HAP: Human Subjects Research (IRB)

Research for University Courses

Research conducted solely for pedagogical purposes may not need IRB review, under the following conditions.

• the instructor's intention is to teach professional research methods such as interviewing, surveying, or experimental design
• the data are gathered solely for the purposes of teaching how to analyze them
• the results will remain in the classroom.
  These data can be presented at the end of the semester within the confines of the institution, for instance, at the SF State Graduate Project Fair. However, if the results will be published, presented at a larger conference off-campus (such as the CSU Research Competition) or generalized in some other way, it will be necessary to obtain IRB approval.

If a class project evolves into a research project that the student/instructor wishes to publish or generalize, then the research will need to undergo IRB review. This should occur as soon as it is known that the data will be used for research. If this is not determined until after the research is completed, it may be possible to submit a protocol to the IRB, requesting permission to use existing data.

Pilot Studies

Pilot studies with human research volunteers, no matter how small, must also get IRB approval. You can include the pilot study as a smaller section of the complete protocol, or you can get approval for the pilot study first, then come through the IRB again for a review of the full "parent" study. At this stage, you may have modified your research to take into account the results of the pilot study. (For example, you may decide to change the survey questions as a result of the pilot study, or change inclusion/exclusion criteria.)

Oral History

The researcher's intention plays a large part in determining whether research is an oral history or not. If the intention is to interview informants who have a unique perspective on a particular historical event or way of life, and the researcher also intends to let the informant's stories stand on their own as a "testimonio" or in an archive, with no further analysis, the research is most likely oral history.

However, if the surveys or interviews are conducted with the intention of comparing, contrasting, or establishing commonalities between different segments or among members of the same segment, it is safe to say your research will be regular survey/interview procedures, because you will be generalizing the results.

Historians explain a particular past; they do not create general explanations about all that has happened in the past, nor do they predict the future.

Moreover, oral history narrators are not anonymous individuals, selected as part of a random sample for the purposes of a survey. Interviewees are selected because of their personal relationship to the topic under investigation. An oral history interview provides one person's unique perspective. A series of oral history interviews offers up a number of particular, individual perspectives on the topic, not information that may be generalized to all research volunteers in the event or time under investigation.

Oral history interviews are not analyzed as qualitative data is generally analyzed. No content analysis, discourse analysis, coding for themes or other qualitative analysis methods of data analysis are performed on the interviews. They stand alone as unique perspectives.

It is primarily on the grounds that oral history interviews, in general, are not designed to contribute to "generalizable knowledge" that they are not subject to the requirements of 45 CFR part 46 and, therefore, can be excluded from IRB review.

Secondary Analysis of Existing Data

Research involving the secondary analysis of existing data must be reviewed by the IRB to ensure that the original data were properly and ethically obtained and to ensure that the objectives of the secondary analysis are in keeping with those for which consent was obtained.

In order for the committee to evaluate research which includes secondary analysis, the researcher will need to provide:

1. A complete protocol for the secondary study;
2. The details of primary data collection (which may include the original protocol, consent and approval, if research), or the source of publicly available data; and
3. If the data are not publicly available, a letter from the source authorizing access to the data or, if the data were purchased commercially, a copy of the contract authorizing the use of the data.

After these documents are submitted, the committee will be able to decide if the research is exempt, non-exempt, requires a new consent, or does not need to be reviewed further.

Terms useful in discussing Secondary Analysis of Existing Data:

Existing data are data that exist at the time the research is proposed.

Existing samples must already be "on the shelf" (meaning, they must have already been gathered) at the time the research is proposed. For example, existing blood samples, existing tissue samples, completed surveys, existing interview notes, and existing audio- and video-tapes.

De-identified data are data from which all identifiers have been removed. Identifiers include obvious information such as name, address, social security or medical record numbers, photographs, address, telephone number, etc. as well as things such as biometric identifiers (voice and finger prints) and even zip code, if there are less than 20,000 people in the geographic area. A birth date coupled with a diagnosis may be sufficient to identify an individual in many research populations.

Non-exempt review
Existing data containing identifiers may need to be reviewed as non-exempt research.

Exempt review
Existing data that are publicly available or are recorded by the researcher in such a manner that the research volunteers cannot be identified (de-identified data, or data for which the key to identities will not be provided the secondary researcher) may qualify for exempt review.

When New Consent is required
If the purpose of the secondary data analysis is found to differ significantly from the purpose of the original study, the IRB may require that informed consent for secondary data analysis is obtained from the research volunteers.

Some research may not have to be reviewed by the IRB because the data are so anonymous that they no longer implicate human research volunteers. For example, some public health data, amalgamations of median income and average longevity, statistics from the U.S. Census Bureau are pooled such that anonymity is ensured.

