In student research projects such as theses and dissertations, the protocol is considered completed when the thesis or dissertation is approved by the corresponding committee or program of study.
Before terminating a protocol, you also have to consider the specifications of the agencies that regulate or fund the research. These agencies may require that the protocol remain active for a longer period and have current CIPSHI approval in place.
Researchers are responsible for using, storing, preserving, and disposing of data, documents, and materials related to participants or study subjects according to the conditions and time established in the protocol authorized by CIPSHI.
Form: Protocol Termination Notice
CITI PROGRAM
- Responsible Conduct of Research
- Conflicts of Interest
- Human Subjects Research
- Laboratory Animal Welfare
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