Policies, Procedures and Regulations

IU HRPP Policies Table of Contents - Overview and application

	Applies to exempt research reviewed by IU IRBs	Applies to non-exempt research reviewed by IU IRBs	Applies to all IU HRPP research, regardless of the reviewing IRB
Adult Individuals Lacking Consent Capacity in Research		√	Section 2.1 Only
Auditing	√	√	√
Children in Research		√
Conflict of Interest Reporting to the IRB	√	√	√
Emergency Research Requesting Exception from Informed Consent (EFIC)		√
Emergency Use of Investigational Test Articles	Not Applicable-not research; applicable to clinicians under jurisdiction of the IU HRPP
Exempt Research	√
Humanitarian Use Devices (HUDs)	Not Applicable-not research; applicable to clinicians under oversight of the IU IRBs
Informed Consent		√
IRB Executive Committee		√
IRB Meeting and Minutes		√
IRB Membership		√
IRB Records and Retention		√
IRB Reporting		√
IRB Review Process		√
KC IRB	√	√	√
Pregnant Women, Fetuses, Neonates in Research		√
Prisoners in Research		√
Recruitment of Human Subjects		√
Reliance		√	√
Reportable Events	√	√
Research Data Management	√	√	√
Research Personnel Responsibilities	√	√	√
Use of Education Records in Research	√	√	√
Use of Personal Health Information (PHI) in Research	√	√	√
Definitions	√	√	√

Indiana University Human Research Protection Program (HRPP) Mission

The overarching mission of the Indiana University Human Research Protection Program (HRPP) is to protect the rights and welfare of human research participants recruited to participate in research conducted under the auspices of Indiana University.  Rather than ensuring mere compliance with federal regulations, IU’s HRPP strives to adhere to the highest ethical standards in its protection of human research participants and seeks to further develop the methods and mechanisms for protecting human research participants.  In service of this mission, the HRPP endeavors to:

• create an atmosphere of respect for, and awareness of, the rights and welfare of human research participants at IU and its affiliated organizations.
• inform established researchers about changes to and ongoing application of federal regulations and ethical principles to their particular area of research in order to keep researchers current with evolving standards.
• educate students, faculty, and staff who conduct research about the ethical principles and federal regulations guiding research with humans.
• assess the effectiveness of the Institutional Review Boards (IRBs) in their review of research activities, facilitation of compliance of researchers with federal regulations, and protection of research participants.
• develop new approaches that better serve the overarching mission of the HRPP, such as state-of-the-art educational materials, more efficient methods for processing applications, tracking and monitoring research activities, and assessing the overall effectiveness of the HRPP.

Indiana University Institutional Review Board (IRB) Charter

The Indiana University Institutional Review Boards (IRBs) and their affiliated organizations are responsible for the review and approval of all research involving human subjects conducted under the auspices of these institutions.  These boards are charged with protecting the rights and welfare of human subjects recruited to participate in research activities and to ensure compliance with applicable university and organizational policies and federal regulations.

These boards are responsible for reviewing all research projects involving human subjects that are conducted at these institutions’ facilities or property; sponsored by these institutions; conducted by or under the direction of any employees or agents of these institutions in connection with their institutional responsibilities; or that involve the use of these institutions’ non-public information to identify or contact human research subjects or prospective subjects.  In addition, the IRBs may be asked by organizational officials to review research protocols on behalf of other institutions with which they have formal affiliation agreements.

The Vice President for Research is the leader of the Human Research Protection Program (HRPP) and has responsibility and authority for implementation of this program.  The Vice President for Research relies on IRB staff for knowledge of the regulations and day-to-day operations and is directly involved in allocation of resources to the HRPP.  The Vice President for Research employs mechanisms to ensure that:

• Human participants are provided protections.
• The HRPP is provided support.
• The research review unit functions independently and free from coercion and undue influence.
• Legal counsel not conflicted by other organizational responsibilities is made available to the research review unit.
• Access to senior officials of the organization, when the IRB deems it to be warranted, is made available to the research review unit.
• The IRBs’ work and meeting spaces are evaluated and resources adjusted when necessary.
• Educational programs for IRB staff and members are provided and the development of Standard Operating Procedures (SOPs) and Policies is supported.
• The IRBs function independently of other organizational entities.