Institutional Review Board

Preparing for Research  |  User Guide to Application Process

A.Overview of the NASA IRB Application Process

1.General Instructions

NASA IRB Review is required if all three questions below are affirmative:

1.   Is the study research, i.e. a systematic investigation designed to contribute to generalizable knowledge?

2.   Does the study involve human subjects (including studying identifiable human biological specimens, medical records and/or other private information)?

3.   Is the study being performed by NASA personnel or does it access NASA facilities or subjects?

If it is uncertain whether the project or activity requires NASA IRB review or a “not human research” determination is required, please complete the following:

Project Description-NHR determination

Please note that human research protocols require a scientific peer review prior to submission to the NASA IRB that includes evidence of approval (e.g., e-mail correspondence, award letter). Proposals generated in response to a NASA Research Announcement (NRA) or an Announcement of Opportunity (AO), etc. must follow the schedule imposed by NASA Headquarters and the NASA IRB review schedule.

2.Exempt Reviews

Certain human subject research activities can be exempted from the Common Rule (45 CFR 46) regulatory requirements and the allowed categories are found at 45 CFR 46.104.

To be considered for an exemption, a new protocol submission must be entered into e-IRB. Any changes to an exempted protocol must be submitted in e-IRB for review.

Upon the revision of the Common Rule, changes to the exemption categories were made therefore, beginning on January 21, 2019, the NASA IRB will apply the new exemption categories to new protocols seeking an exemption.

3.Expedited Reviews

The NASA IRB is allowed by 45 CFR 46.110 to review human subject research by expedited procedures.

An NASA IRB review done by expedited procedure means that the review was conducted by the NASA IRB chairperson or by his/her designee.

Categories of research that may undergo an expedited review procedure:

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html#footnote1

4.Letter of Support/Endorsement

The NASA IRB may request letters of support from a NASA division chief, program leader, or science management office that they have assessed the scientific merit, weighed the priority of the proposed research in light of the existing portfolio of approved studies, and affirmed the potential to meet accrual goals. The endorsement may address the following items:

Provide assurance that the proposed research fits within the mission and focus of the program;

Updated endorsement in conjunction with an amendment that proposes significant changes to the study design, e.g. adding a participant population or significantly changing the objectives of the study.

The NASA IRB may request letters of support from an authorized official of a non-NASA institution involved in a study (Off-Site Research), especially if they are involved with study procedures or subject recruitment, indicating knowledge and endorsement of the project. The endorsement may address the following items:

Agreement by the institution’s administration for the study to be conducted at that site;

Review of the project by someone at the other institution for appropriateness for its human subject population, and adequacy of the facility to perform the procedures as approved by the NASA IRB;

Written confirmation that the facility personnel have the appropriate expertise to carry out the research procedures;

Assurance the personnel from the facility have appropriate training in human subjects protection.

The NASA IRB may request letters of support from an investigator from a non-NASA institution on the facility’s letterhead stationery he/she has reviewed the proposed research and fully supports the study.

5.Financial Conflicts: Key Personnel Disclosure of Financial Conflicts of Interest (COIs)

a.Disclosure

Key Personnel shall provide a signed NASA IRB Financial Disclosure for Investigators upon initial submission and annually thereafter. HRP-055-SOP_Research Team COI_v.2_19Aug2020 further describes NASA IRB policy and procedures for disclosure and management of researcher conflicts.

In addition to completion of the Financial Disclosure for Investigators form, both the eIRB and NASA Protocol template include a section prompting disclosure of any conflicts.

Key Personnel is defined as those involved in the conduct of human subject research in which the persons engaged are in direct contact with research participants consenting and/or collecting data, and/or have access to private and identifiable research data.

b.Background

On May 5, 2004, DHHS issued revised guidance of Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subjects Protection

OHRP’s “Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection” (5/12/2004)

A conflict of interest is any financial or non-financial “set of circumstances that creates a risk that professional judgement or actions regarding a primary interest will be unduly influenced by a secondary interest” (IOM).

c.Managing a Conflict of Interest

At the discretion of the NASA IRB Office and NASA IRB Chair, you may be asked to complete a Research Financial Disclosure and COI Management Plan form where you will work with the NASA IRB to determine how to best manage identified conflicts.

B.NASA IRBs' Review Process

1.Decisions

The NASA IRB will inform the PI in writing of one of four decisions following review:

Approved: the research protocol is accepted and the study can begin.

Modifications Required/Contingent Approval: The NASA IRB approves the study in principle. However, the investigator must provide a written response regarding items of concern, usually minor items such as clarifications or revisions in the protocol or consent form. The study cannot begin until the concerns of the NASA IRB have been satisfactorily addressed and the response is approved.

Deferred: The NASA IRB is not prepared to approve the study without additional information and review. This decision may occur when serious concerns are raised about issues of human subject protection or when other major changes are required to reconsider the protocol. The PI must respond to the request in writing and this response is reviewed by the NASA IRB at a subsequent NASA IRB meeting. Usually, the revised protocol is granted approval or additional minor modifications are requested at the time of the second review. However, the study may be returned again if the NASA IRB requests it.

Disapproval: The NASA IRB finds that the protocol is not acceptable in principle. A denial of approval cannot be overturned without substantial modifications to the risk-benefit aspect of the protocol. The revised protocol must be resubmitted for all required approvals.

Suspension or Termination:

The NASA IRB has the authority to suspend or terminate previously approved research that is not being conducted in accordance with NASA IRB requirements, that has been associated with unexpected serious harm to subjects, or that has been disapproved by another NASA IRB.