Content Experts/Consultants/Key Informants 

It may not necessary to get IRB approval if interview questions are with experts about a particular policy, agency, program, technology, technique, or best practice. The questions are not about the interviewee themselves, but rather about the external topic. For instance, questions will not include demographic queries about age, education, income or other personal information.

IRB review will be required when a researcher is interviewing individuals about content, but there is a research question or hypothesis involved, or an ?agenda.? The researcher intends to analyze and generalize the results, that is, look for common themes in the collected data, try to universalize the interviewees? experiences, or quantify the results in some way.

Examples of content expert projects that may not require human research volunteer review:

In all the following examples, the questions are focused on the facts about the program, policy, software, curriculum, procedures or project. The researcher will simply report the facts as they are related by the content experts. You may not need to submit a protocol or an informed consent form for IRB approval if:

• you are interviewing managers in a company about their billing procedures, or their use of a particular software program, or
• you are interviewing or surveying teachers about what should be included in the development of a particular curriculum unit, or
• you are interviewing entrepreneurs about the obstacles they faced in starting their own businesses, and how they overcame them, or
• you are asking a panel of nurses and doctors to review your antismoking program for teens for correct medical content, or
• you are interviewing social agency directors about their client intake procedures.

Research Done at Another Institution

To conduct research at another institution, SF State faculty, staff or students who are not the sole Principal Investigator on a project must receive approval from the SF State IRB before research may begin. If the researcher is the sole Principal Investigator on the project, the SF State IRB will review the other institution's approved protocol.

Non-Principal Investigators must submit:

• A signed Protocol Approval Form, with signatures from the SF State faculty, (not faculty from the institution where research will be carried out.)
• A copy of the application to the research institute's IRB. (If the institution has no IRB, indicate this and SF State can serve as the IRB of record.)
• A copy of the research institution?s IRB approval letter.
• An SF State protocol detailing the researcher's role in the overall project, and the part of the research that he/she will be conducting.
• A letter from the PI giving you permission to use the data generated for your research.

Unaffiliated investigators who plan to conduct a study that engages the University in research and involves human research volunteers must receive approval from SF State’s IRB prior to initiating recruitment/data collection at SF State. To request approval, unaffiliated investigators should send an email to SF State’s Human and Animal Protections  office (protocol@sfsu.edu) with the following information:

• Description of the study
• Copy of the IRB approval letter from investigator’s home institution
• Copies of the recruitment materials and consent form
• Letter of support from the relevant department at SF State (i.e. if the study will be surveying Biology faculty and students, then a letter from the Chair of the Biology Department would be required)

Note: Depending on the nature of the study, additional information may be requested.

Research that may not need IRB Review 

The IRB office has identified several categories that may not need IRB review, such as:

• a supervised internship or field practicum/field study
• a community health needs assessment
• an Instructional Technology web design evaluation
• a School of Design product design assessment
• a field study designed to improve one's own teaching practice
• a program evaluation, model curriculum, or a needs assessment, which does not lead to research activities such as field testing, and is not generalizable to the larger community (meaning that the results will be delivered only to one school or agency for the purpose of quality improvement, and will not be compared with other assessments, etc.
• a quality improvement project
• an interview with content experts or consultants about factual issues only, in which no personal information is obtained from the interviewees.
• an oral history project which collects personal stories about particular events or periods of time, to let them stand on their own as testimonials or archived historical documents. The stories will not to be compared with each other, analyzed in any way, or used to prove an agenda or hypothesis.
• a case study that reports on treatment strategies that have already been applied to one patient in the course of treatment and are not meant to be generalizable to all patients. A report that "tells a story" of what has already been tried in the course of treatment is considered a case study.

How to let us know you are not using human research volunteers:

Students doing these types of projects are instructed to state their intentions clearly on the Culminating Experience form, by choosing either an 898 form for "No Human Research Volunteers" or checking the box on the 895 form that indicates they are not using human research volunteers.

If the Culminating Experience form clearly indicates that the project does not involve human research volunteers, or is not the kind of research the IRB has to review, the Grad Studies office will be able to approve it immediately and the student may proceed with the project as described on the CE form.

Examples of CE form descriptions that indicate human research volunteers are not involved:

• "I will use field notes, a reflective journal and children's work samples to improve my own teaching practice and to chart my own progress in teaching preschoolers about gardening."
• "I am developing a curriculum for second graders to integrate writing and reading strategies. Methods will include a lit review and interviews with three writing development experts."
• "I am collecting personal recollections of the urban redevelopment program in the Fillmore District during the 1960's, to archive in the History Department."
• "I am consulting experts in the field of teaching reading to construct a model of a curriculum for first grade reading classes. I will not be field testing this curriculum."
• "I am writing a case study of physical therapy treatment for a patient I have worked with."
• "I am conducting a needs assessment for an agency that works with adolescent girls, to help them improve their programs. The data will be given to the agency only, for quality improvement purposes."

