- South Africa
- Hong Kong
- New Zealand
- Czech Republic
- United Kingdom
Appendix 1: Pfizer Human Research Protection Program
Pfizer fosters a research environment that promotes respect for the rights and welfare of individuals recruited for, or participating in, research conducted by Pfizer. Research conducted by Pfizer is guided by the principles of the US Belmont Report 1974 (i.e., respect for persons, beneficence, and justice). Pfizer's research is required to comply with to all applicable local laws and regulations wherever the organization or its agents conduct research. Pfizer has established a Human Research Protection Program (HRPP) to ensure that these goals are met.
The mission of Pfizer's HRPP is to:
- Safeguard and promote the health and welfare of human study participants by ensuring that their rights, safety and well-being are protected;
- Provide timely monitoring of human research projects; and
- Ensure high quality ethical review in the review of research.
The HRPP includes mechanisms to:
- Establish a formal process to monitor, evaluate and continually improve the protection of human study participants.
- Dedicate resources sufficient to do so.
- Exercise oversight of human subject participant protection.
- Educate Pfizer study teams and investigators and research staff about their ethical responsibility to protect study participants.
The Pfizer HRPP operates under the authority of the designated Organizational Official for the company. The Organizational Official oversees the functional areas that are responsible for the following:
- Implementing and maintaining quality control systems within the HRPP.
- Training and educating investigators and research staff on their regulatory and ethical responsibilities to protect study participants in research.
- Selecting qualified investigative sites to conduct research on behalf of the organization.
- Implementing systems for monitoring the data and safety of research.
- Ensuring that procedures are in place to have research involving human study participants reviewed by a qualified Institutional Review Board/Independent Ethics Committee (IRB/IEC).
- Informing participating investigators and IRBs/IECs of any new findings discovered by the organization during the course of research that could affect the safety or medical care of study participants or influence the IRB/IECs ongoing approval of research.
- Communicating findings from data and safety monitoring reports (such as those from a Data Monitoring Committees [DMCs]) to participating research sites and IRBs/IECs in accordance with the protocol.
- Arranging for the communication of findings from a closed study to past study participants when those findings suggest that the safety or medical care of past study participants could be affected.
The Organizational Official oversees Pfizer functional areas to determine whether the resources allocated to the HRPP are sufficient. On a regular basis, and in accordance with the Pfizer budgetary process, the following are evaluated:
- Whether study teams have the appropriate resources in terms of personnel, budget, and materials to train sites on their responsibilities to protect study participants in research.
- Whether there is an appropriate number of qualified staff (ICH-GCP (E6)) to train internal staff and investigators and research sites on their responsibilities to protect study participants in research.
- Whether there is an appropriate number of qualified staff to perform data and safety monitoring functions.
- Whether there is an appropriate number of staff to qualify the IRBs and IECs with whom the organization does business.
- Whether there are an appropriate number of qualified members of staff to ensure that the research sites with which the organization does business are qualified to conduct research.
Management of each Pfizer study team and functional area submit their requested operating budgets in terms of money, staffing, space, and educational needs on an annual basis. The Organizational Official considers budgetary requests against the HRPP resource considerations described above.
3. Feedback from Investigators
Pfizer ensures that investigators and research staff can bring forward concerns or suggestions regarding the HRPP, including the ethics review process. Investigators and research staff should direct such communications to the study monitor responsible for their specific site. The monitor is responsible for addressing the investigator or staff's questions, concerns, or suggestions. If the monitor cannot answer a question or address a concern raised by a researcher, it is forwarded to the project manager for follow-up. Investigators are informed of how to bring questions, concerns, or comments regarding the HRPP to the study monitor in training materials provided to sites prior to study start.
4. Auspices of the HRPP
The protection of the rights and welfare of individuals enrolled in Pfizer-sponsored research is of paramount concern. Therefore, processes for protecting the rights and welfare of individuals must be adhered to any time that Pfizer is conducting research with human subjects. Pfizer considers itself to be conducting research involving human subjects whenever a research activity meets Food and Drug Administration (FDA) or International Conference on Harmonization Guidelines for Good Clinical Practice (ICH-GCP) definitions of "clinical investigation" and "human subject" or "clinical trial/study" and "subject/trial subject." These terms are defined in the Pfizer SOP Glossary as "clinical trial/study" and "subject/trial subject," respectively.
