PART 50—PROTECTION OF HUMAN
SUBJECTS
Subpart A—General Provisions
Sec.
50.1 Scope.
50.3 Definitions.
Subpart B—Informed Consent of Human
Subjects
50.20 General requirements for informed
consent.
50.23 Exception from general requirements.
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Food and Drug Administration, HHS § 50.3
50.24 Exception from informed consent requirements
for emergency research.
50.25 Elements of informed consent.
50.27 Documentation of informed consent.
AUTHORITY: 21 U.S.C. 321, 346, 346a, 348, 352,
353, 355, 360, 360c–360f, 360h–360j, 371, 379e, 381;
42 U.S.C. 216, 241, 262, 263b–263n.
SOURCE: 45 FR 36390, May 30, 1980, unless
otherwise noted.
Subpart A—General Provisions
§ 50.1 Scope.
(a) This part applies to all clinical investigations
regulated by the Food and
Drug Administration under sections
505(i) and 520(g) of the Federal Food,
Drug, and Cosmetic Act, as well as
clinical investigations that support applications
for research or marketing
permits for products regulated by the
Food and Drug Administration, including
food and color additives, drugs for
human use, medical devices for human
use, biological products for human use,
and electronic products. Additional
specific obligations and commitments
of, and standards of conduct for, persons
who sponsor or monitor clinical
investigations involving particular test
articles may also be found in other
parts (e.g., parts 312 and 812). Compliance
with these parts is intended to
protect the rights and safety of subjects
involved in investigations filed
with the Food and Drug Administration
pursuant to sections 406, 409, 502,
503, 505, 510, 513–516, 518–520, 721, and 801
of the Federal Food, Drug, and Cosmetic
Act and sections 351 and 354–360F
of the Public Health Service Act.
(b) References in this part to regulatory
sections of the Code of Federal
Regulations are to chapter I of title 21,
unless otherwise noted.
[45 FR 36390, May 30, 1980; 46 FR 8979, Jan. 27,
1981, as amended at 63 FR 26697, May 13, 1998;
64 FR 399, Jan. 5, 1999]
§ 50.3 Definitions.
As used in this part:
(a) Act means the Federal Food,
Drug, and Cosmetic Act, as amended
(secs. 201—902, 52 Stat. 1040 et seq. as
amended (21 U.S.C. 321—392)).
(b) Application for research or marketing
permit includes:
(1) A color additive petition, described
in part 71.
(2) A food additive petition, described
in parts 171 and 571.
(3) Data and information about a substance
submitted as part of the procedures
for establishing that the substance
is generally recognized as safe
for use that results or may reasonably
be expected to result, directly or indirectly,
in its becoming a component or
otherwise affecting the characteristics
of any food, described in §§ 170.30 and
570.30.
(4) Data and information about a food
additive submitted as part of the procedures
for food additives permitted to be
used on an interim basis pending additional
study, described in § 180.1.
(5) Data and information about a substance
submitted as part of the procedures
for establishing a tolerance for
unavoidable contaminants in food and
food-packaging materials, described in
section 406 of the act.
(6) An investigational new drug application,
described in part 312 of this
chapter.
(7) A new drug application, described
in part 314.
(8) Data and information about the
bioavailability or bioequivalence of
drugs for human use submitted as part
of the procedures for issuing, amending,
or repealing a bioequivalence requirement,
described in part 320.
(9) Data and information about an
over-the-counter drug for human use
submitted as part of the procedures for
classifying these drugs as generally
recognized as safe and effective and not
misbranded, described in part 330.
(10) Data and information about a
prescription drug for human use submitted
as part of the procedures for
classifying these drugs as generally
recognized as safe and effective and not
misbranded, described in this chapter.
(11) [Reserved]
(12) An application for a biologics license,
described in part 601 of this
chapter.
(13) Data and information about a biological
product submitted as part of
the procedures for determining that licensed
biological products are safe and
effective and not misbranded, described
in part 601.
(14) Data and information about an in
vitro diagnostic product submitted as
part of the procedures for establishing,
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§ 50.3 21 CFR Ch. I (4–1–01 Edition)
amending, or repealing a standard for
these products, described in part 809.
(15) An Application for an Investigational
Device Exemption, described in
part 812.
(16) Data and information about a
medical device submitted as part of the
procedures for classifying these devices,
described in section 513.
(17) Data and information about a
medical device submitted as part of the
procedures for establishing, amending,
or repealing a standard for these devices,
described in section 514.
(18) An application for premarket approval
