HRPP Determinations

Table Of Contents

  1. PROCESS OF HRPP REVIEW OF RESEARCH STUDIES
    1. HRPP will determine if the study meets the definition of RESEARCH
    2. HRPP will determine if the study meets the definition of HUMAN SUBJECTS
      1. Examples of what may NOT be human subjects research
      2. Examples of what may be human subjects research
    3. HRPP will determine if the study meets the definition of MINIMAL RISK
    4. HRPP will determine which of the following CATEGORY OF REVIEW the study will be reviewed under
  2. CATEGORIES OF REVIEW
    1. EXEMPT REVIEW
      1. What does it mean for review of a research study to be exempt?
      2. What is the criteria for a study to be exempt?
      3. Is an annual review required when HRPP has made an exempt determination?
      4. How long does it take to get approval under Exempt review?
      5. Do I need to submit modifications for exempt projects?
    2. EXPEDITED REVIEW
      1. What does it mean for a review of a research study to be expedited?
      2. What is the criteria for a review to be expedited?
      3. Is an annual review required when HRPP has made an Expedited decision?
      4. How long does it take to get approval under Expedited review?
      5. Do I need to submit modifications for expedited projects?
    3. COMMITTEE REVIEW
      1. What is the criteria for a Committee Review?
      2. How long does it take to get approval under Committee Review?
      3. Do I need to submit modifications for committee reviewed projects?
  3. MODIFICATIONS
    1. EXAMPLES OF EXEMPT PROJECTS THAT DO REQUIRE MODIFICATIONS
    2. EXAMPLES OF EXEMPT PROJECTS THAT DO NOT REQUIRE MODIFICATIONS
      1. How do I know if I need to submit a modification to HRPP?
      2. How long does it take for changes to be approved?
      3. Once a project has been approved, can changes be made to that project?
      4. Do I need to submit modifications for expedited projects?​
  4. REPORTING NEW INFORMATION
    1. If something unanticipated happens, do I need to report that to HRPP?
    2. What are some examples of information that would need to be reported

        REFERENCES


 

1. PROCESS OF HRPP REVIEW OF RESEARCH STUDIES

1a. HRPP will determine if the study meets the definition of RESEARCH

  • Research: A systematic investigation designed to develop or contribute to generalizable knowledge.
  • If a study does not meet the definition of research, you do not need HRPP oversight.
  • If you are unsure whether your project meets this definition, submit in eCompliance as normal, and HRPP will make a determination on your project.

1b. HRPP will determine if the study meets the definition of HUMAN SUBJECTS

  • Human Subjects: A living individual about whom an investigator (whether professional or student) conducting research obtains 1) data through intervention or interaction with the individual, or 2) identifiable private information.
  • If a study does not meet the definition of human subjects, you do not need HRPP oversight.
  • If you are unsure whether your project meets this definition, submit in eCompliance as normal, and HRPP will make a determination on your project.

i. Examples of what may NOT be human subjects research

  1. Class projects completed specifically (and only) for educational teaching purposes or for a grade or assignment
  2. Research involving deceased individuals or cadavers
  3. Biographies
  4. Oral histories completed ONLY to document a specific historical event with no intent to draw conclusions or generalize findings
  5. Gathering information only about business practices, policies, or products and not ABOUT the human subject being interviewed
  6. Quality improvement methods conducted only for internal use or evaluation
  7. Research involving publicly available, de-identified data (e.g. census data)
  8. Research involving de-identified specimens, or coded specimens in which the researcher CANNOT readily ascertain the identity of the individuals

ii. Examples of what may be human subjects research

  1. Pilot studies conducted in order to collect information that will contribute to future knowledge
  2. Surveys, interviews, focus groups, interventions completed in order to contribute to generalizable knowledge in which information is gathered ABOUT an individual (e.g. personal beliefs, life experiences, opinions, morals, etc.)
  3. Studies involving private information (e.g. medical records, school records, data including names or other identifiers)
  4. Studies involving the collection of biological specimens (saliva, blood, tissue, sweat, breast milk, skin cells, teeth, reproductive organ fluids, etc.)
  5. Studies involving educational interventions
  6. Oral histories conducted to generalize findings (draw conclusions, inform policy) or conducted to create/add to archives for the purpose of providing a research for others to do research
  7. Studies involving moderate exercise or muscular strength testing, body composition assessment, and/or flexibility testing
  8. Studies involving a drug or device
    1. Note: Drugs and devices are subject to FDA regulations and the FDA definition of human subjects research
  9. Studies involving physical sensors, EEGs, EKGs, ERGs, MRIs, thermography, ultrasounds, and DXA scanning

**Please note this is not a comprehensive list of the activities that may meet the definition of human subjects research. If you have questions about your research, you should contact the HRPP office.