5. Organizational Conflict of Interest and Avoidance of Undue Influence
Pfizer has a responsibility to promote high standards in its Research and Development enterprise by conducting its affairs in an ethical manner. Due to the proprietary nature of its research, Pfizer acknowledges that it must be vigilant in ensuring that the rights and welfare of human subjects are not compromised because of proprietary motivations. Pfizer secures ethical review of its research activities from completely independent IRB/IECs, and places the conduct of research with external investigators and study sites, all of which minimizes the potential impact of internal business considerations on these functions. To ensure that the responsibilities of IRBs/IECs are honored, Pfizer must comply with all final determinations and requirements of the reviewing IRBs/IECs. No individual, including investigators, officials of Pfizer or other representatives from Pfizer can overrule the decisions of the reviewing IRB/IEC.
Additional considerations and practices for ensuring integrity in the Pfizer research process are described in the Summary of Pfizer Policies on Business Conduct (Blue Book) and Pfizer Corporate Policy WRD Policy 201 Anti Corruption, GPIHP [Global Policy on Interactions with Healthcare Professionals] and External Funding Controls.
Any attempts to unduly influence an investigator, member of the research staff, or an IRB/IEC is not tolerated. Such attempts should be reported to the Pfizer and is investigated by a member of the Pfizer Compliance Division, Research & Development.
6. Ethical Review of Research
6.1 Review of Protocols
Studies using multiple US sites may use a central (independent, commercial) IRB, but only central IRBs that have accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). For studies where an AAHRPP-accredited IRB will not already be involved in the review of research, Pfizer ensures that an AAHRPP-accredited IRB/IEC provides an ethical review of the research (i.e., PERC review).
The PERC considers each of the regulatory criteria for the approval of research and oversight of ethical and study design issues. The PERC will not be designated as an IRB of record for the study. The site IRB/IEC will provide their normal review of the risks and benefits of the research and the study design.
6.2 Continuing Review and Amendments
When the PERC is involved in the ethical review of a study, it also reviews all proposed substantial amendments according to CT02-GSOP Interventional Clinical Protocol Development and Risk Assessment SOP and CT12-POL Interactions with Institutional Review Boards and Independent Ethics Committees Policy. . For studies in which there is a Data Monitoring Committee (DMC) established in accordance with CT 22 Use of Data Monitoring Committees and Conduct of Interim Analysis SOP Pfizer relies on the DMC to monitor the study in accordance with the DMC Charter for that study to ensure that the risks continue to be reasonable in relationship to the anticipated benefits.
According to CT22 — Use of Data Monitoring Committees and Conduct of Interim Analysis SOP, following DMC meetings, any recommendations made by the DMC are promptly reviewed by Pfizer Senior Management. Senior Management conveys these recommendations to the Study Team, and the Study Team forwards this information to investigators and site IRBs/IECs. The Study Team forwards these DMC recommendations to the PERC, along with any substantial protocol amendments or modifications made in response to the DMC recommendations. If recommendations of the DMC should be enacted immediately to protect the safety of subjects, these may be implemented prior to PERC review of the resulting protocol changes.
After incorporation of any further modifications to the protocol or other study related documents resulting from the PERC review, the Study Team distributes any revised protocol and or/other study related documents to Investigators. Investigators will then submit these changes to their respective local IRB/IECs for review.
6.3 Training and Education
As described in ADM01-GSOP Model for Clinical and Medical Controlled Documents SOP and ADM02-GSOP Development and Management of Training SOP, Pfizer has a training program and learning management system for all Pfizer employees. These training and education efforts contribute to the protection of the rights and welfare of human subjects in Pfizer-sponsored research. Supervisors within each Pfizer department and team are responsible for ensuring that their subordinates fulfill Pfizer training requirements. Employees who do not achieve these requirements cannot perform their delegated duties until training and education requirements are fulfilled. Ongoing non-compliance with these requirements could result in termination.
In addition to these internal training activities, Pfizer also requires training and education of research sites that Pfizer contracts with to conduct its research. The Pfizer required Investigator GCP Training provides investigators and research staff with human research protections training including, but not limited to, the following topics:
- Training on the sponsor's and investigators responsibilities as defined in ICH-GCP (E6) and FDA 21 CFR 312 and 812.
- Obtaining IRB/IEC approval for changes in research
- Complying with the IRB/IEC's requirements and determinations and the authority of the IRB/IEC.
