Information and Consent Materials & Normal Educational Practices Discussion

2.. Information and Consent Materials (i.e., Consent letter (if paper), email script (for online survey), etc.)

3. If you are using an online survey PROVIDE A FULL CITATION for the instrument and discuss reliability and validity of the instrument. Provide a link to your online version just as participants will see it.. Single line text.

4. Interaction with Research Participants: Will the researcher be collecting data by directly interacting with the participants (electronic, paper, or in person)?

yes / no

19. Interaction with Research Participants: Will the researcher be collecting data by directly interacting with the participants (electronic, paper, or in person)?Required to answer. Single choice.

Yes

No

20.Identifiable Private Information: Will identifiable private information be collected from existing records (i.e., medical records, assessment data)?Required to answer. Single choice.

Yes

No

2 – Exemption Categories

Research activities may be classified as exempt when the ONLY involvement of human subjects falls within one or more of the categories below. If any activities do not fit in the categories below, the project is not eligible for exemption. Check one or more of the categories below that apply to the research project.

21.Research involving normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction such as:. Multiple choice.

Most research on regular and special education instructional strategies

Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management

22.Research that only includes interaction involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording) if at least one of the following is met:. Multiple choice.

Information obtained is recorded by the investigator in such a manner that the identity of human subjects cannot be readily ascertained, directly or through identifiers linked to the subjects

Any disclosure of the human subjects’ responses outside of the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation

The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can be readily ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111(a)(7). *Children may only be included in research under this exemption when involving educational tests or observation of public behavior if the investigator(s) do not participate in the activities being observed and the information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot be readily ascertained directly, or through identifiers linked to the subjects.

23.Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collected and at least one of the following is met. Multiple choice.

The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot be readily ascertained, directly or through identifiers linked to the subjects

The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot be readily ascertained, directly or through identifiers linked to the subjects

The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can be readily ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111(a)(7). For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing (e.g., playing an online game, solving puzzles, etc.)If the research involves deception, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research and the subject is informed that they will be unaware of or they will be misled regarding the nature or purposes of the research. Children may not be included

24.Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria are met. Multiple choice.

The identifiable private information or identifiable biospecimens are publically available

Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects

The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR 160 and 164, Subparts A and E (HIPAA), for the purposes of “health care operations” or “research” as those terms are defined under HIPAA or for “public health activities and purposes” under HIPAA

The research is conducted by, or on behalf of a Federal department or agency using government-generated or government-collected information obtained for non-research activities.

25.Research and demonstration projects, which are conducted by or subject to the approval of Federal Department or Agency heads, and which are designed to study, evaluate, or otherwise examine. Multiple choice.

Public benefit or service programs; this exemption is for Federally supported projects and is most appropriately invoked with authorization or concurrence by the funding agency. The following criteria must be satisfied to invoke the exemption for research and demonstration projects examining “public benefit or service programs:” ? The program under study must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services under the Older Americans Act); ? The research or demonstration project must be conducted pursuant to specific Federal statutory authority; ? There must be no statutory requirements that the project be reviewed by an IRB; and ? The project must not involve significant physical invasions or intrusions upon the privacy of participants.

Procedures for obtaining benefits or services under those programs

Possible changes in or alternatives to those programs or procedures

Possible changes in methods or levels of payment for benefits or services under those programs

This exemption is for projects conducted by or subject to approval of Federal agencies and requires authorization or concurrence by the funding agency.

26.Storage or maintenance for secondary research for which broad consent is required:. Multiple choice.

Storage or maintenance of identifiable private information or identifiable biospecimens for post secondary research use if an IRB conducts a limited IRB review and makes the determinations required by 45 CFR 46.111(a)(8).

27.Secondary research for which broad consent is required: Research involving the use of identifiable private health information or identifiable biospecimens for secondary research use, if the following criteria are met. Multiple choice.

Broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens was obtained in accordance with 45 CFR 46.116 (a)(1)-(4), (a)(6), and (d);

Documentation of informed consent or waiver of documentation of consent was obtained in accordance with 45 CFR 46.117;

An IRB conducts a limited review and makes the determination required by 45 CFR 46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in (d)(8)(i);

The investigator does not include returning individual research results to subjects as part of the study plan. (This provision does not prevent an investigator from abiding by any legal requirements to return individual research results).

28.Background (Why is this important? What problem are you trying to solve?)Required to answer. Multi Line Text

29.Which type of study is this?Required to answer. Single choice.

Quantitative

Qualitative (need probram director approval)

Mixed methods (need program director approval)

30.Research questions (at least two)Required to answer. Multi Line Text.

31.Study PopulationRequired to answer. Multi Line Text.

Describe the characteristics of the study population, including the anticipatednumber of subjects, age range, gender, ethnicity, and health status. Specify any inclusion andexclusion criteria.

32.Subject RecruitmentRequired to answer. Multi Line Text.

Describe the process of identifying and recruiting subjects for theresearch activities.

33.Research procedures, consent, data Collection and data AnalysisRequired to answer. Multi Line Text.

Specify the data collection process that will be used. If a survey is sent- who sends it. If data are provided who sends it? If interviews- where and when? This must be clear enough that someone else could follow your steps.How will you analyze your data? For example, how will you measure your independent and dependent variables? What survey items measure the construct and what statistical analysis (if applicable) will you use?

34.Potential RisksRequired to answer. Multi Line Text.

Describe any potential risks that the study poses to subjects, whether seen orunforeseen, including physical, social, psychological, legal, or other risks.

35.Data retention, Records, and Privacy IssuesRequired to answer. Multi Line Text.

Identify the sources of material that will be obtained from subjects, what information will be recorded, concerns relating to privacy of subjects, or confidentiality. (Note: all research-related records must be maintained for three years after the study is completed and these records are subject to audit.)