A project that has been identified as a needs assessment, program evaluation or curriculum model development, and which does not contain any elements of research such as field testing, can be published or presented without any review by the IRB. A notice from the IRB that your project does not need further review because it has been determined to be a needs assessment, etc. is sufficient for journal publication or conference presentation.

Announcing Three (3) Year Approval for Qualifying Minimal Risk Research

Utilizing flexibility available under our Federalwide Assurance (FWA) regarding certain study approval periods, the Institutional Review Board and ORSP - Human and Animal Protections are pleased to announce the following change in policy.  Effective May 1, 2014, the IRB will begin issuing three (3) year approvals for faculty research that qualifies for this extended approval period for new protocols. To qualify, the research must:

1. involve no more than minimal risk to participants (as defined by Federal Regulations for Human Dubjects Research);
2. not be supported by federal funds; and
3. not be subject to federal oversight.

To extend the expiration date on existing approved protocols, please contact our office directly for more information.
 

Start the Application for Determination of Exemption -or- Go to IRB Manager Home Page

Please note that ADE submissions require a completed CITI training certificate entitled "Social/Behavioral Research Course."
 

Online CITI Research Training

All individuals conducting human subjects research are required to pass an online research training course. This includes not only the principal investigator but also all co-investigators, research technicians, research assistants, or student assistants who have contact with the research participants or identifiable data.

A course completion report will be issued upon completion of either course. The report must be submitted with the protocol materials. The reports are valid for 3 years from the date of issue. Certificates that expire before the 1-year protocol approval period will not be accepted for review.

The CITI course at Citi Program, Research, Ethics and Compliance Training Website is recommended for social/behavioral/educational researchers because of the elective modules which may be tailored to your own field of study. 

CITI is free for SF State students, faculty, and staff.

For first time users, please select "Register" at the CITI homepage and on the following screen, enter "San Francisco State University" for the Organization Affiliation. Please select Social/Behavioral Research Course or Basic Human Subjects - Social/Behavioral Focus. Please note: Responsible Conduct of Research: Social and Behavioral Course does not fulfill this requirement.

For those who have protocols approved with NIH trainings in the past, you will need to update your human subjects research trainings through CITI program by August 1, 2019. The IRB requires current (not expired) completed human subjects training certificates for IRB approvals.

Please contact us if you have any issues with our online form or questions!

ADE Application Submission Part 1

ADE Application Submission Part 2

ADE Application Submission Part 3

ADE Application Submission Part 4

Submit an IRB Full Protocol through IRB Manager.

Researchers must include ALL documents and scripts seen, heard, signed, or answered by potential or consenting participants, which may include:

• Recruiting script/text or recruiting flyers/letters/ads
• Informed Consent Document(s) or Implied Consent Document(s) for online surveys
• Final survey
• Interview questions
• Focus Group questions
• Debriefing Document(s) for research with deception
• Photo Releases (if using photographs of participants)
• Video Releases (if video recording participants)

If you are recruiting volunteers through a teacher, department, organization or agency, or if you are conducting research in the classroom, or at a business, organization or agency:

• Letter of permission to recruit and/or conduct research (on official letterhead).

Consult our HAP Forms Library for all forms and templates.

Be sure to include all the necessary forms with proper signatures and formatting. Protocols missing any required documents will not undergo pre-review until all outstanding forms are received.

Protocol Submission

New protocols, revisions, renewals, and modifications are reviewed on a rolling basis based on the date all materials are received. Check with your department for the deadline necessary for department staff to record, sign and submit all protocols to the Grad Studies office by the following dates:

• November 1: To enroll in the thesis/project class in the following spring.
• April 1: To enroll in the thesis/project class the following summer or fall.

We suggest that students planning non-exempt research projects turn in their protocols prior to the department and university deadlines to accommodate the revision cycle during the pre-deadline periods. For instance, submitting a non-exempt protocol to the Grad Studies office in September or early October will assure that the IRB will review it and any requested changes or clarifications before the end of the semester.

The most common documented reason for delay in the revision cycle is researchers’ delays in sending requested revisions. Protocols and revisions are reviewed in the order in which they are received, so every day counts.

Tips on Your Protocol

For both the Informed Consent and other supporting documents (e.g. recruitment materials):

• Use a 12-point font.
  Participants and committee members must be able to see it.
• Adapt the template to your own research.
  Delete the parentheses, directions and italics from the final version. Adapt the template to present your own project information.
• Use everyday language.
  This will allow the widest audience, including the IRB members, to understand the purpose of your research, and the procedures you have planned, and any risks or benefits involved. Please do not use discipline-specific jargon or acronyms. If you must, please define them.
• Separate your personal agenda from the research procedures.
  The protocol is the place to tell the IRB how you plan to interact with your research participants to obtain the data. The informed consent tells the participants what will happen to them during the research project. The thesis is the place to state the conclusions drawn from the data you have collected. Keep personal bias out of the protocol and the informed consent. If you already know the answers, why are you bothering to do this research?

