Policies & Procedures on Research Involving Human Subjects

Human Subjects [+]


Statement of Ethical Responsibility for Research Involving Human Subjects

New School faculty and staff engaged in research or supervising student research projects must be aware of their responsibilities for ethical conduct in any project involving the use of human subjects. Faculty and staff are responsible for research done by students under their supervision with respect to these matters. Each research design must be examined for possible risk to subjects. If even minor risk of physical, psychological, sociological or other harm may be involved, the faculty or staff member must consult with the University Institutional Review Board (IRB) to determine that:

  1. The risks to the subject are so outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept these risks;
  2. The rights and welfare of any such subjects will be adequately protected;
  3. Legally effective informed consent will be obtained by adequate and appropriate methods in accordance with the provisions of this part; and
  4. The conduct of the activity will be reviewed at timely intervals and no less than once per year.

In addition to questions of risk and informed consent, the subjects rights of privacy must be protected.

If a faculty or staff member has any doubts regarding the ethics of a project or steps taken to protect human subjects, he/she should refer them to the IRB. In any case, the IRB should be informed of all research projects involving human subjects.

The New School University Institutional Review Board (IRB) is the official oversight committee for the protection of human subjects in research. It functions under a Multiple Project Assurance (MPA-1445) granted by the Office for Protection from Research Risks (OPRR) of the Department of Health and Human Services (DHHS).

The IRB reviews each applicable research proposal and related materials, including informed consent documents. The IRB has the responsibility and authority to approve, require modification of, or disapprove any research activity involving human subjects. Research protocols will be reviewed not less than every 12 months and perhaps more frequently if required by the IRB on the basis of degree of risk to subjects, amendments made to the protocol, or adverse events reported.

IRB review and approval are independent of the initial endorsement by the institutional official of the extramural research proposal.

Dr. Marcel Kinsbourne is the IRB Chair. Students should contact IRB@newschool.edu with their applications.

Consent Procedures [+]


General Requirements For Informed Consent*
(45 CFR ß46.116)

Except as provided elsewhere in 45 CFR 46, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subjects' 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 subjects' legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

(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;

(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; and

(8) a statement that participation is voluntary, refusal to participate will involve no penalty of loss of benefits to which the subject is otherwise entitled, and 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 subjects' 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 subjects' 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 subjects' willingness to continue participation will be provided to the subject; and

(6) the approximate number of subjects involved in the study. Documentation of Informed Consent (45 CFR ß46.117)

(a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subjects' legally authorized representative. A copy shall be given to the person signing the form.

(b) Except as provided in paragraph (c) of this section, the consent form may be either of the following:

(1) A written document that embodies the elements of informed consent required by ß46.116. This form may be read to the subject or the subjects' 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; or

(2) A short form written consent document stating that the elements of informed consent required by ß46.116 have been presented orally to the subject or the subjects' 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 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.

Modification of Informed Consent Procedures [+]


Modifications of any of the informed consent procedures must be approved by the IRB in the minutes signed by the Chair. Granting of permission to use modified procedures imposes additional responsibility upon the IRB and the University to establish that the risk to any subject is minimal, that use of either of the informed consent procedures would invalidate objectives of considerable immediate importance, and that any reasonable alternative means for attaining these objectives would be less advantageous to the subject.

Guidelines for Preparing an Informed Consent Form [+]


An informed consent form requires a fair and proper explanation of all of the basic elements of informed consent listed in (a)(1)-(a)(8) above. When appropriate, elements from (b)(1)-(b)(6) should also be included. The order of explanations or the use of words should be adapted to the nature of each study and subject.

In addition, the agreement of consent, written or oral, should include no exculpatory language through which the subject is made to waive or appear to waive his/her legal rights or release the institution or appear to release the institution or its agents from liability for negligence.

The name and telephone number of the project director should be clearly indicated on the consent form as should the name and telephone number of Dr. Marcel Kinsbourne, Chair, Human Subjects Committee, 212-229-5727 Ext. 3103, for questions about research subjects' rights and for research-related injuries and complaints.

