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IRB Cheat Sheet

Office of the IRB 3333 New Hyde Park Road New Hyde Park, NY, 11042

Phone: 516-321-2100 www.feinsteininstitute.org/hrpp

irb@northwell.edu CASE MANAGERS: Richard D. Ramdeo, CIP Phone: 516-321-2118 rramdeo1@northwell.edu

Lenox Hill Hospital-All Departments Emergency Medicine Radiation Oncology Radiology Otolaryngology Physical Medicine and Rehabilitation

Dorean Flores, CIP Phone: 516-321-2112 dflores1@northwell.edu

Feinstein Institute/Translational Research Neurology Neuroscience Psychiatry Urology

Haemar Kin, MHA Phone: (516) 321-2117 hkin@northwell.edu

Anesthesiology Dentistry Corporate/Health Services/Outcomes OB-GYN Orthopedic Surgery Pediatrics Pharmacy Surgery

Khadijah Holley, BA Phone: (516) 321-2111 kholley@northwell.edu

Medicine (excluding adult hematology/oncology) Staten Island University Hospital-All Departments Huntington Hospital-All Departments Neurosurgery Ophthalmology

Alison Powell, LAT Phone: (516) 321-2115 apowell6@northwell.edu

Division of Adult Hematology/Oncology Northern Westchester Hospital Phelps Memorial Hospital Pathology/Laboratory Medicine Nursing Population Health

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Does the activity qualify as research with human subjects and does it have to be submitted to the IRB?

No STOP DO NOT SUBMIT

STOP DO NOT SUBMIT

Is the activity a systematic investigation designed to develop

or contribute to generalizable knowledge?

Activity is not research

Yes

The activity is research. Does the research involve obtaining

information about individuals?

Yes

Does the research involve intervention or interaction with

the individuals?

No Activity is not research involving human subjects

No 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)?

Yes

No

Yes

Activity is research involving human subjects. Submit protocol to the IRB.

Examples of studies that do not qualify as human subject research and would therefore not require IRB review and approval: • A review of published literature, publicly

available information, or previously collected data that contains no link or code to subject identity that is breakable by the investigator receiving and utilizing/analyzing the data.

• The analysis/use of discarded or commercially available human tissue where there is no link to subject identity or protected health information.

• The analysis/use of human tissue where there is no link or code to subject identity that is breakable by the investigator receiving and analyzing the tissue.

Developed from Human Subject Decision Charts available at: http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html

For further guidance, click on: FAQs about Research Using Human Specimens, Cell Lines or Data on the Office of Extramural Research website.

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Types of IRB Review If you have determined that your study is human subjects research, there are essentially three types of IRB new study submissions you can apply for:

1) Exempt New Study 2) Expedited New Study 3) Full Board New Study

If you are not sure what type of study you have, the best route is to call the IRB office. You can call or email your case manager directly. Also, you can visit the submission guidance section of the HRPP website: www.feinsteininstitute.org/hrpp/submissions for specific instructions on how to complete each type of submission.

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EXEMPT NEW STUDY 45 CFR 46.101(b) Categories of Exempt Human Subjects Research*

1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:

a. research on regular and special education instructional strategies or b. research on the effectiveness of or the comparison among instructional techniques,

curricula or classroom management methods.

2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

a. information obtained is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects and

b. 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 category # 2 (above) if:

a. the human subjects are elected or appointed public officials or candidates for public office, or

b. 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 the information is recorded by the investigator in such a manner that the 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 (federal) department or agency heads and which are designed to study, evaluate or otherwise examine:

a. public benefit or service programs, b. procedures for obtaining benefits or services under those programs, c. possible changes in or alternatives to those programs or procedures or d. 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, if: a. wholesome foods without additives are consumed or b. 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.

