General Requirements of Informed Consent

Documentation of Informed Consent

Procedure for Committee Review

2008-2009 Committee Members

Forms

Bradley's Office of Sponsored Programs

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Committee on the Use of Human Subjects in Research (CUHSR)

Human Subjects Policies

2009-2010 Meeting Dates

August 28, 2009 - Bradley Hall Room 247
September 25, 2009 - Bradley Hall Room 247
October 23, 2009 - Bradley Hall Room 247
November 20, 2009 - Bradley Hall Room 247
December 11, 2009 - Bradley Hall Room 247
January 29, 2010- Bradley Hall Room 247
February 26, 2010 - Bradley Hall Room 247
March 26, 2010 - Bradley Hall Room 247
April 23, 2010 - Bradley Hall Room 247
May 7, 2010 - Bradley Hall Room 247

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Use BU username and password.

Introduction and Background (top of page)

When human beings are used as subjects in research projects, safeguards must be established to protect their health, well-being, and rights. Under the policies established by the Department of Health and Human Services (HHS), this protection was extended to all human subjects regardless of the nature of research being performed. This protection required that Institutional Review Boards (IRB) at colleges and universities be established to review and act on all research proposals involving human subjects. The review board at Bradley is the University Committee on the Use of Human Subjects in Research (CUHSR). On January 26, 1981 , HHS revised guidelines and exempted certain forms of research involving human subjects from review by Institutional Review Boards. All research must be reviewed by CUHSR to determine whether it is exempt, expeditable, or requires full review.

Research Exempt from Full Review by CUHSR (top of page)

The following are the six categories of exempt research specified by DHHS.

Category 1 Exemption: Normal Educational Practices and Settings

Research conducted in established or commonly accepted educational settings, involving normal educational practices such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Category 2 Exemption: Anonymous Educational tests, Surveys, Interviews, or Observations

Research involving the use of educational tests (cognitive, diagnostic, aptitude achievement), survey procedures, interview procedures, or observations of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through 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.

Category 3 Exemption: Identifiable Subjects in Special Circumstances

Research involving the use of educational tests (cognitive, diagnostic, aptitude achievement), survey procedures, interview procedures, or observations of public behavior that is not exempt under paragraph (b) (2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statues(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Category 4 Exemption: Collection or Study of Existing Data

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 such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

Category 5 Exemption: Public Benefit or Service Programs

Research and demonstration projects that are conducted by or subjects to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or service under those programs; (iii) possible changes in or alternatives to those programs or procedures; (iv) possible changes in methods or levels of payment for benefits or services under those programs.

Category 6 Exemption: Taste and Food Evaluation and Acceptance Studies

Taste and food quality evaluation and consumer acceptance studies; (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Survey research and interview procedures involving children are not exempt.

Expeditable Research (top of page)

Adjunct List of Categories Qualifying for Expedited Review

Category 1

Clinical studies of drugs and medical devices only when condition (a) or (b) is met, (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

Category 2

Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or (b) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

Category 3

Prospective collection of biological specimens for research purposes by noninvasive means, Examples: (a) Hair and nail clippings in a non-disfiguring manner; (b) Deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) Permanent teeth if routine patient care indicates a need for extraction; (d) Excreta and external secretions (including sweat); and (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) Placenta removal at delivery; (g) Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) Supra-and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings, (j) Sputum collected after saline mist nebulization.

Category 4

Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medial device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples: a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subjects or an invasion of the subject’s privacy. (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinoraphy, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight and health of the individual.

Category 5

Research involving materials (data, documents, records, or specimens) that have been collected for any reason or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis)

Category 6

Collection of data from voice, video, digital, or image recordings made for research purposes.

Category 7

Research on group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs, or practices, and social behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

Category 8

Continuing review of research previously approved by a convened IRB as follows: (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for the long term follow-up of subjects; or (b) where no subjects have been enrolled and no additional risks have been identified or (c) where the remaining research activities are limited to data analysis.