Informed Consent Guidelines

The informed consent must give prospective participants the information they need to make an informed decision whether to participate in a research project. Please use the template provided (see IRB Forms Library) to make sure you include all the elements of informed consent.

• Write at a sixth- to eighth- grade reading level.
  Lay people, as well as IRB committee members and staff from outside your own discipline, must understand your informed consent document. Please make this document simple and informative. Writing it at a sixth to eighth grade reading level will allow the widest audience to be eligible to participate in your project.
• Check the readability level of your consent form.
  When you have finished writing your consent, go to the Word menu bar and choose “Tools/Options/Spelling and Grammar.” Check the “Check Grammar with Spelling” box and the “Show Readability Statistics” box. When you run a spell check, the readability statistics will be displayed when the spell check is finished.

• Informed Consent 
• Parental Permission
• Implied Consent for Surveys
• Verbal Consent Form
• Witness Translator Consent Form
• Focus Group Consent Form
• Permission to Recruit / Conduct Research
• Recruiting Script
• Photo Release
• Video Release
• IRB Protocol Renewal Form (Note: this form should only be used if your protocol was not started in IRB Manager)
• IRB Protocol Modification Form (Note: this form should only be used if your protocol was not started in IRB Manager)
• IRB Study Completion Form (Note: this form should only be used if your protocol was not started in IRB Manager)

Guidelines for Obtaining Assent from Minors

Participants who are minors (under the age of 18 and not legally emancipated) cannot give their "informed consent"; but they may assent to participate in research. Assent is defined as a child's affirmative agreement to participate in research. Passive consent, or allowing a parent/child to opt out of a research activity or procedure, is not acceptable.

These Guidelines assume youth who are developmentally and educationally on-track for their chronological age. If necessary, adapt the age cut-offs to fit your specific population and then explain in the Consent section of your protocol why you have chosen a higher or lower level for your age group.

For children 8 years of age and under

In ordinary minimal risk research, the children in this age group should simply be told verbally what the research activity will be, and the description should be extremely simple and age-appropriate. For instance, we will give you some stickers and you will tell us which one you like the most, or you will tell us a story about something that happened to you and I will take notes.  For this age group, the parental consent should include this statement in the Risks section: If your child indicates through his/her behavior, or any other means, that they do not want to participate in one or any of the research activities, their participation will be stopped immediately.  If the children are too young to read or write, or are functioning at that level, please don't submit an assent to be read and signed by them.

The use of a formal verbal assent is complicated, requiring witnesses to attest to the child's understanding, and not recommended, although this may be required for research with more than minimal risk and discomfort to the child such as a clinical trial.

For youth from ages 9-13

The purpose of the assent form for this age group is to inform the youth of what will happen during the research procedures and, out of respect for them as research volunteers, ask them to sign a form to indicate their permission. There is no expectation that the youth necessarily comprehend the concept of risk and benefit or altruism. This should be a written and signed form that is very simple and informative in terms of what will happen. Keep it non-technical, jargon-free and readable by your prospective participants.

For youth from ages 14-17

Since the adult consent form should be written at no higher than an eighth grade reading level, a 14-year-old should be able to understand the same form and concepts. This assent could be a simplified version of our adult informed consent model, assuming that the adult version is written at the eighth grade level. Again, make it non-technical, jargon-free and readable by the 14-17 year olds who will participate in your research.

Many minors at this age do not like to be referred to as children, so please refer to them as "youth or adolescents" in the assent form.

All individuals conducting human subjects research are required to pass an online research training course. This includes not only the principal investigator but also all faculty advisors, coinvestigators, research technicians, research assistants, and student assistants who have contact with the research participants or identifiable data.

A course completion report will be issued upon completion of either course. The report must be submitted with the protocol materials. The reports are valid for 3 years from the date of issue. Note: CITI automatically syncs with IRB Manager every 24 hours and will record training completions ONLY IF you sign up for CITI using your SF State email address.

The CITI course at Citi Program, Research, Ethics and Compliance Training Website is recommended for social/behavioral/educational researchers because of the elective modules which may be tailored to your own field of study.

CITI is free for SF State students, faculty, and staff.

For first time users, please select "Register" at the CITI homepage and on the following screen, enter "San Francisco State University" for the Organization Affiliation. Select the Social/Behavioral Research course to fulfill this requirement. Please note: Responsible Conduct of Research: Social and Behavioral Course does not fulfill this requirement.

Please contact us if you have any issues with signing up for the required course!

