Human Subject Research - Annual Memo

THIS DOCUMENT CONTAINS IMPORTANT REGULATORY AND NEW PROCEDURAL INFORMATION. PLEASE RETAIN FOR FUTURE REFERENCE.

TO:            Members of the University Community

FROM:      Michael E. Breton, Ph.D.
                    Associate Vice President for Research and Sponsored Programs

DATE:        May 22, 2001

RE:             Review of Human Subject Research

CONTENTS
[Clickable Index]

Rutgers Policy
Assurance to OHRP (Federal Authority)
Federal Requirement: Education in the Protection of Human Subjects
Federal Agency Requirements
Categories of IRB Review (as printed in the Federal Register)
    Full Committee Review
    Expedited Review
    Exemption
Rutgers Procedures
    Protocol Submission
    Continuing Review
    Amendments
    Adverse Events
    Student Research Projects
    IRB List-Serve

RUTGERS POLICY

In accordance with Rutgers University policy governing the use of human subjects in research, the Federalwide Assurance (FWA) maintained with the U.S. Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP), all human subjects research conducted by or under the auspices of Rutgers University will be performed in accordance with Title 45 Code of Federal Regulations, Part 46 (45 CFR 46). In addition, the actions of Rutgers University will also conform to all applicable federal, state and local laws and regulations.

All research involving human subjects that is conducted by anyone affiliated with Rutgers (i.e., all faculty, staff, undergraduate, graduate, and postdoctoral students) must be reviewed and approved by the Institutional Review Board for the Protection of Human Subjects in Research (IRB) prior to such studies being undertaken. The IRB is the body at Rutgers charged with reviewing all projects that use human subjects. This policy applies to any work whether new, ongoing, or proposed for funding, whether conducted at the University or elsewhere.

Research is defined in 45 CFR 46 as, "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Human subject is defined in 45 CFR 46 as, "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." Examples of projects that do and do not require submission to the IRB may be reviewed at: http://orsp.rutgers.edu/Humans/irb_exempt.php.

Individuals who plan to conduct research that involves human subjects must complete an Application Form to Request IRB Review of a Research Protocol Involving Human Subjects, which is available on the web, with instructions, at: http://orsp.rutgers.edu/Humans/default.php. In addition, all principal investigators and key personnel must successfully complete the Human Subjects Certification Program (HSCP), and satisfy all applicable agency requirements.

ASSURANCE TO OHRP (FEDERAL AUTHORITY)

Anyone wishing to receive a copy of the Federalwide Assurance should contact the Office of Research and Sponsored Programs (ORSP). The FWA number is FWA00003913 and is required on many grant applications.

FEDERAL REQUIREMENT: EDUCATION IN THE PROTECTION OF HUMAN SUBJECTS

ORSP has developed an education program for all principal investigators and other individuals who are responsible for the design and/or conduct of a research protocol that involves human subjects ("key personnel"). Effective January 1, 2001, successful completion of the Human Subjects Certification Program (HSCP), an on-line WebCT course, has been required for all principal investigators and key personnel named on a protocol. Before a Notice of Approval (Initial, Continuation, or Amendment) or Exemption will be issued, the principal investigator must successfully complete the education program. If the principal investigator has obtained the certification, but key personnel have not, the Notice of Approval or Exemption will be issued with a condition attached that those individuals who have not completed the program may not participate in the conduct of the research until certification is obtained.

In addition, beginning October 1, 2000, NIH has required documentation of education on the protection of human research participants for all investigators submitting NIH applications for grants or proposals for contracts, or receiving new or non-competing awards, for research involving human subjects. Successful completion of the HSCP will satisfy the NIH requirement, and documentation will be provided by ORSP upon request. NIH requires a specific letter that identifies the protocol, states the names of the principal investigator and all key personnel, and indicates the date that each completed education in the protection of human subjects in research. A one sentence description of the education program must be included, and the letter must be countersigned by the institutional official and the principal investigator. NIH will not accept individual letters of certification for the principal investigator and key personnel.

More information about the education program, including procedures to obtain access information, is available at: http://orsp.rutgers.edu/Humans/default.php

FEDERAL AGENCY REQUIREMENTS

In order to provide verification to NIH or other funding agencies, the IRB must verify that the procedures in a proposal are in fact covered by an active approved protocol. Submission of a grant application is required and should be submitted, whenever possible, contemporaneously with the protocol.

