Policies | Research A to Z

Policies

May 26, 2017

Statement of Practice: Sections 15 and 16 of IRB Application

Click here for PDF version. What Agents/Articles must be listed in Sections 15 and 16 of the IRBMED eResearch application? Note : This document outlines IRBMED recommendations for completing the eResearch application. Other committees may make...

Policies

Apr 21, 2017

Indirect Cost Waiver

This policy addresses requests for reduced overhead recovery through the Indirect Cost Waiver mechanism.

Policies

Dec 9, 2016

Institutional Cost Sharing

This policy describes the process and conditions for obtaining a research cost share commitment from the Medical School Dean’s Office, Hospital and Health Center, or EVPMA . It also addresses the process for Medical School units seeking a cost share...

Policies

Dec 9, 2016

Recovering Full Indirect Costs: Industry Funded Research

This policy details the required process that should be used to negotiate the indirect cost rate with industry sponsors . The Medical School does not support indirect cost waivers on industry funded research. Please visit the Indirect Cost Waiver...

Policies

Dec 9, 2016

Indirect Cost Waivers on Federal Patient Pass-Through Costs

This policy describes the process and conditions for Medical School units seeking a reduction of indirect costs on pass-through expenses related to clinical trial patient payments on federal projects. Please review the School’s companion policy on...

Policies

May 1, 2015

Statement of Practice: Flexibility Initiative: Two-Year Approvals - ARCHIVED

This flexibility initiative was active May 1, 2015 - June 10, 2018. It is obsolete as of June 11, 2018. Note : IRB applications granted a two-year approval may not be used to support proposals or future awards involving federal funding. Click here...

Policies

May 1, 2015

Statement of Practice: Flexibility Initiative: Exemption 7 - ARCHIVED

This flexibility initiative was active May 1, 2015 - June 10, 2018. It is obsolete as of June 11, 2018. Note : IRB applications granted Exemption 7 may not be used to support proposals or future awards involving federal funding. Note : Exemption 7...

Policies

May 1, 2015

Statement of Practice: Flexibility Initiative: Exemption 2A - ARCHIVED

This flexibility initiative was active May 1, 2015 - June 10, 2018. It is obsolete as of June 11, 2018. Click here for PDF version.

Policies

Feb 18, 2015

Statement of Practice: External Adverse Event Reports & Unanticipated Problems

Click here for PDF version. UM investigators participating in multi-site trials and those using sponsored agents routinely receive reports of external adverse events . Office of Human Research Protections (OHRP) guidance indicates that individual...

Policies

Feb 27, 2014

Statement of Practice: Approval Dates on Consent Documents & Recruitment Materials - ARCHIVED

This document is obsolete as of August 22, 2018. It has been replaced by Statement of Practice: IRBMED Finalization of Study Documents . Click here for PDF version of the current document . When watermarking consent documents and recruitment...

Policies

Apr 1, 2013

Service Policy on Submitting* PHS Proposals

This policy describes the service level delivery that will be provided by Grant Services & Analysis in the Medical School when submitting PHS proposals. Service levels are determined by the number of days in advance of the deadline the finalized...

Policies

Mar 1, 2002

Establishing Subaccounts

This policy describes the threshold over which the establishment of subaccounts is expected for inter-unit research projects at the Medical School. This policy formalizes existing practice within the School and conforms to the usual expectations for...

Pages