Email: protocol@sfsu.edu

Phone: (415) 338-1093

When a research protocol enters the IRB office, the coordinator and administrator assign each human research volunteer protocol to a specific category of review, depending on the purpose, methods, and risk-to-benefit ratio of that study.

The federal regulations detail the three categories of research review: exempt review, expedited review of non-exempt research, and full committee review of non-exempt research. This section will describe each category, followed by examples of projects that would be assigned to that category.

Administrative Review of Exempt Research

Research protocols in categories defined by the federal regulations (46.101 (b), which exhibit no or very low risks, are assigned to the Exempt research category by the IRB office. This category of research does not undergo full committee review, but is reviewed administratively by IRB staff. Protocols determined Exempt do not expire.

To determine the research review status, the IRB office requires a full protocol submission, all related documents such as recruiting script, final survey or interview instruments, and an informed consent process and documents.

If ORSP-Human and Animal Protections (HAP) determines that a protocol is "exempt" from regulatory oversight, ORSP-HAP will not further review any other documents submitted with the protocol. However, any changes to the project must be submitted to ORSP-HAP with a Modification form in IRBManager.

Faculty advisors and investigators are responsible for ensuring that all publicly viewable documents are clear of grammar, spelling, readability and formatting errors.

The IRB recommends that students conduct exempt research to avoid delay in registration for the culminating experience course.

Examples of Exempt Research:

Surveys or interviews of non-vulnerable adults about non-sensitive topics:

• a survey of small business about the effect of automobile and foot traffic flow on sales figures;
• a survey of business students to determine regional differences in expectations of getting work during economic recovery periods
• survey of emergency room asthma patients to determine if ethnic differences in symptom description affect ER care.

Normal Educational Practices Considered Exempt from Full Committee Review:

Kinds of Data

• students' curriculum-related written work, test scores, grades, artwork and other work samples produced by children
• students' curriculum-related oral and non-verbal communicative responses individually, such as in an interview, in small groups and with the whole class
• students' responses (written, oral or behavioral) to curriculum-related activities
• students' level of active participation in curriculum-related activities
• "a normal educational setting" means preschool, elementary, secondary, and higher educational facilities, and after-school programs (if the project relates to tutoring, or homework help.)
• in Special Education, normal educational practices correspond to the Individualized Educational Program (IEP), which is tailored to each student with an identified disability and may be implemented in diverse settings (e.g., school, home, work, community).

Collection Methods

• teacher's non-participant observation of curriculum-related activity of individual children or groups of children, noting what will be observed and how it will be analyzed, or whether it will be used as anecdotal evidence in the study
• teacher's commentary on students' curriculum-related written work, artwork and other artifacts produced by children
• student journals and communication books related to the curriculum
• student grades and test scores
• teacher journals, notes and reflective comments on student responses and participation in curriculum-related activities
• questionnaires or interviews with students, parents and family members, teachers and administrators
• non-participant classroom observations by colleagues, with the class teacher's permission, stating what will be observed and how it will be used, i.e. how data will be analyzed or whether it will be used as anecdotal evidence

Use of Existing Data

• Secondary analysis of existing data is exempt research, if the data sources are publicly available, or if data is reported in the aggregate. If not either of these, then the investigator must record the information so that volunteers cannot be identified, either directly (by name, address, etc) or indirectly through identifiers (school, grade taught, ethnicity).
• Existing data usage requires a brief protocol telling us what the researcher intends to do with the data, and a letter of permission from the owner of the data saying the current investigator may use the data, and what identifiers the data will come with, if any. Please be aware that in smaller samples, indirect identifiers may actually identify a volunteer.
• If the information is coded anyway, the owner of the data must state in the permission letter that the code key will never be revealed to the current investigator, or that the key has been destroyed and it will not be possible to identify the research volunteers.

Expedited Review of Non-Exempt Research

Expedited review is carried out on protocols that fit very specific descriptions in the regulations. Please be aware that this type of review is not any faster, despite its name, than exempt review.

This category is assigned to research that is not exempt for some reason, according to the regulations, but is lower risk than research requiring full committee review, usually because the methods are non-invasive and the research is social/behavioral/educational.

