Institutional Review Board

Conducting Research  |  Researcher Guidance and Scientific Review

A. Roles and Responsibilities

1. Investigators as Study Participants

Investigators who wish to become involved as research participants in their own experimental projects should consider themselves to be "test subjects" or "study participants". The IRB is authorized to review and approve investigator participation. Such review must occur before research procedures begin in a IRB-approved study. There are two reasons for the required IRB review of proposed self-experimentation:

Protection of investigators and staff from taking unwarranted risks in the excitement of generating new knowledge. Under these circumstances, investigators are enthused about the prospect of new knowledge and concern for any associated risk may be minimized or escape attention

Protection of the process of human investigation in an era when the process has articulate critics

The requirement for IRB review may be viewed as a limitation of person freedom, but the IRB believes that its is most important to protect both individuals and research investigations

2. Principal Investigators

Responsibilities for Research

The Principal Investigator (PI) is ultimately responsible for all aspects of conducting the research study, including the supervising of all staff to whom study responsibilities are delegated (e.g. research coordinators). While the PI may delegate responsibilities as appropriate, the PI is responsible for ensuring that all research activities are executed properly.

The PI must be qualified by education and training in the area in which the research is being conducted. The PI must be familiar with the protocol and hardware being tested and must also comply with the applicable regulatory requirements: Code of Federal Regulations, FDA Good Clinical Practice, and institutional policies and guidelines.

Code of Federal Regulations (CFR) FDA Good Clinical Practice

Responsibilities for Safety and Welfare of Research Subjects

Conduct the study in an ethical manner, including protecting the rights and welfare of human participants who are involved in the research protocol;

Report any correspondence to or from a regulatory agency regarding matters of regulatory compliance (audit findings) to the IRB;

Respond to participants' complaints/concerns or requests for information and reporting to the IRB any significant participant complaints/concerns;

Designing and carrying out the research study with adequate data and safety monitoring when appropriate

Data and Safety Monitoring Plan

Responsibilities for Training and Supervising Staff

Ensure that all participating research staff observe pertinent regulations and institutional policies and guidelines;

Ensure that key personnel performing the study are qualified, appropriately trained and adhere to the provisions of the IRB-approved protocol

Responsibilities for Adherence to Regulatory and IRB Requirements and Guidance

Complete CITI training (valid for a period of 3 years), and be sure to select NASA as the Institution. Save a copy and attach it to your Board Review Application.

Collaborative Institutional Training Initiative

Ensure that all research involving human subjects receives IRB review and approval before commencement of the research, including screening or recruitment;

Seek IRB guidance when in doubt about whether proposed research requires IRB review;

Comply with all IRB decisions, conditions, and requirements;

Obtain IRB review and approval before changes are made to approved protocols or consent forms;

Review Process - Conditions of Approval

Ensure that no test subject is involved in the research prior to obtaining his or her consent;

Ensure the adequacy of the informed consent process;

Ensure that protocols receive at least yearly continuing IRB review and approval;

Provide financial disclosure information or any other potential conflicts of interest that might affect the relationship with the research subject or the outcome of the research.

3. Research Coordinators

Responsibilities for Research

The Research Coordinator (RC) works with and under the direction of the PI. Although the PI is legally responsible for all aspects of the research study, the RC often handles the bulk of the daily study activities and plays a key role in the study conduct and management. The RC is frequently responsible for organizing the documentation and files pertaining to a study and for coordinating the activities of the investigators and the test subjects.

Responsibilities for the Rights and Welfare of Research Subjects

Understand the regulatory, institutional, and protocol requirements for the study;

Complete CITI training (valid for a period of 3 years);

Collaborative Institutional Training Initiative

Comply with all IRB decisions, conditions, and requirements;

Capture and report adverse events to the PI and the IRB;

Reporting Adverse Events

Make sure that all studies have current IRB approval before any study is initiated, continued beyond the period of initial approval (usually one year), or modified in any way.

