Princeton HRPP Operations
The mission of the HRPP is:
- To safeguard and promote the health and welfare of human research subjects by ensuring that their rights, safety and well-being are protected;
- To provide timely and high quality education, review and monitoring of human research projects; and
- To facilitate excellence in human subjects research.
The HRPP includes mechanisms to:
- Establish a formal process to monitor, evaluate and continually improve the protection of human research participants.
- Exercise oversight of research protection.
- Provide guidance and educational tools to the research community.
- Educate investigators and research staff about their ethical responsibility to protect research participants.
- When appropriate, intervene in research and respond directly to concerns of research participants.
Human Research Protections Program Administration
Administrative responsibilities for the HRPP fall into three general areas:
- IRB Communication & Education
- Record keeping & Reporting
- Monitoring & Oversight
Communication & Education Responsibilities
Promoting communication among the research administrators, department heads, investigators, human subjects, and institutional officials ensure that we maintain a high level of awareness regarding the ethical conduct of research and safeguards the rights and welfare of subjects.
We maintain access to the institution's Assurance; copies of pertinent Federal regulations, policies, and guidelines related to the involvement of human subjects in research; and institutional policies and procedures.
The HRPP education program is designed to ensure that the members of our research community help to establish and maintain a culture that is consistent with Federal regulations and institutional policies relevant to the protection of human subjects.
Our program provides researchers working with human subjects, or their personal identifiable data with resources to help them understand the ethical principles which guide such research, the importance of the informed consent process, and the mechanics of institutional review board (IRB) review of research protocols.
Record Keeping & Reporting Responsibilities
The Princeton IRB ensures that records are being maintained per HHS regulations and that those records are accessible, upon request, to authorized HHS officials.
Princeton’s HRPP maintains responsibility for ensuring certification of IRB approval of proposed research to the appropriate HHS agency for HHS-conducted or supported research.
The IRB ensures that changes in approved research, during the period for which IRB approval has already been given, are not initiated without IRB review and approval, except when necessary to eliminate apparent, immediate hazards to the subject.
Ensure prompt reporting to the IRB of all proposed changes in a research activity.
Ensure the prompt reporting to the IRB, appropriate institutional officials, OHRP, and any sponsoring Federal department or agency head of:
· any unanticipated problems involving risks to subjects or others;
· any serious or continuing noncompliance with the regulations or requirements of the IRB, and
· any suspension or termination of IRB approval for research.
Monitoring & Oversight Responsibilities
Appropriate oversight mechanisms and the development of a new program have been implemented to maintain compliance with the determinations of the IRB and to demonstrate our commitment to the improvement of the quality, efficiency, and integrity of our research activities.
The IRB ensures that all cooperating performance sites in HHS-conducted or supported research conducted primarily under the direction of Princeton University have appropriate OHRP-approved assurances and provide certifications of IRB approval to the appropriate federal authorities, when applicable.
Cooperative IRB review arrangements are documented in writing, in accordance with OHRP guidance.
All independent investigators that rely on the Princeton’s IRB have documented, in accordance with OHRP guidance, their commitment to the institution's human subjects protections requirements and to the IRB's determinations.
Institutional Review Board Responsibilities
Princeton University has one IRB which takes very seriously the review process, the cornerstone of the institution's program for the protection of human subjects. The IRB is responsible for ensuring that the rights and welfare of the subjects are adequately protected.
The IRB has the authority to approve, require modifications in to secure approval, or disapprove all research activities covered by the HHS regulations, including proposed changes in ongoing, previously approved, human subjects research. To suspend or terminate the approval of ongoing, previously approved research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected, serious harm to subjects.
The research community along with the IRB plays an important role with shared responsibility for becoming familiar with the requirements of the Federal regulations, applicable state law, the institution's Assurance, and institutional policies and procedures for the protection of human subjects.
Princeton’s distinguished IRB members bring to the committee expertise in a wide variety of disciplines which helps ensure effective and adequate knowledge of subject populations and other factors that can foreseeably contribute to a determination of risks and benefits to subjects and subjects' informed consent.
· abe to judge the adequacy and accuracy of information in the informed consent document, advertising, and any other materials to be presented to subjects.
· regularly reviews research that involves a vulnerable category of subjects such as children, prisoners, pregnant women, or handicapped or disabled persons, and it’s membership does include individuals who are knowledgeable about and experienced in working with these subjects.