of a medical device, described in
section 515.
(19) A product development protocol
for a medical device, described in section
515.
(20) Data and information about an
electronic product submitted as part of
the procedures for establishing, amending,
or repealing a standard for these
products, described in section 358 of the
Public Health Service Act.
(21) Data and information about an
electronic product submitted as part of
the procedures for obtaining a variance
from any electronic product performance
standard, as described in § 1010.4.
(22) Data and information about an
electronic product submitted as part of
the procedures for granting, amending,
or extending an exemption from a radiation
safety performance standard, as
described in § 1010.5.
(c) Clinical investigation means any
experiment that involves a test article
and one or more human subjects and
that either is subject to requirements
for prior submission to the Food and
Drug Administration under section
505(i) or 520(g) of the act, or is not subject
to requirements for prior submission
to the Food and Drug Administration
under these sections of the act,
but the results of which are intended to
be submitted later to, or held for inspection
by, the Food and Drug Administration
as part of an application for a
research or marketing permit. The
term does not include experiments that
are subject to the provisions of part 58
of this chapter, regarding nonclinical
laboratory studies.
(d) Investigator means an individual
who actually conducts a clinical investigation,
i.e., under whose immediate
direction the test article is administered
or dispensed to, or used involving,
a subject, or, in the event of an investigation
conducted by a team of individuals,
is the responsible leader of
that team.
(e) Sponsor means a person who initiates
a clinical investigation, but who
does not actually conduct the investigation,
i.e., the test article is administered
or dispensed to or used involving,
a subject under the immediate direction
of another individual. A person
other than an individual (e.g., corporation
or agency) that uses one or more
of its own employees to conduct a clinical
investigation it has initiated is
considered to be a sponsor (not a sponsor-
investigator), and the employees
are considered to be investigators.
(f) Sponsor-investigator means an individual
who both initiates and actually
conducts, alone or with others, a clinical
investigation, i.e., under whose immediate
direction the test article is administered
or dispensed to, or used involving,
a subject. The term does not
include any person other than an individual,
e.g., corporation or agency.
(g) Human subject means an individual
who is or becomes a participant
in research, either as a recipient of the
test article or as a control. A subject
may be either a healthy human or a patient.
(h) Institution means any public or
private entity or agency (including
Federal, State, and other agencies).
The word facility as used in section
520(g) of the act is deemed to be synonymous
with the term institution for
purposes of this part.
(i) Institutional review board (IRB)
means any board, committee, or other
group formally designated by an institution
to review biomedical research
involving humans as subjects, to approve
the initiation of and conduct
periodic review of such research. The
term has the same meaning as the
phrase institutional review committee as
used in section 520(g) of the act.
(j) Test article means any drug (including
a biological product for human
use), medical device for human use,
human food additive, color additive,
electronic product, or any other article
subject to regulation under the act or
under sections 351 and 354–360F of the
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285
Food and Drug Administration, HHS § 50.23
Public Health Service Act (42 U.S.C. 262
and 263b–263n).
(k) Minimal risk means that the probability
and magnitude of harm or discomfort
anticipated in the research are
not greater in and of themselves than
those ordinarily encountered in daily
life or during the performance of routine
physical or psychological examinations
or tests.
(l) Legally authorized representative
means an individual or judicial or
other body authorized under applicable
law to consent on behalf of a prospective
subject to the subject’s
particpation in the procedure(s) involved
in the research.
(m) Family member means any one of
the following legally competent persons:
Spouse; parents; children (including
adopted children); brothers, sisters,
and spouses of brothers and sisters; and
any individual related by blood or affinity
whose close association with the
subject is the equivalent of a family relationship.
[45 FR 36390, May 30, 1980, as amended at 46
FR 8950, Jan. 27, 1981; 54 FR 9038, Mar. 3, 1989;
56 FR 28028, June 18, 1991; 61 FR 51528, Oct. 2,
1996; 62 FR 39440, July 23, 1997; 64 FR 399, Jan.
5, 1999; 64 FR 56448, Oct. 20, 1999]