Responsibilities for Documents and Protocol Implementation

Review the protocol and other materials (e.g. brochure, data collection forms and sample consent forms) for practical procedures, safety issues, and establishment of a study budget;

Prepare documents for submission to the IRB;

Review test subject eligibility requirements;

Train all personnel involved in the study;

Assess logistical requirements and resources necessary to conduct the study;

Set up and organize study files;

Collaborate with other areas (laboratory, pharmacy, etc.) as indicated;

Collect the documents needed to initiate the study.

Responsibilities for Participating in the Informed Consent Process

Write consent forms according to IRB Guidelines;

Conduct the informed consent process with the potential participant and include the following:

Discuss all aspects of the study;

Review the consent form with the potential study subject;

Answer questions and assess potential study participant's comprehension;

Ensure that all necessary signatures and dates are on the informed consent forms;

Document, distribute, and file signed informed consent forms appropriately;

Ensure that all amended consent forms are appropriately implemented and signed;

Ensure that the consent process is ongoing and continues throughout the duration of the study.

Responsibilities for Managing Study

Recruit and screen potential participants;

Ensure adherence to the study inclusion/exclusion criteria;

Schedule and manage test subject visits (e.g. ensure that all appropriate study procedures are done and documented);

Manage laboratory procedures (draw samples if appropriate, process, package, and ship samples);

Review form entries for completeness and correctness;

Review forms and source documents for adverse events.

4. Study Team Members

All study team members who conduct human subjects research must be listed on the IRB application and approved by the IRB before the team member may conduct study procedures.

Data analysts who have access to Personal Health Information (PHI) need to be added to the study team and complete CITI training. If PHI is removed from the data set, the data analysts or biostatistician does not need to be listed as a study team member.

5. Changing the Principal Investigator or Co-Investigator

Major vs. minor:

A change of PI is a minor modification if the new PI has a background, resources, and privileges that are equivalent to the original PI's;

A change of PI is a major modification in a study if it significantly changes the expertise or resources available to the study or requires other major changes in the conduct of the study.

A change of PI in an expedited study is a minor modification.

A letter signed by the outgoing PI requesting the change in PI must accompany the modification request.

Revised versions of consent forms, and any other participant-contact documents naming the PI or Co-I should be submitted for review.

A revised Disclosure of Investigators' Financial Interest should be submitted if needed.

B. Scientific Review of Human Research Protocols

1. Introduction

A science merit review should be conducted prior to submission of the research protocol to the IRB. Protocols that have not previously received a science merit review may be rejected for IRB review, depending on the particular circumstances, and at the discretion of the IRB chair or other IRB members as assigned by the chair. Science merit reviews help assure the quality of the IRB submission and processes (including IRB members’ decisions about “risk versus benefit”), and reduce turnaround time for review and approval. Because the results of science merit reviews need to be communicated to the IRB, the IRB requires that one copy of any related documentation be included with the IRB application. Moreover any protocol that is submitted without evidence for an earlier science merit review must include a detailed explanation regarding why that review is lacking.

2. Regulatory Criteria 45 CFR 46.111

The regulatory rationale for requiring science merit reviews emanates from 45 CFR 46.111(a)(1) as follows:

Risks to participants are minimized by using procedures consistent with sound research design and which do not unnecessarily expose participants to risk.

Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result.

3. Review Options

Protocol Classification

Non-NASA entity ( DoE, DoD, NIH, NSF, JAXA, ESA, etc.): Appropriate if the submission requests IRB evaluation of a protocol for human research sponsored by an International Partner or non-NASA US governmental agency where funds are not awarded through a NASA mechanism. (Examples of international partners include ESA, JAXA, RSA, CSA etc. Examples of non-NASA US governmental agencies include DoD, DoE, NIH, NSF etc.)

Human in the loop testing & hardware evaluation: Appropriate if the submission requests IRB evaluation of a protocol for human-in-the-loop testing. (Human-in-the-loop testing is defined as testing of hardware/software that requires the participation of a human subject to evaluate the hardware/software. Such activities are not designed to address research questions about the human subject, rather participation of the human subject is necessary to evaluate the hardware/software under test.)

Operational laboratory protocol: Appropriate if the submission requests IRB evaluation of an activity that requires the participation of a human to train equipment operators, develop testing protocols or demonstrate equipment to laboratory visitors. Operational laboratory protocols are not used to gather data for human research studies. An example of an operational laboratory protocol includes demonstration of exercise equipment for VIP visitors to a laboratory.

