Coordinating Center Request for Exemption Research Summary Template

DO NOT SUBMIT THIS INSTRUCTION PAGE

When is it appropriate to use this research summary template?

This research summary template is for eIRB submission of a multi-site Coordinating Center Study Application research protocol(e.g., central clinical coordinating center, statistical coordinating center, or a central resource such as Data Coordinating Center, Health Economics and Quality of Life (EQOL) coordinating center, Clinical Events Committee, Central Imaging, etc.)in which Duke may be considered“not engaged in human subjects research” if:

  1. A Duke investigator does not receive identifiable private information (such as name, subject initials, date of birth) about the subjects of the research that would enable Duke study staff to readily identify the subjects of the research; or
  2. A Duke investigator does not have direct interaction/intervention with human subjects; or
  3. A Duke investigator is not the direct recipient of a grant, contract, or cooperative agreement from the US federal government for human subjects’ research funding the protocol under review, whether research activities occur at Duke or elsewhere; or
  4. A Duke investigator is not the sponsor of the protocol under review (i.e. this is not a Duke PI-initiated study); or
  5. The study does notinvolve an IND or IDE under which regulatory reporting to the FDA would be required for the protocol under review.

NOTE: If your research is not a multi-site coordinating center protocol, and you are not the coordinating center or central resource for the study,this research summary is not applicable to you.

The Research Summary should include sufficient information for evaluation of the proposed research. The PI is expected to provide any additional information requested for review by the IRB.

Use of the template research summary below will insure that certain minimum essential information related to the implementation of the protocol at Duke has been provided to the IRB. The information submitted to the IRB should describe what occurs at Duke in sufficient detail for the IRB to determine that regulatory and institutional requirements have been met.

Using the bolded headings in the research summary will aid reviewers’ understanding of the Department/Institute/CRU responsibilities you are describing in your application. Include research summary version date and page numbers on each page of the summary (e.g., in the document’s footer).Text in italics is an instruction; text in a plain font can be copied and used verbatim.

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Coordinating Center Request for Exemption Research Summary Template

  • Protocol title – insert Protocol title
  • Does this study involve an IND or IDE?
  • Your Department/Institute/CRU roles/responsibilities in the study:

In this part describe your role in the study (e.g., Clinical Coordinating and/or Statistical Center or Outcomes) and your responsibilities in the study (i.e., research management, data management, site coordination/site monitoring, study design, research development and/or implementation, etc.). Provide a detailed description of what is involved in each of these activities.If there are research partners that are identified in the protocol or elsewhere (or if your Department/Institute/CRU has subcontracted research activities to research partners), list those research partners here and briefly explain their responsibilities.

NOTE FOR DCRI STUDIES ONLY: If this is a DCRI submission, and there are multiple DCRI functional groups involved in the study, e.g. Clinical Operations, Outcomes, CEC, Imaging, etc., list each group and their responsibilities in the study.

  • Purpose of the study – [objectives & hypotheses to be tested, brief description]
  • Background & significance – [should support the scientific aims of the research, brief description]
  • Design & procedures – [A brief description of the research that includes the objectives and conduct of the study procedures]
  • The subject population (include number of subjects, age range), or the materials (records, data or specimens and their source) to be used in this study.
  • Funding source and sponsor.Include the following information about your research funding:
  • Is the research federally funded?If no, name the funding source.

If federally funded, are the funds received by Duke sent to one or more intervention/other sites to support:

  • Research activities related to a Coordinating Center, Statistical Center, Central Laboratory, or Reading Laboratory or other similar facility at Duke ONLY?
  • Research activities involving human subjects at Duke orone or more other institutions?

If federal (NIH, FDA, DoD, etc.), provide information about the primary awardee/PI of the grant/contract/cooperative agreement..

**If PI of this application is the primary awardee, do not use this template.

Describe whether or not funds from the federal government sent to Duke will be further distributed to the intervention sites for the research.

State whether or not the funds disbursed by your Department/Institute/CRU will be paying for interventions that are greater than minimal risk either at the intervention sites or under the coordinating center protocol.

