Review Deadlines

Both Exempt and Expedited reviews imply "minimal risk" to participants and have open deadlines. Research that is "greater than minimal risk" to participants must be reviewed by the Full Board at a scheduled meeting and must be submitted by a deadline.*

See the definitions and categories below to determine how your study might be reviewed and the expected timeline for review. The IRB will make the final determination of review category.

*Undergraduate and Master's student investigators may have a different review process. Please view submission details for more information.

Minimal risk means that "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."

 

Types of Risks to Consider

Physical Placing devices on the body, drawing blood, ingesting food or drink, exercise
Psychological Stress/anxiety, embarrassment, boredom during the study
Social Stigmatization, ostracism from family/friends/colleagues, bullying
Economic Loss of employment, time away from work, travel to research facilities, medical bill in event of physical injury
Loss of Confidentiality The result of unintentionally disclosing research participants and harmful information collected about them for research purposes. This can result in social and economic risks as the three are closely linked.

Evaluating Risks

When you identify possible risks in your research, consider the likelihood of that risk occuring, then consider the magnitude, or impact, of that risk. If both likelihood and magnitude are high, the activity will be "greater than minimal risk." If the magnitude of risk is high and the likelihood is low, the IRB is more likely to consider the activity greater than minimal risk.

If appropriate protections are put in place during the collection, maintenance, and reporting of data, the likelihood and magnitude of risk can be mitigated. In some cases, risks cannot be mitigated and are accepted when appropriate emergency protocols are in place.

risk evaluation

Category Requirements

Minimal risk research that fits one or more exempt categories listed below:

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

Surveys, Educational Tests, Interviews, or Observations if data is collected:

  • Anonymously (PI is not collecting identifiable information), or
  • Confidentially (PI is collecting identifiable information) if data could not reasonably place subjects at risk of criminal or civil liability or be damaging to their reputation, employability, financial standing, or insurability, or
  • Educational Tests and Non-Participatory Observations of children.

Secondary data analysis if the data is private, identifiable data and the investigator wants to anonymize the dataset by removing individually identifiable information. Data can be owned by the investigator themselves, by another investigator, or by an agency that will provide the data upon request, a fee, or registration.

Submission Deadline

Please submit your application at any time. It is recommended that students conducting research for a thesis or dissertation wait until they have defended their methods chapter or have discussed their methodology with their advisor in detail.

Review Timeline

Exempt reviews can take up to two weeks, although the majority are approved within a week of submission. Some factors in lengthy reviews are: volume of submissions to the IRB and investigator turnaround of required revisions.

Exempt Informed Consent Form Templates

Please view the Resources page for templates.

Category Requirements

Often research that is minimal risk and does not fit an exempt category is considered expedited due to the clear presence of risk that can be mitigated through appropriate safeguards.

Minimal risk research that fits one or more categories (but not limited to these categories):

Moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

Surveys, tests, interviews, focus groups, and experiments that collect information that could potentially be damaging to the participant unless proper safeguards are implemented to protect against invasion of privacy and breach of confidentiality.

Video or images of participants for research purposes.

Collection of data through non-invasive procedures routinely employed in clinical practice.

Surveys, interviews, and participatory observations involving children.

Submission Deadline

Please submit your application at any time. It is recommended that students conducting research for a thesis or dissertation wait until they have defended their methods chapter.

Review Timeline

The IRB receives two weeks to review and comment or approve an expedited application. Therefore, the review can take between two-four weeks, with an average of three weeks. Some factors in lengthy reviews are: volume of submissions to the IRB and investigator turnaround of required revisions.

Regulated Informed Consent Form Templates

Please view the Resources page for templates.

Category Requirements

This category only involves greater than minimal risk research in which participants are exposed to more risk than one could reasonably anticipate in daily life.

Examples:

More than moderate exercise from a healthy subject.

Collecting data from vulnerable populations that are at risk of abuse, suicide, depression, etc.

The majority of research at Sacramento State is considered minimal risk and will not be reviewed by the Full Board.

Submission Deadline

Studies posing greater than minimal risk to participants must be reviewed by a quorum (more than half the membership including one non-scientist) of the IRB.

Full Review Submission Deadlines Committee Meetings
Sept. 4, 2017 Sept. 18, 2017
Oct. 2, 2017 Oct. 16, 2017
Nov. 6, 2017 Nov. 20, 2017
Nov. 27, 2017 Dec. 11, 2017
Feb. 5, 2018 Feb. 19, 2018
Feb. 26, 2018 Mar. 12, 2018
Apr. 2, 2018 Apr. 16, 2018
Apr. 30, 2018 May 14, 2018

Review Timeline

Applications are due two weeks prior to an IRB meeting. In most cases, some revisions will be required before approval can be secured, which depends on the investigator to turn in those changes after the IRB meeting has occurred. In this best case scenario, the review takes approximately three weeks.

If there is not enough information in the application for the IRB to make any decision, the application will be tabled until the next meeting with comments provided to the investigator. In this scenario, the review can take almost two months. 

If your study involves greater than minimal risk, give yourself two months for the review.

Regulated Informed Consent Form Templates

Please view the Resources page for templates.