/ Human Tissue Act – Research Sector
HTA-SOP-09.v2
STANDARD OPERATING PROCEDURE NUMBER: / HTA-SOP-09.v2
HUMAN TISSUE ACT – RESEARCH SECTOR
TITLE / The Human Tissue Act Virtual Research Environment (VRE)
AUTHOR / Name and role / Mhairi Anderson
Quality Assurance and Development Manager
Signature & Date / 4th April 2017
APPROVER / Name and role / Dr Chris Morris
Designated Individual, Newcastle University
Research HTA licence (Ref: 12534)
Signature & Date / 4th April 2017
EFFECTIVE DATE: / 1st May 2017 / REVIEW
DATE: / 1st May 2019

Distribution

This document will be retained in the following locations:

·  Newcastle Joint Research Office Website (www.newcastlejro.org.uk)

·  Human Tissue Act VRE (https://researchtools.ncl.ac.uk/portal).

Change control

To request any changes to this document please submit a change request using the following form, in accordance with HTA-SOP-8 “Change Control”. http://forms.ncl.ac.uk/view.php?id=6528

Revision category

Category 1 / This is a new/revised document. All personnel required to follow content must read this version and complete training
Category 2 / This is a revised document in which only the area of applicability has changed. All newly impacted personnel required to follow content must read this version and complete training
Category 3 / This is a new/revised document. All personnel required to follow content must read this version / ü
Category 4 / No significant change to document content – no requirement to read or train

Note: As applicable, documentation of reading and/or training must be completed prior to performing the procedure.

1. BACKGROUND

The Human Tissue Act (HTA) is a legal framework which regulates the “removal, storage, use and disposal of human bodies, organs and tissues”. The Act came into effect on the 1st September 2006 and applies to England Wales and Northern Ireland. Newcastle University holds a Research Human Tissue Act licence (Ref. 12534) which licenses the storage of human tissue for research.

Under the terms of The Human Tissue Act, it is essential that all aspects of the establishments work are supported by ratified documented policies and procedures as part of the overall governance process. To ensure compliance, there must be

·  a systematic and planned approach to the management of records

·  a document control system covering all documented policies and standard operating procedures (SOPs), and,

·  a back-up/recover facility in the event of loss of records

ResearchTools is an online framework which has been developed by Newcastle University to provide a Virtual Research Environment (VRE) to support communication, collaboration and file sharing between members of a research group by providing a secure online environment

The VRE is a secure web interface to restrict access to registered users only.

It can be used from anywhere with an internet connection, and can be accessed by both University and non-University staff.

This SOP describes the procedure for accessing, navigating and using the Human Tissue Act Virtual Research Environment (VRE) which is an electronic cloud which has been established under the Newcastle University research HTA licence to store and share records related to the licence in compliance with these standards. These records include Standard Operating Procedures (SOPs), Policies, Newsletters, Manuals etc.

2. SCOPE

This SOP applies to all personnel involved in research activities under the Newcastle University Research sector Human Tissue Act licence (Ref. 12534).

This SOP describes the how to access and navigate the HTA VRE. Further information on the VRE should be obtained from HTA VRE user guides (see section 4.2) and the ResearchTools User Guide, which can be found at the following link.

https://researchtools.ncl.ac.uk/access/content/public/ResearchTools_User_Guide.pdf

3. DEFINITIONS

DI / Designated Individual
HTA / Human Tissue Act
PD / Person Designated
QMS / Quality Management System
SOPs / Standard Operating Procedures
QADM / Quality Assurance and Development Manager
VRE / Virtual Research Environment
NJRO / Newcastle Joint Research Office

4. PROCEDURE

4.1. Accessing the Human Tissue Act VRE

The VRE is supported by the following browsers:

·  Internet Explorer 5.5 and newer (Windows only)

·  Mozilla Firefox

·  Netscape 7.1 and newer

Using any other browser may cause some functionality to be lost.

To access the Virtual Research Environment

1)  Use the following link to access Research Tools. This link can also be found by searching for “Research Tools” from the staff homepage:

https://researchtools.ncl.ac.uk/portal


The first thing you will see when you navigate to ResearchTools is the Gateway site.

2)  On the top right hand corner of the Gateway you will see an icon with “Login” – click on this link.

3)  You will then be asked to select your Identity Provided. Select “Newcastle University” from the drop down list.

4)  For University staff who are already logged into a University computer, you will be automatically signed into the VRE via single-sign on. Otherwise University members can login using their usual campus ID and password.

External users who do not have a University log-in (email and password) must obtain a free user ID using the following link:

https://app.protectnetwork.org/registration.html;jsessionid=30DF42B99BD03408EB7FB98B36B73E48?execution=e1s1

5)  When you log into ResearchTools, you will automatically be directed to the Home Page, known as “My Workspace”.

My Workspace is an individual online worksite that functions as a private workspace for each user.

On My Workspace the top tool bar contains a list of all of the Virtual Research Environments that a user may access. As each Research Group may have its own VRE, each user may be assigned to a number of different VREs.

6)  To access the “Human Tissue Act VRE”, click on the link on the toolbar.

If the Human Tissue Act VRE does not appear on the toolbar, this is because you have not been added as an approved user to this environment.

To gain access, please contact either:

Rachael Gray / Biobank Administration Assistant /
0191 282 5705
Mhairi Anderson / QA and Development Manager /
0191 282 5501

7)  You should now have access to the Human Tissue Act VRE and can navigate the environment to view/add documents, or contribute to discussions.

To save the link to the Virtual Research Environment to your desk top

  1. Click on to your desktop
  2. Right click and select “New” “Shortcut” – then insert the address https://researchtools.ncl.ac.uk/portal - select next, and call the shortcut “VRE”.

4.2. Navigating the HTA VRE

The key function of the HTA VRE is to share Quality Documents. These can be found in the “Resources” menu on the left hand tool bar.

For information on how to navigate and use the HTA VRE, please refer to the following User Guides:

·  “Navigating the VRE”

·  “How to create, add and edit documents”

These user guides can be found on the Newcastle Joint Research Office website (www.newcastlejro.org.uk), and within the HTA VRE under the “Resources” Menu, in a folder called “User Guides”.

Further user guides, including the “Research Tools User Guide”, “How to set up your own VRE” and “How to add new users to a VRE” are also included in this folder.

5. DOCUMENT REVISION HISTORY

Section affected / Description of changes / Reason for change /
Page 1 / Approver changed / Professor Andy Hall replaced with Dr Chris Morris
4.1 part 6 / Contact details changed to remove Rebecca Halmshaw and add Rachael Gray / Staff changes
Page 7 of 7
Wednesday, 05 April 2017
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