CommunityHospital of the MontereyPeninsula

Institutional Review Board

INITIAL IRB REVIEW OF RESEARCH PROTOCOLS

Submitted By: / Therese Beauclair, RPh, IRB Chairperson
Kay Lee, OTR, MBA, IRB Coordinator
Next review date: / 2015
Effective date: / November 2012
Application: / CHOMP Facilities
Approved by: / Institutional Review Board – 11/06/12 ; 01/04/11;10/06/09; 09/09/08; 06/12/07
Reviewed by: / Institutional Review Board
Replaces: / Institutional Review Committee Policy and Procedures, 2006
Inception Date: / 2004
References: / Issuance of Final Rule – Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors Notice #: NOT-OD-11-109, August 22, 2011
FDA Information Sheets “Guidance for Institutional Review Boards and Clinical Investigators” 1998
OPRR Reports, Protection of Human Subjects, Title 45, Code of Federal Regulations, Part 46. April 2, 1996 (prior to creation of OHRP).
“Protecting Human Research Subjects, Institutional Review Board Guidebook”, National Institutes of Health, Office of Extramural Research, Office for Protection from Research Risks, 1993
Distribution: / Institutional Review Board Members
Additional information: / N/A
Related policies: / Medical Staff Bylaws

PURPOSE: To provide guidance and direction for investigators involved in the conduct of research of human subjects.

POLICY: It is the responsibility of all investigators involved in the conduct of research on human subjects to abide by all federal, state and institutional policies and to follow the guidelines of good clinical practice. This policy outlines the requirements for the initial review of research protocols, exempt review procedures, and expedited review procedures.

CONFLICT OF INTEREST DISCLOSURE

Disclosure to the Government:

Investigator conflict of interest disclosureto the government is required by the FDA, Public Health Service and National Science Foundation and occurs at the time of submission to the FDA through the study sponsor, as in the case of marketing applications. Grant awards however, do not require reporting to federal agencies but are required reporting to the CommunityHospital of the Monterey Peninsula Institutional Review Board (CHOMP IRB) as part of the protocol approval process.

Disclosure to the CommunityHospital of the MontereyPeninsula Institutional Review Board:

An investigator shall seek consent only under circumstances that minimize possibility of coercion or undue influence, including financial and nonfinancial conflict of interest. Significant financial interest (SFI)for disclosure is $5,000 in income and any equity interest in non public-traded entities, regardless of value. SFI excludes incomefrom investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decision made in these vehicles.

Disclosure of conflict of interest to CHOMP IRB is required for investigators receiving federal funds from the sponsor. Financial relationships are described when investigators submit a new protocol application for initial review. The Board takes into consideration the funding arrangements between sponsor and the investigator institution and any interest on the part of the investigator that will likely create bias in their judgment or actions that will affect the rights and welfare of the potential subject. Investigators and board members with conflict of interests are prohibited participation in IRB deliberations and vote.

Disclosure to Subjects:

Disclosure of conflict of interest to the subject is required and will be stated in the informed consent process. Subjects will be made aware of study sponsorship by outside entities, either commercial or government, and institution or investigator compensation for conducting this research. Public accessibility concerning identified financial conflict of interest (FCOI) held by senior/key personnel will be available by a written response to any requestor within five business days of a request. Updated information is required at least annually and within 60 days of newly identified FCOI. All investigators involved in funded research activities will be required to complete a financial information form which will include at a minimum: the Investigator’s name; the Investigator’s title and role with respect to the research project; the name of the entity in which the SFI is held; the nature of the SFI and the approximate dollar value of the SFI, or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value. Investigators are also required to disclose any SFI of spouse and those of his/her dependent children.

FCOI Training:

Each Investigator must complete FCOI training prior to engaging in human subject research and thereafter at least every 4 years during research activities.

IRB REVIEW OF PROPOSED RESEARCH STUDIES – SUBMISSION REQUIREMENTS

The CommunityHospital of the Monterey Peninsula (CHOMP) Institutional Review Board (IRB) must review and approve all research activities involving human subjects which fall within its jurisdiction prior to the implementation of such research activities. There are three categories of IRB review of proposed research studies:

1. Exempt review

2. Expedited review

3. Full board review

IRB notification is required for the emergency use of a non-approved investigational drug or biologic or a non-approved investigational device (see Section 3.1.A.).

The IRB will consult experts in various fields to assist in the review of studies, as it deems necessary. These consultants may also assist in determining the risk/benefit ratio, as well as determining whether studies require review more than annually.

The Principal Investigator will be sent a notification letter within 10 days of review by the IRB. This includes full board review, exempt review and expedited review.

1.Exempt Review

Research activities in which the only involvement of human subjects will be in one or more of the categories listed below are exempt from the DHHS Federal Policy regulations including the requirement to obtain informed consent. However, federal and institutional policies require IRB review of human research activities appearing to meet these exempt criteria so as to ensure respective regulatory compliance. Research protocols qualifying for exempt review are reviewed in an expedited manner by the IRB chairperson or his/her designee. Following an initial IRB determination of exempt status, exempt research activities are not subject to annual renewal requirements. These exemptions do not apply to prisoners.

A.Educational practices: Research conducted in established or commonly accepted

educational settings involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods.

B.Surveys, questionnaires, interviews, and observational studies: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless,

  1. information obtained is recorded in such a manner that human research subjects can be identified (by the investigator or others), directly or through identifiers (codes) linked to the individuals and,
  2. any disclosure of the human research subjects' responses outside the research could reasonably place the individuals at risk of criminal or civil liability or be damaging to the individuals' financial standing, employability, or reputation. This exemption does not apply to research involving children, except for research involving the use of educational tests or research involving observation of public behavior of children (i.e., provided that the investigator(s) does not participate in the activities being observed).

