Contracts Assessment Form FAQ
The Contracts Assessment Form (CAF) is essential for the effective processing of research contracts. Copies of CAFs can be found in the subsections. Please refer to the frequently asked questions regarding the CAF below.
The name of the Principal Investigator who will be the research account holder for the Project funding.
If your employment contract ends prior to the project end date please inform your Head of School of same.
If you are unsure of your employment contract end date and/or employment status, please contact the HR Service Centre at hr@tcd.ie or by calling Ext. 3333.
Most Principal Investigators are affiliated with a School or Area. For example, if you are affiliated with the Department of Botany, then you are affiliated with the School of Natural Sciences. However, if you are not affiliated with a school please see TRI in 4(i) and select Not Applicable for Q3.
Examples of TRIs or Trinity Research Institutes include: Trinity Biomedical Sciences Institute (TBSI), Centre for Research on Adaptive Nanostructures and Nanodevices (CRANN), Trinity Long Room Hub (TLRH) and Trinity College Institute of Neuroscience (TCIN) and Trinity Translational Medicine Institute (TTMI). Examples of Non-Academic Areas include the Library, Science Gallery and Trinity Research and Innovation.
Each Project is allocated a specific project code and account by TCD's Financial Services Division (FSD). Each account is set up under a specific School, TRI or Area. If the Project funding is not going to be housed in your affiliated School, then you will need to seek approval of your Head of School and the Head of Area/TRI where the funding will be housed by completing the 'Housing Letter' and returning it to the Contracts Office - rescon@tcd.ie.
The Project Funder, also known as a sponsor, will be named in your contract.
What category (in the dropdown menu) best describes the thematic elements of your research?
Basic - investigation and analysis focused on better or fuller understanding of a subject, phenomenon or basic law of nature.
Applied - the use of theory to develop technology or techniques.
Clinical - collecting evidence to determine the safety and efficacy of new medications and/or devices for treating disease.
Experimental - controlling certain variables and manipulating others to observe if the results of the experiment reflect that the manipulations directly caused the outcomes.
These should be clearly stated by the sponsor in your contract.
The total project funding comprises all direct funding (cash), in-direct funding (sometimes referred to as overheads) and the monetary equivalent of any in-kind contribution (e.g., materials, equipment, etc.). The TCD's total Project Funding should be clearly stated in the budget included in the contract for the Project. Note this figure is exclusive of VAT.
Please see the TCD policy on indirect costs, also known as overheads. Please note research services overheads should be calculated at 40%. Principal Investigator time contribution should also be charged to the Project.
Contributions given to the Project that have a monetary value, however are not cash payments. An in-kind contribution could be in the form of material or resource, e.g., use of equipment, office space, etc.
Projects are co-funded if funding is provided for the same Project by more than one Funder. Matched funding applies to Projects where there is an obligation on TCD to provide funding of any type (i.e., cash or in-kind), in addition to the funding being provided by the Funder(s). Unless Head of School approval to provide matched funding was already obtained (e.g., when submitting a funding application) then Head of School approval (via email, copying the Contracts Office rescon@tcd.ie will be required before the contract for the Project is signed.
In addition to gross salary the total 'on-costs' associated with the employment of a staff member on a fixed-term contract include (1) 10.85% employer's PRSI contribution and (2) 20% employer's pension contribution. Provision for redundancy costs should be included, expect where the Funder classifies redundancy costs to be ineligible. If these on-costs are not included in the Project budget they must be met by the School/TRI/Area etc.
For all staff employment queries contact the HR Service Centre at hr@tcd.ie or by calling Ext. 3333.
Contact your school administrator for further details regarding ethical approval. Proof of current ethical approval for this Project will need to be provided to TCD Contracts Office where applicable.
If my project involves Humans, their tissue or data, I should satisfy myself that my project is appropriately insured. (TCD is not insured for medical malpractice). This clinical trial table should help you to respond to the questions posed.
If you wish to find information regarding Interventional Regulated Clinical Trials of Investigation of Medical Products/ Clinical Investigations of Medical Devices please see HPRA for information.
If my project involves Humans, their tissue or data, I should satisfy myself that my project is appropriately insured. (TCD is not insured for medical malpractice). This table (PDF; 183kb) should help you to respond to the questions posed.
If you wish to find information regarding Interventional Regulated Clinical Trials of Investigation of Medical Products/ Clinical Investigations of Medical Devices please see HPRA for information.
What is health research?
Health research is defined in the Health Research Regulations 2018 as:
- research with the goal of understanding normal and abnormal functioning, at the molecular, cellular, organ system and whole body levels
- research that is specifically concerned with innovative strategies, devices, products or services for the diagnosis, treatment or prevention of human disease or injury
- research with the goal of improving the diagnosis and treatment (including the rehabilitation and palliation) of human disease and injury and of improving the health and quality of life of individuals
- research with the goal of improving the efficiency and effectiveness of health professionals and the health care system
- research with the goal of improving the health of the population as a whole or any part of the population through a better understanding of the ways in which social, cultural, environmental, occupational and economic factors determine health status
Overview of The Health Regulations 2018 as included in an email from the HRB
Minister for Health, Simon Harris signed into law the Data Protection Act 2018 (Section 36(2)) (Health Research) Regulations 2018 (referred to as the Health Research Regulations 2018 in this email).
The Health Research Regulations 2018 govern the use of personal data for health research purposes. These important new regulations will ensure that health research in Ireland is conducted using best practice principles of information governance in line with new GDPR requirements. The regulations protect the rights of participants while at the same time promoting and facilitating the conduct of high quality research in the public interest. The regulations also introduce for the first time a lawful mechanism that allows the processing of personal data for health research purposes in exceptional circumstances without the explicit consent of the individual concerned.
