Transcription of 1 Meets the definition of human subjects research.
1 Exempt human 8 Exemptions Consider subjects Research 1 Meets the definition of human subjects research. Exempt studies involve human subjects research: research involving a living individual about whom data or biospecimens are obtained/used/studied/analyzed through interaction/intervention, or identifiable, NIH Requirements: private information is used/studied/analyzed/generated HS education Inclusion tracking for 2 Meets the criteria of one of the following exemptions: all except 4. 45 CFR 46. exemption 1: conducted exemption 2: uses exemption 3: benign Requirements: in an educational setting educational tests, surveys, behavioral interventions in Limited IRB review for using normal educational interviews, or observations of adults* 7 & 8, and some study practices* public behavior* designs under 2 & 3. *Cannot include any other procedures, such as *Limited IRB review may be required.
2 *Limited IRB review may be required. Broad consent for 7 &. collection of clinical data or biospecimens 8. exemption 4: involves the collection/study of data or specimens if publicly available, exemption 5: public service Cannot involve exemption 6: taste and food or recorded such that subjects program research or prisoners, unless quality evaluations cannot be identified* demonstration projects includes a broader *May be identifiable in limited cases. See population that (d)(4)(iii) and (iv) happens to include prisoners. exemption 7: storage of Cannot involve exemption 8: secondary identifiable information or children in: research use of identifiable biospecimens for secondary exemption 2 if information or biospecimens. research use. Broad consent investigators Broad consent and limited and limited IRB review are participate in the IRB review are required.
3 Required. activity being observed or includes identifiable info, OR. For more information see the NIH OER human subjects Research website. exemption 3. Send questions/comments to exemption 1 exemption 2 exemption 3 exemption 4. (X1) (X2) (X3) (X4). Effectiveness of on-line training as Focus group of adult community Study among young adults Patient data extracted from supplement to regular members to discuss access to evaluating preferred snack foods medical records without name or instructional approach. dental care. following a television program. ID number every 6 months as Effectiveness of activities to Questionnaire about outdoor Study investigating text vs. voice follow up visits occur. increase awareness of oral health exercise, including collection of message appointment reminders A collaborator removes an aliquot delivered at a community science participants' age and zip code on self-reported annual physical of blood from coded samples.
4 Museum. (limited IRB review conducted) appointment attendance. Aliquots are re-labeled to a random, non-linked code. Testing a manual for parents to Substance abuse training for Diet and physical activity De-identified blood drawn from identify severe asthma symptoms. individuals engaged in illegal drug intervention for people with subjects for the study by a blood use, followed by a survey about diabetes. bank. Evaluation of health education the training. that includes collection and Examining reactions of Use of collaborator's coded tissue analysis of heart rate and body Investigator-led focus group of participants during brief exposure samples and the collaborator measurements from students. pre-teens to discuss bullying. to painful stimuli. retains the code key. exemption 5 exemption 6 exemption 7 exemption 8. (X5) (X6) (X7) (X8).
5 Creating a dataset containing Using dataset from prior study Study of barriers to obtaining new identifiers from a previous study to containing identifiers to answer Evaluation of wholesome food Medicare benefits. conduct future research.* subsequent research question.*. preferences. Outcomes assessment from Saving blood samples from Using blood samples from Study looking at approved levels government-sponsored mental collaborator's study for a future collaborator's study for an of an agricultural chemical on taste health services. research question.* additional research question.*. of vegetables. *(Broad consent obtained and limited IRB *(Broad consent obtained and limited IRB. review conducted.) review conducted.). Study evaluating novel food Dataset containing identifiers Using blood drawn from additives . from prior study stored for future Evaluation of investigator- subjects with study specific sponsored diabetes intervention.
6 Testing high doses of research, with informed consent consent for future research environmental contaminant on for study-specific research (no questions. food taste. broad consent). = exempt = non-exempt Please note: these are possible examples only. Final determination of exemptions should be made in accordance with 45 CFR 46.
