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Text Version of OHRP Decision Charts

 Chart 1: Is an Activity Research Involving Human Subjects Covered by 45 CFR part 46? Start here, and then go to Point 1.2.

 

Point 1.2: Is the activity a systematic investigation designed to contribute to generalizable knowledge? [45 CFR 46.102(Ed)] If yes, go to Point 1.3. If no, go to Point 1.9.

 

Point 1.3: Activity is research. Does the research involve obtaining information about living individuals? [45 CFR 46.102(f)] If yes, go to Point 1.4. If no, go to Point 1.10.

 

Point 1.4: Does the research involve intervention or interaction with the individuals? If yes, go to Point 1.5. [45 CFR 46.102(f)(1), (2)] If no, go to Point 1.11.

 

Point 1.5: Activity is research involving human subjects. Is it conducted or supported by HHS? If yes, go to Point 1.6. [45 CFR 46.101(a)(1)] If no, go to Point 1.13.

 

Point 1.6: Unless exempted under 45 CFR 46.101(b), the 45 CFR part 46 subpart A requirements apply to the research. As appropriate, subpart B, (covering pregnant women, fetuses, and neonates), subpart C (covering prisoners), and subpart D (covering children) requirements also apply.  Go to Point 1.7.

 

Point 1.7: Go to Chart 2 after noting Point 1.8.

 

Point 1.8: Other Federal, State, and local laws and/or regulations may apply to the activity.

 

Point1.9: Activity is not research, so 45 CFR part 46 does not apply. Go to Point 1.8

 

Point 1.10The research is not research involving human subjects, and 45 CFR part 46 does not apply. Go to Point 1.8.

 

Point 1.11: Is the information individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information? [45 CFR 46.102(f)(2)] If yes, go to Point 1.12.  If no, go to Point 1.10.

 

Point 1.12: Is the information private? (About behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, or provided for specific purposes by an individual and which the individual can reasonably expect will not be made public) [45 CFR 46.102(f)(2)] If yes, go to Point 1.5.  If no, go to Point 1.10.

 

Point 1.13: Is the research covered by an applicable OHRP approved assurance created under 45 CFR 46.103? If yes, go to Point 1.6. If no, go to Point 1.8.


 Chart 2: Is the Research Involving Human Subjects Eligible for Exemption Under 45 CFR 46.101(b)? Go to Point 2.2.

 

Point 2.2: Has HHS prohibited exemption of the human subjects research? (All research involving prisoners, some research involving children.) [Footnote 1 to 45 CFR 46.101(i), 45 CFR 46 401(b)] If yes, go to Point 2.3. If no, go to Point 2.5.

 

Point 2.3: No exemptions to 45 CFR part 46 apply. Provisions of 45 CFR part 46, subpart A apply, and subparts B, C, and D also apply is subjects are from covered vulnerable populations.  Go to Point 2.4.

 

Point 2.4: End of Chart 2. Go to Chart 8.

 

Point 2.5: Will the only involvement of human subjects be in one or more of the following categories? (Note that “only” means that no non-exempt activities are involved. Research that includes exempt and non-exempt activities is not exempt. Go to Point 2.6.

 

Point 2.6: Category 1: Research conducted in established or commonly accepted educational settings, involving normal educational practices? If yes, go to Point 2.11.

 

Point 2.7: Categories 2 and 3: Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior? If yes, go to Point 2.12

 

Point 2.8: Category 4: Research involving collection or study of existing data, documents, records, or pathological or diagnostic specimens? If yes, go to Point 2.13.

 

Point 2.9: Research studying, evaluating, or examining public benefit or service programs? If yes, go to Point 2.14.

 

Point 2.10: Research involving taste and food quality evaluation or consumer acceptance studies? If yes, go to Point 2.15. If no, go to Point 2.3.

 

Point 2.11: Exemption 45 CFR 46.101(b)(1) may apply. Go to Chart 3.