SF State will conduct an Expedited administrative review on the following categories of research:

1. Research with materials (data, documents, records or specimens) that have been collected, or will be collected for non-research purposes (such as medical treatment or diagnosis).
2. Research with voice, video, digital or image recordings in research that would otherwise be exempt. Risks need to be adequately described in the protocol and consent; the uses to be made of the recordings and their fate need to be stated explicitly; and recordings may only be of activities of a non-sensitive nature.
3. Research employing focus groups in studies that would otherwise be exempt. The research volunteers must be adults, the content of a non-sensitive nature, and the consent form must adequately present the risks associated with a focus group. (Each protocol must contain the paragraph addressing extra protections for focus groups found under ?informed consent? in Forms and Templates.)
   Focus groups not eligible for expedited review include those where disclosure of the participant?s responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants? financial standing, employability or reputation; where sensitive issues are discussed; where the research includes a manipulation; or where a vulnerable population is involved.
4. Continuing review of greater-than-minimal-risk research previously approved by the convened IRB where: (a) the research is permanently closed to enrollment of new volunteers; all volunteers have completed research-related activities; and the research remains active only for long-term follow-up of volunteers or (b) no volunteers have been enrolled and no additional risks identified or (c) remaining research activities are limited to data analysis.
5. Continuing review of research previously approved and determined, at a convened IRB meeting, to be research involving no greater than minimal risk, where no additional risks have been identified.
6. Utilization of the following category more fully for review of some low-risk protocols: Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation or quality assurance methodologies. (this refers only to research that is not Exempt.)
   Expedited review status will be determined, reviewed and approved by the IRB Committee Chair and Administrator, and reviewed by the Protocol Analyst and other IRB members as needed.

Examples of Expedited Review

• Focus groups with adults about non-sensitive topics. The informed consent document must adequately present the risk associated with a focus group, which is that the researcher cannot guarantee the confidentiality of the data collected. (Researcher must add the paragraph regarding focus group risk to the informed consent.)
• Research involving minor deception or omission that poses no risk of adverse effects to the participants.
• Research using data that has been or will be collected for non-research purposes.
• Continuing review of research originally determined at a full committee meeting to involve minimal risk, where administrative reviewers cannot identify any additional risks to the participants.

Full Committee Review of Non-Exempt Research:

The revision cycle includes an administrative screening, pre-review, return of necessary revisions, then assignment to the next available full committee meeting agenda. The committee generally requires further revisions before granting full approval in an emailed letter to the investigator.

"Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities." 45 CFR part 46.102(d)

"Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains

1. Data through intervention or interaction with the individual, or
2. Identifiable private information."

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.? 45 CFR part 46.102 (f)

Examples of Non-Exempt Research (requires full committee review)

• Research with vulnerable populations, defined by 45 CFR 46 as
  pregnant women, fetuses, prisoners, and children. SF State also considers cognitive impairment in determining vulnerability in research.
• Research on sensitive topics with vulnerable populations.
• Survey or interview research with children.
• Observations of private behavior, when the person being observed has a reasonable expectation of privacy, or where the researcher is a participant in the activities being observed.
• Research on social or attitudinal behavior in an educational setting.
• Research involving experimental or invasive methods, or manipulation of the participant?s environment.
• Research where disclosure of the participant?s identity might result in negative legal, financial, economic or social consequences).
• The use of deception in research. (Deception requires a justification by the researchers why this method is necessary. The researcher must not deceive the participants about any physical or emotional harm that might result from the procedures. Use of deception also requires a de-briefing session as soon as possible after the procedures).

After either the office or the committee has reviewed a protocol, the office will send the investigator notice of one of the following outcomes via e-mail.

Exemption Notice

If the protocol is determined to be Exempt from regulatory review, the researcher will receive an Exemption Notice e-mail. This email is to be regarded as approval to begin research. The protocol will not expire, but changes to the research may require review.

Full Approval

When the research is approved, the IRB will send an email with approval letter attached to the investigator. The letter will state the approval date, expiration date and terms of approval. The date of approval will be the same as the date of the full committee meeting at which the research was approved.

Conditional Approval (most common result for non-exempt research)

A conditional approval is awarded if there are minor correctable problems found in the protocol and related documents. The investigator will receive a letter from the IRB office requesting the revisions or clarifications necessary for full approval. Research may not commence until the revisions have been addressed and accepted by the IRB chair, and a letter of approval has been issued to the investigator.

The final letter of approval to the investigator will be dated the same date as the convened committee issued conditional approval, regardless of when the revisions are received and approved. To state this differently, the expiration date will be one year from the date of the full committee meeting at which conditional approval was granted.

Deferral

A protocol is deferred if there are substantive issues that require correction; major clarifications needed on risk or procedures; or information needed to continue review. Research activity may not commence until the investigator has provided the information clarifications or revisions, and the IRB committee has reviewed and approved the response in a second full meeting. Approval date will be the date of the second full committee meeting at which the approval is granted. The expiration date will be one year from the date of this convened meeting.

Disapproval

If the research is disapproved, the investigator may not conduct the proposed research. However, the IRB will provide the investigator with the reason for its decision by email. The investigator must have the opportunity to respond to the committee in writing or in person. The investigator may resubmit a protocol to the IRB for review if the reasons given for disapproval can be corrected and addressed.
 

Criteria for Approval or Suspension of Research

(From the Code of Federal Regulations, title 45 part 46)

§46.111 Criteria for IRB approval of research.

