Study Feasibility Assessment Request

Submit this form to the REB if you wish to review patients’ personal health information
for the purpose of assessing the feasibility of a potential research study at the Nova Scotia Health Authority.
To be completed by Research Ethics Office / Date Received:
Potential Research Study
Protocol Identifier
(if applicable)
Title of Protocol
(or description of potential study)
Researcher
Name
Person to whom Correspondence should be Sent
Name / Study Role
Mailing Address
Phone No. / Fax No.
Email Address
Instructions:
  • Mailing address must be detailed enough to enable successful delivery of return correspondence. Specify dept. / division / program / service, institution, building, and room number as well as any other required information.
  • Print this form as a single-sided document and submit one copy to the REB at the address listed at the top of the page.
  • Note: Incomplete submissions / documents will not be processed and will be returned to sender.

Assessing study feasibility:
  • Before embarking on a research study, it is important to assess the feasibility of conducting the study at the Nova Scotia Health Authority (NSHA). The study should have scientific merit and clinical relevance and be adequately resourced. Resources typically include time, expertise, infrastructure, funding, and a sufficient pool of eligible participants.
  • Where possible, statistical, aggregate or de-identified datashould be used to determine whether thepopulation of potential study participants is sufficient. In some cases, however, it may be necessary to reviewpatients’ personal health information. Submit this Request to the REB to seek permission to review personal health information for this purpose.
  • Personal health information viewed for the purpose of assessing study feasibility may not be collected, retainedor disclosed by the researcher. Researchers are to extract non-identifying information only.
  • If/when it has been decided that the study would be feasible to conduct at NSHA, submit the proposed study to the REB using the REB’s Initial Submission Forms. Participant recruitment cannot begin until full approval has been granted.

Personal health information:
  • “Personal health information” includes all information relating to health and health services that may (alone or in combination with other information) identify an individual, their family or their substitute decision maker.
  • Personal health information does not include statistical, aggregate or de-identified information. If information (either alone or in combination with other information) does not identify an individual, it is not “personal health information”.

Review of Personal Health Information for Assessing Study Feasibility
a)Describe the population to be studied.
b)Describe the type and quantity of personal health information required to assess study feasibility.
c)Identify potential sources of this personal health information. (e.g., patients or previous research participants themselves, health records, previous research records, databases, third parties)
d)Explain why study feasibility could not reasonably be assessed withoutthe personal health information.
e)Will the personal health information be accessed in the most de-identified form possible? / Yes No
—Please comment, and explain how any de-identification will be performed:
f)Have / will individualsconsent to having their personal health information accessed for this purpose? / Yes No
—If Yes, describe how this consent has been / will be obtained:
—If No, explain why you believe that obtaining this consent is not required or would be impracticable:
“Impracticable” refers to a degree of difficulty higher than inconvenience or impracticality but lower than impossibility.
g)Who will accessthe personal health information for the purpose of assessing study feasibility?
Study Role:
It is not necessary to list clinical and support personnel (e.g. lab and pharmacy personnel, clinic nurses, health information staff) who may be privy to participants’ personal health information in the course of their duties at NSHA.
Qualifications:
For individuals employed by NSHA (or the IWK), state “NSHA” (or “IWK”) to indicate that the individuals are qualified in accordance with applicable institutional, provincial and/or Accreditation Canada standards.
For those employed by Dalhousie or other entities, specify their qualifications (e.g., degree(s), professional designation).
Name / Study Role / Qualifications
h)How much time will be needed for this review?
days weeks months

Signature Page

Study Feasibility Assessment Request

Researcher’s Signature
I confirm that:
  1. Review of personal health information will be limited to the extent described in this Request.
  2. Only non-identifying information will be collected, retained or disclosed.

I commit:
  1. To comply with any terms and conditions imposed by the REB and the Nova Scotia Health Authority (the ‘custodian’);
  2. To limit the use of personal health information to the minimum amount necessary and to view the information in the most de-identified form possible;
  3. Not to attempt to identify or contact individuals without their prior consent, unless otherwise authorized by the REB;
  4. Not to publish information in a form where it is reasonably foreseeable in the circumstances that it could be utilized, either alone or with other information, to identify an individual;
  5. To allow the Nova Scotia Health Authorityand the REB to access or inspect the research premises to confirm that the research complies with the terms and conditions of Nova Scotia’s Personal Health Information Act and other applicable standards and agreements;
  6. To notify the Nova Scotia Health Authorityand the REB immediately and in writing if personal health information is stolen, lost, or subject to unauthorized access, use, disclosure, copying or modification;
  7. To notify the Nova Scotia Health Authorityimmediately and in writing of any known or suspected breaches of applicable agreements.

Signature: / Date:
(Researcher) / (yyyy/mm/dd)
Research Ethics Board Use Only
The Nova Scotia Health AuthorityREB has reviewed this Request and authorizes access to personal health information for the purpose of assessing study feasibility for the period:
to
Is referral to the REB Executive Committee recommended? Yes No
Signature: / Date:
(Chair/Co-Chair, REB) / (yyyy/mm/dd)
Print Name:
(Chair/Co-Chair, REB)
Processed by: / Date Processed (yyyy/mm/dd)

Page 1 of 4 Study Feasibility Assessment Request REB Version: 2015/04/01