 

Point 2.12: Exemption 45 CFR 46.101(b)(2) or (b)(3)may apply. Go to Chart 4.

 

Point 2.13: Exemption 45 CFR 46.101(b)(4) may apply. Go to Chart 5.

 

Point 2.14: Exemption 45 CFR 46.101(b)(5) may apply. Go to Chart 6.

 

Point 2.15: Exemption 45 CFR 46.101(b)(6) may apply. Go to Chart 7.


Chart 3: Does Exemption 45 CFR 46.101(b)(1) (for Educational Settings) Apply? Go to Point 3.2.

 

Point 3.2: Is the research only conducted in established or commonly accepted educational settings? (Including but not limited to schools and colleges. May include other sites where educational activities regularly occur.)  If yes, go to Point 3.3. If no, go to Point 3.5.

 

Point 3.3: Does the research study involve only normal educational practices? (Such as research on regular and special education instructional strategies, or research in effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.) If yes, go to Point 3.4. If no, go to Point 3.5.

 

Point 3.4: Research is exempt under 45 CFR 46.101(b)(1) from all 45 CFR part 46 requirements. First of two possible end points for Chart 3. No further review is needed.

 

Point 3.5: Research is not exempt under 45 CFR 46.101(b)(1). Go to Point 3.6.

 

Point 3.6: Second of two possible end points to Chart 3.Go to Chart 2, Point 2.7.


Chart 4: Does Exemption 45 CFR 46.101(b)(2) or (b)(3) (for Tests, Surveys, Interviews, Public Behavior Observation) Apply? Go to Point 4.2.

 

Point 4.2: Does the research involve only the use of educational tests, survey procedures, interview procedures, or observation of public behavior? If yes, go to Point 4.3. If no, go to Point 4.10.

 

Point 4.3: Does the research involve children to whom 45 CFR part 46, subpart D applies? If yes, go to Point 4.4. If no, go to Point 4.10.

 

Point 4.4: Does the research involve survey procedures, interview procedures, or observation of public behavior where the investigator participates in the activities being observed? [45 CFR 46.401(b)] If yes, go to Point 4.5. If no, go to Point 4.8.

 

Point 4.5: Research is not exempt under 45 CFR 46.101(b)(2).  However, the 45 CFR 46.101(b)(3) exemption might apply.  Go to Point 4.6.

 

Point 4.6. Are the human subjects elected or appointed public officials? (Applies to senior officials, such as a mayor or school superintendent, rather than a police officer or a teacher.)  If yes, go to Point 4.7.  If no, go to Point 4.11.

 

Point 4.7: Research is exempt under 45 CFR 46.101(b)(3) from all 45 CFR part 46 requirements. First of two possible end points for Chart 4. No further review is needed.

 

Point 4.8: Is the information obtained recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects

and

could any disclosure of the human subjects’ responses outside the research reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation? If yes, go to Point 4.5. If no, go to Point 4.9.

 

Point 4.9: Research is exempt under 45 CFR 46.101(b)(2) from all 45 CFR part 46 requirements.

 

Point 4.10: Research is not exempt under 45 CFR 46.101(b)(2) or (b)(3).  Go to Point 4.12.

 

Point 4.11: Does any Federal statute require without exception that the confidentiality of personally identifiable information will be maintained throughout the research and thereafter?  If yes, go to Point 4.7. If no, go to Point 4.10.

 

Point 4.12: Second of two possible end points to Chart 4. Go to Chart 2, Point2.8.


Chart 5: Does Exemption 45 CFR 46.101(b)(4) (for Existing Data, Documents, and Specimens) Apply? Go to Point 5.2.

 

Point 5.2: Does the research involve only the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens? (“Existing” means existing before the research is proposed to an institutional official or the institutional review board to determine whether the research is exempt.) (Note: See OHRP guidance on research use of stored data or tissues and on stem cells at http://www.hhs.gov/ohrp/policy/cdebiol.html and http://www.hhs.gov/ohrp/policy/stemcell.pdf, and on coded data or specimens at http://www.hhs.gov/ohrp/policy/reposit.html for further information on those topics) If yes, go to Point 5.3. If no, go to Point 5.6.