Under the terms of NIH Policy #OD-00-031 dated May 1, 2000, IRB approval is not required prior to NIH peer review of most applications. Following NIH peer review and notification of priority score/percentile, IRB review should proceed for those applications that have not yet received IRB approval and that appear to be in a fundable range. The IRB Notice of Approval will then be forwarded to NIH, in accordance with Just-In-Time procedures.

There may be times when IRB approval may be necessary before submission of an application to NIH; for example, when there is a particularly tight time line for an RFA, or when end-of-fiscal-year requirements dictate earlier IRB review and approval. IRB continuing review of NIH-funded protocols should occur prior to the submission of noncompeting continuation applications, so that the notice of approval may be submitted contemporaneously with the continuation application. Federal policy stipulates that no grant award may be made without IRB approval. Therefore, in order to avoid problems and unnecessary delays, protocols may be reviewed and approved prior to the submission of grant applications.

Procedures described in a grant application that involves human subjects research must be approved in one or more human subjects protocols. While an approved protocol may cover one or more grants, all procedures in a grant application must be described in a current approved protocol before the University can attest that the proposal is approved.

CATEGORIES OF IRB REVIEW (AS PRINTED IN THE FEDERAL REGISTER)

There are three types of IRB review. The principal investigator is responsible for making the initial determination of the type of review that a protocol requires, and requesting such review on the Application Form to Request IRB Review of a Research Protocol Involving Human Subjects.

A.  Full Committee Review

All proposals that do not qualify for expedited review or exemption (criteria specified below) will be reviewed at a convened meeting of the full membership of the IRB.

B.  Expedited Review

Research activities that present no more than minimal risk to human subjects, and involve only procedures listed in one or more of the following categories, may be reviewed by the IRB Chair or one or more experienced IRB reviewers designated by the Chair through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are noted on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

Applicability:

a.  The categories in this list apply regardless of the age of subjects, except as noted.

b. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or  civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

c. The expedited review procedure may not be used for classified research involving human subjects.

d. The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review either expedited or convened, utilized by the IRB.

e. Categories one through seven pertain to both initial and continuing IRB review.

The categories of research that may be reviewed by the Institutional Review Board (IRB) through an expedited review procedure are as follows:

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, 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
   (b) 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. NOTE: Children are defined in the DHHS regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." 45 CFR 46.402(a).
   
   
3. 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.
   
   
4. Collection of data through non-invasive 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. For example: (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 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.
   
   
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.
   NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects 45CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.
   
   
8. Continuing review of research previously approved by the convened IRB as follows: (a) 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 (b) where no subjects have been enrolled and no additional risks have been identified; or (c) 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.

C.  Exemption

Research activities in which the only involvement of human subjects is in one or more of the categories listed below, and present no more than minimal risk to subjects, may qualify for a claim of Exemption from full IRB review.

In order to fulfill the federal requirement for the proper review of research, investigators cannot "self exempt" from IRB review. Nor does a claim of exemption necessarily exempt investigators from the requirement of gaining written informed consent from subjects. The following exempt categories do not apply to research involving:

a.  deception of subjects where the investigator does not describe the true purpose of the research and /or the results of the subjects participation in the study;

b.  sensitive behavioral research, or research involving pregnant women, in vitro fertilization, prisoners, the mentally disabled, or other vulnerable populations.

Individuals who plan to initiate studies involving human subjects in one or more of the six exempt categories described in the Federal Regulations must submit an Application Form to Request IRB Review of a Research Protocol Involving Human Subjects, along with appropriate documentation, prior to the start of the project. An IRB subcommittee will determine whether or not a given project needs to be reviewed on a continuing basis; however, the IRB may ask to reconsider a protocol if it deems it necessary. When this happens, the investigator will be asked to provide additional information for IRB review, and the full Board will determine whether the initial exempt ruling should be reversed. It is also an investigator's responsibility to report to the IRB any changes in an exempt protocol. The IRB subcommittee will review the changes and rule on the continuing exempt status of such projects.

