WHAT IS RESEARCH?  According to the Federal definition, research is "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."

WHAT IS A HUMAN SUBJECT?  A human subject is defined as "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."

Activity that does not fall within the above definitions might not qualify as "human subjects research" and may not require review.  Obviously, this does not mean that one's personal ethics or a profession's ethical guidelines for protecting individuals can be ignored.  Investigators are encouraged to consult with the chair or research compliance coordinator when there is a question about if an activity qualifies under the Federal definitions of human subjects research.

When an activity is human subjects research, the guidance below is used.

There are 3 LEVELS of REVIEW FOR HUMAN SUBJECTS RESEARCH. The committee chair and/or research compliance coordinator will determine the final determination.

• Exempt from the regulation-- Please note that a researcher may not unilaterally make a decision that his/her human subjects research is exempt from the Federal regulations and IRB review.  These proposals will be reviewed by one qualified individual and generally require 1 week  or less for the final disposition.
  Activities Exempt From Coverage Under 45 CFR 46
• Expedited-- requires a subcommittee of the IRB for review (1-3 individuals, depending on the type of activity), but does not require full committee review (not greater than minimal risk to the subjects; standard medical tests; non-invasive sample collection). These proposals will generally require 2-3 weeks for the final disposition.
  List of Expedited Review Categories
• Full Committee review--proposals must be reviewed by the full committee (projects not falling into the above categories, projects with more than minimal risk to participants). The disposition of these proposals will be decided on the day of the meeting.

WHAT IS MINIMAL RISK?  According to the Common Rule, 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."

CONFIDENTIALITY VS ANONYMITY Confidentiality does not mean anonymity of subjects. Confidentiality means that only the investigator(s) can identify the responses of the individual subjects. If the protocol does not require identifying individual subjects, then names and unique identifiers should not be requested, (i.e. subjects could be anonymous). However, if identification of individual subjects is needed by the researcher, every effort should be made to prevent anyone outside of the project from connecting individual subjects with their responses. One common method to maintain confidentiality is to assign codes to subjects, record codes only on the data sheet, and keep a copy of subjects' codes only until no longer needed.  Information should be housed in a locking file cabinet, preferably in a locked office.

Consent Vs. AssenT:
Consent - In South Dakota, to give consent the person must be 18 years of age or older and competent to make the decision to participate. (Note that age of emancipation varies by state.) 
Assent - Assent should be obtained if  the subject is under 18 or legally incompetent to make decisions to participate. 
If the subject is under 18 or legally incompetent to consent, then they should assent and their legal guardian must give permission. 

It is important that on Consent Forms and/or Information Sheets the subject be provided with information on contacting the investigators should they have any questions prior to, or following their participation. E-mail addresses or office phone numbers are acceptable. Additionally, the contact information for the SDSU Research Compliance Coordinator should also be included, should the subject have questions about the conduct of the project.

PIs SHOULD use the provided forms.  Grant proposals are generally not acceptable substitutes for the Human Subjects Form. If any PI needs to submit supplements to the Human Subjects Form, these may be attached at the end of the Human Subjects Form. There is no need to submit budgets or vitas.

During the Fall and Spring semesters, 1 week should be planned for the review of exempt proposals, 2-3 weeks for expedited proposals, and those proposals requiring full committee review must be submitted at least 1 week prior to the committee meeting. During the summer review of proposals may take longer.  

One section of the form which can be confusing is the "Project Period" on the front page. This refers only to the time which the PI(s) will have contact with human subjects. The Project Period does not involve preparation time, data analysis time (unless subject identification is maintained on the data), or manuscript preparation time. Project periods may not be dated prior to the date of protocol submission.

Secretary SDSU IRB

Carolyn Curley