Institutional Review Board Mission and Responsibilities
Institutional Review Board Mission
The mission of the Wentworth Institute of Technology Institutional Review Board (IRB) is to oversee and review all projects that involve human subjects meeting the federal definition of “research” conducted at and sponsored by Wentworth Institute of Technology (“covered projects”) and to review all other projects it deems are appropriate for its review.
Institutional Review Board Responsibilities
- a) Developing and disseminating a Policy Regarding Human Subject and Code of Ethics for the protection of human subjects in all projects;
- b) Developing and implementing review procedures for ensuring the protection of human subjects in all covered projects, in collaboration with other members of the Wentworth community;
- c) Promoting professional development within the Wentworth community about the ethical and legal obligations associated with human subjects projects;
- d) Conducting reviews of all covered project proposals to ensure that such research will be carried out in a manner which safeguards the rights and well-being of the subjects.
Institutional Review Board Membership
Members of the IRB will be selected to comply with federal requirements, but generally shall consist of:
- a) A member of the Faculty of a science discipline
- b) A member of the Faculty of a non-science discipline
- c) A member of the higher education community with disciplinary expertise in vulnerable populations
- d) A non-faculty member appointed by the Provost
- e) An individual with relevant expertise or experience who is not an employee of Wentworth Institute of Technology and any additional personnel needed to comply with protection of vulnerable groups.
The Provost shall serve as chair or appoint a designee to serve as chair. The initial term of appointment for members of the IRB shall be one, two and three years. Appointments are renewable. The term after initial appointment shall be for three years. For full IRB review all members will be present and vote on a proposal. For “Expedited Review” applications, the Chair shall determine whether or not the proposal meets the criteria and then two members of the IRB (other than the Chair) will meet to review and vote on the proposal. In the case of a tie, the Chair would cast the deciding vote.
Institutional Review Board Proposal Procedures
- The IRB will meet once a month, as needed, in each of the three semesters (Spring, Summer and Fall).
- In a basic review, the following questions should be answered:
- Are adequate procedures in place to ensure privacy and confidentiality?
- Has informed consent been sought and documented?
- Has the IRB approved the consent form?
- Have the risks to subjects been minimized?
- Are the risks reasonable as compared to anticipated benefits?
- Is the selection of subjects equitable?
- Are safeguards in place to protect vulnerable populations?
- Applications for IRB review and all attachments should be emailed to the IRB Chair. IRB decisions will be promptly communicated to the researcher, in writing, within 15 working days.
- Copies of all applications and approvals as well as annual reviews will be maintained in the Provost’s Office.
Policy Regarding Research on Human Subjects
Wentworth Institute of Technology will oversee and review research projects involving human subjects to safeguard the rights and welfare of human subjects in research activities. The Institute is guided by ethical principles as outlined in the Belmont Report of September 30, 1978. The Institute will apply for federal-wide assurance (FWA) if applicable with the United States Department of Health and Human Services Office for Human Research Protection (OHRP).
Principles Applicable To All Projects Involving Human Subjects
Wentworth Institute of Technology is committed to academic research and the freedom to pursue it. However, in undertaking research, appropriate care must be taken to protect the privacy of the individuals involved and the research methodology must minimize risks and avoid harming individuals. These principles apply to both covered project under the review of the IRB and those not under review by the IRB.
The researcher should not withhold any information the subject requests concerning any aspect of the research likely to be significant to the subject or induce subjects to participate by means that might affect the subject’s ability to decide freely as described in 45 CFR 46.401.
The researcher must maintain confidentiality unless otherwise indicated to subjects and should inform subjects about the researcher’s limits or capacity to adhere to confidentiality.
The researcher should explain the purpose of the research to subjects in terms understandable to the subject given their age, educational attainment and other relevant factors. Care must be taken to ensure that subjects fully understand the risks associated. Subjects must be in a position to freely refuse their participation.
Faculty members are responsible for supervising student research in their courses and departments and the student researcher’s compliance with the Code of Ethics for Projects with Human Subjects, Policy Regarding Research on Human Subjects, and all policies concerning confidentiality, consent, record maintenance.