2.General Conditions of Approval

NASA IRB approval is granted according to 45 CFR 46.111. Please note the following about NASA IRB approval:

The PI may not recruit subjects or initiate research until final approval has been received in writing from the NASA IRB.

A subject must be informed about the study and their consent documented by signing a consent document.

The NASA IRB and other departments if appropriate (such as the legal office) must approve all advertisements (e.g. signs, pamphlets, letters) that solicit research participants prior to its use. The advertisements should be included with the protocol for review.

The PI must verify that arrangements have been made to comply with the level of medical monitoring required by the NASA IRB prior to initiation of a test protocol.

3.Responding to a Modifications Requested Determination

To receive final approval in the shortest possible time, please follow the guidelines below in preparing your response to your contingent approval.

Protocol Comments: Answer the NASA IRB's concerns about the study protocol point-by-point. For example, if there are several recommendations in the NASA IRB letter, you should address each of these points individually in a separate numbered or labeled paragraph in your response, then make changes to the protocol as appropriate. In your letter, answer each point fully; do not simply refer to changes in the protocol. If you disagree with the NASA IRB's recommendations and do not wish to make certain changes, you should explain why in the response. Without an explanation, the response will not be complete and approval may be delayed.

Consent Form Comments: You should respond to all substantive comments regarding the consent form point-by-point. You can respond to typographical and other purely editorial comments by making the corrections in the consent form and saying in your response that you have done so. As with protocol comments, if you disagree with the NASA IRB on a particular comment and do not wish to make a requested change, you should explain why in the response.

Treatment and Compensation for Injury: NASA has a very strict policy regarding Treatment and Compensation for Injury that must exactly match the standard NASA language described on the NASA IRB website.

Additional Modifications: If you intend to make new modifications to the study as well as respond to the NASA IRB's comments, please be sure the modifications are described clearly and separately in your response.

4.Conditions of Approval

Approval Date

The day the NASA IRB determines the protocol is approved or conditionally approved at a convened meeting or at the time of approval by expedited review.

Effective Date

This may be the same day as the approval day or may be the day when the PI has satisfactorily addressed the stipulations.

Expiration Date

An expiration date is clearly listed on the approval letter.

It is the investigator's responsibility to keep track of the expiration date and initiate the renewal process prior to the expiration date.

C.Modifications

1.Post-Approval Modifications Overview

Federal regulations require that all changes to a study, even minor ones, must receive NASA IRB approval before they are implemented.

PIs must seek NASA IRB approval before making any changes in approved protocols, even though the changes are planned for the period for which approval has already been given.

Minor changes (i.e., changes that do not involve increased risk or discomfort) may be approved by expedited procedures. If the change is not minor, the review of the request must be conducted during a fully convened meeting.

Modifications to ongoing research do not extend the original approval expiration date.

2.Modification Categories

a.Major Modifications

Any increase in risk to participants is more than minimal;

Any additional activity or procedure would not be eligible for expedited review if submitted as part of new research;

The research itself involves more than minimal risks and the changes significantly alter the study design.

Examples:

Increasing physical and/or psychological risk/discomfort to the participant;

Major change in the design or goal of the study;

Making multiple changes in the protocol, procedures, hardware, and/or consent;

Adding a new consent form;

Expanding the eligibility criteria;

Increasing the number of participants at risk;

Adding an element that may breach the privacy of the participant (e.g. adding focus groups);

Numerous modifications throughout the year where there may be confusion or a question as to the full scope of the study;

Re-starting study after a hold for safety concerns;

Changing, adding, or deleting drugs, devices, or other treatments being studied;

Change in the PI if it significantly changes the expertise or resources available in the study or requires other major changes in the conduct of the study.

b.Minor Modifications

Any increase in risk to participants is no more than minimal risk;

All additional activities or procedures would be eligible for review using the expedited procedures if submitted as part of new research;

Either the research itself involves minimal risks or the changes do not significantly alter the study design.

Examples:

Reduction of risk/discomfort to the participant;

Adding or removing an institution;

Changing minor procedures (e.g. adding small-volume blood draws, ultrasounds);

Adding minor risks (e.g. risks of small blood draws);

Changing, adding or deleting approved drugs, devices, or other standard treatments that are being sued in standard ways;

Changes or additions to recruitment and advertising;

Change in the PI if the new PI has a background and resources that are equivalent to the original PIs;

Changing the Co-I (Co-Investigator) or other key personnel;

Adding or revising a questionnaire or similar to the one already approved, e.g. uses many of the same questions;

Changing wording in the protocol, questionnaire, and/or consent that does not alter the meaning or procedure;

Consent form modifications that add or remove information from the consent form so that it is consistent with an already approved NASA IRB requirement;

Updating a consent form to use NASA IRB approved boiler plate language.

3.Written Notification of NASA IRB Actions

The NASA IRB approval letter will be sent when the modifications are approved. Please note:

Modifications do not change the expiration date;

Revisions in consent forms are valid only until the original approval date for the research expires.

D.Continuing Review/Renewals

1.Renewal/Continuing Review after Protocol Approval

Ongoing research studies require annual review, or more often if the NASA IRB finds that the degree of risk to subjects warrants more frequent review. This renewal must take place prior to the expiration date noted on the approved protocol. There is no provision for a grace period extending the conduct of the research beyond the approval expiration date.

A renewal/continuing review -submissions includes the following information from the past year (cumulative data must also be included after the first renewal):

Number of subjects enrolled:

Completion of research milestones;

Number of subjects who withdrew prematurely, and reason(s) for their withdrawal;

Number of subjects experiencing an adverse event and details of the events and the outcomes;

Preliminary study results if available;

Current risk/benefit assessment based on available preliminary results.