C.Existing data or specimens: Research involving the collection or study of existing

data, documents, records, pathological specimens or diagnostic specimens. To qualify for this exemption these sources must be publicly available or the information must be recorded by the investigator in such a manner that human research subjects cannot be identified (by the investigator or others), directly or through identifiers (codes) linked to the individuals. Also, the data, documents, records or specimens must have been obtained independent of the research study.

  1. For research protocols limited to the collection and study of existing data:

To qualify for exempt review, the principal investigator must provide written assurance in the research protocol submission that:

  1. the individual(s) responsible for data collection is (are) authorized (i.e., by CommunityHospital of the MontereyPeninsula policies) access to the respective data;
  2. the research is limited to the collection and study of data obtained initially for purposes other than the proposed research study; and
  3. the instrument/form used for data collection will not contain any information (i.e., name, initials, numerical or alphabetical linkage codes) whereby the subject could possibly be identified (by the investigators of the proposed study or others) either directly or indirectly.
  1. For research protocols limited to the study of existing pathological specimens or diagnostic specimens:

To qualify for exempt review, the principal investigator must provide written assurance in the research protocol submission that:

  1. use of the respective specimens for research has been generally authorized (i.e., that use of the respective specimens is not restricted to a specific research activity or specific investigators as a result of conditions imposed by prior subject consent);
  1. the research is limited to the study of specimens obtained initially for purposes other than the proposed research study.
  1. the specimens and data related to the specimens provided to the investigators of the proposed study will not contain any information (i.e., name, initials, numerical or alphabetical linkage codes) whereby the subject could possibly be identified (by the investigator or others) either directly or indirectly.

If it is not possible to perform the research activity under these criteria, the research protocol should be submitted for expedited review (see Section 2.) or full board review (see Section 3.).

1.1Exempt Review Submission Requirements

Submit one (1) copy of the following paperwork:

A.a completed application for IRB review

B.the research protocol

C.attachments (i.e., questionnaires, screening instruments, recruitment materials), if applicable and

D.curriculum vitae of the principal investigator and subinvestigator(s)

1.2Exempt Review Turnaround Time

The IRB chairperson or his/her designee will review research protocols qualifying for exempt review within 10 working days of their receipt at the IRB Office.

2.Expedited Review

Research activities involving no more than minimal risk and in which the only involvement of human subjects or patients will be in one or more of the categories listed below (carried out through standard methods) may be reviewed by the IRB through an expedited review procedure. As defined by Federal Policy regulations, minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Under an expedited review procedure, review of the research protocol and consent form is carried out by the IRB chairperson or his/her designee. In conducting the review, these individuals may exercise all of the authorities of the IRB except that they may not disapprove the research. A research activity may be disapproved only subsequent to full board review.

PLEASE NOTE THE FOLLOWING:

A.The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing; unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

B.The expedited review procedure may not be used for classified research involving human subjects.

C.Standard requirements for informed consent (or its waiver, alteration or exception) apply to the research protocols qualifying for expedited review.

D.Categories 1. through 7. below pertain to both initial and continuing review.

Research activities eligible for expedited review are limited by Federal Policy and FDA regulations to the following:

1.Clinical studies of drugs and medical devices only when condition a. or b. is met.

  1. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
  2. Research on medical devices for which

(1)an investigational device exemption application (21 CFR Part 812) is not required; or

(2)the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

2.Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

  1. from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
  2. from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the less of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

3.Prospective collection of biological specimens for research purposes by noninvasive means. Examples:

  1. hair and nail clippings in a nondisfiguring manner;
  2. deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
  3. permanent teeth if routine patient care indicates a need for extraction;
  4. excreta and external secretions (including sweat);
  5. uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue;
  6. placenta removed at delivery;
  7. amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
  8. supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;
  9. mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
  10. sputum collected after saline mist nebulization.

4.Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples:

  1. physical sensors that are applied either to the surface of the body or at a distance and do not involve the input of significant amounts of energy into the individual or an invasion of the individual's privacy;
  2. weighing or testing sensory acuity;
  3. magnetic resonance imaging;
  4. electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
  5. moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight and health of the individual;

5.Research involving materials (data, documents, records or specimens) that were initially collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis) and in which it will not be possible for the investigators to identify directly or indirectly the respective research subjects.

6. Collection of data from voice, video, digital, or image recordings made for research purposes.

7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural

beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. See Section 1)

8.Continuing review of research previously approved by the convened IRB as follows:

  1. where (1) the research is permanently closed to the enrollment of new subjects; (2) all subjects have completed all research-related interventions; and (3) the research remains active only for long-term follow-up of subjects; or
  2. where no subjects have been enrolled and no additional risks have been identified; or
  3. where the remaining research activities are limited to data analysis.

9.Continuing review of research, not conducted under an investigational new drug application or investigational device exemption, where categories 2. through 8. do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

2.1Expedited Review Submission Requirements

Submit one (1) copy of the following paperwork:

a completed application for IRB review

the research protocol

the informed consent document(s)

attachments (i.e., questionnaires, screening instruments, recruitment materials), if applicable

curriculum vitae and evidence of human protection training from the principal investigator and subinvestigator(s)

2.2Expedited Review Turnaround Time

The IRB chairperson or his/her designee will review research protocols qualifying for expedited review within 7-10 business days of their receipt at the IRB Office.

3.Full Board Review

Research activities that do not qualify for exempt review (see Section 1.) or expedited review (see Section 2.) under the stated categories must be reviewed and approved by a full IRB committee at a regularly scheduled meeting. The IRB will consult experts in various fields to assist in the review of studies, as it deems necessary. These consultants may also assist in determining the risk/benefit ratio, determining whether studies may require review more often than annually, and determining which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review.