IRB Frequently Asked Questions

Link to: FAQ about informed consent and consent forms

  

Do you need IRB approval for your project?

All CSUSM faculty, staff, and students undertaking any university-supported research activity involving human subjects must have their proposed procedures approved by the campus Institutional Review Board (IRB) or by one of its duly appointed subcommittees.  For the purposes of IRB review,  

• Research means a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for the purposes of this policy, whether or not they are supported under a program which is considered research for other purposes. --- 45 CFR46.102(d)

• Human subject means a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. --- 45 CFR 46.102(f)(1),(2)

• Identifiable private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonable expect will not be made public (for example, a medical record). --- 45 CFR 46.102(f)(2)

• Informed consent must be sought under circumstances that minimize the possibility of coercion of undue influence and must include the eight basic information elements described in the regulations. Information must be presented in language understandable to the subject or the subject's legally authorized representative. --- 45 CFR 46.116(a),(b)

• Informed consent must be documented with a written form approved by the IRB and signed by the subject or the subject's legally authorized representative. --- 45 CFR 46.117

What type of IRB approval do I need? 

For a more detailed description, please ready the Cal State San Marcos Policy for the Protection of Human Subjects.

A.  Exempt Review

In most cases the following categories of research qualify for Exempt review:  

1.   Research conducted in established or commonly accepted educational settings, involving normal educational practices.

2.   Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior only if:

      a. research is completely anonymous (no links or identifiers to subjects) AND

      b. there is NO risk of disclosure of the human subjects' responses

OR

      c. the human subjects are appointed public officials or candidates for public office.

3.   Research involving the collection or study of existing data (i.e. SPSS datasets), documents, records, 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.

 

 

B.   Expedited Review.

Certain kinds of research involving no more than minimal risk, and where confidentiality can be assured, may qualify for expedited review.  For example:

 

1.   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.

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

3.    Collection of data or biological specimens through non-invasive means.

 

Exceptions: Where there are vulnerable populations or sensitive topics a full review may be required.

  

 

C.  Full Review

Survey, interviews or observational research involving sensitive topics and/or vulnerable populations, or where confidentiality cannot be assured may be subject to a full review,. 

 

For the purposes of IRB review, "sensitive topics" are defined as those dealing with behaviors, which, if publicly disclosed, could be damaging to subjects or place them at risk of criminal or civil prosecution.

 

"Vulnerable populations" are defined as those who are vulnerable to coercion or undue influence; including children under 18 years of age if studied outside normal daily activities, prisoners, hospitalized or institutionalized populations, the mentally or cognitively impaired, fetuses, and pregnant women.

 

Examples of Risk (From University of Wisconsin)

 

What is required for Informed Consent?

See Page on Informed Consent.

 

My form is complete, what is next?

Deliver original with the original signature from your sponsor or project advisor to the Office of Graduate Studies and Research, Craven Hall, Room 5210.  Be sure to provide the specified number of copies.  IRB Contacts

 

How long will it take to get approval for my project?

The length of time to approval has many variables.  The most important of which is the thoroughness and clarity of your proposal.  If you are a student, be sure your faculty advisor reviews it carefully to be sure the proposal has covered the required topics well.

 

Full Reviews:  Only Full reviews require the full committee to review and discuss the project. If your research requires a full review, you should hear from the IRB committee within a week of the meeting in which your IRB is reviewed.    The committee meets twice a month.  Proposals must be received one week in advance of a meeting to be reviewed at that meeting.  If your full review requires no modifications or clarifications, you will receive approval 3-4 weeks after submission.

 

Expedited Review:  These are reviewed by just one of the IRB committee members and is an on-going process.  If your research is Expedited and requires no clarifications or amendments when reviewed, the process takes about  two weeks.

 

Please note:  You may not begin to collect data, interview subjects, distribute surveys or any other interaction/intervention with human subjects until your proposal is approved and you have received  your approval letter and the stamped, approved consent forms.

 

How will I know that my project has been approved by the IRB?

You will receive an email from the reviewer either stating approval or requesting additional information if needed.  If more than 2-3 weeks have passed and you have not heard on the status of your approval, please call the IRB Administrative Support.  IRB Contacts  

 

What is considered a minor modification?

A change in advisor or sponsor, a change in the methodology, a change in the questions being asked, a change in demographics, any of these would require a minor modification form to be submitted.

 

What is a certification of confidentiality and when is it required?

See PowerPoint Presentation

 

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