(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:

(1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

(4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by §46.116.

(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.

(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

§46.112 Review by institution.

Research covered by this policy that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB.

Criteria for Suspension of Research

§46.113 Suspension or termination of IRB approval of research.

An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head.

(Approved by the Office of Management and Budget under control number 0990-0260.)

Modifying your Protocol

If you would like to make changes to any aspects of your project, these changes must be reviewed and approved by the IRB office. Note that no changes may be implemented before they are officially approved. Please allow one month for modification processing: our office may request clarifications or revisions that must be addressed by the researcher(s) before modification(s) can be approved.

Modification requests will not undergo pre-review until all pertinent documents have been received. All modification requests must include:

• IRB Modification Form specifying all proposed changes.
• All corresponding documents affected by the change(s). The documents required for various types of modifications are outlined in the Modification Request Form (above).
• Highlighted changes within the corresponding documents.
• If adding research assistants or changing the Primary Investigator, please provide their qualifications and a current CITI or NIH certificate.

* Please note that Expedited and Non-Exempt studies require the submission of an updated protocol. 

Renewing your Protocol

If you wish to continue your project (including the analysis of any identifiable data), you are responsible for renewing it annually. The renewal must be approved by our office before the day of expiration. Please allow one month for renewal processing: our office may request clarifications or revisions that must be addressed by the researcher(s) before renewal can be approved.

Renewals will not undergo pre-review until all pertinent documents have been received.

Additionally, your research progress must be addressed in your submission: you may update your protocol with information about the progress of your project or attach a cover letter summarizing the advancement of your research in the past year. When discussing your progress, please include the number of participants that have been recruited and any changes to methods and/or personnel.

An adverse event is an event that occurs during the course of the research protocol that causes or increases the risk of physical or psychological harm to the research volunteer, or results in a loss of privacy and/or confidentiality to the research volunteer or others.

Investigators are encouraged to contact HAP if they have a question about whether or not an adverse event requires a report. We will attempt to maintain confidentiality until a formal adverse event report is filed; however, we are required to follow-up on any indication that a serious or significant adverse event has occurred.

IRB Unanticipated Problem Report (LINK)

Adverse events may be:

• Anticipated: An adverse event that is reasonably expected in nature, severity, and frequency, and is included in the protocol and consent form as a possible risk of participating in the research
• Unanticipated: An adverse event whose nature, severity, or frequency was not identified in the protocol and consent form as a possible risk of participating in the research.
• Related: Only adverse events that are caused by or affect the study design or procedures of the research need to be reported to Human and Animal Protections.

Adverse events may be:

• Serious: adverse events defined by 21 CFR 312.32, including death, a life-threatening adverse experience, hospitalization or prolongation of hospitalization, a persistent or significant disability or incapacity, or a congenital abnormality/birth defect. Serious adverse events must be reported to HAP as soon as possible for the protection of the research volunteer, but at least within 5 working days and may need to be reported to the federal Office for Human Research Protections (OHRP).
   
• Significant: adverse events not specified by federal code; however, events that SF State considers grave, requiring immediate attention. These would include e.g., a psychotic or schizophrenic break not requiring hospitalization; a suicide attempt that does not result in hospitalization; suicide threat; a serious breach of confidentiality or privacy of research volunteers or others by the researcher or focus group members that results in or could result in, e.g., deportation, arrest, expulsion, suspension, loss of job, loss of family support; loss of laptop with private, identifiable information about research volunteers. Significant adverse events must be reported to HAP as soon as possible for the protection of the volunteer, but at least within 5 working days.
   
• Minor: Minor adverse events should be reported to HAP only if they result in a modification of the protocol to mitigate and/or detail this event.

Reporting adverse events:

• Serious and Significant adverse events must be reported to HAP as soon as possible for the protection of the research volunteer, but within at least 5 working days using the Serious/Significant Adverse Event Report Form. This form must be completed and signed by the Principal Investigator, although an electronic notification from the PI is acceptable with a signed, hard-copy follow-up. The report will include actions taken to mitigate the current adverse event and to avoid the adverse event in the future, if appropriate. A copy of the current informed consent document and any other supporting documentation must be included for review. This event will usually trigger a modification of the protocol and related documents. All resulting modifications to the protocol must be approved by the IRB.
   
• Minor adverse events that require reporting should be reported on the Minor Adverse Event Report Form to HAP in a timely manner.

Review of adverse events:

Adverse events are reviewed by the Institutional Review Board (IRB) Chair to determine level and relatedness of the event. Possible consequences are listed below.