Applications for IRB Review of a Research Protocol Involving Human Subjects that request exemption are reviewed as they are received, however, those unsure of whether their projects will qualify for an exemption are advised to adhere to the deadline schedule set forth in this memorandum. Then, if an exemption request is denied, the project can be referred to the full IRB in a more timely fashion. The categories of potential exemption are as follows:

1. Research may be exempt if it is conducted in an established or commonly accepted educational setting and involves normal educational practices such as research on regular and special education instructional strategies or 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 may be exempt, unless the information obtained is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects, and 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. NOTE: This exemption does not apply to research with children except for research involving observation of public behavior where the investigator does not participate in the activities being observed.
   
   
3. Research involving the use of education tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that would not exempt under paragraph (2) may be exempt if the human subjects are elected or appointed public officials or candidates for public office, or 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 previously existing data, documents, records, pathological specimens, or diagnostic specimens may be exempt if they are being obtained from publicly available sources 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. NOTE: If the records involved are those of Rutgers students, the project is not exempt and must be reviewed by the IRB. Such research must conform with the Family Education Rights and Privacy Act of 1974, a copy of which may be obtained from the Assistant Director, Research Subjects Administration.
   
   
5. Research and demonstration projects may be exempt if they are conducted by or subject to the approval of Federal department or agency heads, and are designed to study, evaluate, or otherwise examine public 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.
   
   
6. Taste and food quality evaluation and consumer acceptance studies may be exempt if wholesome foods without additives are consumed or a food is consumed that contains a food ingredient at or below the level and for a use 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.

 

RUTGERS PROCEDURES

A.  Protocol Submission

The Application Form to Request Review of a Research Project Involving Human Subjects has been revised and is available in hard copy or on the web at: http://orsp.rutgers.edu/Humans/default.php. Requests for exemption, expedited review, and full panel review must all be submitted on the revised forms. PI's are required to download the latest application form from the website, instead of using outdated forms provided to them by their department or colleagues .

When submitting a protocol for review, a total of 5 copies (the original and 4 additional copies) are required. A total of 5 copies of all supporting documentation is also required.

The deadline for submission of a human subjects (full committee, expedited or amendment) is the 12^th of the month. Protocols submitted by the 12^th of the month will be reviewed at the next month's meeting. For example, protocols submitted on November 12 will be reviewed at the December meeting.

There is no meeting in August. Any change in this schedule will be announced on the human subjects website and through GrantNet.

Exemption reviews are done on a rolling basis. Therefore there is no specific date for exemption.

All materials are to be sent to the Institutional Review Board for the Protection of Human Subjects in Research, Office of Research and Sponsored Programs, ASB III, 3 Rutgers Plaza, New Brunswick, N.J. 08901. Questions can be directed to the IRB Administrator, at 732-932-0150 or by email to: gibel@orsp.rutgers.edu.

B.  Continuing Review

Federal regulations do not allow the IRB to approve a study for more than one year. For multi-year research the principal investigator is responsible for submitting a continuation application one month prior to the expiration of the current IRB approval. Continuing review forms are mailed a few months prior to the expiration date of the current approval period. If the continuation form is not received in a timely manner, the protocol will administratively be made inactive. Continuing review and approval is still necessary if recruitment of subjects stops, but previously enrolled subjects continue to participate in the research, or if the study is in the data analysis phase.

C. Amendments

If a significant change from a previously approved protocol is to be made an amendment must be submitted for review. There is no set form for this procedure. Investigators should reference the original protocol form as a guide to the type of information required when submitting an amendment.

D.  Adverse Events

The Institutional Review Board for the Protection of Human Subjects in Research (IRB) has approved the use of a new form to report adverse and/or unexpected events that are experienced by human subjects in research protocols. This is a routine reporting procedure that is required by the federal Office of Human Research Protections (OHRP) for use by investigators in the event that one or more of their subjects experiences an unanticipated event that involves increased risk to themselves or others, while enrolled in a research study. Federal policy [45 CFR 46] includes adverse event reporting as a component of mandatory continuing review of approved protocols, with the stipulation that serious adverse events be reported immediately if they occur. The Adverse/Unexpected Event form may be downloaded from the web at: http://orsp.rutgers.edu/Humans/downloads/Adverse/hs_adverse.doc.