· has the professional competence necessary to review the specific research activities presented for approval.
· in its discretion, the IRB may invite individuals with competence in special areas to assist in the review of issues, which require expertise beyond, or in addition to, that available on the IRB.
Review of Performance Sites
The IRB roster submitted to OHRP should include members knowledgeable about any other institution for which the IRB regularly conducts reviews, when applicable. For performance sites that the IRB does not regularly conduct reviews, the IRB must obtain effective input on the local research context from knowledgeable persons other than those conducting the research.
The Princeton IRB provides the investigators and the institution with written notification of decisions to approve or disapprove research and of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, the written notification includes reasons for the decision and gives the investigator an opportunity to respond in person or in writing, as appropriate.
Criteria for IRB approval of research:
· risks to subjects are minimized by using procedures which are consistent with sound research design and do not unnecessarily expose subjects to risks, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
· risks to subjects are reasonable in relation to anticipated benefits, if any, to the 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;
· 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;
· informed consent will be sought from each subject or the subject's legally authorized representative; informed consent will be appropriately documented, in accordance with, and to the extent required by the HHS regulations.
· the research plan makes adequate provision for monitoring the data collected to ensure subject safety;
· there are adequate provisions to protect the privacy of the subjects and confidentiality of data;
· when some of all of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards are included to protect the rights and welfare of these subjects.
All criteria for approval above must be satisfactorily met before human subjects research may be approved by the IRB.
HHS regulations allow some categories of minimal risk research to be reviewed by the IRB through an expedited review procedure. Expedited review may be carried out by the IRB chairperson or by one or more experienced IRB members designated by the chairperson. All of the requirements for IRB approval of research mentioned above apply to expedited review. Expedited review should not be viewed as a less rigorous review. Under expedited review, the reviewers may exercise all of the authorities of the IRB, except that the reviewers may not disapprove the research.
Expedited review procedures may be used for:
1. research appearing in the published list of eligible research, per HHS regulations, and found by the reviewer to involve no more than minimal risk.
2. minor changes in previously approved research during the authorized approval period.
Expedited Research Categories
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.
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 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.)
(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.
: 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.)
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.
The Princeton IRB observes the following requirements for convened meetings:
A majority of the members of the IRB must be present including at least one member whose primary concerns are in non-scientific areas. If the required number and type of members is lost during a meeting, no action may be taken until a quorum is restored. In order for research to be approved, it must receive the approval of a majority of those members present at the meeting.
Scheduled meetings of the IRB occur at intervals appropriate to the level of reviewed research and with sufficient frequency so that the IRB can adequately oversee the progress of the research it has approved.
Convened meetings may be conducted by telephone conference call, provided that each participating IRB member has received all pertinent material prior to the meeting and can actively and equally participate in the discussion of all protocols.
Minutes of such meetings must clearly document which members were present via conference call and that the criteria for a member's participation via conference call have been satisfied.
Minutes of IRB meetings include:
· a list of attendees at the meeting;
· actions taken by the IRB;
· the vote on these actions, including the number of members voting for, against, and abstaining;
· the basis for requiring changes in or disapproving research;
· a written summary of the discussion of controverted issues and their resolution.
IRB Record Keeping
The IRB prepares and maintains adequate documentation of IRB activities, including the following:
Copies of all research proposals reviewed; scientific evaluations, if any, that accompany the proposals; approved sample consent documents; progress reports submitted by investigators; and reports of injuries to subjects.
· Minutes of IRB meetings.
· Records of continuing review activities.
· Copies of all correspondence between the IRB and the investigators;
· A list of IRB members.
· Written procedures for the IRB.
· Statements of significant new findings provided to subjects, when appropriate.
The IRB must conduct continuing review of ongoing approved research at intervals appropriate to the degree of risk, but not less than once per year. For approved research, the IRB determines which activities require continuing review more frequently than every 12 months. Continuing IRB reviews are preceded by receipt of appropriate progress reports from the investigator, including any additional relevant documents or findings. Continuing review must be substantive and meaningful.
Relying on Another IRB
In such cases where the an institution is engaged in research and the Princeton IRB is not the IRB of record, Princeton may rely on another IRB and has the following responsibilities:
· To ensure that the reviewing IRB is in compliance with the requirements in the Federal regulations;
· To ensure that the particular characteristics of the institution's local research context are considered, either through knowledge of its local context by the reviewing IRB; or through subsequent review by appropriate designated institutional officials.