Subpart B—Informed Consent of Human Subjects

SOURCE: 46 FR 8951, Jan. 27, 1981, unless otherwise noted.

§ 50.20 General requirements for informed consent.

Except as provided in §§ 50.23 and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.

The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

[46 FR 8951, Jan. 27, 1981, as amended at 64 FR 10942, Mar. 8, 1999]

§ 50.23 Exception from general requirements.

(a) The obtaining of informed consent shall be deemed feasible unless, before use of the test article (except as provided in paragraph (b) of this section), both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following:

(1) The human subject is confronted by a life-threatening situation necessitating the use of the test article.

(2) Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject.

(3) Time is not sufficient to obtain consent from the subject’s legal representative.

(4) There is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject.

(b) If immediate use of the test article is, in the investigator’s opinion, required to preserve the life of the subject, and time is not sufficient to obtain the independent determination required in paragraph (a) of this section in advance of using the test article, the determinations of the clinical investigator shall be made and, within 5 working days after the use of the article, be reviewed and evaluated in writing by a physician who is not participating in the clinical investigation.

(c) The documentation required in paragraph (a) or (b) of this section shall be submitted to the IRB within 5 working days after the use of the test article.

(d)(1) Under 10 U.S.C. 1107(f) the President may waive the prior consent requirement for the administration of an investigational new drug to a member of the armed forces in connection with the member’s participation in a particular military operation. The statute specifies that only the President may waive informed consent in this connection and the President may grant such a waiver only if the President determines in writing that obtaining consent: Is not feasible; is contrary to the best interests of the military member; or is not in the interests of national security. The statute further provides that in making a determination to waive prior informed consent on the ground that it is not feasible or the ground that it is contrary to the best interests of the military members involved, the President shall apply the standards and criteria that are set forth in the relevant FDA regulations for a waiver of the prior informed consent requirements of section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)). Before such a determination may be made that obtaining informed consent from military personnel prior to the use of an investigational drug (including an antibiotic or biological product) in a specific protocol under an investigational new drug application (IND) sponsored by the Department of Defense (DOD) and limited to specific military personnel involved in a particular military operation is not feasible or is contrary to the best interests of the military members involved the Secretary of Defense must first request such a determination from the President, and certify and document to the President that the following standards and criteria contained in paragraphs (d)(1) through (d)(4) of this section have been met.

(i) The extent and strength of evidence of the safety and effectiveness of the investigational new drug in relation to the medical risk that could be encountered during the military operation supports the drug’s administration under an IND.

(ii) The military operation presents a substantial risk that military personnel may be subject to a chemical, biological, nuclear, or other exposure likely to produce death or serious or life-threatening injury or illness.

(iii) There is no available satisfactory alternative therapeutic or preventive treatment in relation to the intended use of the investigational new drug.

(iv) Conditioning use of the investigational new drug on the voluntary participation of each member could significantly risk the safety and health of any individual member who would decline its use, the safety of other military personnel, and the accomplishment of the military mission.

(v) A duly constituted institutional review board (IRB) established and operated in accordance with the requirements of paragraphs (d)(2) and (d)(3) of this section, responsible for review of the study, has reviewed and approved the investigational new drug protocol and the administration of the investigational new drug without informed consent. DOD’s request is to include the documentation required by § 56.115(a)(2) of this chapter.

(vi) DOD has explained:

(A) The context in which the investigational drug will be administered, e.g., the setting or whether it will be self-administered or it will be administered by a health professional;

(B) The nature of the disease or condition for which the preventive or therapeutic treatment is intended; and

(C) To the extent there are existing data or information available, information on conditions that could alter the effects of the investigational drug.

