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.
CIPSHI Meeting Calendar
Academic Year 2024-25
CIPSHI Members
PRESIDENT
Yarimar Rosa Rodríguez, Ph.D.
College of Education
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
Víctor E. Bonilla Rodríguez, Ph.D.
College of Education
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.
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.
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.
Initial Review
The steps to requesting the initial review of a protocol are as follows:
- Key research personnel must compete the training required by CIPSHI.
- If you are a student and the project is a thesis or dissertation, the proposal must have been approved conforming you department or school’s procedure.
- Send the following documents to cipshi.degi@upr.edu:
- Consent or assent forms (or substitute documents). Verify that these documents contain the information required by CIPSHI.
- The instruments that will be used to collect the information or data (question or interview guides, questionnaires, observation guides, lists of variables from a data bank, etc.). If electronic forms will be used, provide the link and a PDF copy of the content as it will be accessed by participants.
- Certificate of training required by CIPSHI.
- Other pertinent documents according to the research protocol.
Protocol evaluation procedure:
- Compliance personnel affiliated to DEGI receives and preliminary evaluates the documents.
- If the documentation or information is incomplete, the pending documents or information will be requested in approximately the next 5 business days.
- The Compliance Officer determines the corresponding review:
- Administrative review
- There is no deadline for submission. However, the period during which CIPSHI ceases work should be taken into consideration.
- The research must correspond to the categories of so-called “exempt” research established in federal regulation 45 CFR 46. Note that there are research projects that qualify for administrative review, however, they may require expedited review or review by a CIPSHI member.
- The evaluation takes approximately 7 business days once the application is completed.
- The research is declared exempt from CIPSHI review.
- The authorization has no expiration date, which means that there is no need for renewal.
- Even if the research is declared exempt, it must be conducted following the ethical principles and complying with the applicable institutional or legal regulations.
- When a research is declared exempt from regular CIPSHI review, it is only valid for the protocol described in the application. Changes done to the protocol must be immediately notified through the protocol modification form. The Compliance Officer will notify whether or not the modification requires an additional review by CIPSHI.
- When the research is completed, send the protocol termination notice.
- Expedited review
- There is no deadline for submission. However, the period during which CIPSHI ceases work should be taken into consideration.
- Only minimal risk research qualify.
- The research must fall into the exempt categories, which require a limited review, or expedited as established in federal regulation 45 CFR 46 and on the Federal Registry.
- The application is evaluated by a single member or a panel of CIPSHI members.
- The CIPSHI member doing the evaluation does not have the power to deny the authorization of the protocol. If they believe the protocol must not be authorized, they will refer it for consideration by the full committee at the next available meeting. They will also refer protocols if they consider that they must be evaluated by the full committee due to their complexity or risks.
- The result of the expedited review will be notified in approximately the next 15 business days after the application is completed.
- Full committee
- The protocol must be evaluated at a meeting constituted by a quorum of the CIPSHI members.
- The deadline to submit the applications can be found in the CIPSHI Meeting Calendar.
- The result of the protocol review will be notified in approximately the next 7 business days from the date of the meeting.
- The result of a protocol evaluation can be:
- Authorized with conditions. The protocol cannot begin until the conditions stipulated by CIPSHI in order for it to be authorized are met.
- Deferred review. The protocol is incomplete or requires additional information. The review of the protocol will be suspended until the required documents or missing information is submitted.
- Referred to the full committee. The reason for referring the protocol to the full committee will be notified and it is assigned to the next meeting on the calendar.
- Not authorized by the full committee. The reason for not authorizing the protocol 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.
- Administrative review
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
- Information Privacy Security