Click on the following for more information about our AAHRPP visit:
Tufts Health Sciences’ Human Research Protection Program (HRPP) accreditation largely depends on these interviews during the site visit. You will be expected to:
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.
Susan Blanchard, the Vice President for Research, serves as the Institutional Official (IO) for the Tufts Medical Center and Simin Nikbin Meydani, DVM, PhD, Vice Provost for Research 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:
The Tufts Health Sciences IRB’s goal is to ensure that any research study under Tufts IRB jurisdiction is in compliance with federal, state, and institutional regulations. The IRB upholds the highest standards, ensuring compliance with ethical principles and regulatory requirements, while serving the Tufts community of scholars and administering a thorough review in a timely and efficient manner.
The review and conduct of research at Tufts is guided by principles set forth in the Belmont Report and performed in accordance with Department of Health and Human Services (DHHS) regulations (45 CFR 46 or the “Common Rule”), and Food and Drug Administration (FDA) regulations (21 CFR 50, 21 CFR 56), as well as all other applicable federal, state, and local laws and regulations such as the Health Insurance Portability and Accountability Act (HIPAA).
The Belmont Report identifies and summarizes three main ethical principles that should govern research with human subjects:
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:
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.
IRBs must obtain sufficient information prior to review of applications for initial or continuing review so that it can apply and satisfy the requirements for approval of research (see our for what is required during the review process, including scientific review).
The IRB considers the following with respect to each application for initial, amendment, or continuing review:
These determinations are made consistent with the guidance provided at the US Department of Health and Human Services Human Subject Regulations Decision Charts and in consultation with IRB administrators or chairs, as appropriate. If the research:
IRBs ensure research is approved only when all of the requirements in 45 CFR 46.111 or 21 CFR 56.111 (for FDA-regulated research) are met. The criteria for IRB approval includes: (a) scientific merit and feasibility; (b) minimizing risk; (c)risk-benefit analysis; (d)equitable subject selection; (e)informed consent and parental permission; (f)data monitoring; (g) privacy and confidentiality; (h)vulnerable subjects; (i)test article accountability procedures; and (j)resources.
Because Tufts Health Sciences IRB reviews FDA-regulated clinical trials, they have additional requirements including: determining whether an IND or IDE is required; for device studies, making significant/non-significant risk determinations; emergency use notification and reporting procedures; procedures for reviewing protocols for anticipated additional use in emergency situations; waiver of informed consent for certain emergency research, if permitted by the IRB; adverse event reporting guidelines and procedures; communications, if any, with sponsors and IND and IDE holders; and test article accountability procedures.
Minimizing risks to subjects and ensuring subjects’ rights and welfare are key components of human subjects protections. Below are some strategies through which these goals can be accomplished.
Subject privacy – Relates to an individual’s having control over the extent, timing, and circumstances regarding the sharing of information about themselves with others.
Confidentiality – Relates to the protection of subject data that has been shared with the researcher with the expectation that it will be protected and not disclosed.
For further guidance on study risk levels, refer to the Guidelines for Using Magnitude of Harm in Categorizing Risk Level.
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.
Research at Tufts must be conducted in compliance with IRB, as well as other institutional and regulatory requirements. Below are some requirements that you should be aware of related to this responsibility.
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 Medical Center or Tufts University. Please take the time to read both of the linked policies for more detailed information about COI disclosures at the Medical Center and the University.
Principal investigators must perform or delegate to qualified research staff all necessary tasks to carry out research, including specifically:
The PI is also ultimately responsible for proper conduct of the study and fulfillment of related obligations, including specifically:
Tufts Medical Center and Tufts University are committed to the continuing education of persons engaged in human subject research at the institutions to ensure that high quality research is conducted with integrity. As a result, the institutions require that all IRB members and office staff must receive formal training in the protection of human subjects.
The Collaborative Institutional Training Initiative (CITI) program is the option for the required education. IRB members and staff must complete mandatory training via the CITI program and must undergo continuing education.
Please refer to the IRB website for more information on this continuing education.
IRB members are also trained through a detailed orientation procedure to provide them with the knowledge and skills to effectively discharge their duties and uphold the federal and local laws, institutional policies, and ethical standards related to human subjects research. Continuing education for new and existing IRB staff and members is also required and is provided in the form of workshops, presentations, quarterly newsletters, national webinars, and printed and electronic materials that are shared on an ongoing basis. IRB members and staff are also kept informed of opportunities for continuing education and encouraged to attend.