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OCU Research Policies and Submission Guidelines

Many regulations govern research involving human subjects conducted at federally funded research institutions. Pursuant to federal law and Oakland City University policy, all research (funded or unfunded) involving human and/or animal subjects, conducted by OCU faculty and/or student investigators, must be reviewed and approved by Oakland City University's Institutional Review Board (IRB) prior to the commencement or recruitment of subjects and data collection.

Please review all policies and procedures and apply to the IRB for the necessary approval of all research activities involving human and animal subjects.

Instructions for Completing the Institutional Research Application

Forms for Download

Method for Processing Research Applications

OCU research policy is designed to provide an efficient and fair method for processing research applications. Following the procedures and protocol outlined in this policy is the only way to ensure that all proposed research is provided the necessary level of review. To ensure that Oakland City University is in compliance with federal and University regulations, the cooperation of all faculty, staff and students is requested in following all outlined research policies and procedures. Additional information regarding the application and review process may be obtained by contacting any member of the Internal Review Board (IRB) or the Dean of the School.

As of January 1, 2009, all applicants submitting research proposals for IRB approval are required to pass an online quiz. This quiz is designed to insure that all participants fully understand the ethical issues pertaining to research involving human and/or animal subjects. The online quiz must be successfully completed with a score of 70% or higher before the participant's application will be reviewed by Oakland City University's IRB. Online training is recommended before completing the online quiz.


OCU IRB Exempt Status Criteria


The following information is from 45 CFR 46.101.

In order for a research proposal to qualify for exempt status, all of the research proposal's activities must qualify in one or more of the following categories and meet the criteria and conditions set forth in the category.

Categories to Qualify for Exempt Status

(1) The research is conducted in established or commonly accepted educational settings, involving normal educational practices, such as:

(a) Research on regular and special education instructional strategies,
(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, if the research meets all of the following conditions (NOTE: All three of these conditions must apply).

(a) The information obtained is recorded in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects;
(b) The disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, or reputation;
(c) The subjects are not under the age of 18 or members of a vulnerable class, including prisoners, pregnant women, or individuals who are mentally disabled or economically or educationally disadvantaged.

(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that does not qualify for Exempt Status under Category 2 above because the research failed to meet any one of the conditions set forth under Category 2 above, but only if the research meets one (1) of the following:

(a) The human subjects are elected or appointed public officials or candidates for public office;
(b) Federal statue(s) require(s) 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 data, documents, records, pathological specimens, or diagnostic specimens, if:

(a) These sources are publicly available;
(b) If the information is recorded by the researcher in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

(5) Research which is conducted by or subject to the approval of the Dean of the School or Program Director and which is designed to study, evaluate, or otherwise examine one (1) or more of the following:

(a) Service or public benefit programs;
(b) The procedures for obtaining services or benefits under those programs;
(c) Potential changes in or alternatives to those programs or procedures;
(d) Possible methods changes or levels of payment for benefits or services under these programs.

(6) Research involving a taste and food quality evaluation and consumer acceptance studies, and if the research meets (1) of the following conditions:

(a) Wholesome foods without additives are consumed;
(b) The food consumed 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 the Food Safety and Inspection Service of the USDA.


OCU IRB Expedited Review Status Criteria


Federal guidelines identify those research activities that may qualify for Expedited Review Status, (meaning they receive an expedited review by the IRB and do not require a Full Review by the IRB). If a proposed research activity meets the applicability requirements set forth below and falls under one of the expedited review categories identified below, submit the Universal Research Application as an Expedited Review Status. The following information on expedited review applicability requirements and review categories is from the Federal Register (63 FR 60364-60367, November 9, 1998) and is subject to revision.

Applicability Requirements

(1) The research activities present no more than minimal risk to human subjects and involve only procedures listed in only one (1) of the expedited review categories listed below. (Note: The activities and procedures listed in the following expedited review categories below are NOT to be deemed minimal risk simply because they are included in the list of categories. Inclusion on the list merely means that the activity is eligible for review through the Expedited Review Status when the specific circumstances of the proposed research activities actually involve no more than minimal risk to human subjects.)

(2) The expedited review categories listed below apply regardless of age of the subjects.

(3) Expedited Review Status may not be utilized for proposed research activities that may include any classified research involving human subjects.

(4) The standard requirements for informed consent apply to an expedited review of a proposed research activity included in an application for approval under the Expedited Review Status.

(5) The expedited review of a proposed research activity 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, employment, insurability, or 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.

(6) All categories listed below (A through G) pertain to initial and continuing IRB review.

If all the above criteria/conditions are applicable to the research proposal/activities, then the research proposal/activities must qualify to be classified in only one (1) of the following research categories:

Research Categories:

A. Clinical studies of drugs and medical devices, only when one of the following conditions is met:

(1) Research on drugs for which an investigational new drug application (21 CFR 312) is not required, or

(2) Research on medical devices for which (a) an investigational device exemption (21 CFR 812) is not required; or (b) the medical device is cleared/approved for marketing and the medical device is being used in accordance to its cleared and approved labeling.

B. Blood sample collection by utilizing finger stick, heel stick, ear stick, or venipuncture collection methods; provided the blood samples are taken from:

(1) Healthy, non-pregnant adults who weigh at least 110 pounds, and the amounts drawn on such subjects may not exceed 550 ml in an 8-week period and collection may not occur more frequently than 2 times per week; or

(2) Other adults and children (anyone under the age of 19 years) considering 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 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.

C. Noninvasive collection of biological specimens (i.e., hair and nail clippings, saliva, and sweat) may be used in a study.

D. 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 medical devices are not generally eligible for expedited review, including studies of cleared medical devices for new indications.

E. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis) may be used in research. This listing refers to only items not listed in the exempt status criterion.

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

G. Research on individual or group characteristics or behavior or research that uses surveys, interviews, oral histories, program evaluations, human factor evaluations, or quality assurance methodologies. (NOTE: Some research in this category may be exempt in accordance to 45 CFR 46.101(b)(4) and this listing refers only to research that is not exempt.)

H. Review of continuing research that has previously been approved by the IRB if the research qualifies under one of the following:

(1) The research is closed permanently to new enrollment of subjects, all subjects have completed all research-related interventions, and the research remains active only for long-term follow-up of subjects; or

(2) Where no new subjects have been enrolled and no new risks have been added or been identified; or

(3) Where the remaining research activities are limited to data analysis.

I. The research is a continuing review of data collected in the research study, not conducted under an investigational new drug application or investigational device exemption where categories B through H above do not apply, but the IRB has determined and documented at a meeting of the IRB that the research involves no greater than minimal risk and no additional risks have been identified.


Basic Elements of Informed Consent


No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator/researcher, the sponsor, the institution, or its agents. In seeking informed consent, the researcher will provide the following information to each subject:

(1) A statement that the study involves research, and explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental.

(2) A description of any reasonably foreseeable risks or discomforts to the subject. (Note: This includes any information about procedures that might make a subject hesitant to participate.)

(3) A description of any benefits to the subject or to others that may reasonably be expected from the research.

(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.

(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.

(6) A statement about research involving more than minimal risk, an explanation as to whether any compensation will be made, and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.

(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.

(8) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

In addition to the foregoing required information, under certain circumstances an informed consent may require additional information be given to the subject. All researchers/students should read and be familiar with the all the requirements of 45 CFR 46, on which this information is based.

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