 

Point 5.3: Are those sources publicly available? If yes, go to Point 5.4. If no, go to Point 5.5.

 

Point 5.4: Research is exempt under 45 CFR 46.101(b)(4) from all 45 CFR part 46 requirements. First of two possible end points for Chart 5. No further review is needed.

 

Point 5.5: Will information be recorded by the investigator in such a manner that the subjects cannot be identified, directly or through identifiers linked to the subjects? If yes, go to Point 5.4. If no, go to Point 5.6.

 

Point 5.6: Research is not exempt under 45 CFR 46.101(b)(4) from 45 CFR part 46 requirements. Go to Point 5.7.

 

Point 5.7: Second of two possible end points to Chart 5. Go to Chart 2, Point 2.9.


 Chart 6: Does Exemption 45 CFR 46.101(b)(5) (for Public Benefit or Service Programs) Apply? Go to Point 6.2.

 

Point 6.2: Is the research or demonstration project conducted or approved by the Department or Agency Head? If yes, go to Point 6.3. If no, go to Point 6.8.

 

Point 6.3: Does the research or demonstration project involve only the study, evaluation, or examination of public benefit or service programs? If yes, go to Point 6.4. If no, go to Point 6.5.

 

Point 6.4: Research is exempt under 45 CFR 46.101(b)(5) from all 45 CFR part 46 requirements. First of two possible end points for Chart 6. No further review is needed.

 

Point 6.5: Does the research or demonstration project involve only the study, evaluation, or examination of procedures for obtaining benefits or services under public benefit or service programs? If yes, go to Point 6.4. If no, go to Point 6.6.

 

Point 6.6: Does the research or demonstration project involve only the study, evaluation, or examination of possible changes in or alternatives to public benefit or service programs or to procedures for obtaining benefits or services under public benefit or service programs? If yes, go to Point 6.4. If no, go to Point 6.7.

 

Point 6.7: Does the research or demonstration project involve only the study, evaluation, or examination of possible changes in methods or levels of payment for benefits or services under those public benefit or service programs? If yes, go to Point 6.4. If no, go to Point 6.8.

 

Point 6.8: Research is not exempt under 45 CFR 46.101(b)(5). Go to Point 6.9.

 

Point 6.9: Second of two possible end points to Chart 6. Go to Chart 2, Point 2.10.


 Chart 7: Does Exemption 45 CFR 46.101(b)(6) (for Food Taste and Acceptance Studies) Apply? Go to Point 7.2.

 

Point 7.2: Does the research involve only a taste and food quality evaluation or a food consumer acceptance study? If yes, go to Point 7.3. If no, go to Point 7.6.

 

Point 7.3: Are wholesome foods without additives consumed?  If yes, go to Point 7.4. If no, go to Point 7.5.

 

Point 7.4: Research is exempt under 45 CFR 46.101(b)(6) from all 45 CFR part 46 requirements. First of two possible end points for Chart 7. No further review is needed.

 

Point 7.5: Is food consumed that contains a food ingredient, agricultural chemical, or environmental contaminant at or below the level found to be safe by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture? If yes, go to Point 7.4. If no, go to Point 7.6.

 

Point 7.6: Research is not exempt under 45 CFR 46.101(b)(6).  Go to Point 7.7.

 

Point 7.7: Second of two possible end points to Chart 7. Go to Chart 8.


 Chart 8: May the Institutional Review Board Review Be Done by Expedited Procedures Under 45 CFR 46.110?

 

Note: See expedited review categories and OHRP guidance on the use of expedited review procedures at http://www.hhs.gov/ohrp/policy/exprev.html for further information on expedited review. Go to Point 8.2.

 

Point 8,2: Has the research been previously reviewed and approved by the institutional review board? If yes, go to Point 8.3. If no, go to Point 8.8.