• Serious/significant adverse event:
  If it is determined by the IRB Chair that the adverse event is related to the research and is serious or significant, the event is reported to the IRB. The IRB Chair may: suspend or terminate the research immediately, followed by IRB involvement; or report his/her findings at the next scheduled meeting of the IRB for their input; or call an emergency meeting of the IRB to discuss the matter. If the IRB determines that the research volunteer may be placed at an immediate risk, the IRB also has the authority to suspend or terminate approval of a protocol, requiring the immediate cessation of data collection from research volunteers.
  The Adverse Event Report is sent to the Institutional Official (Associate Vice-President of Research and Sponsored Programs) or the Dean of Graduate Studies for students with the IRB's acceptance or their recommendations for any action needed beyond the mitigation proposed by the researcher. Serious adverse events may need to be reported to OHRP, sponsors, and/or the FDA, as required. These reports must include the actions the institution is taking or plans to take.
• Minor adverse event:
  Minor adverse events are reviewed by HAP to assure that protocol modifications are initiated, if necessary.

Possible outcomes following an adverse event:

• Serious/significant adverse event:
  Possible actions that may be taken may include: acceptance of the mitigations proposed; revise the protocol; revise the informed consent; suspend research volunteer enrollment; inform enrolled research volunteers of the adverse event; requirement for additional information to be provided to past and current research volunteers; requirement that current research volunteers re-consent to participation; monitoring of the research by HAP; reduction of approval period to less than one year; suspension or termination of the research; confiscation of the data.
   
• Minor adverse event:
  Continued occurrence of minor adverse events may trigger a report to the Institutional Official (or the Dean of Graduate Studies for students) for further action.

All investigators will be notified in writing, of all actions that the committee, the IRB Chair, and/or HAP have taken.

Researchers are expected to adhere to the protocol and consent documents that were approved by the Institutional Review Board (IRB) or Human and Animal Protections.

Planned protocol modifications: Modifications to the protocol must be submitted to HAP on the Protocol Modification Form. They must be approved by HAP or the IRB before their implementation.

Unplanned protocol deviations/violations and unanticipated problems:
For unanticipated problems, see Adverse Events.

Unplanned protocol deviations or violations: These include deviations from the approved protocol that have already occurred and breaches of scientific integrity and ethics on the part of the researchers.

IRB Unanticipated Problem Report(LINK)

Protocol Violations

Protocol violations are extremely serious situations that require immediate investigation by HAP and the IRB Chair and reporting to the Institutional Official (Vice President of Research and Sponsored Programs), the Dean of Graduate Studies for students, and appropriate external agencies, including the Office for Human Research Protections (OHRP), when warranted. Examples of protocol violations include: events that result from willful or knowing misconduct on the part of the investigator; events that impact ethical principles; events that undermine the scientific integrity of the data; procedures not approved by the IRB that caused or had the potential to cause substantive harm to research volunteers; failure to use an approved informed consent form; failure to report a known, significant/serious adverse effect.

Protocol violation reports may come from a variety of sources, including research volunteers, research staff, community members, etc. All reports will be held in confidence. SF State's Human Resources policy and the California Whistleblower Protection Act protect an individual's identity and shield the individual from reprisal, retaliation, threats or coercion for reporting such information. The IRB adheres to these policies.

Incidents of alleged or known protocol violations will be investigated by the IRB Chair, who may initiate a review to determine the validity of the complaint. Both the IRB and the Institutional Official (or the Dean of Graduate Studies for students) will be notified of all complaints and the outcome of any investigation. If, after investigation by the Chair, the violation is verified, the situation will be forwarded to the Institutional Official (or the Dean of Graduate Studies for students) for further action. Reports, including the actions the institution is taking or plans to take to address the noncompliance (e.g., educate the investigator and/or the research staff, suspend the protocol, suspend the investigator, expulsion of a student etc.) will be sent as required to OHRP, sponsors, and/or the FDA.

Protocol Deviations:

A minor deviation does not harm or potentially harm a research volunteer, e.g., changing minor wording on a survey, altering time required for interview, administrative changes to research volunteer documents (phone number). These should be reported to HAP when discovered during the course of the research and/or no later than 5 working days after their occurrence. These deviations can be reviewed in HAP; they may or may not require a modification (see Modifying your Protocol).

Major deviations may include such things as neglecting to obtain signatures on a part of a consent form; 'interviewing' a survey participant; not following stated inclusion/exclusion criteria; making substantive changes (not administrative) to documents, including materials given to research volunteers; lapse in approval; collecting data after protocol approval expiration. These should be reported to HAP when discovered during the course of the research and/or no later than 5 working days after their occurrence.

Major deviations need to be reviewed by the IRB to decide action. These deviations may or may not require a modification (see Modifications), which will need to be reviewed by the IRB. The IRB may give permission to the investigator to use data collected during non-compliance.

Continued occurrence of deviations may trigger a report to the Institutional Official (or the Dean of Graduate Studies for students) for further action.