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Submission Process

The application form, protocol, consent form, and supporting documents should be submitted to:
Malinda Reddish Douglas, DrPH, CPH, IRB Administrator
Oklahoma State Department of Health, Room 606
1000 NE 10th St.
Oklahoma City, Oklahoma 73117-1299

All OSDH Staff conducting research or researchers conducting studies on OSDH clients or staff must submit an Institutional Review Board (IRB) application to the OSDH IRB. Researchers outside of OSDH that want to enroll OSDH clients or staff as human subjects must have a collaborating investigator within OSDH or a letter of approval from an agency representative. All researchers should review the OSDH IRB Policies and Procedures. The IRB Application is required for all research projects, including those that are requesting exempt or expedited review. IRB Application should include the following:

1. IRB APPLICATION FORM (25.6K MS Word file)
2. PATIENT CONSENT FORM(S) See Sample Consent, Telephone Survey.
3. RESEARCH PROTOCOL
4. QUESTIONNAIRES/SURVEYS (Required, if used.)
5. ADVERTISEMENTS (Any time they are to be used – Radio, TV, Newspaper, Posters, Handouts – Press Releases; Interviews if information pertains to a specific study).

If collaborating institutional investigators outside of OSDH want to affiliate with the OSDH IRB, an Institutional Review Board (IRB/Independent Ethics Committee (IEC) Authorization Agreement must be completed, signed, and filed in both the OSDH and the collaborating agency or organization. If the collaborating agency or organization is the primary awardee of a Department of Health and Human Services (HHS) supported award, the institution must obtain its own OHRP approved Federalwide Assurance (FWA).

Board Review: The OSDH Institutional Review Board (IRB) meets monthly the third Wednesday of the month. Proposals should be received 10 days prior to the meeting so that IRB members can give studies a complete review. Principal Investigators may attend the meeting to provide clarification to IRB member questions. Federal regulations require a review on the scientific merit of the proposal by the Institutional Review Board. Review of scientific merit is relevant and important as a factor in deciding if the risks/benefit ratio is appropriate. Thus, the Board determines if the risks to the subjects are reasonable as compared to the direct benefit. Additional assessments the IRB makes include:
· The additional safeguards the study utilizes for protected groups (i.e., pregnant women, fetuses, socially or economically disadvantaged, decisionally-impaired, etc).
· The informed consent form has detail to assure that: the purpose of the research is conveyed accurately; the study is described in sufficient detail for the subject to decide what is involved; and the risks and benefits are accurately portrayed. The consent form must be written in a language appropriate to the study population. Regulatory agencies recommend a reading level of no higher than eighth grade for all consent forms.
· Subject selection is equitable.
· Subject safety, privacy, and confidentiality are maximized.

Several outcomes are possible: outright approval, study approved upon changes or clarifications (most common outcome), deferral (the protocol and/or the consent form must have significant revision before the submission can be reviewed again by the full Board), and disapproval (given when the Board is not convinced that the submission can be salvaged into an approved protocol).

Board Letter: Within two weeks of the Board meeting, letters outlining the Board’s decision concerning the study are prepared. This letter will address the steps/changes needed to re-submit the study to the Board. It is the responsibility of the Principal Investigator (PI) to communicate with the IRB Chair if the PI feels the recommended suggestions are inappropriate or will misrepresent the study to the subject.

Initial Approval: If the study was approved with minor changes, timely submission of revisions will be followed by review by the Chair or IRB Administrator. If adequate changes have been made and all questions answered, immediate Board approval will be granted. If the study was deferred, resubmission to the entire Board is required. The Chair cannot overrule the deferral. In the case of a deferral, the Board chair or IRB Administrator may also speak with the PI personally to facilitate the resubmission process.
Continuing Compliance: Approval is granted for a period determined appropriate to the risks involved in the study, this period cannot exceed one year (365 days). Once initial approval is granted, continued interaction with the Board is required, including a Periodic Progress Report (PPR) to be submitted at least annually or more frequently depending on the approval period. The PPR must be reviewed by the IRB Chair, Administrator, Vice Chair or designated Board Member and approved by the Board no later than the date of expiration in order for the study to be in compliance with federal regulations. Federal regulations do not allow for ANY grace period for renewal. For example, if a study is approved by the Board in July 2005 and the initial approval is through June 2006; a satisfactory progress report must be received, reviewed, and on the agenda for the June 2006 IRB meeting. In order to facilitate the process, the IRB office mails the first PPR notice 6 weeks prior to the due date. If no response is received a second notice is sent about four weeks later. If the due date approaches and a PPR has not been received, a notice to inactivate the study with a final deadline is sent to the investigator. These dates do not necessarily reflect the date that your IRB approval will expire, these dates will reflect the time which the IRB office needs to receive your report in order to assure that the Board has time to review, meet; discuss and approve this matter. Once the expiration date of initial (or most recent) approval passes with no response, the study is administratively inactivated and a letter of notification is mailed to the investigator. NOTE: Failure to complete progress reports in a timely manner will result in study being closed as well as no further research being approved until such time as reports are completed.

For more information:
·
Federal regulations on human research protection (45 CFR 46) can be found at: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.html
· Contact Malinda Douglas at 405-271-7637 or Cindy Cannady at 405-271-3272.

 Criteria for Expedited Status

Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110.  The categories in this list apply regardless of the age of subjects, except as noted.

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 (i.e., financial standing, employability, insurability, reputation, or 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. The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB.

1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met
a. 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.)
b. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) 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:
a. From healthy, nonpregnant 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
b. From other adults and children (defined as persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted), considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser 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: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) 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; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) 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; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) 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: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) 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 have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis)

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.

8. Continuing review of research previously approved by the convened IRB as follows:
a. Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
b. Where no subjects have been enrolled and no additional risks have been identified; or
c. 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.

NOTE: These categories represent minimal requirements of review by 45 CFR 46. The OSDH Institutional Review Board reserves the right to require a more stringent review of any study as deemed appropriate.

 Criteria for Exempt Review

The IRB may exempt from Full Board and/or continuing review research activities in which the only involvement of human subjects will be in one or more of the following categories. These categories are established by the Federal Regulations and require submission to the OSDH IRB Chair to determine appropriateness.

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
a. Research on regular and special education instructional strategies, or
b. Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) survey procedures, interview procedures or observation of public behavior on subjects 18 years of age or older, unless:
a. Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
b. Any disclosure of the human subjects' response outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) survey procedures, interview procedures or observation of public behavior that is not exempt under paragraph 2 (b) of this section, if:
a. The human subjects are elected or appointed officials or candidates for public office; or,
b. Federal statute(s) require without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

4. Research involving the collection or study of existing (i.e. on the shelf, already collected and/or banked prior to the date the study is to start) data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
a. Public benefit or service programs;
b. Procedures for obtaining benefits or services under those programs;
c. Possible changes in or alternatives to those programs or procedures; or
d. Possible changes in methods or levels of payment for benefits or services under those programs.

6. Taste and food quality evaluation and consumer acceptance studies:
a. If wholesome foods without additives are consumed, or
b. If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or Food Safety and Inspection Service of the U.S. Department of Agriculture.

NOTE: These categories represent minimal requirements of review by 45 CFR 46. The OSDH Institutional Review Board reserves the right to require a more stringent review of any study as deemed appropriate.

Revised 11/02/2010

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