Human Subjects Research Handbook

Researcher: Submit via IRB MANAGER

• You can work on your application and save your progress before submitting

HRPP: Pre-review conducted within 5 business days

Researcher: Respond to all inquiries, questions, and revisions requested

• Take your time responding to ensure you’ve addressed all of the issues raised by HRPP

HRPP: Exempt determination made OR assigned to IRB member for official review and approval

• Reviewers may have additional comments or questions which will be sent to you via IRB Manager

Researcher: If making changes through life of project, submit amendment.

• This includes administrative and substantive changes (personnel updates, enrollment numbers, change to inclusion criteria, design alterations, changes to procedures or measures, etc.)

Researcher: Once study is completed, submit final report to close project

CUNY is considered engaged in a particular human subjects research project when CUNY employees or agents obtain, for the purposes of the research project, (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.

Employees or agents refers to individuals who: (1) act on behalf of CUNY; (2) exercise institutional authority or responsibility; or (3) perform institutionally designated activities.  This can include staff, students, contractors, and volunteers, among others, regardless of whether the individual is receiving compensation.

Review the definition of ethnography research.

A human subject is a living individual about whom an investigator is obtaining data either through intervention or interaction with the individual OR by obtaining private identifiable information about the individual.

An interaction is a communication/interpersonal contact between investigator and subject.

An intervention involves procedures by which data are gathered and manipulations of the subject or the subjects’ environment are performed for research purposes.

Not Human Subjects Research (NHSR) is research that does not involve human subjects as per the definition above. If you are conducting NHSR, no IRB review is required and no approval is necessary.

The Principal Investigator (PI) is ultimately responsible for the ethical conduct of the research and for compliance with applicable regulations and policies. You may act as the PI if you are one of the following:

• Full time CUNY faculty and staff and RF-CUNY staff
• Adjunct faculty
• Students and postdoctoral scholars (Note: You must have a faculty member listed on the project as an advisor/mentor)

Research is systematic investigation designed to develop or contribute to generalizable knowledge.

Privacy and Confidentiality Considerations

Privacy means having control over the extent, timing, and circumstance of sharing oneself (physically, behaviorally, intellectually) with others.

• The IRB considers privacy of subjects during recruitment, screening, informed consent, and study procedures

Confidentiality describes the treatment of information about participants and management of their data in a way that protects it from improper use, disclosure to outside individuals, and appropriate methods of coding or protecting the data have been established. 

• The IRB considers confidentiality of date when evaluating how you will store, share, and protect the data. 

Please use this Research Information Sheet document as the template consent form for exempt research studies.

1. Research, conducted in established or commonly accepted educational settings, that specifically involves 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. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research that only includes interactions involving 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 criteria is met:
   • The information obtained 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;
   • Any disclosure of the human subjects' responses outside 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; or
   • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
3. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
   • The information obtained 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;
   • Any disclosure of the human subjects' responses outside 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; or
   • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §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. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
     • If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
4. 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 is met:
   • The identifiable private information or identifiable biospecimens are publicly 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 parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
   • The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
5. Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
   • Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
6. Taste and food quality evaluation and consumer acceptance studies:
   • If wholesome foods without additives are consumed, or
   • If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or 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.
7. Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).
8. Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:
   • Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d);
   • Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117;
   • An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) 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.

1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
   • (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. 
   • (b) 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
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
   • (a) 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
   • from other adults and children, 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.
3. Prospective collection of biological specimens for research purposes by noninvasive means.
4. 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.
5. 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).
6. Collection of data from voice, video, digital, or image recordings made for research purposes.
7. 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.
8. Continuing review of research previously approved by the convened IRB as follows:
   • 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
   • where no subjects have been enrolled and no additional risks have been identified; or 
   • where the remaining research activities are limited to data analysis
9. 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.

IS ORAL HISTORY HUMAN SUBJECTS RESEARCH?

Per the federal regulations, 45 CFR par 46, oral history is not officially included in the definition of human subjects research (HSR). Depending on the intent of the oral history you will conduct or collect, however, IRB review may still be required. Please use the decision chart to evaluate whether you are conducting HSR and therefore require IRB review.

• Oral history activities that only document a specific historical event or the experiences of individuals without intent to draw conclusions or generalize findings would not constitute "research" as defined by HHS regulations 45 CFR part 46. 
• Systematic investigations involving open-ended interviews that are designed to develop or contribute to generalizable knowledge (e.g., designed to draw conclusions, inform policy, or generalize findings) would constitute "research" as defined by HHS regulations at 45 CFR part 46.
• Oral historians and qualitative investigators may want to create archives for the purpose of providing a resource for others to do research. Such a repository of information meets the definition of “research” because it includes “research development.”

OHRP GUIDANCE ON SCHOLARLY AND JOURNALISTIC ACTIVITiES

ORAL HISTORY ASSOCIATION UPDATE ON IRBS

Flowchart - Outline Description

Question (top of chart): Does your oral history document a specific historical event or the experiences of individuals?

1. Yes. I am conducting a systemic investigation.
   • Do you intend to draw conclusions or generalize findings?
     1. Yes. This is HSR. IRB review is required.
     2. No. This is not HSR. IRB review is not required.
2. Yes. I am creating an archive or repository for the purpose of providing a resource to others for future research.
   • This is HSR because it involves "research development." IRB review is required.
3. No. This is not HSR. IRB review is not required.