EXPEDITED REVIEW

advertisement
HSSREC Ref:
Info Ed Ref:
.............................................
............................................
EXPEDITED REVIEW
Application for the Expedited Approval of Research Projects Involving Human (Non-NHS)
participants, their data or tissue.
Humanities and Social Sciences Research Ethics Committee (HSSREC)
Expedited review of research can occur where the potential for risk of harm to participants and
others affected by the proposed research is minimal, for this reason the review of minor research
amendments, research involving only secondary or historical data and research where participant
involvement is limited to a consultancy or advisory input may be undertaken via an expedited
review process as detailed below:
Please complete sections A and B of this form together with one of the annexes and return to the
secretary of the HSSREC along with a copy of the study protocol.
Annex A) Approval of minor amendments to projects that have already received Ethical
Approval.
Annex B) Approval of research involving the review of secondary or historical data where
there is no participant involvement.
Annex C) Approval of research
consultancy/advisory input only.
where
participant
involvement
is
limited
to
No research project with ethical considerations may begin before the relevant Sub-Committee of
the UREC has issued its written approval. Written confirmation of the Sub-Committee’s decision
will be emailed to the principal investigator as soon as possible after the expedited review. The
Sub-Committee may request a full ethical review for this research project if deemed necessary.
Before completing this form, applicants must refer to the University’s Statement and Guidelines on
Ethical Practice (http://www2.warwick.ac.uk/services/rss/) in conjunction with any other guidance or
ethical principles relevant to their specific research.
Section A: GENERAL INFORMATION
1.
Project Title:
2.
Applicant:
3.
Department:
4.
Email:
5.
Telephone
6.
Other investigator(s)
Institution(s)
7.
Proposed Start Date
8.
9.
10.
Duration
Funding body
Are there any potential conflicts of
interest?
Y/N
If yes, please specify
11.
Is this a student project?
Y /N
If yes, name of student:
Email
Section B: DECLARATION

The information in this form together with any accompanying information is complete
and correct to the best of my knowledge and belief and I take full responsibility for it.

I undertake to abide by the ethical principals underlying the Declaration of Helsinki
(http://www.wma.net/e/policy/b3.htm) and to abide by the University’s Research Code
of Conduct (http://www2.warwick.ac.uk/services/rss/) alongside any other relevant
professional bodies’ codes of conduct and/or ethical guidelines.

If the research is approved, I undertake to adhere to the study protocol without agreed
deviation.

I undertake to inform the HSSREC of any changes in the protocol that would have
ethical implications for my research.

I am aware of my responsibility to be up to date and to comply with requirements of the
law and the appropriate guidelines relating to security and confidentiality of participants’
personal data.
Signature of
Principal Investigator: ……………………………………………………………
Name (Please Print): ………………………………………… Date: ……………
Signature of Student (if applicable) ……………………………………………………………
Name (Please Print): ………………………………………… Date: …………
N.B. For student projects, signatures from both the supervisor and the student are required.
Signature of
Chair of Department: ……………………………………………………………..
Annex A:
PROJECT AMENDMENTS & APPROVALS GRANTED BY ANOTHER INSTITUTION
1.
Please provide the name of the Ethics Committee that reviewed the original application and
confirm the date approval was granted (please attach a copy of the original approval letter)
2.
Please give a brief summary of the original project (in lay terms), including the scientific
benefit.
3.
Please summarise the original methodology to be used.
4.
Please detail the proposed changes to the research method and/or aim.
5.
Please describe briefly any ethical issues and / or sensitive topics that will arise from these
changes.
6.
How do you intend to handle these areas?
7.
Please provide any additional information that you believe to be relevant and provide a
copy of the original study protocol.
Annex B:
SECONDARY AND HISTORICAL DATA REVIEW (No participant involvement)
1.
Please give a brief summary of the project (in lay terms), including the scientific benefit
2.
Please provide a description of the data source to be used, specifying the era the data
relates to and if possible how the data was originally collected.
3.
Please provide details of any ethical review that has taken place regarding the initial
collection of the data.
4.
Will approval from another organisation be required in order to gain access to this data, if
so please provide the details.
5.
Who will have access to the data?
6.
Please describe any ethical issues/sensitive topics that will be covered during the course of
this research.
7.
How do you intend to handle these areas?
8.
When publishing the research findings what precautions will be taken to safeguard, in the
case of
a. Literary review, the sensitivities and/or anonymity of living relatives
b. Pre-existing datasets, the continued confidentiality and anonymity of personal data
9.
Please provide any additional information that you believe to be relevant and provide a
copy of the original study protocol
Annex C:
ADVISORY/CONSULTANCY PARTICIPANT INVOLVMENT
1.
Please give a brief summary of the project (in lay terms), including the scientific benefit.
2.
Please summarise the methodology to be used.
3.
Please provide details regarding how the participants are to be recruited and the nature of
the information to be obtained, specifying whether any personal information will be
recorded.
4.
Is there a need for confidentiality/anonymity regarding the information to be disclosed by
the participants? Please provide details.
5.
Will the participants be briefed on the research objectives/purpose of their involvements
and consent obtained for their participation? Please provide details.
6.
Will payment be offered for their involvement?
7.
Please describe any ethical issues/sensitive topics that will be covered during the course of
this research
How do you intend to handle these areas?
8.
9.
Please provide any additional information that you believe to be relevant and provide a
copy of the original study protocol
Download