  • In addition, give the following specific information about your research activities:

a)Do you obtain informed consent of human subjects for research?

b)Is your Department/Institute/CRU responsible for developing the template consent form for subjects at the intervention sites? If so, provide a copy for review. This informed consent should be attached in the same section as the research summary.

c)Is your Department/Institute/CRU responsible for ensuring that all sites have IRB/Ethics board review/approval and, when applicable, FWAs? If so, provide a copy of the approvals when available or, if greater than 10 sites, the location where they are stored and whom to contact if the IRB, CTQA or other HRPP office requests access to them.

d)Is your Department/Institute/CRU responsible for any audit functions of sites conducting the research? If so, please describe the process, frequency, where the audit records are stored and whom to contact if the IRB, CTQA or other HRPP office requests access to them.

e)Does your research involve an interaction/intervention with a living individual for research purposes?

f)For this study, what subject information will be collected and from where?

g)What subject-specific information will be collected/received by your Department/Institute/CRU along with the research data/health information: for example, are you collecting/receiving any subject identifiers such as birth date, procedure dates, initials, ZIP code, etc.? Are you collecting/receiving clinical or research data from the subjects? Are you collecting/receiving information from medical records?

h)If your Department/Institute/CRU receives any subject identifiers, direct or indirect, such as birth date, initials, procedure dates or ZIP code, include information about the following:

  • Can your study team members readily identify any subjects using the information?
  • Will your study team members obtain or seek to obtain the key to the code that could be used to identify subjects?
  • If your study team members inadvertently receive information from a site that can identify a research subject, describe whether or not the information will be accepted. (When applicable, your study team will work with sites to ensure they send only information and identifiers that have been requested)
  • If receipt of subject information by your Department/Institute/CRU is not specifically described in the consent/authorization form for the study, provide a request for a waiver of consent/HIPAA Authorization for receipt of that information. The waiver must be attached to the IRB application in the same section where the research summary is attached.
  • If the subject information is from DUHS patients and any of the study team members for the coordinating center have access to direct subject identifiers (for example, if they are on the study team for the intervention site at Duke), provide a description of how those study team members will be unable to readily identify the subjects from the data they will use/have access to, in the coordinating center protocol (if applicable) or the purpose of those study team members retaining access to the identifiable information.

i)For a research using coded subject information or samples, were the data or samples obtained specifically for this research?

j)Does your research involve the use of coded data or specimens linked to identifiable private information, such as a subject’s name or Social Security number with a key/code? If so, who keeps and has access to the key/code?

k)Does your research involve the use of coded data or specimens that are linked to a code in such a way that the subject is readily identifiable to your research team based on the code? If so, was consent/authorization specifically obtained for your Department/Institute/CRU to receive that information?

l)Does your research involve use of anonymized data/specimens (no key/link has been kept between the coded data and direct subject identifiers)?

m)For a research using coded private information, is a written agreement in place prohibiting the release of the key to the research team under any circumstances?

  • Privacy, Data storage and confidentiality.

[Describe how the data obtained by your Department/Institute/CRU are labeled (with what subject information) and what clinical information is obtained for each subject. Describe whether there is a key linking the data to the subjects and if so, who maintains and has access to the key.

Describe where data will be stored and who will be granted access to the data. Please ensure the answer includes processes for paper records and for electronic records as appropriate. Describe how the research records and data received by your Department/Institute/CRU will be protected against inappropriate use or disclosure, or accidental loss or destruction. If data will be shared with other investigators, explain why this is necessary. Do not just say that HIPAA regulations, HRPP policies, or IRB recommendations will be followed. Explain exactly what your Department/Institute/CRU will be doing to meet the regulatory and institutional requirements.]

NOTE:Data may be collected on case report forms, survey instruments, etc. and entered in databases or spreadsheets. Records and data include, but are not limited to, informed consent documents, case report forms, study flow sheets, survey instruments, databases, spreadsheets, screening logs, telephone eligibility sheets, web-based information gathering tools, audio/video/photo recordings of subjects, labeled (biological) specimens, data about subjects, subject identifiers, and identifiable private information (including PHI).

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