To start and/or continue a study, researchers must follow the following criteria:


Minimizing Risk (45 CFR 46.111)

  • Using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and

  • Whenever appropriate, using procedures already being performed on the subjects for diagnostic or treatment purposes


Risks and Benefits (45 CFR 46.111)

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

  • IRB should consider only those risks and benefits that may result from the research

  • IRB should NOT consider possible long-range effects of applying knowledge gained from research as among those research risks that fall within the purview of its responsibility


Equitable Selection (45 CFR 46.111 & Belmont Report)

  • IRB should take into account the purposes of the research and the setting in which the research will be conducted

  • The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons

  • The ethical principle, “Justice”, is relevant to the selection of subjects of research at two levels: the social and the individual

  • Researchers should not offer potentially beneficial research only to some patients who are in their favor or select only “undesirable” persons for risk research


Informed Consent (45 CFR 46.116)  

Informed Consent means that subjects understand the important implications of the decision to participate in research, and they actively agree to such participation.

The informed consent process must involve these elements:

  1. Providing all participants a copy of the “Experimental Subject’s Bill of Rights” before consent to participate in any medical experiment is obtained.

  2. Conducting the process in a manner and location that ensures participant privacy;

  3. Giving adequate information about the study in language understandable to the participant;

  4. Providing adequate opportunity for the participant to consider all options;

  5. Answering the participant's questions;

  6. Ensuring that the participant has comprehended the information provided;

  7. Obtaining the participant's voluntary agreement to participate and;

  8. Continuing to provide information as the participant or research requires


Who Must be Consented?

  • Potential subjects who are thought to fulfill the inclusion/exclusion criteria for the study


Who May Obtain Consent?

  • Qualified research team members trained in Human Subject Protection & with sufficient knowledge about the specific study. This may include the Principal Investigator (PI), sub-investigators, research coordinators or other research team member approved by the IRB.Elements of Informed Consent


8 Required Elements of Informed Consent:

  1. Research - statement that study involves research, its purpose, duration, procedures, & identification of experimental procedures

  2. Risks - or discomforts, that are reasonably foreseeable

  3. Benefits - to subject or others, that are reasonably expected

  4. Alternative - procedures or treatments available, if any

  5. Confidentiality - of records identifying subject, though may be inspected by authorized entities (i.e., FDA, IRB, CMC, UCSF, Sponsor)

  6. Research-related Injury - available treatment and compensation (if study is greater than minimal risk)

  7. Contact - person for questions regarding the study, subject’s rights, or research-related injury

  8. Voluntary - no penalty or loss of benefits for choosing not to participate & may discontinue at any time


Additional Elements of Informed Consent:

  1. Unforeseeable Risks - may be involved

  2. Participation Termination - circumstances under which PI may terminate subject’s participation without their consent

  3. Additional Costs - to subject due to participation

  4. Withdrawal - consequences of subject’s decision to withdraw & withdrawal procedures

  5. Significant New Findings - subjects will be notified of new findings which develop during the course of research that may relate to their willingness to continue participation

  6. Subject Numbers - approximate number involved in study


The 8 basic elements are required in all consents. Additional elements are used when appropriate and as required by IRBs.

 

Consent Documentation

  • If there is voluntarily agreement to participate, obtain printed name, signature, initials where indicated, and date/time from the subject on the CA Experimental Subject’s Bill of Rights, Study Consent, Sub-Study Consents (if applicable), and the Use and Disclosure of PHI Consent

  • Consenter must also print name, sign and date/time, as well as the PI on the Study Consent and Sub-Study Consents (if applicable)

  • The witness must print name, sign and date/time the CA Experimental Subject’s Bill of Rights, Study Consent, Sub-Study Consents (if applicable), and CMC Use and Disclosure of PHI Consent

  • Provide a copy to the subject and maintain the original in the subject’s study file

  • Complete a progress note detailing the encounter & file in the subject’s study file


For more information check Community Medical Centers IRB Informed Consent Policy on CyberIRB.

 

Progress Notes

Progress notes to document the informed consent process is part of the industry standard for good clinical practice and good documentation practices.
 
This can be provided in any form as long as it meets the requirements.
 
Documentation should include:

  • Evidence of informed consent (case history of each individual shall document that informed consent was obtained prior to participation in the study)

  • For any use of a device by the investigator without informed consent, any written occurrence of a licensed physician and a brief description of the circumstances justifying the failure to obtain informed consent

  • Progress notes of the physician

  • Nurses notes 

  • The Individuals hospital chart(s)

 
21 CFR  312.62(b) and 812.140(a)(3)(i).
 
http://www.imarcresearch.com/blog/bid/301723/Documentation-of-the-Informed-Consent-Process-What-is-Required