- Obtaining continuing approval of research.
- Reporting possible non-compliance.
- Reporting unanticipated problems involving risks to study participants or others.
- The informed consent process and documentation of informed consent.
- Disclosing potential conflicts of interest.
- Reporting potential safety events to Pfizer.
- Communications between the investigator and the study monitor.
Research sites that do not complete training and educational requirements for a particular study will not be initiated for study participation.
6.4 Community Engagement, Outreach and Communications with Study Participants
As part of its mission of social responsibility and ensuring the highest levels of protection for study participants, Pfizer seeks to enhance the understanding of current study participants, prospective study participants, and communities about the clinical research process.
When appropriate based on the indication under study, Pfizer actively works with disease-community advisory boards, conducts focus groups on perceptions towards research and research goals, and engages advocacy groups in specific disease areas. Each of these activities is performed with the intent of engaging communities in the research process. Additionally, for its public health initiatives, such as vaccine development, Pfizer coordinates with governmental and non-governmental agencies to offer public education about vaccine research and the eradication of disease through the use of vaccines.
In addition to Pfizer's outreach activities described above, Pfizer provide information to prospective and current study participants on the Pfizer website ıClinical Research and Trialsı and at the Understanding Clinical Trials section of the Clinicaltrials.gov (http://clinicaltrials.gov/ct2/info/understand) to enhance their understanding of the research process.
In accordance with the annual evaluation schedule of the HRPP's resources described in the Governance section above, Pfizer also evaluates its outreach activities on an annual basis to determine whether they continue to be adequate. An evaluation of these outreach materials and activities is reviewed with each of the departments and teams responsible for their development and a report is made to the Organization Official detailing, what, if any, changes are needed to Pfizer's current outreach activities. If outreach activities are determined to be insufficient, new activities are recommended for implementation.
Pfizer ensures that there are safe, confidential, and reliable channels for current, prospective, or past study participants to discuss problems, concerns and questions, obtain information, or offer input about Pfizer's research or HRPP. Primarily, Pfizer ensures that the informed consent documents direct study participants to the IRB/IEC with any questions, concerns, or comments about the research study or their rights and welfare as subjects. As stated previously in this section, prospective study participants can also access the Understanding Clinical Trials section of the Clinicaltrials.gov website through the Pfizer website to obtain information about the clinical research process and their rights as study participants.
When Pfizer is contacted directly by current or former study participants, by contacting Pfizer these communications are typically routed to the investigator for follow-up with the study participants. Based on these communications, investigators can contact the appropriate Pfizer representative (e.g., monitor) if they are uncertain about how to answer specific questions, address concerns, or require additional input. Depending on the nature of the event, the investigator may also be directed to the IRB/IEC for additional information and guidance.
6.5 Regulatory Compliance and Cultural Context
As Pfizer's research activities span many different countries and locations, Pfizer's Regulatory and Safety Groups are responsible for identifying country-specific and local regulations relevant to the protection of human subjects. Study teams work with regulatory and safety representatives on a project-by-project basis to ensure that research will be conducted in accordance with local laws. Pfizer typically uses in-country study teams to work with investigators and research staff, clinical research organizations (CROs), and IRBs/IECs. This process ensures that, beyond compliance with local laws, local context and cultural customs are understood and considered in the conduct of research.
6.6 Reportable Events
Pfizer ensures that unanticipated problems involving risks to subjects or others and potential cases of non-compliance are reported by research sites to IRBs/IECs. Pfizer defines an unanticipated problem involving risks to subjects or others as follows: Unanticipated problems involving risk to participants or others. Unanticipated problems involving risks to participants or others refer to any incident, experience, outcome, or new information that:
- Is unexpected
- Is related or possibly related to participation in the research, and
- Indicates that subjects or others are at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
When Pfizer becomes aware of unanticipated problems involving risks to subjects or others or cases of possible non-compliance that are related to a study and not to an individual site, Pfizer reports these events to the reviewing IRBs/IECs.
Non-compliance is defined as a failure to follow the regulations governing the conduct of research, regulations governing the protection of study participants, or the requirements and determinations of the IRB/IEC. Any potential non-compliance should be reported by a site to Pfizer as well as the IRB/IEC for review. If applicable, a reported event of non-compliance must also be managed in accordance with requirements defined by QMS01-GSOP.