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Overview of AAHRPP Accreditation

Click on the following for more information about our AAHRPP visit:

Overview of AAHRPP Accreditation

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.
The accreditation process includes several steps:
  1. Application – completed and submitted!
  2. On-site evaluation – possibly late December / early January
  3. Review by the AAHRPP council
  4. Notification of accreditation status

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 

Week 1

General Tips

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 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. Below are examples of the type of general questions you might be asked.

Possible General Questions

About Your Own Studies:

  • Describe your study. What are the procedures? How do you recruit? What is the consent process?
  • What kinds of harms can occur in your study? How do you minimize those harms?
  • Do you communicate results with your subjects after the completion of your research?
  • How did you interact with the IRB on this study?

Relationship with the IRB:

  • What is AAHRPP accreditation and why is it important to Tufts? We value AAHRPP accreditation because it demonstrates that we are committed to scientifically and ethically sound research and strive for continuous improvement.
  • What is the IRB’s reputation on campus?
  • What are typical turnaround times? Typically 10 business days for non-human subjects, new exempt and new expedited studies. The timing varies for new full committee studies; they are always sent to the next available meeting depending on the completeness of the submission and whether it needs to go to the Scientific Review Committee (SRC) first. Amendments are reviewed and approved within 7-10 business days.  Continuing reviews have their own deadlines and are reviewed based on their expiration date.
  • How did the IRB prepare you to conduct your research? Anyone conducting research is required to be up to date on the CITI education requirements. Additionally, the IRB offers educational opportunities, trainings, drop-in hours, and quarterly newsletters to help people conduct their research.
  • How do you feel about the IRB?
  • Do you think IRB reviews are fair?
  • What do you think about the IRB and their efforts to protect human subjects?
  • Do you know how often the convened (full) IRB meets? It meets twice a month with one committee meeting the 2nd Tuesday of every month and the other meeting on the 4th Thursday of every month.

Week 2

Human Research Protection Program (HRPP) Structure

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:

  • 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
Possible General Questions
  • Who are the Institutional Officials responsible for research at Tufts Health Sciences? Susan Blanchard (Tufts MC) and Simin Nikbin Meydani (Tufts University)
  • What are the components of the Tufts Health Sciences HRPP? See points above
  • Where would you go for help on regulatory or ethical issues? IRB Office and other supporting offices listed above

Week 3

Ethical Conduct of Research and Federal Regulations

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.
Possible General Questions
  • What is the PI’s primary responsibility in conducting the research? Safeguarding human subjects by protecting their rights and welfare.
  • What is the Common Rule (45 CFR 46)? See above.
  • What are the Belmont Principles and when did you first hear of them? Respect, Justice, Beneficence
  • Are there additional requirements for Department of Defense-sponsored studies? Department of Education-sponsored research? See links above.

Week 4

Minimizing Risks to Subjects and Protecting Subjects' Rights and Welfare

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.

  • 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 (e.g., personnel, facilities, equipment, etc.).
  • 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 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 enhanced protection 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.

Possible General Questions
  • What is the process of scientific review for your research?
  • Do you know the difference between minimal and minor increase over minimal risk? Minimal risk is no more risk than encountered in daily life while minor increase is a greater risk.  This distinction is what the IRB analyzes when determining whether a child can participate in research, since there are special protections put into place for children participating in research.
  • What is the difference between privacy and confidentiality? See above.
  • How do you protect subject privacy and confidentiality of data?
  • How/who do you recruit for your research?
  • How do you ensure that only subjects meeting the inclusion criteria are enrolled?
  • What additional mechanisms do you have in place to protect your research subjects?

Week 5

Compliance with IRB and Other Review Unit Requirements

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, 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.
  • 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 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.
Possible General Questions
  • How do you notify the IRB about proposed changes to your research? Submit an amendment.
  • What would you do if you lost your research data and who would you tell? Would submit a Reportable New Information form to the IRB office and also notify the HIPAA Privacy Officer.
  • Do you know how to report a subject complaint or a problem with your study? Would submit a Reportable New Information form to the IRB office.
  • What is an unanticipated problem regarding risks to subjects or others (UP)? Have you ever had one on a study? See definition above.
  • How would you report an UP? Would submit a Reportable New Information form to the IRB office.
  • Do you know what noncompliance is and when and how to report it? See above, would submit a Reportable New Information form to the IRB office.

Week 6

Obtaining and Documenting Informed Consent

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
    • 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.
  • 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.
Possible General Questions
  • What are the required elements of informed consent? See above.
  • Describe your consenting process. Does the subject get a copy? If yes, when do they get it?
  • What is the process for obtaining consent? Who does it? Where are subjects approached? Do subjects have time to think about it before they agree to participate?
  • What would you do if you recruited a non-English speaking subject? How would you consent? Either have the ICF fully translated into the other language, or use IRB short forms.
  • How do you know if the subject understands the consent document?
  • Who answers questions about the research?
  • What is the difference between a waiver of consent and a waiver of documentation of consent? Waiver of consent means that the IRB may approve a consent process that does not include, or that alters, some of the elements of informed consent, or may waive the requirement to obtain informed consent. A waiver of documentation of consent means that subjects still need to consent but the requirement to document informed consent with a signed written ICF is waived.

 

Week 7

Conflict of Interest Disclosure

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.

Possible General Questions
  • What do you know about conflict of interest?
  • What do you disclose to subjects regarding a conflict of interest?

Week 8

Accountability and Additional Administrative Requirements

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.
Possible General Questions
  • Who prepares the IRB application and who submits the application?
  • Who communicates with the IRB?
  • What are the qualifications of your study team?
  • How does your study team work together (delineation of roles)?
  • How do you communicate within your team?
  • How are you trained in the details of the study protocol?
  • How do you ensure that study protocols are followed?
  • Do you maintain a regulatory file for the study? Where is it?
  • Where are your research records maintained?
  • What kind of workload do you have?
  • Do you have the appropriate resources to conduct the research properly?
  • Do you work on any other studies?

Week 9

Education

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.

Possible General Questions
  • What kind of training did you receive?
  • What training do you require/provide for your staff?
  • Were you trained in human subjects research, ethics, and carrying out your research duties?
  • How do you verify CITI certification status for yourself and other study team members?