If your project involves research involving interaction or intervention with live human subjects or access to personally identifiable private information, it must be submitted to the HRRC for approval prior to implementation. This includes research studies that qualify as exempt.
The primary role of the HRRC is to protect the rights, interests and welfare of human research participants and assuring research related risks are reduced as much as possible.
The HRRC is a part of the Research Protections Program (RPP) located in 059 JH Zumberge. It is a subunit of the Center for Scholarly and Creative Excellence.
The HRRC has fifteen members, including two alternates and three community members. A meeting quorum requires a majority of members to be present, including one non-scientist. Some are active researchers, some are teaching faculty in the sciences and humanities, and others are representatives from the pubic community. For protocols involving protected categories of subjects such as prisoners or children, members or consultants with special experience are consulted and often present but have no voting rights regarding approvability.
There are four major areas of focal concern that are evaluated in determining whether participants' rights and welfare are protected.
1) The research design is written so as to assure scientific merit and validity of the research activity. In some cases this is done by a peer review process using established review mechanism and records.
2) The balance of harm and benefit; risk of harms must minimized, and ratio of potential benefits (direct to participants or indirectly to the general welfare of society through increased scientific knowledge) to the anticipated potential harms to participants are reasonable.
3) The process and documentation of informed consent. This is an ongoing dialogue between researchers and subjects in which a shared understanding of the project is maintained at all times, including th e option to withdraw at any point without penalty.
4) The selection of subjects in potentially beneficial studies. This is necessary to assure that the potential benefits and risks of harms are fairly distributed.
Three basic principles of ethics are particularly relevant to the protection of human subjects in research.
1. Respect for Persons: recognition of the personal dignity and autonomy of individuals and special protection of those persons with diminished autonomy;
2. Beneficence: obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of four types of harm; and
3. Justice: fairness in the distribution of research benefits and burdens through equitable selection procedures for participation in research activities.