MSU HRPP Manual Section 5-6

5-6, Contact Information

Individuals who wish to report problems, concerns, or complaints, or to ask questions, obtain information, or offer input to the Michigan State University Human Research Protection Program (HRPP) and/or the Institutional Review Boards (IRB) are encouraged to do so. If an individual feels they have been harmed or put at risk by participation in a research study, or treated in a way that is inappropriate, the subject is encouraged to inform the IRB. Individuals may report anonymously, if they wish. However, information such as a principal investigator name and/or study title would be needed to identify the study so corrective actions can be taken, if appropriate. See HRPP Manual 9-4 “Subject Complaints” for specific guidance on how or who to report complaints. If the inquiry appears to involve noncompliance, HRPP Manual 9-2 “Noncompliance” will be followed to ensure that subjects are protected.

There are multiple mechanisms through which any individual, including investigators, research staff, students, and subjects, may seek answers to questions, express concerns, or to convey suggestions regarding the HRPP.

Individuals are encouraged to contact:

  • IRB staff: Scheduling an appointment to speak with an IRB staff member regarding any questions they may have regarding areas such as IRB applications, submission status of IRB applications, IRB review, IRB meetings or deadlines is encouraged, but not needed. 

  • Compliance staff: Scheduling an appointment to speak with a Compliance office staff member regarding any questions they may have regarding areas such as site visits, U.S. Food and Drug Administration (FDA) requirements, Health Insurance Portability and Accountability Act (HIPAA), Protected Health Information (PHI), clinical research billing compliance, coverage analysis, clinicaltrials.gov registration and compliance help is encouraged, but not needed. 

  • IRB chairs: The IRB chair is available to meet with individuals and may act as a liaison between the individual and the IRB, bringing concerns of the investigators or subjects to the IRB’s attention or to each member reviewing the study.

  • HRPP director or the assistant vice president (AVP) for the Office of Regulatory Affairs (ORA): Inquiries regarding the IRBs or other aspects of the HRPP distinct from the IRBs may be brought to the HRPP director or to the AVP ORA for mediation if necessary. 

Contact information for the IRB or Compliance Office, HRPP, and AVP ORA is provided below. Individuals may also submit information to these individuals using the online feedback form available on the HRPP website. Individuals may submit comments anonymously, if they wish, or may include contact information for follow-up. If contact information is not provided, the inquiry will be addressed to the extent possible based on the information provided. If contact information is provided, the inquiry will be addressed directly or referred to the appropriate individual.

When an inquiry is received from a research subject:

  • Complaints will be handled in accordance with HRPP Manual 9-4 “Subject Complaints”

  • Concerns or problems will also be handled as complaints where appropriate

  • Suggestions from subjects will be provided to the HRPP director

  • Questions will be addressed by HRPP staff or will be referred to another individual as appropriate (e.g., IRB chair, study related question to PI)

When an inquiry is received from a researcher:

  • Typically, the IRB or Compliance staff or the IRB chair will address study specific questions, concerns, problems, suggestions, or input

  • General (non-study specific) questions, concerns, problems, suggestions, or input can be addressed by the HRPP staff or can be referred to another contact as appropriate (e.g., IRB chair, HRPP managers, HRPP director, AVP ORA)

Documentation will be maintained in accordance with HRPP Manual 4-7 “Recordkeeping.”

Michigan State University has implemented a telephone and web reporting Hotline to help maintain adherence to ethical practices. The purpose of the Hotline is to provide an anonymous method to report known or suspected misconduct for Michigan State University related to fiscal matters, conflicts of interest, employment, medical/HIPAA, research, safety, athletics, discrimination/harassment, privacy, retaliation, or any other area of legal, policy, or ethical concern not specifically listed. (http://misconduct.msu.edu/)

IRB Office and HRPP Contact Information

408 West Circle Drive
Olds Hall, Room 207
Michigan State University
East Lansing, MI  48824-1047
Phone: (517) 355-2180     Fax: (517) 432-4503
E-mail: irb@ora.msu.edu

Office hours: Monday – Friday, 8:00 A.M. – 5:00 P.M.
Office is closed on university holidays.

Compliance Office Contact Information
408 West Circle Drive
Olds Hall, Room 101
Michigan State University
East Lansing, MI  48824-1047
Phone: (517) 355-2180     Fax: (517) 432-4503
E-mail: hrl@ora.msu.edu
Email: crbc@ora.msu.edu

Office hours: Monday – Friday, 8:00 A.M. – 5:00 P.M.
Office is closed on university holidays.

ORA Contact Information
408 West Circle Drive
Olds Hall, Room 204
Michigan State University
East Lansing, MI  48824-1047
Phone: (517) 432-4500     Fax: (517) 432-4503
E-mail: ora@ora.msu.edu

Office hours: Monday – Friday, 8:00 A.M. – 5:00 P.M.
Office is closed on university holidays.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 3-3-2005. Revision 1 approved by VP Research & Graduate Studies on 4-5-2006. Revision 2 approved by VP Research & Graduate Studies on 3-9-2008. Revision 3 approved by VP Research & Graduate Studies on 7-19-2011. Revision 4 approved by Assistant VP Regulatory Affairs on 11-18-2015.

Related HRPP Manual Sections

Approved PDF Version

Please note that hyperlinks have been added to the web version of this document for ease of use. View approved PDF version of Section 5-6, Contact Information.