TITLE:

ES&H Manual

 

DOCUMENT ID:

3800 Human Subjects Research (HSR) Protection Program

 

 

1.0            Purpose

 

Jefferson Lab participates in conducting joint research and providing technical support in Human Subjects Research (HSR) studies.  It is the policy of the Laboratory to maintain an agreement by which HSR is reviewed and approved for the protection of human subjects.

 

This program has been established in accordance with 10 CFR 745 Protection of Human Subjects, 45 CFR 46 Protection of Human Subjects, and DOE Order 443.1B Protection of Human Research Subjects. 

 

2.0            Scope

 

A human subject is a living individual about whom an investigator conducting research obtains:

1)      Data through intervention or interaction with the individual, or

2)      Personally identifiable information (PII).

 

The requirements of this program apply to any HSR conducted with DOE funding, DOE institutions regardless of funding, or by DOE contractor personnel regardless of funding source or location conducted.

 

No research involving human subjects can be initiated or conducted without prior approval by the Institutional Review Board (IRB) that is registered with the Department of Health and Human Services (DHHS), as evidenced by a Federal Wide Assurance (FWA) issued by the Office of Human Research Protection (OHRP).

 

3.0            Responsibilities

 

3.1              Principal Investigator

·         Notifies Procurement Services of proposed work involving HSR (see Figure 1), and requests Cooperative Research and Development Authority (CRADA) package, or other appropriate agreement.

·         Completes and submits CRADA, or other agreement, to Procurement Services and other appropriate parties for review.

·         Provides FWA number from partner/sponsor as evidence of IRB approval for any contracted work involving HSR activities.

·         Ensures compliance with the Human Subjects Protection (HSP) Program procedures and other requirements.

·         Immediately notifies AD, ESH&Q of:

o   Any significant adverse event, unanticipated problem, and complaints about the research;

o   Any suspension or termination of IRB approval;

o   Any significant non-compliance with HSP Program procedures or other requirements which require reporting to the IRB for further evaluation; or

o   Any suspected or confirmed data breach involving PII in printed or electronic form.

 

3.2              Associate Director, ESH&Q

·         Reviews proposed work involving HSR to assess risks to participants and potential ES&H hazards involved in research activities.

·         Assures compliance with applicable Federal and DOE regulations and requirements involving HSR.

·         Maintains list of work involving HSR activities.

·         Performs notifications to DOE HSP Program Manager as required by DOE O 443.1B.

·         Performs oversight of HSR Protection Program through the Jefferson Lab Contractor Assurance System (CAS).

·         Ensures relevant personnel participate in HSP training as appropriate.

 

3.3              Procurement Services

·         Provides CRADA package, or other appropriate agreement, to Principal Investigator upon request.

·         Manages CRADA process, or other business arrangements, in accordance with department procedures.

 

3.4              Everyone at Jefferson Lab

·         Does not perform any work involving HSR without prior IRB approval.

·         Safeguards the welfare, privacy, and rights of human subjects who take part in research experiments.

·         Immediately notifies Principal Investigator of any unanticipated or potential problems related or possibly related to HSR activities.

 

 

Figure 1 – Does Activity Involve Human Subjects Research?

Modified from DHHS Chart 1: Is an Activity Research Involving

Human Subjects Covered by 45 CFR part 46?

 

4.0            Referenced Documents

 

10 CFR 745, Protection of Human Subjects

45 CFR 46, Protection of Human Subjects

DOE Order 443.1B, Protection of Human Research Subjects

 

5.0            Revision Summary

 

Revision 0 – 07/01/13 - New material written to reflect current laboratory operations.

 

 

 

ISSUING AUTHORITY

TECHNICAL POINT-OF-CONTACT

APPROVAL DATE

REVIEW REQUIRED DATE

REV.

 

 

ESH&Q Division

Mary Logue

07/01/2013

07/01/2016

0

 

This document is controlled as an on line file.  It may be printed but the print copy is not a controlled document.  It is the user’s responsibility to ensure that the document is the same revision as the current on line file.  This copy was printed on 7/12/2013.