The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) promotes high-quality research through an accreditation process that helps organizations worldwide strengthen their human research protection programs (HRPPs).

To earn accreditation, organizations must provide evidence—through policies, procedures, and practices—of their commitment to scientifically and ethically sound research and to continuous improvement.

The goals of accreditation are to:

• Improve the systems that protect the rights and welfare of individuals who participate in research, and
• Communicate to the public the strength of our commitment to the protection of human research participants.

Tufts Health Sciences’ Human Research Protection Program (HRPP) accreditation largely depends on these interviews during the site visit. You will be expected to:

• Understand the Tufts Health Sciences HRPP structure
• Know your role in the Tufts Health Sciences HRPP
• Know where to find Tufts Health Sciences HRPP policies
• Know how to report noncompliance and adverse events
• Understand and describe the ethical aspects, the purpose, and the value of your work
• Know the regulatory standards that apply to your research
• Know IRB application terminology and describe your IRB submissions
• Understand what constitutes a conflict of interest
• Know how a potential conflict of interest is disclosed and reviewed at Tufts Health Sciences
• Describe the human subjects training you have had (e.g. CITI, HIPAA training, GCP)
• Know how to recruit subject ethically and in an equitable manner while adhering to inclusion/exclusion criteria

If interviewed, we recommend that you respond directly to the question asked. If a question seems unrelated to the type of work you do, please let the interviewer(s) know. For example, if a question regarding Food and Drug Administration (FDA) regulations is asked, a social/behavioral researcher should let the interviewer(s) know that drugs or medical devices are not part of their research. Additionally, if you do not know the answer, let the interviewer know how you would go about finding out the answer (i.e. asking your superior, referring to a specific website or document, etc.) Below are examples of the topics that might be covered during site visit.

The following section summarizes key elements of the Tufts Health Sciences HRPP structure that you should be familiar with for your interview. The source of this information is the HRPP Plan.

Helen Boucher, MD, FACP, FIDSA, Dean and Professor of Medicine and Tufts University School of Medicine (TUSM) Chief Academic Officer, serves as the Institutional Official (IO) for the Tufts Medical Center and Theodore Myatt, ScD, Associate Vice Provost for Research Integrity, serves as the IO for Tufts University.  Together, they are responsible for the conduct of research at Tufts Health Sciences. The IOs established the HRPP at Tufts Health Sciences.

The purpose of the HRPP is to protect the rights and welfare of human subjects participating in biomedical and social behavioral research conducted at Tufts Health Sciences or elsewhere by Tufts faculty, staff and trainees; promote compliance with relevant legal requirements and ethical standards at all levels; and support investigators in their research activities.

The HRPP is supported by:

• Tufts Medical Center Research Administration and Tufts University Office of Research Administration
• Tufts Health Sciences IRB Office and Tufts Social, Behavioral & Educational Research (SBER) IRB Office
• Tufts Health Sciences Executive Committee
• The Medical Center to which faculty, staff, and trainees engaged in human research are appointed
• The IRBs (IRB-RED and IRB-BLUE)
• Academic units, including schools, colleges, and other academic units to which faculty, staff, and trainees engaged in human research are appointed
• Other research review and support units and committees, such as the Scientific Review Committee, Conflict of Interest Committees, Investigational Drug Service, Institutional Biosafety Committee, Radiation Safety Officer and Committee
• Key executive and administrative offices, including the Office for Technology Transfer and Industry Collaboration and Legal Counsel, Tufts Medical Center Internal Audit and Corporate Compliance Office, Tufts University Audit and Management Advisory Services, and Tufts Clinical and Translational Science Institute

Investigators have primary responsibility for protecting the rights and welfare of human subjects. Safeguarding human subjects takes precedence over the goals and requirements of any research endeavor. The principal investigator (PI), co-investigator (CO-I), and other members of the research team are expected to be knowledgeable about and adhere to:

• The Belmont Report identifies and summarizes three main ethical principles that should govern research with human subjects:
  • Respect for persons (autonomy/voluntary participation/adequate information)
  • Beneficence (risks of research are reasonable in relation to the benefits the research may provide to subjects or science)
  • Justice (selection of subjects is equitable and is representative)
• The Common Rule (45 CFR 46) is the federal regulatory framework that governs federally funded research with human subjects and codifies the ethical principles of the Belmont Report. Under the Common Rule, research with human subjects is defined as follows:
  • Research – A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
  • Human subject – A living individual about whom an investigator (whether professional or student) conducting research obtains: (1) data through interaction or intervention, or (2) identifiable private information.
• 21 CFR 50 and 21 CFR 56 serve as the regulatory framework for research regulated by the FDA (i.e., research involving drugs, devices, biologics). This set of regulations is derived from the Common Rule, but there are some notable differences in their content.

• Other federal and state laws and regulations that apply to research (i.e. DOD, ED, EPA).

• Institutional policies and procedures.