(vii) DOD’s recordkeeping system is capable of tracking and will be used to track the proposed treatment from supplier to the individual recipient.

(viii) Each member involved in the military operation will be given, prior to the administration of the investigational new drug, a specific written information sheet (including information required by 10 U.S.C. 1107(d)) concerning the investigational new drug, the risks and benefits of its use, potential side effects, and other pertinent information about the appropriate use of the product.

(ix) Medical records of members involved in the military operation will accurately document the receipt by members of the notification required by paragraph (d)(1)(viii) of this section.

Food and Drug Administration, HHS § 50.24

(x) Medical records of members involved in the military operation will accurately document the receipt by members of any investigational new drugs in accordance with FDA regulations including part 312 of this chapter.
(xi) DOD will provide adequate followup to assess whether there are beneficial or adverse health consequences that result from the use of the investigational product.
(xii) DOD is pursuing drug development, including a time line, and marketing approval with due diligence.
(xiii) FDA has concluded that the investigational new drug protocol may proceed subject to a decision by the President on the informed consent waiver request.
(xiv) DOD will provide training to the appropriate medical personnel and potential recipients on the specific investigational new drug to be administered prior to its use.
(xv) DOD has stated and justified the time period for which the waiver is needed, not to exceed one year, unless separately renewed under these standards and criteria.
(xvi) DOD shall have a continuing obligation to report to the FDA and to the President any changed circumstances relating to these standards and criteria (including the time period referred to in paragraph (d)(1)(xv) of this section) or that otherwise might affect the determination to use an investigational new drug without informed consent.

(xvii) DOD is to provide public notice as soon as practicable and consistent with classification requirements through notice in the FEDERAL REGISTER describing each waiver of informed consent determination, a summary of the most updated scientific information on the products used, and other pertinent information.

(xviii) Use of the investigational drug without informed consent otherwise conforms with applicable law.

(2) The duly constituted institutional review board, described in paragraph (d)(1)(v) of this section, must include at least 3 nonaffiliated members who shall not be employees or officers of the Federal Government (other than for purposes of membership on the IRB) and shall be required to obtain any necessary security clearances. This IRB shall review the proposed IND protocol at a convened meeting at which a majority of the members are present including at least one member whose primary concerns are in nonscientific areas and, if feasible, including a majority of the nonaffiliated members.

The information required by § 56.115(a)(2) of this chapter is to be provided to the Secretary of Defense for further review.
(3) The duly constituted institutional review board, described in paragraph (d)(1)(v) of this section, must review and approve:
(i) The required information sheet;
(ii) The adequacy of the plan to disseminate information, including distribution of the information sheet to potential recipients, on the investigational product (e.g., in forms other than written);
(iii) The adequacy of the information and plans for its dissemination to health care providers, including potential side effects, contraindications, potential interactions, and other pertinent considerations; and
(iv) An informed consent form as required by part 50 of this chapter, in those circumstances in which DOD determines that informed consent may be obtained from some or all personnel involved.
(4) DOD is to submit to FDA summaries of institutional review board meetings at which the proposed protocol has been reviewed.
(5) Nothing in these criteria or standards is intended to preempt or limit FDA’s and DOD’s authority or obligations under applicable statutes and regulations.

[46 FR 8951, Jan. 27, 1981, as amended at 55 FR 52817, Dec. 21, 1990; 64 FR 399, Jan. 5, 1999; 64 FR 54188, Oct. 5, 1999]

§ 50.24 Exception from informed consent requirements for emergency research.