Category 9

Continuing review of research not conducted under an investigational new drug application or investigational drug exemption where categories 2 through 8 do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

Research Requiring Review by CUHSR (top of page)

CUHSR reviews and has the authority to approve, require modification (to receive approval) or disapprove all research activities covered by HHS guidelines. In order to approve a research project, CUHSR shall determine that all of the following requirements are satisfied:

Risks to the subjects are minimized.
Risks to the subjects are reasonable in relation to anticipated benefits, if any, to the subjects, and the importance of the knowledge that may be reasonably expected to result.
Selection of subjects is equitable.
Informed consent will be sought from each prospective subject or the subject's legally authorized representative.
Informed consent will be appropriately documented.
Where appropriate, there are adequate provisions to protect privacy of subjects and to maintain the confidentiality of data.
Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as persons with acute or severe physical or mental illness, persons who are economically or educationally disadvantaged, children, prisoners, and the elderly appropriate additional safeguards have been included in the study to protect the rights and welfare of these subjects.

CUHSR shall have the authority to suspend or terminate approval of research that is not being conducted in accordance with its requirements or that has been associated with unexpected serious harm to subjects.

CUHSR regulations require that research involving any level of deception be followed by an appropriate debriefing of all subjects. Debriefing procedures should be specified in the CUHSR application form.

General Requirements of Informed Consent (top of page)

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 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.

Basic elements of informed consent shall include the following:

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 which are experimental;
A description of any reasonably foreseeable risks or discomforts to the subject;
Description of any benefits to the subjects 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 advantageous to the subject
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
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 research-related injury to the subject
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.

Where appropriate, the following elements of informed consent must also be included:

A statement that the particular treatment or procedure may involve risks to the subject 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 research which may relate to the subject's willingness to continue participation will be provided to the subject; and
The approximate number of subjects involved in the study.

CUHSR has the authority to approve a consent procedure which does not include or which alters some or all of the previously mentioned elements of informed consent or waive the requirements for informed consent if, either:

1.(a) The research involves no more than minimal risk;

(b) The waiver or alteration does not adversely affect the rights and welfare of the subjects;

(c) The research could not practically be carried out without waiver or alteration; and

(d) Wherever appropriate, the subjects will be provided with additional pertinent information.

OR

2.(a) The research is to be conducted for the purpose of demonstrating or evaluating:

1. federal, state, or local benefit or service programs which are not themselves research programs;
2. procedures for obtaining benefits or services under these programs; or
3. possible changes in or alternatives to these programs or procedures; and

(b) The research could not practicably be carried out without the waiver or alteration.

Documentation of Informed Consent (top of page)

Informed consent shall be documented by the use of a written consent form approved by CUHSR and signed by the subject or the subject’s legally authorized representative. A copy shall be given to the person signing the form. See forms for a model consent form.

Procedure for Committee Review (top of page)

It is the responsibility of the investigator (faculty member, administrator, or student) using human subjects in a covered research project to submit the appropriate application materials for Committee review according to the following guidelines:

Complete the application form and an appropriate informed consent form.
Submit all completed forms to OSP - Bradley Hall, Room 215. During the current academic year, the Committee will meet monthly. Application materials must be submitted by 11:00 a.m. on the Wednesday one week prior to the meeting. Submit 1 copy of all application material to OSP Bradley Hall Room 215.
Written responses concerning Committee action and/or approval forms will be sent to the applicant within one week following final action by the Committee.
The Committee reserves the right to consult with the subject matter, medical, or legal experts concerning any projects submitted for review. If expert review of a proposal is deemed necessary by the Committee, a substantial delay in Committee action should be anticipated.
In the event that a project is denied approval by the Committee, the applicant will be notified in writing of the reasons for disapproval and will be given the opportunity to respond in person or in writing.
All research projects that have been approved by the Committee may be subject to further review or disapproval by appropriate officials of the University. Projects that have been disapproved by the Committee may not be subsequently approved by any other University's Officer.
Major changes in the research design and/or procedures following Committee approval must be resubmitted to the Committee as an amended proposal. In addition, progress reports must be submitted at least annually and more often if so specified by the Committee.
Approval of a project does not remove the researcher's legal responsibility for the project. The researcher is expected to retain signed individual informed consent forms for a period of five years. The Committee's approval of a project constitutes only a statement by the Bradley Committee that it believes the rights of human beings will be adequately protected.
Questions concerning application procedures and guidelines should be referred to the Chairperson of CUHSR.
For full copy of the policies and procedures see the faculty handbook.