| A statement that the study involves research | 21 CFR 50.25(a)(1) | 45 CFR 46.116 (a)(1) | ICH E6 4.8.10 (a) |
| An explanation of the purposes of the research. (ICH adds -the trial treatment(s) and the probability for random assignment to each treatment) | 21 CFR 50.25(a)(1) | 45 CFR 46.116 (a)(1) | ICH E6 4.8.10 (b) |
| The expected duration of the subject’s participation | 21 CFR 50.25(a)(1) | 45 CFR 46.116 (a)(1) | ICH E6 4.8.10 (s) |
| A description of the procedures to be followed | 21 CFR 50.25(a)(1) | 45 CFR 46.116 (a)(1) | ICH E6 4.8.10 (d) |
| The subject’s responsibilities | ------ | ------ | ICH E6 4.8.10 (e) |
| Identification of any procedures that are experimental | 21 CFR 50.25(a)(1) | 45 CFR 46.116 (a)(1) | ICH E6 4.8.10 (f) |
| A description of any reasonably foreseeable risks or discomforts to the subject. | 21 CFR 50.25(a)(2) | 45 CFR 46.116 (a)(2) | ICH E6 4.8.10 (g) |
| A description of any benefits to the subject or to others which might be expected from the research | 21 CFR 50.25(a)(3) | 45 CFR 46.116 (a)(3) | ICH E6 4.8.10 (h) |
| A disclosure of appropriate alternative procedures or courses of treatment, if any, that may be advantageous to the subject. | 21 CFR 50.25(a)(4) | 45 CFR 46.116 (a)(4) | ICH E6 4.8.10 (i) |
| A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained, and | 21 CFR 50.25(a)(5) | 45 CFR 46.116 (a)(5) | ICH E6 4.8.10 (o) |
| A statement that notes that the FDA may inspect the records. | 21 CFR 50.25(a)(5) | ------ | ------ |
| A statement that a description of the clinical trial will be available on http://www.clinicaltrials.gov | 21 CFR 50.27 (c) | ------ | ------ |
| That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will be granted direct access to the subject’s original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that by signing the informed consent form, the subject or the subject’s legally authorized representative is authorizing such access. | ------ | ------ | ICH E6 4.8.10 (n) |
| For research involving more than minimal risk, | 21 CFR 50.25(a)(6) | 45 CFR 46.116 (a)(6) | ICH E6 4.8.10 (j) |
| (1) an explanation as to whether any compensation and | ------ | ------ | ------ |
| (2) an explanation as to whether any medical treatments will be available if injury occurs and, if so, what they consist of, and | ------ | ------ | ------ |
| (3) where further information may be obtained . | ------ | ------ | ------ |
| An explanation of whom to contact for answers to pertinent questions: | 21 CFR 50.25(a)(7) | 45 CFR 46.116 (a)(7) | ICH E6 4.8.10 (q) |
| (1) about the research (PI name and number) | ------ | ------ | ------ |
| (2) and research subject’s rights, discuss problems, concerns and questions; obtain information and offer input (IRB contact info [person unaffiliated with the research study]); and, | ------ | ------ | ------ |
| (3) who to contact in the event of a research-related injury to the subject. | ------ | ------ | ------ |
| A statement that participation is voluntary | 21 CFR 50.25(a)(7) | 45 CFR 46.116 (a)(8) | ICH E6 4.8.10 (m) |
| A statement that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled. | 21 CFR 50.25(a)(7) | 45 CFR 46.116 (a)(8) | ICH E6 4.8.10 (m) |
| Additional Elements (Required when applicable) | | | |
| A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or becomes pregnant) which are currently unforeseeable. | 21 CFR 50.25(b)(1) | 45 CFR 46.116 (b)(1) | ICH E6 4.8.10 (g) |
| Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent. | 21 CFR 50.25(b)(2) | 45 CFR 46.116 (b)(2) | ICH E6 4.8.10 (r) |
| Additional costs to the subject that may result from participation in the study. | 21 CFR 50.25(b)(3) | 45 CFR 46.116 (b)(3) | ICH E6 4.8.10 (l) |
| Compensation or payment to subjects for participating in the trial & the schedule of the payments | ------ | ------ | ICH E6 4.8.10 (k) |
| The consequences of a subject’s decision to withdraw from the course of the research, and | 21 CFR 50.25(b)(4) | 45 CFR 46.116 (b)(4) | ------ |
| Procedures for the orderly termination of participation by the subject. | 21 CFR 50.25(b)(4) | 45 CFR 46.116 (b)(4) | ------ |
| A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject. | 21 CFR 50.25(b)(5) | 45 CFR 46.116 (b)(5) | ICH E6 4.8.2 |
| The approximate number of subjects in the study. | 21 CFR 50.25(b)(6) | 45 CFR 46.116 (b)(6) | ICH E6 4.8.10 (t) |
| Date of the subject’s (or legally authorized representative’s) signature. | 21 CFR 50.27(a) | 45 CFR 46.117(a) | ICH E6 4.8.8 |
| A copy of the signed written ICF will be provided to the subject. | 21 CFR 50.27(b) | 45 CFR 46.117(a) | ICH E6 4.8.11 |
| Signature of the subject or legally authorized representative | 21 CFR 50.27(a) | 45 CFR 46.117(a) | ICH E6 4.8.8 |
| Signature of the person obtaining consent | ------ | ------ | ICH E6 4.8.8 |
| Signature of witness | 21 CFR 50.27(b)(2) – short form | 45 CFR 46.117(b)(2) – short form | ICH E6 4.8.9 |
| State, Site or IRB Specific Requirements | | | |
| California Patient Bill of Rights (separate front page with signature /date line for subject or Legally Authorized Representative) | ------ | ------ | ------ |
| IRB Required Signatures: (such as) | ------ | ------ | ------ |
| Statement that a copy of the signed written ICF will be provided to the subject | | | |
| Date of the subject’s (or legally authorized representative’s) signature. | | | |
| Printed name & signature of the subject or legally authorized representative | | | |
| Date of the person explaining and witnessing consent’s signature. | | | |
| Printed name & signature of the person explaining and witnessing consent | | | |
| Time of subject’s (or legally authorized representative’s) signature & time of signature of person explaining & witnessing the consent | | | |