Fillable Determination Of Human Subject Research Checklist printable pdf download

Washington State University Institutional Review Board (IRB)

Determination of Human Subject Research Checklist

Not

YES

Sure

Is the data being obtained about living individuals?

Section A.

Does Your

Is the data collected through intervention or interactions with individuals?

Activity Involve

Human Subjects?

Does the data contain identifiable private information?

If any question in section A is “YES”, go to section B.

If all questions in section A are “NO”, no IRB review required.

If section A is “Not Sure”, go to Section B & C.

Section B.

Is the activity a systematic investigation, including research* development, testing and

evaluation, designed to develop or contribute to generalizable knowledge?

Is it Research*?

If any question in section A is “YES” and section B is “YES”, submit Human Subject Application.

If section B is “NO”, go to Section D.

If section B is “Not Sure”, go to Section C.

Does the activity involve secondary data sets with identifiable private information?

Does the activity use identified specimens or cell lines from other institutions or are they

commercially available?

Is the data collected for administrative purposes with the intention of publication?

Does the activity involve the use of publicly available data that contains sensitive, personal, or

identifiable data?

Section C.

Does the interview or survey focus on experiences, opinions, and sensitive information about

people?

Is IRB Review

Is the activity a biography that is generalizable?

Required?

Is the activity an oral history that is generalizable?

Does the activity involve case histories of multiple patients?

Is the activity a genetic study providing private information about live relatives?

Is the activity a class related project that will lead to publication or poster presentation?

If any question in section C is “YES”, submit Human Subject Application

If all questions in section C are “NO”, go to section D.

If any question in section C is “NOT SURE”, contact IRB.

Does the activity intentionally focus on or include one or more specific populations?

If “YES”, also check the box(s) below.

Children under 14 years outside an educational setting

Neonates/Fetuses

Section D.

Prisoners

Pregnant women

Decisionally impaired

Is the Focus on

HIV/AIDS patients

Native American Tribes with whom WSU has agreement

a Specific

Crime victims

Substance abusers

Non-English speaking

Terminally ill

Population?

Student or employee under the supervisory or evaluative authority of the researcher

Institutionalized individuals

Other ________________________________________________________

If any question in section D is “YES”, contact ORA.

If all questions in section D are “NO”, no IRB review required.

If any question in section D is “NOT SURE”, contact ORA.

*Research includes all theses, dissertations, publications, and/or presentations. For a complete explanation, check the definitions.

This checklist is a guide to assist researchers in determining if their activities should be reviewed by the WSU IRB.

All researchers must comply with the policies and procedures in the IRB manual. Version: February 2008

Determination Of Human Subject Research Checklist

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