Review level is determined using criteria defined within the Code of Federal Regulations (See 45CFR46.101 for exemptions, and 45CFR46.110 for expedited review categories).

The term "Exempt" means that the research involving human subjects is not covered by the federal regulations. SDSU's process for verifying that the research meets the criteria noted in the regulations is to have a Division of Research Affairs' compliance analyst review a protocol describing the research activity. SDSU has standards for the conduct of exempt research specific to recruitment, informed consent and data management.

Exempt categories:
(1) 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.

(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses 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 (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(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 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: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) 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, (i) if wholesome foods without additives are consumed or (ii) 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 the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Expedited review occurs outside of the convened committee and is conducted by the IRB chair and a compliance analyst. The research must meet one of the nine categories described within 45 CFR 46.110 and not exceed minimal risk of harm to the participant.

Applicability

(A) 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 activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

(B) The categories in this list apply regardless of the age of subjects, except as noted.

(C) 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.

(D) The expedited review procedure may not be used for classified research involving human subjects.

(E) IRBs are reminded that 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.

(F) Categories one (1) through seven (7) pertain to both initial and continuing IRB review.

Research Categories

(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 children2, 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 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). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)

(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. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)

(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 two (2) through eight (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.

Full committee research:

Studies not eligible for exempt or expedited review are reviewed by the convened IRB membership. For example, studies that involve the following require review by the convened IRB:

A. Studies that involve more than minimal risk of harm;

B. Studies that include data collection from vulnerable populations like prisoners, wards of the court, or cognitively impaired individuals

C. Studies that include exercise testing such as: maximal aerobic power, endurance test protocols, bone mineral density (DXA) scans, and exercise in the heat

Research may involve procedures that meet criteria of more than one review category (e.g., adults who complete an anonymous survey who are also prisoners or children in a classroom setting who will be videotaped), will be reviewed based on the most conservative criteria. (That is, the anonymous survey of adult prisoners would be reviewed by the convened committee while videotaping children in the classroom would receive an expedited review).

IRB comments are posted to the protocol section where revisions are required. From the "Protocol Main" page of your protocol, click on "Protocol Document." Under the "Status" heading on the right, all sections labeled "conditional" require revisions. Click on the section title to the left of the conditional status (e.g., "Abstract" or "Subject Identification"). Once the text box for that section has opened, select "IRB comments" in red located below the text box. This will open a new text box where the IRB comment has been posted.

To submit your response to IRB comments posted within your protocol, you must revise the sections marked "conditional." Do not respond within the body of your text. Instead, type the word "RESPONSE" at the bottom of your text box and insert the requested information. Next, re-save the section(s) and resubmit your protocol for IRB review by clicking the "IRB Submission" link in the top menu bar and clicking "Submit This Protocol" in the Protocol Main Menu. If changes are required for any of the supporting documents (e.g., consent form(s), recruitment announcement(s), etc.), upload the revised document(s) within the supporting documents section.

Save the document to your hard drive under your last name and file type (e.g. Researcher_Informed Consent). Attach the document by clicking "Browse", and selecting the document from your hard drive. After the document is selected from your hard drive, click the "Upload" button. To attach additional documents, you may return to the "Supporting Documents" page. A window confirming that your document has been successfully uploaded will appear.

Graduate students who have been advanced to candidacy and who have an officially appointed thesis committee are permitted to enroll in 799A. There are two options to enroll in 799A:

If you have solidified the details of your research with your advisor, you may submit your protocol to the IRB for review. An automatically generated email will be sent to you as soon as you electronically submit your protocol. You may use this email notification to enroll in 799A. To do so, attach a copy of the email to your Appointment of Thesis/Project Committee form prior to submitting the completed form to Graduate Affairs.

Alternatively, if plans for involvement of human subjects in a thesis research project are not fully developed prior to the Thesis 799A deadline, you may submit an Approval in Principle. This option allows you to provide a tentative description of the planned thesis research. Once the Approval in Principle is reviewed and accepted, you will receive an auto-generated email that can be used to enroll in 799A. Please note: The Approval in Principle review process may require 1-2 weeks to complete and does not constitute an IRB approval. Any involvement of human subjects in the research is not authorized until the IRB has reviewed and approved a complete IRB protocol.

SDSU offers a web-based training located at http://www-rohan.sdsu.edu/~gra/login.php.

Certification is valid for 2 years.

After logging into your tutorial account, a copy of your certificate of completion of the tutorial can be obtained by clicking on the "certification" link on the main tutorial page and then "display certificate."

Certification by only one of the institutions is necessary. Include verification within your protocol that you have competed either the SDSU or UCSD human subjects tutorial.

