AAHRPP Site Visit Information for IRB Members & Staff
Tufts Health Sciences Human Research Protection Program
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:
- Understand the Tufts Health Sciences HRPP structure
- Clearly describe your role in the Tufts Health Sciences HRPP
- Know the Tufts Health Sciences HRPP policies
- Understand the AAHRPP accreditation process
- Understand and describe the ethical aspects, the purpose, and the value of your work
- Know where to obtain answers to ethical/regulatory questions
- Know the process for noncompliance reporting at Tufts Health Sciences
- Know human subjects training requirements and resources at Tufts Health Sciences
- Describe the training you’ve had as an IRB reviewer
- Understand what constitutes conflict of interest at all levels (i.e. staff, IRB, institution)
- Understand how a conflict of interest is managed at Tufts Health Sciences
- Know the ethics of recruitment and 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 type of general questions you might be asked.
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 Heather Gipson-Cosier, JD, Associate Vice Provost for Research Compliance 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
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:
- 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.
- Institutional policies and procedures.
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:
- Does the activity described in the IRB application meet the definition of research with human subjects as defined in the Common Rule?
- Is the activity human research as defined in FDA regulations?
- Is Tufts Health Sciences engaged? Is the research exempt from IRB oversight?
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:
- Involves activities or data subject to other rules or regulations such as the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, the Health Information Technology for Economic and Clinical Health Act (HITECH) Security Rule, the Family Educational Rights and Privacy Act (FERPA) or rules of other federal agencies, the review ensures compliance with these other regulations or rules.
- Is not regulated, a designated IRB staff member will issue a “not regulated” (non-human subjects research) determination. There is no regulatory requirement for IRB review of research that is not-regulated under the Common Rule.
- Is exempt, an IRB staff member ensures that the application indicates the request for an exempt determination or directs the PI to revise the application to do so.
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.
- Design and implement protocols that comply with applicable regulatory and institutional policies, as well as the principles of the Belmont Report.
- Verify procedures are consistent with sound research design by ensuring that the research is reasonably expected to answer the proposed question and that the resulting knowledge is expected to be sufficiently important to justify the research.
- Ensure that recruitment procedures foster the equitable selection of subjects.
- Utilize procedures already being performed for diagnostic or treatment purposes, when possible.
- Ensure that appropriate resources are available to conduct the research.
- Establish adequate provisions for monitoring subjects to identify adverse events and to review data collected to ensure subject safety, when appropriate.
- Develop plans for protecting subject privacy and the confidentiality of data. In human subjects research, these terms are defined as follows:
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.
- Put in place additional protections for subjects vulnerable to coercion or undue influence (e.g., children, prisoners, pregnant women, mentally disabled persons, etc.).
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.
- 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 (a)) 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
- 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.
- 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.
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.
- All research with human subjects must obtain IRB review and approval or a determination of exemption before work can begin.
- IRB disapproval decisions may be appealed to the IRB, but cannot be overruled by any other institutional official or organization.
- The requirements of the IRB (i.e., initial review, continuing review, amendments, 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.
- 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 in a timely manner. 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, subject complaints, or loss of research data must be reported to the IRB via a Reportable New Information form.
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:
- 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.
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.