*Important Notes:. • "Existing" means at the time the research is proposed. • These exemptions do not apply to research involving prisoners (45 CFR Part 46 Subpart C). • Exempt, Category 2 does not apply to research with children (45 CFR Part 46 Subpart D) except for research involving educational tests (cognitive, diagnostic, aptitude, achievement) or observations of public behavior when the researcher(s) do not participate in the activities being observed.

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DOCUMENTS REQUIRED FOR EXEMPT RESEARCH STUDIES:

1) IRB Application for Exemption (will serve as the protocol) 2) Any documents that will be given to or presented to subjects 3) If you are doing a data review study, you must also submit a blank data collection sheet 4) If you are doing an educational test, survey, or interview, you will need to submit a copy of this

document, as well as an information sheet that will be provided to the subjects. This information sheet will serve as informed consent. The template can be found online.

Examples of Exempt Category 1: An investigator investigates whether their new PowerPoint presentation on hand sanitizing is better than the standard hand sanitizing education at decreasing the number of hospital related infections. The presentation is done during a nurses training seminar. Category 2: An investigator anonymously surveys patients before and after laparoscopic surgery to determine if their diets have changed because of the surgery. Category 3: An investigator anonymously surveys a senator regarding a concentration of cancer patients in a region with known water pollution. Category 4: An investigator reviews medical charts to determine if hepatitis B is related to tuberculosis. The investigator does not record any of the 18 protected health identifiers. Category 5: An investigator, on behalf of the FDA, examines whether West Nile spraying has an effect on lung conditions in people. Category 6: An investigator examines which flavor of two wholesome and additive-free foods are preferred by patients in the hospital during recovery, An exempt study can consist of multiple exempt categories. Under category 4: If information about patients is being collected from multiple sources, a temporary link is allowed in order to correctly account to whom the information belongs; however, this link must be destroyed immediately after data collection and prior to any data analysis occurring.

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EXPEDITED NEW STUDY: 45 CFR 46.110 Categories of Expedited Human Subjects Research*

(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. (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.)

(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, non-pregnant 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

(b) from other adults and children2, 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. Examples: (a) hair and nail clippings in a non-disfiguring 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.

(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. (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:

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(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.

(5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research 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.

DOCUMENTS REQUIRED FOR EXPEDITED RESEARCH STUDIES:

1) IRB Application for New Study a. Or Application for Chart Review if the intended study is strictly data review

2) Any documents that will be given to or presented to subjects 3) If you are doing a data review study, you must also submit a blank data collection sheet 4) If you are doing an educational test, survey, or interview, you will need to submit a copy of this

document. In addition, you will need to submit an information sheet or formal consent form that will be provided to the subjects.

5) Research Protocol(s) (if doing a data review study, the chart review application will serve as the formal protocol)

6) Consent form or application for waiver of informed consent and HIPAA authorization 7) Any advertising or recruitment materials 8) Appendices may also be required if the study involves: the department of defense, drugs,

devices, cognitively impaired individuals, prisoners, children, pregnant women, fetuses, or neonates.

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FULL BOARD NEW STUDY A submission will require review by the Full Committee of the IRB if

a) The study poses greater than minimal risk to subjects or b) The study is minimal risk but does not fall into an available Expedited category

Studies that qualify for Full Board review are assigned to the next available IRB meeting. The IRB usually meets every Tuesday and Thursday. WHAT WILL HAPPEN AT THE FULL BOARD? The reviewers will be selected according to the specific expertise needed to review the protocol properly. In addition to scientific expertise, consideration will be given to special issues and populations when reviewers are assigned whenever possible (e.g. gender-specific studies will be assigned to at least one reviewer of the gender under study, research involving a special population will be assigned to someone familiar with that population). The entire committee will receive the study documents. After a discussion, the board makes a determination as follows: APPROVAL: Approved as submitted with no modifications required. The approval letter will include the date of approval expiration and any other conditions that apply. CONTINGENT APPROVAL: Protocol requires minor revisions that do not affect the safety of the research subject. The IRB Chair/designee may approve the study upon receipt of the satisfactory revisions without further review by the convened IRB. If no revisions are received by the IRB within 60 days, the protocol will be withdrawn from consideration. DEFERRED/TABLED: Substantive issues regarding the protocol and/or consent form must be addressed. The investigator’s response to initial review requests must be reviewed by the IRB at a convened meeting. If the PI does not respond within 60 days, the protocol will be withdrawn from consideration. DISAPPROVAL: Questions are of such significance that the IRB feels approval of the study to be unwarranted. Review of a previously disapproved protocol that has been revised and resubmitted requires full-board review.