1c. HRPP will determine if the study meets the definition of MINIMAL RISK

  • Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
  • If a study meets the definition of human subjects research but is found to be more than minimal risk, it will be reviewed by the IRB committee. If a study does not fit into an exempt/expedited review category, even if the study is no more than minimal risk, the project will be reviewed by a full committee.
  • If the study meets the definition of human subjects research but is found to be no more than minimal risk, the study will be reviewed by a HRPP designated reviewer.

1d. HRPP will determine which of the following CATEGORY OF REVIEW the study will be reviewed under:

  • Exempt
  • Expedited
  • Committee Review

 


2. CATEGORIES OF REVIEW

What are the different categories of review under 45 CFR 46?

  1. Exempt
  2. Expedited
  3. Committee Review

What is 45 CFR 46

  • Federal Regulations for Protection of Human Subjects
    • Title 45 – Code of Federal Regulations
    • Part 46 – Protection of Human Subjects
      • Subpart A: Basic HHS Policy for Protection of Human Research Subjects (Common Rule)
      • Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
      • Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
      • Subpart D: Additional Protections for Children Involved as Subjects in Research

2a. EXEMPT REVIEW

i. What does it mean for review of a research study to be exempt?

  • The study is exempt from certain requirements of 45 CFR 46.
  • An HRPP staff member must determine that your project is exempt.

 

ii. What is the criteria for a study to be exempt?

  • Research activities must present no more than minimal risk to subjects
  • Must be determined to fit into one or more of the following review categories:

 

(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices

(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:
(i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

(5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are 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.

(6) Taste and food quality evaluation and consumer acceptance studies

 

iii. Is an annual review (Continuing Review) required when HRPP has made an Exempt determination?

  • An annual review is not required. HRPP may require that you check-in 3 years after your approval date to determine if your project is still active.

 

iv. How long does it take to get approval under Exempt review?

  • A reviewer will typically respond to you within 5-7 business days. An exempt review will typically take 5-10 business days; however, approval times vary based on the study.

 

v. Do I need to submit modifications for exempt projects?

 

2b. EXPEDITED REVIEW

i. What does it mean for a review of a research study to be expedited?

  • The review does not need to be conducted by the IRB committee.
  • The study will be reviewed internally by a designated reviewer.
  • Must be determined to fit into one or more of the following review categories:

 

ii. What is the criteria for a review to be expedited?

  • Research activities must present no more than minimal risk to subjects
  • Minor changes in previously approved research during the period (of one year or less) for which approval is granted
  • Research which includes noninvasive procedures, collection of specimens from healthy individuals, and social and behavioral methods
  • One or more of the following criteria must be met:

 

    1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.

  1. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
  2. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

 

  1. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
  1. From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
  2. From other adults and children [2], considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

 

  1. Prospective collection of biological specimens for research purposes by noninvasive means.
    Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
  2. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
    Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
  3. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
  4. Collection of data from voice, video, digital, or image recordings made for research purposes.
  5. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
  6. Continuing review of research previously approved by the convened IRB as follows:
  1. Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
  2. Where no subjects have been enrolled and no additional risks have been identified; or
  3. Where the remaining research activities are limited to data analysis.

 

  1. Continuing review of research, not conducted under an investigational new drug application or               investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

iii. Is an annual review (Continuing Review) required when HRPP has made an Expedited decision?

  • Yes, an annual review is required.

 

iv. How long does it take to get approval under Expedited review?

  • A reviewer will typically respond to you within 5-7 business days. An expedited review will typically take 5-14 business days; however, approval times vary based on the study.

 

v: Do I need to submit modifications for expedited projects?

  • You are required to submit and receive approval from HRPP for any changes to your project.

 

2c. COMMITTEE REVIEW

i. What is the criteria for a Committee review?

  • Research activities present more than minimal risk to subjects
  • The study does not meet the criteria for Exempt or Expedited review
  • The study involves the use of deception of subjects
  • The study involves vulnerable populations such as: Minors, Incarcerated Individuals, or Pregnant Women
  • The IRB committee determines that the following criteria are met for your project:

 

(1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

(4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by §46.116.

