The Washington Research Institute Human Subjects Review Board is responsible for reviewing and approving the plans and protocols for all research and related activities conducted by Institute staff.
The purpose of Board review is to determine:
- that the rights and welfare of subjects are adequately protected;
- that risks to individuals are minimized and not unreasonable, and are outweighed by the potential benefits to them, and by the knowledge to be gained, and
- that the proposed project design and methods are adequate and appropriate in light of the stated project purposes.
The Review Process
To fulfill this policy, WRI has established the WRI Human Subjects Review Board. The composition of the Board is:
5 members to be drawn from a pool of Senior Researchers and unaffiliated outside members.
Each review meeting will include one unaffiliated person. The WRI Executive Director will also attend, as a nonvoting member, to provide technical assistance, as needed.
All research will be discussed and reviewed by at least a 5-member Board.
All Board decisions will be by majority vote. The quorum of the Board shall be a minimum of 5 voting members, at least one of whom is an outside, unaffiliated member.
The process for a Board review is as follows:
- Principal investigator completes the Human Subjects Application.
The application should include a concise but full description of the research purpose and procedures. If appropriate, pages of the grant application containing this information may be appended. Copies of data collection measures already developed and available should be included. Consent/assent letters must be included.
- All Board members review application materials.
After all members have reviewed the application, the Board will meet. If necessary, telephone conference review can be arranged. All reviews, in-person and via telephone, are subject to quorum requirements.
- Application for Human Subjects Review should be made as early as possible after the research design is final, and at least 2 months prior to the beginning of project activities. Applications will most typically be submitted after a research grant application has been submitted to the funding agency.
Research Approval and Disapproval
Research subject to review and approval by the WRI Human Subjects Review Board must satisfy the following requirements:
- Risks to subjects must be minimized, using procedures consistent with sound research design which do not unnecessarily expose subjects to risk.
- Risks to subjects must be reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be reasonably expected to result. The Review Board shall not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within its responsibility.
- Selection of subjects must be equitable.
- Informed consent must be sought from each prospective subject, or the subject’s legally authorized representative.
- Informed consent must be documented.
- Where appropriate, the research plan shall provide for monitoring the data collection to ensure safety of subjects.
- Where appropriate, there shall be adequate provisions to protect the privacy of subjects and maintain confidentiality of data.
- Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards shall be provided to protect the rights and welfare of these subjects.
The Board Chair will notify investigators of the Board’s decision to approve or disapprove the proposed research activity, or of modifications required for Board approval.
If the Board disapproves a research activity, the Board will include in its written notification a statement of the reasons for the Board’s decision.
Informed Consent Procedures
When informed consent is obtained, the following information shall be provided to each subject or representative:
- Statement that the study involves research, an explanation of the purposes of the research, duration of subject’s participation, description of procedures
- Description of reasonably foreseeable risks to the subject
- Description of benefits to the subject
- Disclosure of alternative procedures
- Statement describing extent to which confidentiality or records identifying the subject will be maintained
- Explanation of whom to contact for answers to questions about research and subjects’ rights
- Statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled.
If a researcher requests a waiver of the written consent provision, written documentation as to the reasons for not seeking informed consent must be provided to the Board.
The WRI Human Subjects Review Board may approve consent procedures which do not include, or which alter, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent, provided the Review Board finds and documents that:
- The research involves no more than minimal risk to the subjects
- The waiver or alteration will not adversely affect the rights and welfare of the subjects
- The research could not practicably be carried out without the waiver or alteration
- Whenever appropriate, the subjects will be provided with additional information after participation.
When required, a consent form may be either:
- A written consent that embodies the elements (#1-7) of the informed consent listed above. This form may be read to the subject or the subject’s 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
- A “short-form” written consent document stating that the elements of informed consent listed above have been presented orally to the subject or to the subject’s legally authorized representative. When this method is used, there shall be a witness to the oral presentation. The Review Board shall require a written summary of what is to be said to the subject or the representative. Only the short form itself needs to be signed by the subject or representative. However, both the investigator and the witness shall sign both the short form and the summary. Copies of the form and the summary shall be given to the subject or the representative.
The WRI Human Subjects Review Board may waive the requirements of written and signed informed consent if it finds either:
- 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 would be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or
- 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 the research context.
In cases where the documentation requirement is waived, the Review Board may require the investigator to provide the subjects with a written statement describing the research.
- External Board members will be paid a $100 honorarium for each meeting attended.
- Training requirements for Board members are in the process of being adopted.