Office for Protection from
Research Risks
6100 Executive Blvd Suite 3B01
NIH MSC 7507
Rockville, MD 20892-7507
Summary of Basic Protections for
Human Subjects
December 23, 1997
Summary
Definitions
IRB Knowledge of Local Conditions
Exempt Activities
Waiver or Alteration of Informed
Consent Requirements
Research Involving Children
Research Involving Prisoners
Certificates of
Confidentiality
Summary
Protections for human subjects of research are required under
Department of Health and Human Services (HHS) regulations at 45 CFR 46. Subpart A of the
HHS regulations constitutes the Federal Policy (Common Rule)
for the Protection of Human Subjects, which has been adopted
by an additional 16 Executive Branch Departments and Agencies.
Each institution engaged in (non-exempt) HHS-supported human
subjects research must provide a written Assurance of
Compliance, satisfactory to the Office for Protection from
Research Risks (OPRR), that it will comply with the HHS human
subjects regulations. --- 45
CFR 46.103(a)
Institutions conducting (non-exempt) HHS-supported human
subjects research must provide Certification to the
supporting agency that the research has been reviewed and
approved by an Institutional Review Board (IRB) designated
under an OPRR-approved Assurance. Under no circumstances may
(non-exempt) human subjects research be supported prior to
Certification. --- 45 CFR
46.103(f)
Except where the IRB specifically approves a waiver in
accordance with HHS regulations, no investigator may involve a
human being as a subject in (non-exempt) research unless the
investigator has obtained the legally effective informed
consent of the subject, or the subject's legally authorized
representative. The meaning of "legally effective" and
"legally authorized" is determined in part by
applicable State law.
Definitions
- Research means a systematic
investigation, including development, testing, and
evaluation, designed to develop or contribute to
generalizable knowledge. Activities which meet this
definition constitute research for the purposes of this
policy, whether or not they are supported under a program
which is considered research for other purposes. --- 45 CFR46.102(d)
- Human subject means
a living individual about whom an investigator conducting
research obtains (1) data through intervention or
interaction with the individual, or (2) identifiable
private information. --- 45 CFR 46.102(f)(1),(2)
- Identifiable private information includes
information about behavior that occurs in a context in
which an individual can reasonably expect that no
observation is taking place, and information which has
been provided for specific purposes by an individual and
which the individual can reasonable expect will not be
made public (for example, a medical record). --- 45 CFR 46.102(f)(2)
- Informed consent must be sought
under circumstances that minimize the possibility of
coercion of undue influence and must include the eight
basic information elements described in the regulations.
Information must be presented in language understandable
to the subject or the subject's legally authorized
representative. --- 45
CFR 46.116(a),(b)
- Informed consent must be documented
with a written form approved by the IRB and signed by the
subject or the subject's legally authorized
representative. --- 45
CFR 46.117
IRB Knowledge of Local
Conditions
HHS regulations at 45 CFR
46.107 require that IRBs be knowledgeable about the local
research context:
- The IRB must be sufficiently qualified through the
experience and expertise and diversity of its members,
including race, gender, cultural background, and
sensitivity to such issues as community attitudes
to promote respect for its advice and counsel.
- The IRB must be able to evaluate research in terms of institutional
commitments and regulations, applicable law, and
standards of professional conduct and practice.
Exempt Activities
Six categories of research are exempt from the
regulatory requirements, including the following:
- Research conducted in established or commonly accepted educational
settings, involving normaleducational practices, such
as (i) research on regular or special education
instructional strategies, or (ii) research on the
effectiveness of the comparison among instructional
techniques curricula, or classroom management methods. ---
45 CFR 46.101(b)(1)
- Research involving the use of educational tests
(cognitive, diagnostic, aptitude, or achievement), survey
procedures, interview procedures, or observation of
public behavior, unless: (i)
information obtained is recorded in a manner that human
subjects can be identified, directly or though
identifiers linked to the subjects; and
(ii) any disclosure of the human subjects' responses
outside the research could reasonably place the
subjects at risk of criminal or civil liability or be
damaging to the subjects' financial standing,
employability, or reputation. --- 45 CFR 46.101(b)(2)
- Research involving the collection or study of existing
data, documents, records, pathological specimens, or
diagnostic specimens, if these sources are publicly
available or if the information
is recorded by the investigator in a manner that subjects
cannot be identified, directly or through identifiers
linked to the subjects. ---
45 CFR 46.101(b)(4)
Waiver or Alteration of
Informed Consent Requirements
Under HHS regulations at 45
CFR 46.116(d), an Institutional Review Board (IRB)
may a approve a waiver or alteration of informed consent
requirements where it finds and documents that:
- (1) the research involves no more than minimal
risk to subjects;
(2) the waiver or alteration will not adversely
affect the rights and welfare of subjects;
(3) the research could not practicably be carried
out without the waiver or alteration; and
(4) where appropriate, the subjects will be provided with
additional pertinent information after participation.
The IRB may also approve a wavier of the requirement for
written documentation of informed consent under limited
circumstances described at 45 CFR
46.117(c).
Research Involving
Children
Subpart D of the HHS regulations requires additional
protections for research involving children:
- Children are persons who have not attained the
legal age for consent in the jurisdiction in which
the research will be conducted. --- 45 CFR 46.402(d)
- The IRB must find that the activity represents one of
four permissible categories of research, and that
adequate provisions are made for soliciting the assent
of the children and the permission of each child's
parents or guardian. --- 45
CFR 46.404-408
- Children who are wards of the State or any other
agency, institution, or entity can be included in
research only under certain conditions. --- 45 CFR 46.409
Research Involving
Prisoners
Subpart C of the HHS regulations requires additional
protections for research involving prisoners as subjects:
- Prisoner means any individual involuntarily
confined or detained in a penal institution,
including individuals detained in other facilities which
provide alternatives to criminal prosecution or
incarceration, and individuals detained pending
arraignment, trial, or sentencing.--- 45 CFR 46.303(c)
- At least one member of the Institutional Review
Board (IRB) must be a prisoner or a prisoner
representative with appropriate background and
experience. --- 45
CFR 46.304(b)
- The IRB must find and certify to OPRR that six
additional protections specific to prisoners have
been satisfied. --- 45
CFR 46.305
- The IRB must find, and OPRR must determine, that the
research represents one of four permissible categories of
research. Certain research may go forward only after
OPRR has consulted with appropriate experts in penology,
medicine, and ethics. --- 45 CFR 46.306
Certificates of
Confidentiality
Section 301(d) of the Public Health Service (PHS) Act gives the
HHS Secretary authority to issue Certificates of
Confidentiality which protect the privacy of subjects in health
research projects against compulsory legal process. Contact
Ms. Olga Boikess, NIMH, 17-C-02 Parklawn Building, 5600 Fishers
Lane, Rockville MD 20857 (301-443-3877).