Procedure for Determination that Necessary Resources are Available for Care and Safety of Human Research Participants - IRB PRO137

Procedure for Determination that Necessary Resources are Available for Care and Safety of Human Research Participants - IRB PRO137

Abstract:
This procedure outlines the responsibilities for the investigator, institution and IRB to determine that necessary resources are available for care and safety of human research participants.
Effective Date:
1/25/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO137
Effective Date:   3/30/07
Revision Date:  1/25/10
Subject:  Procedure for Determination that Necessary Resources are Available for Care and Safety of Human Research Participants

PROCEDURE

Investigator Responsibilities

An investigator identifies necessary resources to protect participants in research studies including:

  • Facilities to conduct and complete the research;
  • Access to participant population allowing for necessary recruitment goal;
  • Research staff of sufficient number and experience level;
  • Research staff training regarding the protocol and their research-related duties and functions;
  • Availability of medical, social, or psychological services that may be required as the result of participation in research;
  • Ancillary services or special equipment to protect participants;
  • Special needs for communication with participants (e.g., sign language, translation services).

Institutional Responsibilities

The Departmental Chair or designee

  • Ensures research studies have available necessary resources to protect the safety of research participants.

IRB Responsibilities

The IRB reviews research to ensure the research plan:

  • Makes provisions for adequate collection and review of data to protect the safety of participants; and
  • Identifies necessary resources for participant safety, as appropriate.

Approved on March 1, 2010, by:

Richard B. Marchase, PhD
Vice President for Research and Economic Development

Ferdinand Urthaler, MD
IRB Chair