IRB Forms/Documents to Submit for a Full Board Research Study � Electronic Application � Research Protocol(s) � Consent Form (if applicable) � Data Collection Forms (if appropriate) � Survey and/or other research instruments � Any other written information to be provided to subjects � Any advertising or recruitment materials � Investigator’s Brochure (if applicable/study involves investigational drug) � Form FDA 1572 (if investigator initiated study involving an investigational drug) � New study submission may also require the submission of an application appendix.

Please check the HRPP Website for further direction.

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Progress Reports A progress report must be submitted for each non-exempt study in order to obtain approval to continue the study. The continuing review cycle is set to a maximum of 1 year; based on study risks. Along with a completed and signed continuing review application, you must also submit: full copies of the consent forms that were completed/signed by the last two subjects enrolled into the study, any items that you would like to have re-approved for use for another year (i.e. recruitment flyers), and any reports regarding the study (i.e. reports from the data and safety monitoring board).

Modifications A modification is any change to the research study or any of its documents. In order to request a modification, you must submit a completed and signed copy of the application for modification. In addition, you will need to submit track changed copies of the revised documents for review.

Protocol Exceptions A protocol exception is a temporary change to the study. These “exceptions” to the current study must have a justification and not adversely affect the study or place the subject at an increased risk than others that may be enrolled. An example of an exception would be to enroll a patient with vitamin D deficiency in a study that only includes patients with normal vitamin D levels. These must be requested by submitting a completed and signed copy of the application for modification.

Protocol Deviations A protocol deviation is an unapproved divergence from the approved study. Minor deviations can be reported on the renewal application. Major deviations must be reported within days of discovering the occurrence. This can be done by submitting the reportable events form.

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CRITERIA FOR IRB APPROVAL OF RESEARCH 45 CFR 46.111 and 21 CFR 56.111

POINTS TO CONSIDER

RISKS TO SUBJECTS ARE MINIMIZED (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.

• Have the rationale and basis for the study hypothesis been provided in the background information?

• Has the research been preceded by adequate laboratory and/or animal studies? • Are the design of the research and the proposed research procedures adequate to answer the

research questions posed? • Can data from procedures or tests being performed for diagnostic or treatment purposes be

used in lieu of procedures or tests being performed solely for research purposes? • Could procedures that involve less risk be used to answer the research question? • Is the sample size (number of subjects) adequate? • Is the method proposed for selecting and assigning subjects to treatment groups unbiased? • Are the study endpoints and methods of data analysis appropriate for the study?

RISK/BENEFIT RATIO (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.

• What are the anticipated physical, psychological, social, legal, or economic risks to individual subjects?

• What are the potential benefits, if any, to individual subjects? • What information is likely to result from the research and what impact, if any, will the

information have on furthering the understanding of human physiology or diagnosis or treatment of the disease or condition being studied?

• Are there any groups of people who might be more susceptible to the risks presented by the study and who therefore ought to be excluded from the research? Are the procedures for identifying such individuals adequate?

• Are there adequate plans to exclude subjects who are vulnerable to injury during the period of withdrawal of active and effective therapy, if that is part of the research design?

EQUITABLE SELECTION OF SUBJECTS (3) Selection of subjects is equitable.