ISS, analog, or shuttle complement, data sharing: Appropriate if the submission is intended as an informational briefing or a flight/analog complement presentation or data sharing plan. (Flight/analog complements are composed of individual studies having previously received IRB approval. Informational briefings and complement presentations do not seek evaluation/approval of an experimental protocol. Data sharing plans are developed for an experiment or cohort of experiments that have previously received IRB approval. A data sharing plan does not seek approval for a new experimental protocol. Signed data sharing plans are maintained by ISSMP.)

View information related to the Overview, Process, and Example of Increment 27-28 HRMRB Package

Human research by NASA, other than HRP entity: Appropriate if the submission requests IRB evaluation of a protocol for human research sponsored by a NASA mechanism outside of HRP.

NASA Human Research Program: NASA/NSBRI solicited (NRA-SBIR-Open Innovation): Appropriate if the submission requests IRB evaluation of a protocol for human research sponsored through HRP or NSBRI and funded by an NRA, SBIR or Open Innovation funding mechanism.

NASA Human Research Program: unsolicited (directed research task): Appropriate if the submission requests IRB evaluation of a protocol for a research project sponsored through HRP and funded by an unsolicited proposal, request for proposal or directed task funding mechanism?

Other: Appropriate when none of the mechanisms described in 1-7 above apply. Requires an explanation that will be utilized by SMO Merit Review Coordinator when evaluating the proposal.

The following guidelines provide questions to consider when reviewing for scientific merit. Not all questions are relevant for every study and there may be additional questions to ask for any given study.

Sound scientific basis and rationale: Is the protocol scientifically sound and based on well-established scientific principles? Is there convincing clinical evidence that the study will have valuable results? Is the technology/understanding sufficiently advanced to warrant detailed clinical study?

Appropriateness of the Proposed Study Design: Are the primary objectives scientifically sound? Is the study designed to meet the objectives? Are the sample sizes appropriate? Is the statistical design appropriate? Are the endpoints clearly defined?

Adequacy of Proposed Resources: Does the investigative team bring sufficient expertise to the project? Is there sufficient access to resources (e.g., appropriate personnel, equipment, facilities) for the successful and safe conduct of this study?

4. References

NASA Procedural Requirement (NPR) 1080.1A, Requirements for the Conduct on NASA Research and Technology (R&T)

http://nodis3.gsfc.nasa.gov/displayDir.cfm?t=NPR&c=1080&s=1A

HRP Science Management Plan, Revision C (HRP-47053):

http://stic.jsc.nasa.gov/dbase/dis/jsc/hrp-47053_revc.pdf

C. Space Act Agreement

Objectives of Aeronautical and Space Activities: The aeronautical and space activities of the United States shall be conducted so as to contribute materially to one or more of the following objectives:

The expansion of human knowledge of the Earth and of phenomena in the atmosphere and space.

The improvement of the usefulness, performance, speed, safety, and efficiency of aeronautical and space vehicles.

The development and operation of vehicles capable of carrying instruments, equipment, supplies, and living organisms through space.

The establishment of long-range studies of the potential benefits to be gained from, the opportunities for, and the problems involved in the utilization of aeronautical and space activities for peaceful and scientific purposes.

The preservation of the role of the United States as a leader in aeronautical and space science and technology and in the application thereof to the conduct of peaceful activities within and outside the atmosphere.

The making available to agencies directly concerned with national defense of discoveries that have military value or significance, and the furnishing by such agencies, to the civilian agency established to direct and control nonmilitary aeronautical and space activities, of information as to discoveries which have value or significance to that agency.

Cooperation by the United States with other nations and groups of nations in work done pursuance to this chapter and in the peaceful application of the results thereof.

The most effective utilization of the scientific and engineering resources of the United States, with close cooperation w\among all interested agencies of the United States in order to avoid unnecessary duplication of effort, facilities, and equipment.

The preservation of the United States preeminent position in aeronautics and space through research and technology development related to associated manufacturing processes.

http://www.nasa.gov/offices/ogc/about/space_act1.html#FUNCTIONS