Ethics Considerations

Template for Ethics Applications

It is necessary to supply information (to the Department of Human Services) now about how human data will be stored in our data repository (data bank).

Here is a (word) template for filling in the relevant sections of the Ethics application: module1_databank_template_responses.doc

In addition, the guidelines indicate that subject consent falls into one of three categories:

• Specific - use data only for the original purpose for which it was acquired
• Extended - use data for original and related projects
• Unspecified - use data for any research purpose

Your ethics application and patient consent form must clearly specify this usage, and subsequently you must adhere to this specification. The following section describes how to do this with our Mediaflux-based data repository.

Working with Ethics via the Portal

It is essential that the conditions under which data were acquired (subject consent as listed above) are honoured.

Subjects will have signed an agreement specifying how their data can be used. Usually, you will have one agreement for all subjects, but subjects may specify their consent individually. For example, the Project as a whole may be designated extended, but an individual subject may require their data can only be used for specific use. Therefore, a Subject's consent may over-ride that of the Project, provided it does not widen the usage. For example, we do not allow Project wide consent of specific and a Subject to specify extended.

Project-Wide Data-use Specification

Projects are created in the system by senior scientists or their delegate. These people have the primary responsibility to ensure that the consent is adhered to.

When you create a Project, there is some mandatory meta-data that you must fill in. It is labelled hfi.pssd.ethics.consent in the portal.

You must select a value from the list (specific, extended, unspecified) that is consistent with your Project's ethics agreement.

Granting User Access to the Project

When a user applies to join the Project team that can access your project's data, you must establish if they want to use the data in a way that is consistent with the Project's ethics (look at the Project object with the portal to see the ethics specifcation again). If it is not, you must deny their request to access the data.

For example, the Project data-use specification might be specific. If a user applies for extended use then they are not allowed to gain access. The following table shows the access pattern.

By definition, any user that you grant access to the Project must use the data consistently with the Project's data-use specification. It is your responsibility to manage this.

Subject Over-ride

It is possible that regardless of the overall Project data-use specification, that a Subject will not agree to an extended or unspecified use of their data.

To handle this, we must know how a specific Subject's data should be used and and how the team-member wants to use it.

Team-member Specification

When you create the Project, or add a new team-member to it, you must provide that member's 'data-use' specification (how they will use the data) for this Project. Of course, you have already verified that their usage is consistent with the Project-wide data-use. With the portal, when you supply the user's team-member role, you must also select their data-use specification (if you specify a team-member data-use that is not consistent, it will be silently set to the Project data-use specification).

This data-use specification is only relevant to the team-member roles member and guest. By definition, a project-admin must be able to access all data. By definition, a subject-admin role is specific use. If a user who is a subject-admin decides that they want to use the data for extended purpose, their team-role should be changed to member.

Subject Specification

When you create the Subject with the portal, you can optionally set the data-use specification for that Subject. In this way, a Subject data_use of, say, specific can over-ride a Project data-use of, say, extended. (if you specify a subject data-use that is not consistent, it will be silently set to the Project data-use specification).

If you don't set the data-use on a Subject, then no additional restrictions apply and any team-member who has been granted access to the Project can access that Subject's data.

Example

Depending on the user's data-use role, certain Subject's data may not be visible to them. For example, consider a Project with data-use=extended and a Subject with data-use=specific. Then a user with team-member role=member and data-use=extended (which is consistent with the Project specification) will not be able to access that Subject. However, a team-member with data-use=specific will be able to access that Subject's data.

-- NeilKilleen - 03 Sep 2009