Investigators and research staff have a responsibility for ensuring research is conducted in compliance with IRB, as well as other institutional and regulatory requirements. Below are some requirements that investigators and research staff should be aware of related to this responsibility:

• All research with human subjects must obtain IRB review and approval or a determination of exemption before work can begin.
• The requirements of the IRB (i.e., initial review, continuing review, modifications, and reporting of adverse events and unanticipated problems) must be met.
• Research must be conducted as specified in the IRB-approved protocol.
• All proposed changes to the research, no matter how minor, must be approved by the IRB prior to implementation unless necessary to eliminate immediate hazard to subjects.
• PIs are responsible for the content of all submissions to the IRB (e.g., initial application, supporting documents, etc.).
• Materials must be submitted to the IRB in a timely fashion (e.g., requests for changes, stipulations, continuing review applications, etc.).
• Reportable New Information (RNI) must be reported to the IRB within 5 business days of learning of the issue. RNI is any unanticipated problem involving risk to subjects or others, non-compliances, and other events.
• An Unanticipated Problem (UP) is an event that is not expected in terms of its nature, severity, or frequency and for which there is a reasonable possibility that the event may have been caused by or linked to the research. The event suggests that the research places subjects or others at greater risk of harm than previously known or recognized.
• Potential noncompliance with laws, regulations, or IRB requirements by the research team or others must be reported, even if this noncompliance was unintentional or discovered during the course of quality assurance activities. Subjects being exposed to unnecessary risk may also be reported as potential noncompliance.
• Protocol deviations, unresolved subject complaints, or loss of research data must be reported to the IRB by selecting the Report New Information button in eIRB..

Informed consent is the voluntary choice of an individual to participate in research based on a complete and accurate understanding of the study. Informed consent is not a single event or document but rather an ongoing process involving the investigator (or designees) and the research participant.  Informed consent requires full disclosure of the nature of the research and the participant’s role in that research, understanding of that role by the potential participant, and the participant’s voluntary choice to join the study.

• Investigators are responsible for obtaining and documenting informed consent before the research begins unless the IRB waives this requirement.
• Informed consent must be conveyed in language that is understandable to participants or their legally authorized representative.
• Consent must be sought under circumstances that minimize potential for coercion or undue influence.
• Time for questioning between the initial request for participation and the final decision as recorded in the consent document should be allowed.
• It must be made clear to subjects that their participation is voluntary and that they may withdraw at any time with no penalty.
• Consent is documented by use of a consent form approved by the IRB unless a waiver of informed consent or a waiver of documentation of informed consent is granted.
• The Common Rule (45 CFR 46.116 (b)) outlines the required elements of informed consent:
  • A statement that the study involves research;
  • Information on the purpose of the research;
  • The expected duration of subject participation;
  • A description of the procedures (identification of experimental procedures);
  • A description of reasonably foreseeable risks or harms;
  • A description of any benefits to subjects or others;
  • Disclosure of appropriate alternative treatments/procedures, if the research involves clinical treatment;
  • A description of how the confidentiality of records will be maintained;
  • A description of procedures related to compensation for injury, if the research is more than minimal risk;
  • Contact information for the PI and IRB; and A statement that participation is voluntary and that the subject may withdraw at any time with no penalty or loss of benefits.
  • Either a statement that information or biospecimens from the research could be used for future research or distributed to other researchers after identifiers are removed, or a statement that this will not take place even if identifiers are removed.
• The participant (or their legally authorized representative) must be provided with a copy of the consent document at the time of consent unless this requirement is waived by the IRB.
• Investigators are responsible for retaining signed consent documents for at least three years after completion of the research (seven years if protected health information will be used or disclosed in connection with the study) or longer if required by the institution or research sponsor.
• In some cases, an IRB may waive the requirement to obtain consent or waive the requirement for documentation of informed consent.

A potential conflict of interest (COI) exists whenever personal, professional, commercial, or financial interests or activities outside of Tufts have the possibility (either in actuality or in appearance) of (1) compromising a faculty or staff member’s judgment; (2) biasing the nature or direction of scholarly research; (3) influencing a faculty or staff member’s decision or behavior with respect to teaching and student affairs, appointments and promotions, uses of Tufts resources, interactions with human subjects, or other matters of interest to Tufts; or (4) resulting in a personal or family member’s gain or advancement at the expense of Tufts. Family members include spouse, domestic partners and dependents. With respect to research, COIs must be managed to ensure they do not improperly affect, or give the appearance of affecting, the conduct of the research.

Potential financial COIs are identified through annual disclosure requirements through Research Administration and through the IRB by submitting the COI Form with new studies, continuing reviews, and whenever a new member is added to a research team.  They are then reviewed by the COI committees at either Tufts Medicine or Tufts University.  Please take the time to read both of the linked policies for more detailed information about COI disclosures at Tufts Medicine and Tufts University.

Principal investigators must perform or delegate to qualified research staff all necessary tasks to carry out research, including specifically:

• Obtaining IRB approval before research begins;
• Obtaining informed consent of participants prior to study enrollment;
• Conducting continuing review in a timely manner;
• Informing the IRB of any disapprovals, suspensions, or terminations by other review units; and
• Creating and maintaining accurate records.

The PI is also ultimately responsible for proper conduct of the study and fulfillment of related obligations, including specifically:

• Appropriate training for staff on protocol and safety issues;
• Cooperating with investigations/inspections by authorized internal oversight activities as well as external reviews; and
• Supporting student researchers and the protection of human subjects in the students’ research, if applicable.