• Does the nature of the research require or justify using the proposed study population? • Will the solicitation of subjects avoid placing a disproportionate share of the risks and

discomfort as well as inconvenience of the research on any single group of individuals? • Are women of childbearing potential eligible for participation or, if not eligible, has their

exclusion been justified? • Has the selection process overprotected potential subjects who are considered vulnerable so

that they are denied opportunities to participate in research? • Are any payments to subjects reasonable, based upon the complexities and inconveniences of

the study and the particular subject population?

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INFORMED CONSENT PROCESS (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 45 CFR 46.116 and 21 CFR 50.25.

• Who will be explaining the research to potential subjects? Should the principal investigator or physician co-investigators be required to obtain consent? Should someone in addition to or other than the investigator be involved in the consent process (e.g., subject advocate)?

• Does the investigator serve a dual role that may pose a conflict of interest? • Will the consent process take place under conditions most likely to provide potential subjects

an opportunity to make a decision about participation without undue pressure?

DOCUMENTATION OF INFORMED CONSENT (5) Informed consent will be appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117 and 21 CFR 50.27.

• Are the language and presentation of the information to be conveyed appropriate to the subject population, taking into consideration the reading level, use of complex sentence structure and use of technical terms as well as the need for translation into languages other than English?

• Do the consent documents describe the study design (including plans for randomization, use of placebos, and the probability that the subject will receive a given treatment) and conditions for breaking the code (if the study is masked)?

• Do the consent documents describe the risks and benefits of each of the proposed interventions and alternative courses of action available to the participants?

• Do the consent documents clearly describe the extent to which participation in the study precludes other therapeutic interventions?

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

• How will the trial be monitored? Is the plan appropriate given the risks, size, type and complexity of the trial?

• How will decisions about stopping the trial be made? By whom? On what basis?

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

• Do the methods for recruiting and consenting subjects adequately protect their privacy? • Are study related discussions or interviews conducted in a private setting? • If the investigator wants to review existing records to select subjects for further study, are

subjects recruited through their physician or health care provider involved in their care? • Will the investigator(s) be collecting sensitive information about individuals (e.g., related to

sexual practices, substance abuse, or illegal behavior)? If so, have they made adequate provisions for protecting the confidentiality of the data through coding, destruction of identifying information, limiting access to the data, or whatever methods tmay be appropriate to the study?

• If the information obtained about subjects might interest law enforcement or other government agencies to the extent that they might demand personally identifiable information, should a

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certificate of confidentiality be sought from a federal or state agency to protect the research data and the identity of the subjects from subpoena or other legal process?

• Are there adequate plans to protect participants from the risks of breach of confidentiality and invasion of privacy? If the protocol involves an epidemiologic study, will subjects or their relatives be protected from learning inappropriate information?

VULNERABLE POPULATIONS When some or all of the subjects are likely to be vulnerable to coercion or undue influence, NSLIJ employees, students, children, pregnant women, neonates, fetuses, prisoners, cognitively impaired, mentally or physically disabled, considered an individual of Limited English Proficiency, or economically or educationally disadvantaged persons, have additional safeguards been included in the study to protect the rights and welfare of these subjects.

Refer to http://www.feinsteininstitute.org/professionals/resources-for-investigators/human-research-protection-program/forms for more information since the inclusion of some populations may require additional forms.

CLINICAL INVESTIGATIONS OF DRUGS OR BIOLOGICAL PRODUCTS, OR MEDICAL DEVICES

• Is the research being conducted under an IND? If not, is an IND required? (Refer to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=312)

• Is the research being conducted under an IDE? If not, is an IDE required, i.e., is this a significant risk device study or a non-significant risk device study? (Refer to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812)

• Is this being conducted under a sponsor-investigator IND/IDE? If so, refer to http://www.feinsteininstitute.org/professionals/resources-for-investigators/human-research-protection-program/tools-and-guidance/ and contact the IRB office for assistance.