Institutional Review Board

Preparing for Research  |  Consent Guidance

A.Overview

Researchers must obtain and document consent from the prospective research subject before initiating any screening or study procedures. Any exceptions must be reviewed and approved by the IRB beforehand;

Research investigators must ensure the voluntary participation of research subjects. The recruitment plan, consent process and consent documents to be used with prospective subjects must be carefully designed so that subjects' consent will be well-informed and freely given.

All human research at NASA must comply with the federal regulations of the Office for Human Research Protections (OHRP) found at 45 CFR 46. The same regulations are found under NASA’s 14 CFR 1230. If applicable, human research must also comply with the Food and Drug Administration (FDA) regulations regarding informed consent in research involving human subjects.

Human research conducted or funded by the Department of Health and Human Services (DHHS) must comply with the informed consent requirements found at:

45 CFR 46.116 45 CFR 46.117

Research involving products regulated by the FDA (drug, device, or biologic) must also comply with informed consent requirements found at:

21 CFR Part 50 Subpart B

IRB records, including consent forms, shall be retained for at least 3 years after completion of the research (45 CFR 46.115 (b)).

Subject Briefing presentation must detail the study information that will be explained to the subjects. Include a list of personnel that will attend the briefing and the procedures that will be explained or demonstrated at the briefing.

The Informed Consent document must be understandable, include enough information to make an educated decision, accurately reflect the study, and include all regulatory elements.

The Investigator must provide:

all study procedures and tests required for the study, in sequence and in detail;

time commitment per visit and in total for the study;

specific locations where study procedures will be performed. (If the study involves more than minimal risk, a description of the equipment on hand to protect participants is appropriate.)

explanation of the instruments used for interviews, questionnaires, or surveys;

explanation for any study procedures or tests performed off-site by study personnel.

B.Medical Safety Risks and Hazards

Describe all anticipated hazards from the procedures (biological sample collections, new diagnostic procedures and treatments), materials (radioactive substances, etc.), or any other experiment-related conditions, including immediate, delayed, or long-term effects. Include assessment of degree of risk (minimum or reasonable) and proposed acceptable risk-benefit ratio. Include assessment of residual risk.

Describe details of medical intervention procedures in the event of an adverse reaction. Include information on the availability of a physician and medical facilities during and after the study, and post-experiment medical check up requirements, and precautionary measures to avoid any complications (immediate and delayed) that are experiment related.

Test protocols using any form of maximum strength testing must include a rationale and utility and must include a well-defined upper limit for maximum physical exertion that will minimize the likelihood of injury.

C.Risks and Benefits

1.Risks

The term "risk" refers to a possibility that harm may occur and expresses probabilities. There are risks of psychological harm, physical harm, legal harm, social harm, and economic harm.

Research involving human subjects should only be conducted if the importance of the objective outweighs the inherent risks and burdens to the subject. This is especially important when the human subjects are healthy volunteers.

Risks and Discomforts:

Describe the risks and discomforts of any investigational or approved drugs, devices and procedures being used or assigned for study purposes. Describe the expected frequency of particular side effects.

Describe the steps you have taken to minimize the risks/discomforts to subjects. Examples include: designing the study to make use of procedures involving less risk when appropriate; minimizing study procedures by taking advantage clinical procedures conducted on the study participants; mitigating risks by planning special monitoring or conducting supportive interventions for the study. If appropriate, provide a rationale for risky procedures.

2.Benefits

Describe what is the importance of the knowledge expected to result from the research.

Describe the potential direct benefits to study subjects.

Describe the potential benefits to society.

Describe how benefits outweigh the risks to subjects.