Holiday Review Schedule
No reviews will be conducted between November 17th and 26th or between December 14th and January 22nd for the Thanksgiving and Winter Breaks.
IRB Forms, Addenda, and Templates
Basic Materials for Initial Review
102 Request for Review (38 KB). This application is required for a Request for Initial Review, Request for Continuing Review, or Request for Review of Protocol Modification.
Addenda, include as appropriate
201 Research Involving Children Addendum (31 KB). Use this addendum if your research involves children under the age of 18.
202 Research in Public Schools Addendum (29 KB). Use this addendum if your research will take place in public schools.
203 Research with Persons who are Decisionally Challenged Addendum (29 KB). Use this addendum if any of your participants have cognitive delays or disabilities, or who have any degree of dementia. Also use this addendum if any of your participants will be approached for Informed Consent while they are in a temporary state of distress that could impact their decision-making abilities.
205 Research in International Settings Addendum (27 KB). Investigators should use this addendum if they plan to conduct research in countries outside the United States.
206 Data Collection via the Internet or Social Media Addendum (31 KB). Investigators should use this addendum if they are using the Internet, online survey tools, social media, etc. for data collection.
207 Research Conducted Through Multiple Instiutions Addendum (29 KB). Investigators who are conducting research through colleges and universities, research facilities, or medical centers in addition to MSU Denver should use this addendum.
208 Research Involving Neonates Addendum (30 KB). Investigators should use this addendum when conducting research with babies who are between birth and 30 days old.
209 Research with Pregnant Women and Fetuses Addendum (29 KB)
210 Research Involving Prisoners Addendum (32 KB)
211 Research with Persons Who Have Limited English Skills Addendum (27 KB)
212 Request for Waiver of Consent (28 KB). Use this addendum if requesting either a full waiver of consent or just a waiver of written consent.
213 Grant Funded Research Addendum (26 KB)
214 Faculty Research with their Own Students (27 KB). Researchers should use this addendum when their participants will MSU Denver students who are enrolled in their current classes or advisees.
Templates
The following templates are provided as a courtesy and are not required if researchers have their own versions they prefer provided they include all of the required information.
301 Consent for Participants with Limited English Skills (28 KB)
302 Parent Consent for a Child Template (29 KB). A parental consent is used when the participants are children and informed consent is required in addition to assent.
303 Assent Templates (31 KB). Use an assent when conducting research with persons under the age of 18.
304 Implied Consent Template (26 KB). Modify this template for use with anonymous surveys.
305 Recruiting Script Template (26 KB). A recruiting script is the wording investigators use when inviting participants to take part in their research.
306 Letter of Cooperation Template (26 KB). A letter of cooperation is used to establish, in writing, that an organization such as a nonprofit or school district has agreed to allow an investigator to conduct research in their setting.
307 Photo Release Template (25 KB). Modify this photo release template to your needs if you wish to take and use photos of your participants.
308 Video Release Template (26 KB). Modify this video release template to your needs if you wish to take and use video of your participants.
309 Check for Understanding of Consent (28 KB) Use this template to ensure continuing consent and to confirm consent with participants who have limited English or reading skills.
310 Short Form for Consent (26 KB) Investigators should use this version of the consent form when participants are illiterate or do not speak or understand English.
311 Informed Consent to Participate in a Research Study (31 KB). 45 CFR 46 is very specific in what information must be included in an informed consent form. This template includes all of the required elements and can be customized. Researchers are not required to use it if they have another Informed Consent they prefer and it includes all of the required elements.
Additional Materials
403 Adverse Event Report (27 KB). Investigators are obligated to submit an adverse event report within 5 days of an adverse event. An adverse event is any untoward or unfavorable occurrence in a human subject temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. Adverse events encompass both physical and psychological harms.
405 Unanticipated Problem Report. Coming soon.