(a) The IRB responsible for the review,
approval, and continuing review
of the clinical investigation described
in this section may approve that investigation
without requiring that informed
consent of all research subjects
be obtained if the IRB (with the concurrence
of a licensed physician who is
a member of or consultant to the IRB
and who is not otherwise participating
in the clinical investigation) finds and
documents each of the following:
(1) The human subjects are in a lifethreatening
situation, available treatments
are unproven or unsatisfactory,
and the collection of valid scientific
evidence, which may include evidence
obtained through randomized placebocontrolled
investigations, is necessary
to determine the safety and effectiveness
of particular interventions.
(2) Obtaining informed consent is not
feasible because:
(i) The subjects will not be able to
give their informed consent as a result
of their medical condition;
(ii) The intervention under investigation
must be administered before consent
from the subjects’ legally authorized
representatives is feasible; and
(iii) There is no reasonable way to
identify prospectively the individuals
likely to become eligible for participation
in the clinical investigation.
(3) Participation in the research
holds out the prospect of direct benefit
to the subjects because:
(i) Subjects are facing a life-threatening
situation that necessitates intervention;
(ii) Appropriate animal and other
preclinical studies have been conducted,
and the information derived
from those studies and related evidence
support the potential for the intervention
to provide a direct benefit to the
individual subjects; and
(iii) Risks associated with the investigation
are reasonable in relation to
what is known about the medical condition
of the potential class of subjects,
the risks and benefits of standard therapy,
if any, and what is known about
the risks and benefits of the proposed
intervention or activity.
(4) The clinical investigation could
not practicably be carried out without
the waiver.
(5) The proposed investigational plan
defines the length of the potential
therapeutic window based on scientific
evidence, and the investigator has committed
to attempting to contact a legally
authorized representative for
each subject within that window of
time and, if feasible, to asking the legally
authorized representative contacted
for consent within that window
rather than proceeding without consent.
The investigator will summarize
efforts made to contact legally authorized
representatives and make this information
available to the IRB at the
time of continuing review.
(6) The IRB has reviewed and approved
informed consent procedures
and an informed consent document
consistent with § 50.25. These procedures
and the informed consent document
are to be used with subjects or
their legally authorized representatives
in situations where use of such
procedures and documents is feasible.
The IRB has reviewed and approved
procedures and information to be used
when providing an opportunity for a
family member to object to a subject’s
participation in the clinical investigation
consistent with paragraph (a)(7)(v)
of this section.
(7) Additional protections of the
rights and welfare of the subjects will
be provided, including, at least:
(i) Consultation (including, where appropriate,
consultation carried out by
the IRB) with representatives of the
communities in which the clinical investigation
will be conducted and from
which the subjects will be drawn;
(ii) Public disclosure to the communities
in which the clinical investigation
will be conducted and from which
the subjects will be drawn, prior to initiation
of the clinical investigation, of
plans for the investigation and its risks
and expected benefits;
(iii) Public disclosure of sufficient information
following completion of the
clinical investigation to apprise the
community and researchers of the
study, including the demographic characteristics
of the research population,
and its results;
(iv) Establishment of an independent
data monitoring committee to exercise
oversight of the clinical investigation;
and
(v) If obtaining informed consent is
not feasible and a legally authorized
representative is not reasonably available,
the investigator has committed,
if feasible, to attempting to contact
within the therapeutic window the subject’s
family member who is not a legally
authorized representative, and
asking whether he or she objects to the
subject’s participation in the clinical
investigation. The investigator will
summarize efforts made to contact
family members and make this information
available to the IRB at the
time of continuing review.
(b) The IRB is responsible for ensuring
that procedures are in place to inform,
at the earliest feasible opportunity,
each subject, or if the subject
remains incapacitated, a legally authorized
representative of the subject,
or if such a representative is not reasonably
available, a family member, of
the subject’s inclusion in the clinical
investigation, the details of the investigation
and other information contained
in the informed consent document.
The IRB shall also ensure that
there is a procedure to inform the subject,
or if the subject remains incapacitated,
a legally authorized representative
of the subject, or if such a representative
is not reasonably available,
a family member, that he or she may
discontinue the subject’s participation
at any time without penalty or loss of
benefits to which the subject is otherwise
entitled. If a legally authorized
representative or family member is
told about the clinical investigation
and the subject’s condition improves,
the subject is also to be informed as
soon as feasible. If a subject is entered
into a clinical investigation with
waived consent and the subject dies before
a legally authorized representative
or family member can be contacted, information
about the clinical investigation
is to be provided to the subject’s
legally authorized representative or
family member, if feasible.
(c) The IRB determinations required
by paragraph (a) of this section and the
documentation required by paragraph
(e) of this section are to be retained by
the IRB for at least 3 years after completion
of the clinical investigation,
and the records shall be accessible for
inspection and copying by FDA in accordance
with § 56.115(b) of this chapter.
(d) Protocols involving an exception
to the informed consent requirement
under this section must be performed
under a separate investigational new
drug application (IND) or investigational
device exemption (IDE) that
clearly identifies such protocols as protocols
that may include subjects who
are unable to consent. The submission
of those protocols in a separate IND/
IDE is required even if an IND for the
same drug product or an IDE for the
same device already exists. Applications
for investigations under this section
may not be submitted as amendments
under §§ 312.30 or 812.35 of this
chapter.
(e) If an IRB determines that it cannot
approve a clinical investigation because
the investigation does not meet
the criteria in the exception provided
under paragraph (a) of this section or
because of other relevant ethical concerns,
the IRB must document its findings
and provide these findings promptly
in writing to the clinical investigator
and to the sponsor of the clinical
investigation. The sponsor of the clinical
investigation must promptly disclose
this information to FDA and to
the sponsor’s clinical investigators who
are participating or are asked to participate
in this or a substantially
equivalent clinical investigation of the
sponsor, and to other IRB’s that have
been, or are, asked to review this or a
substantially equivalent investigation
by that sponsor.
[61 FR 51528, Oct. 2, 1996]