(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.

(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

 

ii. How long does it take to get approval under Committee Review?

  • A Committee Review will typically take 3-6 weeks to review. The IRB Committee reviews studies on the first Thursday of every month.

iii. Do I need to submit modifications for Committee reviewed projects?

  • You are required to submit and receive approval from HRPP for any changes to your project.

3. MODIFICATIONS

3a. EXAMPLES OF EXEMPT PROJECTS THAT DO REQUIRE MODIFICATION

1. Change to the Principal Investigator

2. Addition of a federal funding source

3. Inclusion of children/minors in your research study that previously only included adults

4. Inclusion of identifiable or coded biological specimens or existing data

5. Addition of new interventions

6. Your procedures will require that you now collect identifiers or videos/voice/image recording (when not previously collected and data collected may be sensitive in nature)

7. Your procedures now include questions that are sensitive in nature (e.g. illegal activity, drug/alcohol use, sexual behaviors) or could cause participants a loss of employability or affect their reputation

7. Inclusion of incarcerated individuals in your research study

8. Disclosing a new financial interest

9. Use of a device or drug/supplement/food/additive

10. Collection of biospecimens (e.g. blood, saliva, ear wax, hair or nail clippings, vaginal swabs, rectal swabs).

11. Inclusion of invasive procedures (e.g. procedures that require you to enter the body; inputting energy into the body)

 

3b. EXAMPLES OF EXEMPT PROJECTS THAT DO NOT REQUIRE MODIFICATION

1. Addition of study team members, but it’s recommended that all study team members complete the training before they conduct research procedures

2. Editing/adding interview/survey questions that still fall within the original scope of the approved questions (e.g. not sensitive in nature)

3. Editorial or administrative changes to the consent document or study documents

4. Adding a new recruitment material, assuming it follows HRPP recruitment/advertisement recommendations

5. Increasing/decreasing the number of subjects you are recruiting, as long as it does not include a new subject population (e.g. children/minors, incarcerated individuals)

i. How do I know if I need to submit a modification to HRPP?

  • All projects with an Expedited determination or projects that required Committee Review will need to submit all modifications to HRPP.
  • Certain projects with an Exempt determination will need to submit to HRPP.

ii. How long does it take for changes to be approved?

  •  ​For minimal risk studies, a modification review will typically take 7-10 business days. For more than minimal risk studies, the modifications will need to be reviewed by the full committee and this will typically take 3-4 weeks.

iii. Once a project has been approved, can changes be made to that project?

  • Certain changes will need to be approved by a HRPP designated reviewer before the changes can be made. A Modification Request must be sent to HRPP through eCompliance.

iv. Do I need to submit modifications for expedited projects?

  • You are required to submit and receive approval from HRPP for any changes to your project.

4. REPORTING INFORMATION ABOUT A STUDY AFTER IT HAS BEEN APPROVED

If something unanticipated or harmful happens to a participant during a study, do I need to report that to HRPP?

  • You will need to report any unanticipated information to HRPP by submitting an RNI (Reportable New Information) report.
    • An RNI report encompasses any information that affects the confidentiality of the research participants, or any information regarding a situation with a participant that is beyond the risks of the consent form.

What are some examples of information that would need to be reported?

  1. Any unfavorable medical occurrence in a human subject, including abnormal sign, symptom, or disease that is associated with the participation in the research.
    1. These can be caused by one or more of the following:
      1. The procedures involved in the research
      2. An underlying disease, disorder, or condition of the subject
      3. Other circumstances unrelated to either the research or any underlying disease, disorder, or condition of the subject
  2. Any incident or experience that is unexpected
  3. Any suggestion of a greater risk to harm than originally expected


REFERENCES

Human Subjects Research Determination Chart: /sites/research.ku.edu/files/docs/HSR%20Determination%20Chart.docx

Federal Regulations for Protection of Human Subjects: http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

45 CFR 46 Subpart A: Basic HHS Policy for Protection of Human Research Subjects (Common Rule): http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#subparta

45 CFR 46 Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research: http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#subpartb

45 CFR 46 Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects: http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#subpartc

45 CFR 46 Subpart D: Additional Protections for Children Involved as Subjects in Research: http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#subpartd

Exempt Review Criteria: http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.101

Expedited Review Criteria: http://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html

Committee Review Criteria: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.111

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