Policies & Procedures |
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Documents:
IUPUI SOP IRB Bylaws (v03/01/08) Guidance for Research with Existing Data
Indiana Laws Affecting Research (v03/01/08)
Guidelines for Participation by
Non-Afilliated
Investigators - v05/01/09
IU Links:
Principal Investigator and Faculty Sponsor
Eligibility Guidelines
Guidelines for Determining an
Amendment Type
Students as Subjects Simplification Guide to Medical Terms
(A resource provided
by the University of
Michigan)
IUPUI Media Relations
IUPUI Conflict of Interest Policy
Radiation Safety Office Relevant Federal
Regulations Links:
DHHS Regulations on the Protection of Human
Subjects (45CFR46)
FDA Regulations on the Protection of Human
Subjects (21CFR50)
FDA Regulation on Institutional Review
Boards (21CFR56)
FDA Regulations on Investigational New Drug
Applications (21CFR312)
FDA Regulations on Investigational Device
Exemptions (21CFR812)
e-CFR Resources
Other Resources Links:
Belmont Report
Significant Differences in FDA and HHS Regulations
for Protection of Human
Subjects
The following guidelines provide a summary of some of the important principles governing the conduct of research involving humans, recombinant DNA, or biohazardous materials. These policies apply to all research regardless of whether or not it is funded by the University or with external funds. It is critical that all faculty members who plan to conduct research be familiar with these requirements since failure to adhere could have serious consequences for both the individual investigator as well as the institution. Required documentation and further guidance in any of these areas can be obtained by contacting Research Compliance Administration. For contact information see 'Contact us' to the left.
All research conducted at Indiana University-Purdue University Indianapolis (IUPUI) involving humans, recombinant DNA, or biohazardous research must be reviewed and approved by the respective campus research risk review boards. These boards review research plans and monitor ongoing research to insure full compliance with federal regulations and University policies. Protocol submission and requests for approval of research to each of these boards involve separate procedures. Transmittal of a proposal for external funding does not constitute a request for protocol review. Therefore, it is important that the investigator initiate each procedure well in advance of any deadlines to allow adequate time for the review and approval process.
All research documentation is subject to federal audit. Since these requirements and, consequently, the application forms, undergo constant revision, it is important to make sure that all research submissions are completed on the current forms.
Most research conducted on behalf of IUPUI must be under the direction supervision of a faculty member who is responsible for insuring that the research is conducted in accordance with all applicable institutional policies, governmental regulations, funding agency requirements, and contractual commitments. Refer to the Principal Investigator and Faculty Sponsor Eligibility for information on eligibility criteria.
The Office of Research administration maintains a library of resource materials available to faculty. These materials include videotapes, manuals, CD-ROMS, and publication on a variety of topics pertaining to research.
IUPUI Standard Operating Procedures for Research with Human Subjects: Indiana University Purdue University Indianapolis (IUPUI), Clarian Health Partners (Clarian), and their affiliates are dedicated to protecting the rights and welfare of human participants recruited to participate in research conducted under the auspices of these organizations. The IUPUI/Clarian SOPs provide a central resource for researchers to find important information on required federal and state regulations and institutional policies governing these research activities.
Principal Investigator and Faculty Sponsor Eligibility Guidelines: These guidelines are applicable for determining whether an individual is eligible to serve as a principal investigator for a human subjects research study or a faculty sponsor for student projects.
Guidelines for Determining an Amendment Type: The IRB requires that any proposed changes in approved research, during the period for which IRB approval has already been given, be reviewed and approved prior to implementing these changes to determine whether the modified research continues to fulfill the criteria for approval, except where necessary to eliminate apparent immediate hazards to human participants. Investigators may request approval of proposed changes by the completion and submission of an Amendment form. This guidance document provides additional information for determining whether an Amendment may be reviewed and approved using expedited review procedures or if the Amendment must be reviewed at a convened IRB meeting. Please note that it is ultimately the Research Compliance Administration staff and IRB who makes the review level determination.
Guidance for Research with Existing Data: This flow chart provides guidance on determining the appropriate IRB submission for an activity involving research with existing information or specimens (non-genetic).
Simplification Guide to Medical Terms: It is required that documents given to participants are in a language appropriate to the subject population. This guide provides suggestions for simplifying medical terms so that they are presented in a language appropriate for the subject population.
Guidelines for Participation by Non-Affiliated investigators – 06/07: These guidelines pertain to investigators or practitioners not employed or otherwise affiliated with Indiana University-Purdue University, Indianapolis (IUPUI) or Clarian Health Partners (Clarian).
