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:
HRRC review of proposed research should involve an assessment of the scientific validity and merit (SVM) of the protocol. This requirement is inherent in §46.111(a)(1) and (2): "(1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk..." and
"Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result."
If the protocol review application includes an attestation statement of the SVM design and content from a formal review process conducted by persons other than the investigator and participating personnel, the HRRC may accept that as evidence of adequate SVM for purposes of protecting subjects from unnecessary risk of harm.
Flipping a coin or rolling dice is not a truly random method of assignment and may assign many more individuals in one of the groups than the other. To avoid such an imbalance and ensure that the proportions of those with different characteristics are similar in the control and experimental groups may require stratifying on the variable. For additional assistance on this and related design questions, see the statistics resource page or contact the GVSU Statistical Consulting Center at 331-3355.
The HRRC is responsible for protecting research subjects from coercion and undue influence to participate in research studies. Financial incentives rarely rise to the level of coercion, but differing amounts may constitute undue influence, especially to various vulnerable subject groups such as children, low income or homeless persons, etc. In addition, the IRS requires reporting of all income totaling $600/person or more in a calendar year. For these reasons, the HRRC asks investigators to specify the dollar value amount of any financial or other incentives offered to potential subjects. Whenever feasible, non-cash incentives are preferred, but this is not a requirement.
New Business and Finance guidelines: for cash or gift card payments to subjects in excess of $50 please complete a Human Subject Voucher and submit along with participant's W-9 (if participant is a minor, have parents complete form on their behalf) when filing for reimbursement. See Business & Finance policy and procedures for further details. GVSU policy on payments to research subjects
For research surveys conducted of all or part of the GVSU community, including selected groups of students, faculty or staff, contact information can be provided by the Office of Institutional Analysis. Written authorization to contact the target population must be secured from Mr. Philip Batty, Director of OIA, (331-8648; email@example.com) and submitted with the research protocol application as a separate document.
This authorization should include all of the following information. If you have any questions relating to human subjects in research that has not been answered here, please send a message to the HRRC firstname.lastname@example.org or call 616-331-3197 Mon-Thursday.
1. Title of the research study
2. Names of all principal investigators
3. Department official authorizing the research (e.g., unit head, research chair, etc)
4. description of survey target population
5. method and frequency of inviting participation in the research (specify if OIA or investigator controlled)
6. survey method (i.e. phone, paper, e-mail, website, Blackboard, etc.)
For electronic based surveys, the following disclaimer should be provided:
You are asked to voluntarily provide specific information to this web site. You may skip any question, or stop participating at any time. The information collected will be used for the stated purposes of this research project only and will not be provided to any other party for any other reason at any time except and only if required by law. You should be aware that although the information you provide is anonymous, it is transmitted in a non-secure manner. There is a remote chance that skilled, knowledgeable persons unaffiliated with this research project could track the information you provide to the IP address of the computer from which you send it. However, your personal identity cannot be determined.