All research documents and data will be maintained for three years.
All researchers will comply with the Code of Ethics for Projects with Human Subjects
All researchers and supervisors of student research will be trained through the Office for Human Research Protections.
Wentworth Institute of Technology
Code of Ethics for Projects with Human Subjects
The Wentworth Institute of Technology Code of Ethics for Projects with Human Subjects (hereafter “the Code”) is based upon, and consistent with, the federal Common Rule for the Protection of Human Subjects at 45 CFR 46. The requirements of the Code, as well as the requirements of the Common Rule
upon which it is based, show what investigators must oversee and review all projects involving research with human subjects conducted at and sponsored by Wentworth Institute of Technology. Wentworth has elected to apply the principles of the Code to all projects with human subjects whether or not under review by the IRB as covered projects.
The importance of demonstrating respect for research participants – both investigators and their human subjects – is reflected in the following Code of Ethics. It is founded on the basic principles generally used to define ethical research and the regulations, policies, and guidance that describe the implementation of those principles, and should be used to assist in resolving the ethical problems that surround the conduct of research with human subjects. Based on those articulated by the NIH and The Belmont Report (1973), these principles are:
- Respect for Persons. Incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.
- Beneficence. Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being.
- Justice. Consideration of who ought to receive the benefits of research and bear its burdens.
Requirement 1: Appropriate Risk/Benefit Ratio
Anticipated risks to the subjects must be minimized and reasonable in relation to anticipated project benefits. 45 CFR 46.111 (a) (1), (2) and (6).
1. Project costs (time, energy, inconvenience)
2. Different kinds of project risks (psychological, social and economic, physical)
3. Different levels of project risk
4. Special risks for vulnerable populations
5. Project benefits
6. Quality of project design
Steps investigators must take:
1. Anticipate risks and benefits accurately
2. Determine whether risks can be further reduced
3. Determine whether costs and risks are justified
4. Make provisions for any special risks posed to vulnerable participants
Requirement 2: Appropriate Procedures for Subject Selection
Subject selection must result in a fair distribution of the risks, costs, and benefits of the project. 45 CFR 46.111(a)(3) and (b).
Steps investigators must take:
1. Select subjects so as to match the burdens of participation with project benefits as closely as possible.
2. Avoid unwarranted exclusion of subjects.
3. Avoid overprotection of subjects.
Requirement 3: Appropriate Protection of Privacy and Confidentiality
Investigators must protect the privacy of the subject and the confidentiality of the subject’s data before, during, and after the conduct of the project [45 CFR 46.111(a)(7)].
1. Respecting subjects’ privacy
2. Ensuring the confidentiality of the subjects’ information
Steps investigators must take:
To respect privacy:
1. Secure appropriate authorization for access to institutional records.
2. Abide by all WIT policies for the protection of human subjects.
To maintain confidentiality:
1. Whenever possible, ask subjects to provide information anonymously.
2. If anonymity is not possible, “anonymize” data as it is gathered.
3. Do not disclose the identities of the subjects who participated in the project without their consent.
4. Do not include personally-identifiable information about individual subjects in project reports without their consent.
5. Keep the subjects’ data physically secure.
Requirement 4: Appropriate Provisions for Obtaining Informed Consent
In most cases, investigators must secure the legally effective informed consent of the subject before involving the subject in the project. 45 CFR 64.111 (a) (4) and (5); 45 CFR 46.116; 45 CFR 46.117
1. Sufficiency of information provided to the subjects
2. Understandability of information provided to the subjects
3. Voluntary nature of any decision to participate
4. Appropriate documentation
5. Preservation of the subjects’ legal rights and recourse
6. Circumstances warranting alteration in informed consent procedures
Steps investigators must take:
1. Determine whether project information should be provided in writing.
2. Provide basic information about the project in an accurate and understandable way (see checklist for preparing basic project information).
3. Provide a written consent form, if appropriate.