 

Point 8.3: Is the review a continuing review? [45 CFR 46.109(e)] If yes, go to Point 8.4. If no, go to Point 8.5

 

Point 8.4: First of two possible end points for Chart 8. Go to Chart 9.

 

Point 8.5: Does the review involve a minor change in approved research during the (one year or less) period of approval? [45 CFR 46.110(b)(2)] If yes, go to Point 8.6. If no, go to Point 8.10.

 

Point 8.6: Research is eligible for institutional review board review through expedited procedures. Agency head may restrict, suspend, terminate, or choose not to authorize an institution’s or institutional review board’s use of the expedited review procedure. [45 CFR 46.11(d)]  Go to Point 8.7.

 

Point 8.7: Second of two possible end points for Chart 8. Go to Chart 10.

 

Point 8.8: Does the research present no more than minimal risk to human subjects, and does the research involve only procedures included in categories 1 through 7 on the list of categories of research than may be reviewed through an expedited review procedure? [45 CFR 46.110(b)(1)] If yes, go to Point 8.9. If no, go to Point 8.10.

 

Point 8.9: Is the research classified? [Paragraph (D) of Categories of Research That May Be Reviewed by an Institutional Review Board through an Expedited Review Procedure] If yes, go to Point 8.10. If no, go to Point 8.11.

 

Point 8.10: Review by the convened institutional review board is required. Go to Point 8.7.

 

Point 8.11: Could identification of subjects put them at risk of criminal or civil liability, or be socially or economically damaging? [Paragraph (C) of Categories] If yes, go to Point 8.12. If no, go to Point 8.6.

 

Point 8.12: Are measures in place to make risks no more than minimal? If yes, go to Point 8.6. If no, go to Point 8.10.


 Chart 9: Can Continuing Review Be Done by Expedited Procedures Under 45 CFR 46.110?

 

Note: See expedited review categories, OHRP guidance on the use of expedited review procedures and on continuing review at http://www.hhs.gov/ohrp/policy/exprev.html  and http://www.hhs.gov/ohrp/policy/continuingreview2010.html for further information on expedited review. Go to Point 9.2.

 

Point 9.2: Has the research been previously reviewed and approved by the institutional review board using the expedited procedures? If yes, go to Point 9.3. If no, go to Point 9.6.

 

Point 9.3: Have conditions changes such that the research is no longer eligible for expedited review (such as a protocol change, or experience shows research to be of greater than minimal risk)? If yes, go to Point 9.4. If no, go to Point 9.7.

 

Point 9.4: Review by the convened institutional review board is required.  Go to Point 9.5

 

Point 9.5: End of Chart 9. Go to Chart 10.

 

Point 9.6: Have conditions changed to make the research eligible for expedited review under the applicability criteria A through F and categories 1 through 7 on the list of categories that may be reviewed by expedited procedures(such as research is within those categories and experience confirms the research to be of no greater than minimal risk)? [45 CFR 46.110(a)] If yes, go to Point 9.7. If no, go to Point 9.8.

 

Point 9.7: Research is eligible for institutional review board review through expedited procedures.  Go to Point 9.5.

 

Point 9.8: Expedited review Category 8(a). For this site, are all three of the following conditions met? (i) Is the research permanently closed to enrollment of new subjects? (ii) Have all subjects completed all research interventions? (iii) Does the research at this site remain active only for long-term follow-up of subjects? If yes to all three conditions, go to Point 9.7. If no to any of the three conditions, go to Point 9.9.

 

Point 9.9: Expedited review Category 8(b). Have no subjects been enrolled at this site and have no additional risks been identified anywhere?  If yes to both conditions, go to Point 9.7. If no for either of the conditions, go to Point 9.10.

 

Point 9.10: Expedited review Category 8(c). Are the remaining research activities at this site limited to data analysis? If yes, go to Point 9.7. If no, go to Point 9.11.

 

Point 9.11: Expedited review Category 9. Is the research conducted under an investigational new drug exemption or investigational new device exemption? If yes, go to Point 9.4. In no, go to Point 9.12.