A statement that the subject has been given a copy of the consent form to keep should also be included. The form should include an authorization section, for example:

I, the undersigned, have understood the above explanation and give consent to my voluntary participation in

(Dr./Mr./Ms.)_______________________________ research project.

Date________________ Location_____________

________________________________________Signature of subject

________________________________________Signature of legal representative (if applicable)

________________________________________Signature of person obtaining consent

________________________________________Signature of witness (if applicable) * Source: Protection of Human Subjects,

Title 45, Code of Federal Regualtions, Part 46. Revised June

IRB Submission [+]


Instructions and Application for Submitting Research Proposals to the Institutional Review Board

The IRB is chaired by Dr. Marcel Kinsbourne, Professor, Psychology at The New School for Social Research. Please contact him with any questions and to submit the IRB Application.

Dr. Marcel Kinsbourne
Professor, Psychology Chair,
New School Institutional Review Board
The New School for Social Research
80 Fifth Avenue, Room 731
New York, NY 10011
212-229-5727 Ext. 3103
kinsboum@newschool.edu

Informed Consent Checklist to HRP [+]


Informed Consent Checklist - Basic and Additional Elements

A Statement that the study involves research

An explanation of the purposes of the research The expected duration of the subject's participation

A description of the procedures to be followed Identification of any procedures which are experimental

A description of any reasonably foreseeable risks or discomforts to the Subject.

A description of any benefits to the subject or to others which may reasonably be expected from the research

A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject

A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained 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

( ) Research Questions

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.

( ) Rights Questions

( ) Injury Questions

A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled

Additional elements, as appropriate

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 Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent

Any additional costs to the subject that may result from participation in the research

The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject

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 The approximate number of subjects involved in the study

§46.117

Documentation of Informed Consent Checklist a. Except as provided in paragraph "c" of this section, informed consent shall be documented by the use of a written consent form approved by the IRB, and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.

WRITTEN

The consent form may be either of the following:

1. A written consent document that embodies the elements of informed consent required by §46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator should give either the subject or the representative adequate opportunity to read it before it is signed.

DONE ORALLY

2. A short form written consent document, stating that the elements of informed consent required by §46.116 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 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.

WAIVER of req't for signed formc.

An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects, if it finds either:

1. That the only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or

2. That the research presents no more than minimal risk of harm to subjects, and involves no procedures, for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

IRB Latitude to Approve a Consent Procedure that Alters or Waives some or all of the Elements of Consent

§ 46.116 - An IRB may approve a consent procedure, which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent, provided the IRB finds and documents that:

C: 1.The research or demonstration project is to be conducted by, or subject to the approval of, state or local government officials, and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and

C: 2.The research could not practicably be carried out without the waiver or alteration.

D: 1. The research involves no more than minimal risk to the subjects;

D: 2.The waiver or alteration will not adversely affect the rights and welfare of the subjects;

D: 3.The research could not practicably be carried out without the waiver or alteration; and

D: 4.Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Special Requirements - 45 CFR 46 Subpart D - Additional DHHS Protections for Children Involved as Subjects in Research

Assent/Waiver

The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted, or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children, and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances, in which consent may be waived in accord with §46.116 of Subpart A.

Parents

The IRB may find that the permission of one parent is sufficient for research to be conducted under §46.404 or §46.405. Where research is covered by §46.406 and §46.407, and permission is to be obtained from parents, both parents must give their permission, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.

If the IRB determines that a research protocol is designed for conditions or for a subject population, for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, state or local law.

OHRP Tips on Informed Consent OHRP [+]


The process of obtaining informed consent must comply with the requirements of 45 CFR 46.116. The documentation of informed consent must comply with 45 CFR 46.117. The following comments may help in the development of an approach and proposed language by investigators for obtaining consent and its approval by IRBs:

Informed consent is a process, not just a form. Information must be presented to enable persons to voluntarily decide whether or not to participate as a research subject. It is a fundamental mechanism to ensure respect for persons through provision of thoughtful consent for a voluntary act. The procedures used in obtaining informed consent should be designed to educate the subject population in terms that they can understand. Therefore, informed consent language and its documentation (especially explanation of the study's purpose, duration, experimental procedures, alternatives, risks, and benefits) must be written in "lay language", (i.e. understandable to the people being asked to participate). The written presentation of information is used to document the basis for consent and for the subjects' future reference. The consent document should be revised when deficiencies are noted or when additional information will improve the consent process.

