Terms of Reference

Objectives

The Tasmanian Scientific Research Advisory Committee is a committee of Human Research Ethics Committee (Tasmania) Network. The objective of the committee is to ensure the scientific validity, merit, integrity and safety of health and medical research applications prior to their consideration by the Tasmanian Health and Medical Human Research Ethics Committee. 

Overall Function

The function of the Tasmanian Scientific Research Advisory Committee is to provide independent and expert scientific assessment with regard to the validity, safety, integrity and merit of health and medical research applications, which have been submitted for the consideration of the Tasmanian Health and Medical Human Research Ethics Committee.  
The considerations and recommendations of the Tasmanian Health and Medical HREC and the Tasmanian Scientific Research Advisory Committee are subject to the guidelines laid down in the NHMRC National Statement on Ethical Conduct in Human Research 2007 (National Statement).

Specific Functions

• The committee will evaluate according to the National Statement, as detailed but not limited to the list below:

• the clinical data
• the rationale and clinical relevance
• the methodology (randomisation/stratification)
• the sample size
• the objectives of the proposed study
• the design issues (placebo controlled, blinding etc)
• the expected outcomes
• the statistical analysis
• the safety and merit
• the PICF for accuracy and validity against the protocol
• the relevant expertise of the research team
• the integrity of the proposed study

• The committee will provide assistance or scientific advice and encouragement to researchers as appropriate.

• The committee will provide

• Feed-back to the researcher and where appropriate, a reasonable level of discussion with researchers on revising the application so that it does meet an acceptable standard.  The committee has the authority to return the application for re-submission.

• Endorsement and/or advice to the HREC of the scientific validity and integrity of the project based on the items above. To inform their decision the committee will provide and/or arrange appropriate reviews.

• The committee may alert the HREC to other areas of concern of an ethical nature

• The committee will work with the HREC on other such matters such as work flow and responses to complaints

| Back to Top |

Membership

There will be an open call for membership and a selection committee will appoint members with appropriate expertise.

The Tasmanian Scientific Research Advisory Committee will have a minimum of 12 members and will comprise a core membership body with relevant expertise in the areas/disciplines of the projects considered.

Currently, members will have knowledge and/or experience in methodology, pharmacology, clinical research and trial coordination, statistics and general research.

The quorum is 7, however if members are unable to attend, comments on agenda items will be accepted as adequate consideration and render meetings quorate. 

Each member will be appointed for a two-year term and may choose to extend the appointment for a further two years. The recommended maximum term of membership is four years.

Membership will lapse if a member fails to attend three consecutive meetings or send comment without apology or reasonable excuse. The Secretary will notify the member in writing accordingly.

The Chair will be selected by agreement between DHHS and UTAS authorities after appropriate consultation

The Committee will select the Deputy Chair.

It is a firm requirement that all members carefully read all applications, attend a 1-2 hour meeting on a regular monthly basis and provide written reviews of applications when requested.

Conflict of Interest

Any member who has an interest or a strong personal view that would unreasonably influence the Committee’s decisions or communication with researchers should declare this at the beginning of the meeting. The Committee will determine if the declaration is a conflict of interest and the member will be asked by the Chair to refrain from entering the discussion when appropriate.

Administrative Support

As the Scientific Research Advisory Committee is a committee of the HREC (Tasmania) Network, administrative and secretarial support will be provided by HREC to SRAC. This will include provision to communicate decisions and advice to both applicants and HREC.  

An agenda will be submitted to the Committee in a timely fashion prior to the meeting.