An important new policy which will help assure the protection of human subjects involved in research protocols conducted by Rutgers University students was instituted in May, 2000. All academic programs (e.g. undergraduate honors programs, graduate dissertation programs, special problems courses) that include research involving human subjects require each student's written certification that approval from the IRB has been obtained for their research project and that approval was granted prior to the initiation of the research. In addition, each report and/or dissertation that is based on human subject research is required to carry a citation of the approved IRB protocol title and number.

The IRB strongly recommends that honors programs and graduate programs incorporate into their honors projects/dissertations a certification form related to the use of human subjects. The form should ask if human subjects will be used in the project, and state that the work may not start until the IRB has issued the Notice of Approval, or Exemption. The final project must cite the human subjects protocol number.

In the case of a student course-related research project assignment, it may be difficult at times to draw the line between that which would require either an IRB or exemption review, and that which is designed simply to provide an experience in research methodology. In an effort to clarify the matter, the IRB has established the following guidelines for determining when institutional review and approval is necessary for projects that are part of an academic course:

1.  Student projects that are solely classroom directed exercise that [i] take place in a Rutgers University classroom, departmental, dormitory, or other (Rutgers University) campus setting, or in a public setting with generally unlimited access to the public, such as a shopping center, park, or street, and [ii] involve only the learning of research techniques. Such projects should not put the subjects at more than minimal risk, and the data must be recorded anonymously by the students (i.e., with no names, social security numbers, or any other codes that can be linked to a list of names). These projects shall be deemed to be "classroom exercises" and are not subject to review by the IRB.

2.  Student projects qualifying under one or more of the six federally allowed exempt categories, but not suited to item 1 above. As an example, all of the students' projects might involve interview procedures in which data is collected anonymously (i.e., with no names, social security numbers, or any other codes that can be liked to a list of names) or otherwise qualifying under exemption category 2 of the Federal Regulations. Requests for granting this type of exemption must be received at the IRB office not later than September 12 for the Fall term or February 12 for the Spring term. The request for exemption should be submitted at least a month before the students will begin their projects. For the purposes of this guideline, an exemption request form should be completed by the course instructor, and all of the student projects, qualifying as exempt shall be aggregated as "one classroom project." Exemption requests are considered and acted upon by a subcommittee of the IRB.

3.  All non-exempt student research projects must be submitted for full IRB review. A faculty member may choose to have the students design and conduct individual projects that do not qualify under an exemption category. All requests for review of non-exempt projects that are to be completed during the Fall semester must be submitted by September 12 for consideration at the October IRB meeting. For non-exempt projects to be completed during the Spring semester, the requests for review must be submitted to the IRB no later than February 12 for review at the March IRB meeting. In the case of a two-semester course, the students should submit their requests for review at least a month before they wish to start their data collection. It shall be the responsibility of faculty members to familiarize themselves with the Rutgers regulations for approval of these projects, to review and, if necessary, to assist students in the modification of each project before it is submitted to the IRB office. The IRB is aware that, if approval of student projects is not obtained according to the above schedule must be submitted by February 12, it may not be possible for the projects to be completed in a timely manner, and will provide consultation to the extent that its resources allow.

NOTE: Student research as described in categories 2 and 3 do not meet the definition of research (45 CFR 46), as strictly interpreted, because there is no intent, at the time of submission of the protocol, to disseminate the results (i.e., develop or contribute to generalizable knowledge). Nonetheless, IRB policy is to review these types of student research, which incorporate all of the elements of protocol design utilized by more experienced researchers. In fact, there exists the possibility that the protocol may be so well-designed and orchestrated, and yield such significant results, that general conclusions may be drawn from analysis of the data. The IRB has resolved that the competency level of the researcher should not remove the protocol from the purview of the IRB, in essence due to lack of intent to disseminate results, and therefore requires review of all student research projects that do not meet the criteria of category 1 described above.

Students submitting a protocol must have a faculty sponsor. The faculty sponsor must certify that the student is knowledgeable about the regulations and policies governing research with human subjects and has sufficient training and experience to conduct the particular study.

F.  IRB List-Serve

Upon submission of a protocol to the IRB, the principal investigator and all key personnel named in the protocol will be added to the IRB list-serve of email addresses, and a welcome message will be sent to each individual. The IRB list-serve is utilized as a means of direct communication between the IRB and research personnel, including transmission of the periodic Rutgers University IRB Newsletter. The newsletter keeps researchers at Rutgers abreast of changes in IRB or federal policies, forms, and procedures.

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