As some of your researchers may be directly affected by these regulations, the HRB is informing all Research Offices directly of the release of these regulations. You may also wish to bring this email to the attention of your organisation’s Data Protection Officer for their information.
The HRB is committed to supporting the health research community in Ireland understand its data protection responsibilities under GDPR and the new Health Research Regulations 2018. In this context it has published detailed GDPR guidance for health researchers which may be accessed on its website at: GDPR guidance for health researchers.
The Health Research Regulations 2018 set explicit consent as the default position for all processing and further processing, of personal data for health research purposes.
Personal data in this regulation includes all personal data that is being used for health research purposes including but not limited to biometric and genetic data as well as pseudonymised personal data.
However, the regulations also recognise that there may be exceptional situations where personal data may need to be processed without an individual’s explicit consent. In such circumstances researchers may seek a declaration that the explicit consent of the individual is not required. Such “consent declarations” will only be considered when it is clearly demonstrated that the public importance of carrying out the research outweighs to a significant degree the public interest to require explicit consent of data subjects. Such data processing will be subject to a range of additional safeguards designed to protect individuals and their information.
Under the regulations, the Minister for Health will establish a new Health Research Consent Declaration Committee (HRCDC) to consider whether or not a consent declaration should be granted. The HRCDC will report to the Minister for Health and will have its own identity. It will be supported by a secretariat that will be a new team within the HRB. It is expected that the HRCDC and its secretariat will be in place by 1st November 2018. Once these are established, a consent declaration application process and associated application forms will be announced.
The regulations also provide for an 9 month transition period (i.e. up to 30 April 2019) for current research (defined as research projects that have been approved by a research ethics committee on or before 07 August 2018) to either reach the required GDPR consent standard or for researchers to apply for a consent declaration from the HRCDC under the transitional arrangements.
Queries from health researchers
Given the importance of these new regulations, the HRB recognises that there are likely to be many questions regarding their impact and how the regulations will be implemented coming from the health research community. Until such time that the HRCDC and its secretariat are in place, the HRB will support health researchers by documenting queries from the health research community and providing guidance on the regulations.
If you or researchers within your organisation have queries about the new Health Research Regulations 2018, they should be submitted using the Health Research Regulations 2018 enquiry form.
In response to queries, the HRB has created a dedicated Health Research Regulations 2018 FAQ webpage which will be updated regularly until the HRCDC and its secretariat are in place. We will send out email alerts accordingly to notify people of updates to the FAQ. This is to ensure consistency of responses to all of the health research community.
It should be noted that while HRB aims to provide as much information and as much clarity as it can regarding the implementation of the new regulations and the establishment of the new HRCDC and its secretariat, it will not able to pre-empt answers to questions that fall under the remit of the HRCDC. In particular, the HRB cannot provide any advice whether or not a particular research project is compliant with GDPR and the new regulations nor whether or not a research project is of sufficient public interest to warrant the granting of a consent declaration.
In all cases, it is strongly recommended that you contact your institution’s DPO in order to get project specific advice.
Useful links:
- Read more about GDPR and health research
- Submit a query about the new Health Research Regulations 2018
- Read a copy of the full Health Research Regulations 2018
GDPR and the Health Research Regulations 2018 provide certainty, clarity and consistency in the data protection rules governing the collection, use and disclosure of personal health data for health research purposes and are critical for maintaining patient and public trust in this important activity.
“Personal Data” means any information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person.
"Anonymisation" of data means processing it with the aim of irreversibly preventing the identification of the individual to whom it relates. Data can be considered anonymised when it does not allow identification of the individuals to whom it relates, and it is not possible that any individual could be identified from the data by any further processing of that data or by processing it together with other information which is available or likely to be available.
"Pseudonymisation" means the processing of personal data in such a manner that the personal data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organisational measures to ensure that the personal data are not attributed to an identified or identifiable natural person;
For further information on Data Protection please refer to TCD’s Data Protection website: https://www.tcd.ie/info_compliance/data-protection/
“Special categories of Personal Data” refers to personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, genetic data, biometric data, data concerning health or data concerning a natural person's sex life or sexual orientation.
If you propose to engage a third party to carry out part of TCD's research for a Project (i.e., a subcontractor to carry out analysis of samples or to create a website) or to engage a third party provide some other consultancy services/advice to TCD in respect of a Project, then a subcontract /consultancy service agreement will need to be put in place and procurement guidelines must be adhered to. The Contract Office will provide a suitable template agreement. If services to be rendered are greater than the value of EUR 1,500 then a subcontract must be put in place for further advice please see Procurement.
If the contract is solely awarded to TCD with no other recipients TCD is the Sole Awardee. If there are several other parties involved in the Project, as partners/collaborators/co-applicants then TCD is the Lead Collaborator. If another party is Lead Collaborator for the Project, then TCD is a Collaborator. If TCD is providing research services/consultancy then TCD is classified as a research services/consultancy provider.
Where TCD is the Lead Collaborator on a Project involving other parties, depending on the type of Project and/or the source of the Project funding a collaboration agreement/arrangement will need to be put in place with the other parties. The Contracts Office will advise on the type of collaboration agreement/arrangement required depending on the Project and roles of the parties.
If you feel one of your personal or business relationships may cause conflict of interest in the Project, or are uncertain if a conflict may arise, please email the TCD Technology Transfer Office. Please also see the TCD Conflict of Interest Policy in pp. 15-16 of the Good Research Practice Policy.
See pages 27 - 28 of Good Research Practice Policy for Declaration of Interest Form