§ 50.25 Elements of informed consent.

(a) Basic elements of informed consent.
In seeking informed consent, the following
information shall be provided to
each subject:
(1) A statement that the study involves
research, an explanation of the
purposes of the research and the expected
duration of the subject’s participation,
a description of the procedures
to be followed, and identification of
any procedures which are experimental.
(2) A description of any reasonably
foreseeable risks or discomforts to the
subject.
(3) A description of any benefits to
the subject or to others which may reasonably
be expected from the research.
(4) A disclosure of appropriate alternative
procedures or courses of treatment,
if any, that might be advantageous
to the subject.
(5) A statement describing the extent,
if any, to which confidentiality of
records identifying the subject will be
maintained and that notes the possibility
that the Food and Drug Administration
may inspect the records.
(6) For research involving more than
minimal risk, an explanation as to
whether any compensation and an explanation
as to whether any medical
treatments are available if injury occurs
and, if so, what they consist of, or
where further information may be obtained.
(7) An explanation of whom to contact
for answers to pertinent questions
about the research and research subjects’
rights, and whom to contact in
the event of a research-related injury
to the subject.
(8) A statement that participation is
voluntary, that refusal to participate
will involve no penalty or loss of benefits
to which the subject is otherwise
entitled, and that the subject may discontinue
participation at any time
without penalty or loss of benefits to
which the subject is otherwise entitled.

(b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:

(1) 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 may become pregnant) which are currently unforeseeable.

(2) Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent.

(3) Any additional costs to the subject that may result from participation in the research.

(4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.

(5) 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.

(6) The approximate number of subjects involved in the study.

(c) The informed consent requirements in these regulations are not intended to preempt any applicable Federal, State, or local laws which require additional information to be disclosed for informed consent to be legally effective.

(d) Nothing in these regulations is intended to limit the authority of a physician to provide emergency medical care to the extent the physician is permitted to do so under applicable Federal, State, or local law.

§ 50.27 Documentation of informed consent.

(a) Except as provided in § 56.109(c), informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative at the time of consent. A copy shall be given to the person signing the form.

(b) Except as provided in § 56.109(c), the consent form may be either of the following:

(1) A written consent document that embodies the elements of informed consent required by § 50.25. This form may be read to the subject or the subject’s legally authorized representative, but, in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed.

(2) A short form written consent document stating that the elements of informed consent required by § 50.25 have been presented orally to the subject or the subject’s legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining the consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative in addition to a copy of the short form.

[46 FR 8951, Jan. 27, 1981, as amended at 61 FR 57280, Nov. 5, 1996]