HRPP

The Human Research Protection Program (HRPP) is the global USC program that oversees the safety and welfare of participants in Human Subjects Research in accordance with all applicable federal regulations, state laws, and USC policy. At the institutional level, the HRPP includes five areas: USC as an academic institution; the Institutional Review Boards; the investigators and their study personnel; the study sponsors; and the research participants themselves.

HRPP, in partnership with the research community, is responsible for:

• Providing the highest level of research participant protection standards.
• Ensuring the ethical and equitable treatment of all human research participants in studies being conducted at USC and its affiliates and partners and/or being conducted by USC faculty regardless of site of activity.
• Ensuring compliance with federal regulations, state laws and USC policies as well as national standards for research involving human participants.

The Mission of the HRPP is:

• Promoting the adherence to and enactment of the Belmont Report principles of Respect for Person, Beneficence, and Justice.
• Facilitating the protection of rights and welfare of human research participants.
• Helping ensure compliance with federal regulations, state laws and USC policies as well as national standards for research involving human research participants, and
• Providing timely high-quality education, review, and monitoring for human research projects.

There are four Institutional Review Boards (IRB) at USC responsible for protecting the rights and welfare of study participants. There are three Biomedical IRBs and one Social Behavioral IRB. 

Each IRB is sufficiently qualified through the experience, expertise, and diversity of its members (46.107). Each IRB has a minimum of five members:

• At least one member with scientific background
• At least one member with non-scientific background
• At least one member not affiliated with USC
• Representatives of administration
• Alternate members – Formally appointed alternate IRB members may represent IRB members, provided the alternate’s qualifications are comparable to the primary member to be replaced.

Length of Service and Attendance Requirements

Appointments to the IRBs are for a period of one year. Continued tenure on the IRB is at the discretion of the HRPP Director and IRB Associate Directors in consultation with the IRB Chairs.

If a member is unable to attend a meeting, the IRB office must be informed sufficiently in advance so that an alternate can be invited to attend. Frequent absences will be cause for removal.

Duties

Members of each IRB or their designated alternates are required to:

• Participate in agreed upon number of convened IRB meetings
• Review the IRB application and informed consent form for research proposals
• Review and complete a written critique of research proposals including review of clinical trial protocol, questionnaire(s), advertisement(s), investigator’s drug brochure, and informed consent form when assigned as a reviewer by the Chair or IRB staff
• Review expedited actions of the Chair and IRB designee
• Review and promptly inform the Chair of corrections or additions to Full Board
  meeting minutes
• If substantive changes have been requested to a study, members, at a convened meeting, must review and verify that contingencies have been satisfied.
• Selected IRB members may be appointed as expedited reviewers and can review changes to previously approved research during the period covered by the original approval. Changes that may be reviewed by an expedited reviewer are those that do not alter the original approval criteria. Additional training is provided to IRB members who are appointed to be expedited reviewers

Please view Chapter 5 of our policies for more information.

If interested in joining as an IRB member, please email hrpp@usc.edu. 

The HPC brings together members of the USC research community to provide advice and support regarding the Human Protection efforts at USC. The charter for the group will be to:

1. Identify pain points with the IRB submission and review process and brainstorm solutions.
2. Operate as a sounding board for plans being made to improve efficiency in relation to the IRB review and approval process.
3. Operate as a sounding board regarding educational needs for faculty, staff, and students regarding the ethical conduct of human subjects research and the IRB review and approval process.
4. Advocate on behalf of the HRPP with USC leadership and members of the research community regarding the ethical conduct of human subjects research and the IRB review and approval process.

The program would send out a communication which would identify key points of contact.

In case of an emergency the HRPP will communicate to the research community what appropriate actions will take place.

Potential actions during an emergency include:

• • Continuing low-risk studies (e.g., online or off-site activities).
  • Postponing in-person studies with minimal participant benefit.
  • Restricting new recruitment or enrollment while continuing activities with existing participants.
  • Revising studies for alternative activities (e.g., remote visits, video conferencing), with some activities continuing without revision (e.g., mandated screening procedures).
  • Prioritizing continuing reviews, emergency-related research, and therapeutic studies over others during limited review capacity.
  • Temporarily shutting down all research in extreme situations.

AAHRPP Element I.1.H.

The organization has and follows written policies and procedures specifically designed to protect the rights and welfare of research participants during an emergency.

Forms for Manual Amendment Submission

• iStar Amendment (Declared Emergency)
• iStar Reportable Event (Declared Emergency)

When do I use these forms?

1. Please use these forms if there is an emergency and you have been notified by the HRPP at USC that emergency measures are in place.
2. Your study was already approved by the IRB as full board (Greater Than Minimal Risk).
3. You must submit an amendment because the risk to participants may be affected.

What do I do when I am finished filling out the form?
You will send an email to the hrpp@usc.edu. In the subject line of the email please write: “Insert your Study number here”: Submission under emergency procedures.

When will I hear back?
Within 72 business hours of a member of the IRB or HRPP will confirm that your information is under review.