Policy Regarding Research on Human Subjects

Explore

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).

Concerns:

  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).

Concerns:

  1. Exploitation
  2. Exclusion
  3. Overprotection

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)].

Concerns:

  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

Concerns:

  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.