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).