Click on the following for more information about our AAHRPP visit:
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:
As Principal Investigator or member of the research team, you may be selected to be interviewed during the on-site evaluation. AAHRPP will provide a list of individuals selected about 3 weeks before the on-site evaluation. If you are selected, we will provide you with additional information.
Interviews will take approximately ½ hour and be conducted as either individual or group interviews.
Questions will be focused on regulatory issues related to human subjects research, and may also relate to your impression of the Tufts human research protection program & IRB.
Early preparation is key for the site visit. Over the course of the next couple of months we will be sending all members of the research community weekly emails to help each of you prepare.
Keep your eyes out for “Preparing for our AAHRPP Site Visit” weekly emails that will cover a variety of topics to prepare you for the on site evaluation:
|• General Tips||• Obtaining and Documenting Informed Consent|
|• HRPP Policies & Procedures||• Conflict of Interest Disclosure|
|• Roles and Responsibilities of Investigators and Research Staff||• Accountability and Additional Administrative Requirements|
|• Minimizing Risks to Subjects and Protecting Subjects’ Rights and Welfare||• Education|
|• Compliance with IRB and Other Review Unit Requirements||• Additional Resources|
|• Sample Questions|
Tufts Health Sciences’ Human Research Protection Program (HRPP) accreditation largely depends on these interviews during the site visit. You will be expected to:
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. Below are examples of the type of general questions you might be asked.
About Your Own Studies:
Relationship with the IRB:
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.
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:
Investigators and research staff have a responsibility for minimizing risks to subjects and for ensuring subjects’ rights and welfare. Below are some strategies through which this can be accomplished.
For further guidance on study risk levels, refer to the Guidelines for Using Magnitude of Harm in Categorizing Risk Level.
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.
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.
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 researchers involved in human subjects research must receive formal training in the protection of human subjects.
The Collaborative Institutional Training Initiative (CITI) program is the option for the required education at both institutions. Investigators and research team members conducting human subject research must complete mandatory training via the CITI program prior to beginning any human subjects research and must undergo continuing education.
It is the PI’s responsibility to keep evidence of this certification on file for each member of the research team. Please refer to the IRB website for more information on this continuing education.