 

Point 9.12: Has the institutional review board determined and documented at a convened meeting that the research involves no more than minimal risk? If yes, go to Point 9.4. If no, go to Point 9.13.

 

Point 9.13: Have any additional risks been identified since institutional review board review at a convened meeting? If yes, go to Point 9.4. If no, go to Point 9.7.


 Chart 10: Can Informed Consent be Waived or Consent Elements Be Altered Under 45 CFR 46.116(c) or (d)?

 

(Note: If subjects include children to whom 45 CFR part 46, subpart D applies, an alternative provision for waiver of parental permission might apply. [See 45 CFR 46.408(c)].) Go to Point 10.2.

 

Point 10.2: Will the research or demonstration project be conducted by or subject to the approval of state or local government officials? [45 CFR 46.116(c)(1)] If yes, go to Point 10.3. If no, go to Point 10.8.

 

Point 10.3: Is the project designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs? [45 CFR 46.116(c)(1)] If yes, go to Point 10.4. If no, go to Point 10.5.

 

Point 10.4: Is it practicable to conduct the research without the waiver or alteration? [45 CFR 46.116(c)(2)] If yes, go to Point10.5. If no, go to Point 10.7.

 

Point 10.5: No waiver of informed consent or alteration of consent elements is allowed.  Go to Point 10.6.

 

Point 10.6: End of Chart 10. Go to Chart 11.

 

Point 10.7: Waiver of informed consent or alteration of consent elements is allowed if the Institutional Review Board documents these findings and approves waiver or alteration.  Go to Point 10.6.

 

Point 10.8: Will the research involve greater than minimal risk, as defined in Section 46.102(i)? [45 CFR 46.116(d)(1)] If yes, go to Point10.5. If no, go to Point 10.9.

 

Point 10.9: Is it practicable to conduct the research without the waiver or alteration? If yes, go to Point 10.5. If no, go to Point 10.10.

 

Point 10.10: Will waiving or altering the informed consent adversely affect the subjects’ rights and welfare? [45 CFR 46.116(d)(2)] If yes, go to Point 10.5. If no, go to Point 10.11.

 

Point 10.11: Will pertinent information be provided to subjects later, if appropriate? [45 CFR 46.116(d)(4)] If yes, go to Point 10.7. If no, go to Point 10.5.


 Chart 11: Can Documentation of Informed Consent Be Waived Under 45 CFR 46.117(c)? Go to Point 11.2.

 

Point 11.2: Would the consent document be the only record linking the subject and the research and would the principal risk be potential harm resulting from a breach of confidentiality? [45 CFR 46.117(c)(1)] If yes, go to Point 11.3. If no, go to Point 11.4.

 

Point 11.3: The Institutional Review Board may waive the requirement for a signed consent form for some or all subjects. If the Institutional Review Board allows waiver of documentation under 45 CFR 46.117(c)(1), go to Point 11.4. If the Institutional Review Board allows waiver of documentation under 45 CFR 46.117(c)(2), go to Point 11.8.

 

Point 11.4: Does the research present no more than minimal risk and involve no procedures for which for which written consent is normally required outside the research context? [45 CFR46.117(c)(2)] If yes, go to Point 11.3, If no, go to Point 11.5.

 

Point 11.5: The Institutional Review Board may not waive the requirement for a signed consent form for any subjects. Go to Point 11.9.

 

Point 11.6: The investigator will ask each subject if he or she wants documentation linking the subject with the research. [45 CFR 46.117(c)(1)] Go to Point 11.7

 

Point 11.7: The subject’s wishes will govern whether informed consent is documented. [45 CFR 46.117(c)(1)] Go to Point 11.8.

 

Point 11.8: The Institutional Review Board may require the investigator to provide subjects with a written statement regarding the research. [45 CFR 46.117(c)]. Go to Point 11.9.

 

Point 11.9: End of Chart 11 and end of Decision Charts.