Clinical Research Department

The Code of Federal regulations defines Research as:

  • A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge... [45 CFR 46.102(l)]

and defines Human Subject as:

  • A living individual about whom an investigator (whether professional or student) conducting research:  (i) obtains information or biospecimens through intervention or interaction with the individual, and uses,  studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. [45 CFR 46.102(e)(1)]

The Clinical Research Department must evaluate all research that is conducted with human subjects, regardless of funding, to ensure the protection of the rights and welfare of all research subjects. Research activities included under the federal definitions are the collection of tissues, blood, genetic material, private information, and any chart review. No research involving human subjects conducted under the auspices of PeaceHealth can be done without Clinical Research Department approval.

We have completed a Policy Manual that will serve as a guide to researchers involved in human subject research. If you have any questions regarding this website, the status of your protocol, or any question involving human subject research compliance, please contact the Clinical Research Department.

Education

Web-based tutorials on human subjects protection

Certificates should be added to your user profile on IRBNet and attached to all new research project applications.

  • CITI Program Human Subjects Protection Tutorial. Register and affiliate yourself with PeaceHealth. You will be presented several options to enable you to enroll in the Learner Group appropriate to your role in Human Subject Research as decided by PeaceHealth. 

Conferences on human subjects protection

Forms

All regulatory forms and applications can be found on IRBNet under Forms and Templates. Please revise bookmarks as necessary and delete any prior document versions saved to your computer.

Staff

Meeting dates and deadlines

  • The Clinical Research Department will meet at least ten times per year on the first Friday of every month from 7:00 to 9:00 a.m. or as determined by quorum of members.
  • The deadline for submitting materials is two weeks prior to the convened Clinical Research Department meeting. 

Submission process

What do I need to submit to the Clinical Research Department for review?

Submission Requirements for Full Department or Expedited Initial Review

  • Research Project Application
  • Administrative Checklist, signed by the appropriate department officials
  • $2250 initial processing fee, $1500 expedited review
  • Financial Disclosure Form
  • Research protocol
  • Proposed informed consent document/Assent and permission documents (if applicable)
  • PeaceHealth Authorization to Use and Disclose Health Information (if applicable)
  • Investigator Brochure, or device specifications
  • Questionnaires & assessment instruments
  • Supporting material, such as examples of recruitment advertising, etc.
  • Documentation of completion of required human participant protections training (Principal Investigator, co-investigators, and study coordinator)
  • Curricula vita
  • FDA Form 1572 (drug study) or signed investigator agreement (device study)
  • Contract of funding agency minus the budgetary pages (if applicable)
  • Processing fee waiver request form (if applicable)

Submission Requirements for Exempt Research 

  • Exempt Project Application
  • Administrative Checklist, signed by the appropriate department officials
  • A protocol summary
  • Informed consent, if appropriate
  • Questionnaires, survey, interview questions if used
  • Advertisements, if used
  • Documentation of completion of required training

Submission Requirements for Modification/Amendment

  • Project Modification Application
  • $500 processing fee for substantive amendments to protocol and/or consent forms review (This includes all revisions that are reviewed by the Full Department)

Submission Requirements for Continuation/Renewal

  • Progress Report Form
  • Copy of the current consent document(s)
  • A copy of the current HIPAA Authorization document, if separated from the informed consent
  • Any other relevant documents provided by the investigator
  • $1000 processing fee
How long does the review process take?

The deadline for submission is two weeks prior to the full department meeting.  If materials are complete and the study is placed on the next meeting’s agenda notification will be sent to the Principal Investigator within 5 working days. For more information see meeting dates and deadlines.  

What happens during the initial review process?
  • The department support staff will review the submitted materials for completeness and compliance with PeaceHealth Clinical Research Department procedures and guidelines.
  • The Clinical Research Department Chair will determine the level of review (i.e., exempt, expedited, full board).
  • After preliminary review, the Clinical Research Department staff may return the materials to the investigator for modification; they may also request that the investigator submit additional materials prior to Clinical Research Department full board review. Prompt response to Clinical Research Department requests will significantly shorten the review process.
  • Once preliminary review is complete, the study will be scheduled for review.
  • If the study is judged exempt from Clinical Research Department review, a confirmation letter will be sent to the investigator and no further action is needed.
  • For expeditable studies, materials are reviewed administratively and the study contact is notified if changes are required.
  • All initial study materials for studies requiring full board review are sent to a primary and secondary reviewer. A protocol summary and consent forms are sent to all Clinical Research Department members attending the meeting at which the protocol will be reviewed.
  • If the reviewers have questions prior to the meeting, they may try to contact the investigator to resolve any uncertainties by phone or email using IRBnet.
  • Investigators are encouraged to attend the Clinical Research Department meeting.
  • Following the Clinical Research Department meeting, the investigator will be notified in writing of the Clinical Research Department's recommendations, typically within 3-5 working days of the meeting through IRBNet.
What are the possible outcomes of Clinical Research Department review?
  • Approved as Presented:  In this case the investigator is notified that the Clinical Research Department application is approved and does not require modification.
  • Modifications Required:  If modifications are required by the Clinical Research Department, the investigator must resubmit the necessary materials for subsequent review and approval. In most cases, the modifications will be reviewed and administratively approved. See the Consent Form Approval and Revision Process for more information.
  • Deferred:  If the proposal generates significant ethical questions, or appears to be scientifically unsound, the study will be deferred and further information will be requested. Studies may also be deferred if the protocol or consent documents are poorly written or do not provide sufficient information. If a study is deferred, the resubmitted materials must be re-reviewed at a subsequent Clinical Research Department meeting.
  • Disapproved:  Studies will be disapproved if they are judged to be ethically or scientifically unsound. Investigators are not advised to resubmit disapproved studies without consulting the Clinical Research Department. This is a rare - but possible - outcome.
What happens after Clinical Research Department approval?