The IRB recognizes that students may have limited research experience. Within this section describe training you have received in research ethics and experience you have working on a research project. If you have no experience working on a research project, you may include within this section a discussion of the classes you have taken that address human subjects issues, such as a research methods class and training received to carry out the procedures proposed in your study. Include information about the related experience of the faculty member supervising your research as well as how that person will guide you throughout the process of conducting your research.

Anonymity means that the identity of the subject is never recorded or associated with the data collected. Maintaining confidentiality involves recording but concealing the subject's identity or using codes linking identifying information to research data.

The SDSU Human Research Protection Program Guidance Manual may be download here and provides important information that may assist in the development of ethical research practices and help the researcher develop a protocol that adheres to SDSU's IRB guidelines.

On average, the review process takes 2-3 weeks. However, this may vary depending on the completeness of your protocol and completeness of your response to any conditions posted to your protocol. During heavy submission times (i.e., March and October), reviews may take longer as protocols are reviewed on a first-come first-served basis. Note that the IRB office is open during the summer. Consider submitting protocols during this time, if your timeline permits.

To verify that research is exempt requires 1-2 weeks. Expedited review will require 2-3 weeks provided the protocol is complete and requires few revision. The convened committee meets once each month. If the research is not eligible for exempt or expedited review, it will be reviewed at the monthly IRB meeting and notification of the review will be sent within a week of the meeting.

To submit a request to renew an approved study, open the protocol which you would like to renew. Click on the "Protocol Maintenance" section on the Protocol Main page. Under "Protocol Maintenance" there is a section labeled "Reports of Progress." Click on this option. You will be prompted to provide information about current study activities, the number of individuals included in the study, etc.

All protocols must be submitted for renewal prior to their expiration date if data is still in collection or if data analysis is still occurring. If all data collection and analysis is complete, the study may be closed using the "Final report" option within the "Reports of Progress" section within the protocol main page.

The expiration date for your study has been included within your initial approval letter. For expedited and full committee studies, the study expiration date will be included on the approval stamp on the consent documents.

Studies that receive expedited or full committee review are approved for a year; exempt studies may be approved for up to 5 years.

To submit a request to modify an approved study open the protocol for which you would like to implement changes. Click on "Protocol Maintenance" on the Protocol Main page. Under "Protocol Maintenance" there is a section labeled "Modifications." Click on this option. You will be prompted to provide a description of the modification and the rationale for the modification. You will also be asked to respond to a few additional questions about any changes to risks, changes to the consent forms, etc. Should your requested change require revision to any study documents (e.g., consent form, recruitment announcement, etc.) upload the revised documents within the "supporting documents" section. Note that changes may not be made to a study until IRB approval for the modification has been received.

JDP students: Students enrolled in a SDSU/UCSD Joint Doctoral Program (JDP) who plan to involve human subjects in research are only required to obtain approval from one Institutional Review Board in advance of initiating research. The Reviewing IRB is determined by the primary institutional affiliation of the faculty mentor responsible for oversight of the proposed research with one exception: the UCSD IRB will be the Reviewing IRB for all eligible studies that involve the UCSD MRI facility, VA facilities, and Rady Children’s Hospital. Note: Only research that does not exceed minimal risk and meets criteria for exempt or expedited review can be reviewed under this new process. Research that requires full committee review is excluded from this review process and should be submitted following procedures outlined below.

For more information on the submission process for JDP students, please see the full submission instructions located on the main IRB page.

For non-JDP students, faculty, and full committee research: You will need to submit a protocol to both the SDSU and the UCSD IRB for review. You should submit your protocol for review and approval first to the institution associated with the site of performance (e.g., if the study involves the collection of data from patients at the VA, submit your protocol to the UCSD IRB first). If the site of performance is not affiliated with SDSU or UCSD, submit your protocol first to the institution where your faculty advisor is affiliated.

Joint USD/SDSU students should submit protocols only to the SDSU IRB for review. Once the SDSU IRB has approved the protocol, a copy of the complete protocol document is sent by the SDSU IRB to the USD IRB. Any additional conditions the USD IRB has will be communicated to the SDSU IRB to provide to the student.

Consent forms for joint USD/SDSU studies should include the following information:

1. Name of both universities in the heading

2. Contact information for both IRBs (see USD address below).

Contact information to be included in the consent form:

Office of the Vice President and Provost

University of San Diego

5998 Alcala Park

San Diego, CA 92110

619-260-4553

You will need to submit your protocol for review and approval first to the clinic/hospital's IRB. In this case, the hospital/clinic IRB has greater oversight over study activities conducted on their premises and should comment on the protocol prior to review at SDSU.