Use of the first person (e.g., "I understand that ...") can be interpreted as suggestive, may be relied upon as a substitute for sufficient factual information, and can constitute coercive influence over a subject. Use of scientific jargon and legalese is not appropriate. Think of the document primarily as a teaching tool not as a legal instrument. Describe the overall experience that will be encountered. Explain the research activity, how it is experimental (e.g., a new drug, extra tests, separate research records, or nonstandard means of management, such as flipping a coin for random assignment or other design issues). Inform the human subjects of the reasonably foreseeable harms, discomforts, inconvenience and risks that are associated with the research activity. If additional risks are identified during the course of the research, the consent process and documentation will require revisions to inform subjects as they are re-contacted or newly contacted.

Describe the benefits that subjects may reasonably expect to encounter. There may be none other than a sense of helping the public at large. If payment is given to defray the incurred expense for participation, it must not be coercive in amount or method of distribution.

Describe any alternatives to participating in the research project. For example, in drug studies the medication(s) may be available through their family doctor or clinic without the need to volunteer for the research activity.

The regulations insist that the subjects be told the extent to which their personally identifiable private information will be held in confidence. For example, some studies require disclosure of information to other parties. Some studies inherently are in need of a Certificate of Confidentiality which protects the investigator from involuntary release (e.g.,subpoena) of the names or other identifying characteristics of research subjects. The IRB will determine the level of adequate requirements for confidentiality in light of its mandate to ensure minimization of risk and determination that the residual risks warrant involvement of subjects.

If research-related injury (i.e. physical, psychological, social, financial, or otherwise) is possible in research that is more than minimal risk (see 45 CFR 46.102[g]), an explanation must be given of whatever voluntary compensation and treatment will be provided. Note that the regulations do not limit injury to "physical injury". This is a common misinterpretation.

The regulations prohibit waiving or appearing to waive any legal rights of subjects. Therefore, for example, consent language must be carefully selected that deals with what the institution is voluntarily willing to do under circumstances, such as providing for compensation beyond the provision of immediate or therapeutic intervention in response to a research-related injury. In short, subjects should not be given the impression that they have agreed to and are without recourse to seek satisfaction beyond the institution's voluntarily chosen limits.

The regulations provide for the identification of contact persons who would be knowledgeable to answer questions of subjects about the research, rights as a research subject, and research-related injuries. These three areas must be explicitly stated and addressed in the consent process and documentation.

Furthermore, a single person is not likely to be appropriate to answer questions in all areas. This is because of potential conflicts of interest or the appearance of such. Questions about the research are frequently best answered by the investigator(s). However, questions about the rights of research subjects or research-related injuries (where applicable) may best be referred to those not on the research team. These questions could be addressed to the IRB, an ombudsman, an ethics committee, or other informed administrative body. Therefore, each consent document can be expected to have at least two names with local telephone numbers for contacts to answer questions in these specified areas.

The statement regarding voluntary participation and the right to withdraw at any time can be taken almost verbatim from the regulations (45 CFR 46.116[a][8]). It is important not to overlook the need to point out that no penalty or loss of benefits will occur as a result of both not participating or withdrawing at any time. It is equally important to alert potential subjects to any foreseeable consequences to them should they unilaterally withdraw while dependent on some intervention to maintain normal function.

Don't forget to ensure provision for appropriate additional requirements which concern consent. Some of these requirements can be found in sections 46.116(b), 46.205(a)(2), 46.207(b), 46.208(b), 46.209(d), 46.305(a)(5-6), 46.408(c), and 46.409(b). The IRB may impose additional requirements that are not specifically listed in the regulations to ensure that adequate information is presented in accordance with institutional policy and local law. Revised 3/16/93

 
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