The investigator can proceed with the research agenda after:

  • Clinical Research Department approval has been obtained
  • funding has been established
  • Any needed approvals from other PeaceHealth committees have been granted
  • Contracts/Agreements have been fully executed

Further contact with the Clinical Research Department is required:

  • If revisions or amendments to the research protocol or consent form are made. The investigator must receive Clinical Research Department approval before initiating any change. See the Consent Form Approval and Revision Process for more information.
  • When unexpected adverse events occur. These must be reported to the Clinical Research Department in a timely manner. Deaths should be reported to the Clinical Research Department immediately.
  • For periodic review. This should happen no less than once per year or as directed by the Clinical Research Department.
  • When Study Closes
Where Can I Get More Information About Federal Regulations Governing Human Subjects Research?
  • FDA Information Sheets provide guidance for Clinical Research Departments and Clinical Investigators regarding regulations governing human subjects enrolled in research involving investigation drugs or devices. The web site is: http://www.fda.gov/oc/ohrt/irbs/default.htm
  • DHHS Guidelines from the Office for Human Research Protections (OHRP). DHHS guidelines govern all research done at PeaceHealth regardless of funding source. The web site is: http://ohrp.osophs.dhhs.gov/polasur.htm

Release of Information (ROI) Guidelines for Research

Research studies in medical science and other health care fields often require that researchers review medical records. Researchers may request the release of records for their review to:

  • Determine whether specific patients are suitable subjects for a proposed or planned research study such as testing a new drug, device, or procedure;
  • Follow the course of a specific patient over a period of time, often many years; or
  • Study outcomes in large populations of patients with similar diagnoses, treatment, demographics, and/or other common traits.

Authorization for Release of Information in Research

Written authorization from the patient is not always required to release records for research. However, the PeaceHealth Clinical Research Department must approve any research study in which patient information is to be released without patient authorization (see below).

Any authorization provided for release of records for research must meet all the requirements and include all the components listed in the authorization checklist to be considered valid. However, HIPAA Privacy regulations do permit the following regarding authorizations for release of information for research:

  • A specific expiration date or event is not required. However, an expiration statement must be included. Acceptable expiration statements include “none,” “end of research study,” or anything similar.
  • The authorization may be combined with any other type of written permission for the same research study, such as consent to participate in the study.

Clinical Research Department Approval Required

HIPAA Privacy regulations permit releases of information for a research study without patient authorization, but only for specific purposes and only with Clinical Research Department approval. If the Clinical Research Department has approved the research study, patient records may be released without patient (or personal representative) authorization only in the following circumstances:

  • The researcher is reviewing records to prepare a research study,
  • The research study is specific to patients who are deceased, or
  • The PeaceHealth Clinical Research Department has waived the necessity for obtaining patient authorization for the specific research study.

Important note: If the request is for the purpose of preparing a research study, the released records may not actually leave the premises. The Clinical Research Department will provide guidance when this is the case. In addition to providing or printing records for the researcher’s review, you may need to provide the researcher with a work space to perform the review.

You may determine whether a given research study or protocol has been approved by the Clinical Research Department by accessing the Clinical Research Department website on Crossroads and selecting “Approved Protocols” from the menu.

Approval or Certification from a Clinical Research Department other than PeaceHealth’s

Occasionally, researchers submit requests for patient records for a research study approved by an Institutional Review Board other than PeaceHealth’s Clinical Research Department. Although HIPAA Privacy regulations permit a release of patient information in this situation, PeaceHealth policy generally does not allow it.

On rare occasions for a specific research study, the PeaceHealth Clinical Research Department may enter an agreement with another Clinical Research Department to approve the study protocols. This is done on a study-by-study basis only – an agreement with an outside Clinical Research Department for a specific study does not carry over to a different study. Therefore, “Clinical Research Department certification” from an outside Clinical Research Department in most cases will not permit us to release patient information to the requesting researcher. 

Contact the Clinical Research Department Coordinator for clarification.